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| ABSTRACTS |
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| Year : 2015 | Volume
: 47
| Issue : 7 | Page : 57-177 |
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Poster Session Abstracts
| Date of Web Publication | 11-Dec-2015 |
Correspondence Address:
 Source of Support: None, Conflict of Interest: None  | Check |
How to cite this article:
. Poster Session Abstracts. Indian J Pharmacol 2015;47, Suppl S1:57-177 |
AIN-1
Study of Anti-inflammatory and Ulcerogenic Potential of some Structurally Similar 1, 3, 4-oxadiazole Analogues
Bichave A, Aggarwal A, Shinde PK, Pimple S
Department of Pharmacology, V.E.S. College of Pharmacy, Chamber, Mumbai, Maharashtra, India
Objectives: The Objectives of the study was to evaluate the anti-inflammatory activity and ulcerogenic potential of 1, 3, 4-oxadiazole derivatives. Materials and Methods: In-vitro anti-inflammatory activity was evaluated by the given Methods: Inhibition of protein denaturation was studied using 5% w/v bovine serum albumin and recording absorbance using spectrophotometer. Membrane stabilization activity was on human RBCs by recording absorbance using spectrophotometer. Proteinase inhibitory activity was studied by trypsin-casein and recording absorbance using spectrophotometer. In-vivo anti-inflammatory activity was evaluated by the following Methods: Female Wistar rats were administered 0.1 mL of 1% carrageenan in the sub-plantar portion of hind paw to induce edema and then the present inhibition of edema calculated to study effect of drugs on acute inflammation. Effect on chronic inflammation was evaluated by implanting 10 mg sterile cotton pellets subcutaneously into the groin region of female Wistar rats and determining % decrease in weight of the cotton. The ulcerogenic index was calculated by removing the stomachs of rats dosed for 7 days and examining the mucosa for lesions. Results: Drugs under study (A, B and C) exhibited dose dependent anti-inflammatory activity and no ulcerogenic potential; however test compound A exhibited highest activity among the analysed analogues and was comparable to standard drug i.e. diclofenac. Conclusion: The test compounds have the potential to be used as safer alternatives to the currently used NSAIDs and can be explored further with more detailed study.
AIN-2
Evaluation of Anti-inflammatory Activity of Hyoscine Butyl Bromide in Albino Wistar Rats
Firdose N, Suresha RN
Department of Pharmacology, J.S.S. Medical College, Mysore, Karnataka, India
Objectives: To study the anti-inflammatory activity of Hyoscine butyl bromide in acute and sub-acute animal models. Materials and Methods: Adult Albino Wistar rats of either sex, weighing 150-200 grams were randomly divided into 3 groups of 6 rats each. The control, standard and test groups received Normal saline 5 ml/kg body weight, Indomethacin 10 mg/kg body weight and hyoscine butyl bromide 9 mg/kg body weight respectively. Acute inflammatory activity was assessed through carageenan induced paw oedema and sub-acute activity was assessed through cotton pellet induced granuloma model. Results: In this study hyoscine butyl bromide showed significant anti-inflammatory activity in carageenan induced paw oedema model as well as cotton pellet induced granuloma model. It can be a promising anti-inflammatory agent in inflammatory conditions associated with or without allergic reactions. Conclusion: Hyoscine butyl bromide showed significant anti-inflammatory activity.
AIN-3
Pharmacological Evaluation of the Bryonia Alba (Cucurbitaceae) in Freund's Complete Adjuvant Induced Arthritis in Rats
Patil JK, Patil JD, Patil RC, Goyal SN, Mahajan UB
Department of Pharmacology, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra, India
Objectives: To evaluate the anti-arthritic effects of Bryonia Alba mother tincture and its dilutions in experimental induced arthritis. Materials and Methods: Arthritis was induced in male Wistar Albino rats with a single sub-plantar injection of FCA (0.1 ml). Crude form Mother tincture and 3X, 6X, 30X dilution of Bryonia alba and Standard dexamethasone (1 mg/kg) were given for 21 th days in rats for evaluation of different parameters for anti-arthritic activity. Results: Sub-plantar injection of FCA in rats showed primary and secondary lesions as well as haematological changes. On treatment with 6X and 30X theses arthritic changes were significantly attenuated. Treatment with BA crude, MT and combination with MT haven't shown significant prevention of arthritic lesions but showed anti-inflammatory effects. Conclusion: The present study showed the protective effect of 6X and 30X BA in FCA- induced arthritis.
AIN-4
Pharmacological Evaluation of Anti-arthritic Activity of Toxicodendron Pubescence
0Pawar M, Gadekar A, Goyal SN, Patil CR
Department of Pharmacology, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra, India
Objectives: To evaluate the anti-arthritic effects of RhusToxicodendron and its various dilutions in animal model of arthritis. Materials and Methods: Rats were randomly divided into seven groups: Control, RhusTox (10 mg/kg/day, p. o.), RhusTox (3X/day, p. o.), RhusTox (6X/day, p. o.), RhusTox (30X/day, p.o.), RhusTox (200X/day, p.o) for 21 consecutive days. On Day 0, each rat was injected with 100 μL of Freund's complete adjuvant (FCA) into right hind limb. After 21 days parameters were evaluated. Results: Body weight gain in groups receiving RhusTox was more than control animals. RhusTox was found to be effective in reducing arthritis score, flexion pain test score and mobility test score. Stance score showed decrease in WBC count and ESR while increases haemoglobin content and RBC count. The concentration of C-reactive protein (CRP) and Rheumatoid factor (RF) was decreased in groups which received RhusTox at different doses. Thymus weight was decreased while spleen weight was increased on treatment with RhusTox in FCA induced arthritis. Conclusion: RhusTox (in crude as well as diluted form) possesses potent anti-arthritic activity. Significant activity of RhusTox in FCA induced arthritis suggest its usefulness in control of various chronic inflammatory diseases like rheumatoid arthritis.
AIN-5
A Battery of Test Comprising in-vitro Genotoxicity, ex-vivo Cytokine Assessment and Antioxidant Assay Predicts the Possible Anti-inflammatory Potential of Gramine
Pathak MP 1,2 , Policegoudra RS 1 , Goyary D 1 , Das A 2 , Veer V 1 , Chattopadhyay A 1
1 Division of Pharmaceutical Technology, Defence Research Laboratory, Tezpur, Assam, India, 2 Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh, Assam, India
Objectives: Gramine, 3-(N, N-dimethylaminomethyl) indole, is a natural indole alkaloid found in different plants such as Avena sativa L., Hordeum vulgare L. etc. Gramine exhibits wide pharmacological activities such as relaxation of bronchial smooth muscle, vaso relaxation and bronchial asthma. Recently, Gramine has been identified as an adiponectin agonist through a high throughput screening showing affinity for Adipo R1 receptor. To the best of our knowledge no studies have been undertaken to evaluate in-vitro genotoxicity of Gramine. Ex-vivo anti-inflammatory assay and anti-oxidant activity of Gramine is also evaluated to correlate with genotoxicity. Materials and Methods: In-vitro anti-oxidant activity was determined by FRAP assay. Ex-vivo anti-inflammatory activity evaluated in Lipopolysaccharide induced whole blood from Wistar rat. Gramine was assessed for genotoxicity effect using Ames reverse mutation test, micronucleus and chromosomal aberration according to OECD test guidelines. Results: FRAP Assay of Gramine at 1.0 mg/ml concentration exhibited potential reducing capacity. ELISA results clearly indicates that Gramine is a potent inhibitor of TNF whereas IL-4 secretion stimulated in ex-vivo rat whole blood. Gramine strongly showed anti-mutagenic activity inhibited by Sodium Azide up to 95% and 2-Nitrofluorene up to 76.36% respectively. Micro nucleated erythrocyte cell counts of gramine treated group were not statistically different than negative control indicating no genotoxicity effect as well as no structural chromosomal aberrations such as centric fusion, rings etc., was seen in bone marrow cells. Conclusion: Results from the present study suggest that Gramine may be considered as a therapeutic agent for treating inflammatory diseases such as airway hyper responsiveness.
AIN-6
A Case Report of Diclofenac-Serratiopeptidase induced Toxic Epidermal Necrolysis
Rajanikanth M, Alahari S, Shaik AH, Sharon SS, Swarnalatha K
Department of Pharmacology, Kurnool Medical College, Kurnool, Andhra Pradesh, India
Toxic epidermal necrolysis (ten), a severe cutaneous adverse drug reaction which is infrequently caused by exposure to certain drugs. It causes significant morbidity and mortality. Only a few reports of diclofenac and Serratiopeptidase-induced ten are published till date. In this backdrop, we report a case of 55 year old woman who developed diffuse exfoliative rash over upper limb, trunk and lower limb after administration of a combination of diclofenac potassium & Serratiopeptidase.
AIN-7
Synthesis and Evaluation of Anti-inflammatory Activity of some Novel 5-mercapto, 4-arylidine, 3-(acetyl-oxy-phenyl-2yl)-1, 2, 4-triazole derivatives
Namdeo KP, Bodakhe SH
S.L.T. Institute of Pharmaceutical Sciences, G.G. Vishwavidyalaya, Bilaspur, Chhattisgarh, India
Objectives: The present study was aimed to synthesise some novel 5-Mercapto, 4-arylidine, 3-(Acetyl-oxy-phenyl-2yl)-1, 2, 4-Triazole derivatives and their evaluation for possible anti-inflammatory activity. Materials and Methods: In the present study some novel 5-Mercapto, 4-arylidine, and 3-Acetyl-oxy-phenyl-2yl)-1, 2, 4-Triazole derivatives were synthesized in three steps reactions as per the Methods described by Tozkoparan et al. 1999 was followed and evaluated for anti-inflammatory activity. Synthesis of methyl-2-acetoxybenzoate (I), Synthesis of 3-aryl,4-amino-5-mercapto-1,2,4-triazole (II) and Synthesis of final compounds novel 5-Mercapto, 4-arylidine, 3-(Acetyl-oxy-phenyl-2yl)-1, 2,4-Triazole, III). The purity of the synthesized compounds were determined by TLC Methods using silica gel G. Structures of the synthesized compounds were confirmed on the basis of IR, NMR, Mass, carbon, hydrogen and nitrogen analysis. All the synthesized compounds were tested against Carrageenan induced rat paw oedema for anti-inflammatory activity and compared with the standard drug Aspirin. Results: In the synthesized compounds, few were found active as anti-inflammatory against carrageenan induced rat paw oedema and showed significant decrease inflammation with reference to standard. The compound A 11 showed highest activity. Conclusion: The Methoxy-substituted compound showed best anti-inflammatory activity than methyl and hydroxy substituted compounds.
AIN-8
Supplementation of Pomegranate Rind Extract Ameliorates Joint Damage in Rheumatoid Arthritis: An Experimental Study
Karwasra R, Prernakalra, Singh S, Gupta YK
Department of Pharmacology, AIIMS, New Delhi, India
Objectives: Rheumatoid arthritis (RA) is a debilitating autoimmune disease characterized by synovial inflammation and erosion of bone and cartilage, leads to destruction of the affected joints. The present investigation was designed to evaluate the anti-inflammatory and ant arthritic potential of pomegranate rind extracts in carrageenan-induced paw edema model and complete Freund's adjuvant (CFA)-induced arthritis. Materials and Methods: Anti-inflammatory activity of Pomegranate rind extract was evaluated using the carrageenan-induced paw edema in rats. Arthritis was induced in rats by sub-plantar administration of CFA. Joint size was measured at regular intervals by using micrometre screw gauge. An acute and 28-day oral toxicity study was carried outto evaluate the safety of the test drug. Results: Pre-treatment with Pomegranate rind extract produced a dose-dependent reduction in carrageenan-induced paw edemaand CFA-induced arthritis models and was as effective as indomethacin. It also inhibited the delayed increase in joint diameter as seen in control and indomethacin-treated animals in CFA-induced arthritis. The 100 and 200 mg/kg doses of Pomegranate rind extract caused a significant (p < 0.05) reduction in paw swelling in both the models. Conclusion: Based on these Results, it was suggested that Pomegranate rind extract could be considered as a potential anti-inflammatory and anti-arthritic agent. So, it can be used as a dietary supplement for the treatment of patients with rheumatoid arthritis.
AIN-9
In vivo Anti-granuloma and Macrophage Inhibitory Potential of Glorisa superba Linn. in Experimental Models of Inflammation
Kumar R, Singh S, Gupta YK
All India Institute of Medical Sciences, New Delhi, India
Objectives: Glorisa superba L. (Liliaceae) has been traditionally used in treatment of rheumatoid arthritis and other inflammatory disorders. In the present study, we scientifically investigate the anti-granuloma and macrophage inhibitory potential of Glorisa superba hydroalcoholic extract (GSHE) in experimental models of inflammation. Materials and Methods: Anti-granuloma and macrophage inhibitory activity of Glorisa superba hydroalcoholic extract (GSHE) were evaluated in experimental models viz. Cotton pellet induced granuloma formation, and CFA induced stimulation of peritoneal macrophages in rats. Levels of macrophage derived inflammatory mediator's viz. TNF-α, IL-1 β, IL-6, IL-10, TNF-R1 and COX-2 were evaluated in serum and peritoneal macrophages to assess the macrophage inhibitory potential hypothesis. Results: Treatment with GSHE Resulted in dose dependent reduction (p < 0.01) in dry granuloma weight. This inhibition in granuloma weight was well substantiated with reduced serum levels of inflammatory cytokine (TNF-α, IL-1β and IL-6) accompanied with increased anti-inflammatory cytokine, IL-10 in GSHE treated group. Additionally, GSHE inhibited macrophage derived inflammatory mediators, TNF-α, IL-1 β, IL-6, TNF-R1 and COX-2 along with increased IL-10 expression in stimulated peritoneal macrophages. Conclusion: Results of the present study thus demonstrates and validates the use of Glorisa superba in chronic inflammatory disorder via inhibiting macrophage derived inflammatory mediators.
AIN-10
Evaluation of Acute Anti-inflammatory Property of Pioglitazone and Rosiglitazone in Wistar Rats
Purohit A, Khanwelkar CC, Thorat VM, Jadhav SA, Matule S, Sadanandan S
Department of Pharmacology, Krishna Institute of Medical Sciences, Karad, Maharashtra, India
Objectives: To evaluate the acute anti-inflammatory property of Pioglitazone and Rosiglitazone in Wistar rats by carrageenan induced hind paw edema in Wistar rats and to compare the Results with that of the standard drug Diclofenac. Materials and Methods: Wistar rats of either sex, weighing 150-250 gm. were used for the study. Acute inflammation was induced by injecting 1% carrageenan in sub plantar area of hind paw of rats. Rats were divided into nine groups of six each (n = 6). Standard drug Diclofenac was administered 40 minutes prior, test drugs Pioglitazone and Rosiglitazone were administered 90 minutes and 60 minutes prior to the induction of edema. 0.05 ml of 1% carrageenan in normal saline was injected into the sub plantar region of one of the hind paw. A mark was put on the hind limb at the malleolus. The paw edema volume in millilitre was measured with the help of plethysmograph at zero hour. The same procedure was repeated at 0.5, 1, 3, 4 and 5 hours. The difference between 0 hour and subsequent reading was taken as actual edema volume. The percentage inhibition of edema in the various treated groups was then calculated. Results: One way ANOVA test showed very significant difference in two doses of Rosiglitazone (5 & 10 mg/kg) and two doses of Pioglitazone (10 & 15 mg/kg) when compared to respective control groups (p < 0.001). Also Diclofenac group showed extremely significant difference when compared with its control group (p < 0.0001). While there was no significant difference when Diclofenac group was compared with Results of Pioglitazone at their doses 10 and 15 mg/kg, Rosiglitazone 5 and 10 mg/kg respectively. Conclusion: Pioglitazone at 10 and 15 mg/kg, Rosiglitazone at 5 and 10 mg/kg demonstrated good acute anti-inflammatory activity in this carrageenan induced acute inflammatory model. The acute anti-inflammatory activity of Pioglitazone and Rosiglitazone at two higher doses was comparable to Diclofenac activity.
AIN-11
Anti-inflammatory Properties of Antidepressants in Reducing Neuro Inflammation in Psychiatric Disorders: A Review
Rajesh V, Patil BV
Department of Pharmacology, M.R. Medical College, Sedam Road, Gulbarga, Karnataka, India
Objectives: Neuroimmunological abnormalities occur in classical psychiatric disorders (for example, major depressive, bipolar, schizophrenia, and obsessive-compulsive disorders). Investigations into the pathophysiology of these conditions traditionally stressed dysregulation of the glutamanergic and monoaminergic systems, but the mechanisms causing these neurotransmitter abnormalities remained elusive. There is a high prevalence of depression in patients with asthma, chronic inflammatory diseases, and neurological diseases like Alzheimer's disease, Huntington's, Parkinson's disease etc., supporting role of neuroinflammation in depression. Materials and Methods: We reviewed several articles in Indexed journals. Proinflammatory cytokines include IL-1 β, IL-2, IL-6, TNF-α and IFN-g. Secreted by activated microglia promote harmful inflammation and contribute to pathology of depression. Anti-inflammatory cytokines include IL-4, IL-5 and IL-10 secreted by astroglia limit harmful inflammation. Glial loss in psychiatric illnesses such as MDD, BPD, and in some cases of schizophrenia may contribute to neuroinflammation through several mechanisms, including abnormal cytokine levels, dysregulated glutamate metabolism, increased oxidative stress, and altered BBB function. Results: A strong inflammatory component was found to be present in several psychiatric illnesses. Abdel-Salam and co-workers found that amitriptyline produces an anti-inflammatory effect on carrageenan-evoked paw swelling in rats. In LPS induced septic shock and allergic asthma in animal models, it was found that desipramine and fluoxetine have significant anti-inflammatory properties by reducing NF-B, AP-1 and TNF-α production. SSRIs may work by suppressing T cell proliferation, inhibiting interferon (IFN) production and suppression of NF-κB. Imipramine and clomipramine induce apoptosis in human lymphocytes. Conclusion: Other studies have suggested that the anti-inflammatory mechanism of antidepressants is not correlated with inhibition of norepinephrine and/or serotonin reuptake transporters and further studies are needed to clarify the exact mechanism of their anti-inflammatory action.
AIN-12
Evaluation of Analgesic Activity of Pioglitazone in Albino Mice
Shruthi SL, Kalabharathi HL, Amoghimath S, Sibgatullah MD, Jayanthi MK, Pushpa VH
Department of Pharmacology, J.S.S. Medical College, J.S.S. University, Mysore, Karnataka, India
Objectives: To evaluate analgesic activity of Pioglitazone in mice. To compare the analgesic activity of Pioglitazone with the standard drugs Tramadol and Aspirin, in mice. Materials and Methods: Albino mice were divided into 4 groups, containing 6 (n = 6) in each group (control, standards - 1 and 2, and test group). Group-I: Control received saline solution 25 ml/kg orally, Group-II: Standard 1 received Tramadol at a dose of 10 mg/kg intra-peritoneal, Group-III: Standard 2 received Aspirin at a dose of 300 mg/kg orally, Group-IV: Test received Pioglitazone at a dose of 20 mg/kg orally. Pioglitazone and normal saline was administered 2 h before, whereas the tramadol and aspirin were administered 1 h prior to Eddy's hot plate, Acetic acid induced writhing Methods and tail clip Methods. The decrease in number of writhes, the delay in reaction time in tail clip and Eddy's hot plate Methods denoted the analgesic activity. Results: Pioglitazone decreased the number of writhes, delayed the reaction time in tail clip and Eddy's hot plate Methods considerably when compared with control (normal saline), but less when compared with standard (Tramadol and Aspirin). Conclusion: Pioglitazone exhibits analgesic activity in thermal, chemical, and mechanical pain models in Albino mice.
AIN-13
Comparative Study of Anti-inflammatory Activity of Two Extracts of Hibiscus Cannabinus Leaf
Shaikh S 1 , Kadam V 2
1 Department of Pharmacology, Anjuman-I-Islam's Kalsekar Technical Campus, School of Pharmacy, New Panvel, Mumbai, Maharashtra, India, 2 Department of Pharmacology, Bharati Vidyapeeth's College of Pharmacy, C.B.D. Belapur, Navi Mumbai, Maharashtra, India
Objectives: The present study was undertaken to investigate and compare the anti-inflammatory activity of aqueous and methanolic extract of Hibiscus cannabinus L (Malvaceae) using carrageenan induced rat paw edema. Materials and Methods: Aqueous and methanolic extracts of Hibiscus cannabinus was prepared and tested for anti-inflammatory activity in female Spargue Dawley rat weighing 150-180 gm. The animal was randomly divided into 6 groups of 6 each. First group served as vehicle control, second group served as standard, third and fourth group served as high and low dose of methanolic extract of Hibiscus cannabinus leaves (MHCL) respectively and fifth and sixth group as high and low dose of aqueous extract of Hibiscus cannabinus leaves (AHCL) respectively. The in vivo anti-inflammatory activity was studied using carrageenan induce rat paw edema animal model. Anti-inflammatory activity was expressed as Percent inhibition (PI). The biochemical estimations were done on liver and blood. Statistical analysis was performed using One-way analysis of variance (ANOVA) followed by Dennett's t test. Results: The anti-inflammatory activity of all groups was found comparable to standard indomethacin group. The maximum present inhibition in paw edema was found in Methanolic extract of Hibiscus cannabinus at dose of 400 mg/kg 52.00% with significant anti-inflammatory activity p < 0.001. Conclusion: An anti-inflammatory activity was found in both the extracts i.e., methanolic and aqueous extract of Hibiscus cannabinus L. But the methanolic extract of Hibiscus cannabinus showed more significant anti-inflammatory activity.
AIN-14
Screening of some Medicinal Plants of Euphorbiaceous Family for COX Inhibitory Activity
Chauhan VS, Solanki NR, Manek RA, Sheth DB, Modi KP
Department of Pharmacology, B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India
Objectives: To screen some medicinal plants of Euphorbiaceous family for COX inhibitory activity. Materials and Methods: Four plants from Euphorbiaceous were selected for present study viz. Abrus Precatorius (HEA), Mimosa Pudica (HEM), Clitoria Ternatea (HEC) and Cyamopsis Tetragonoloba (HEG). Hydro-alcoholic extract were prepared by cold maceration method. Extract were screened for confirmation of anti-inflammatory potential in RBC membrane stabilization activity model. Evaluation of effect on COX enzyme was done using Prostaglandin synthesis inhibition activity (in-vitro using isolated rat uterus) & COX assay kit. Results: All plants showed statistically significant (p < 0.05) dose dependent stabilization of plasma membrane of sheep erythrocytes which was comparable with effects produced by standard further all extracts impaired amplitude and/or frequency of spontaneous contractions of the isolated rat uterus. HEM, HEG, shown statistically significant COX-1 inhibition at higher concentration. Although, all plant extracts have shown COX-2 inhibition but HEA and HEG shown statistically significant COX-2 inhibition. And HEA plant showed only COX-2 inhibition. Conclusion: All the medicinal plant selected in study is having good effect on COX enzyme which may partially or fully contribute to its anti-inflammatory action. Further fractionation of extracts and isolation of phytoconstituents will give clear idea for understanding the basis for their usefulness in treatment of inflammatory disorders.
AIN-15
Screening of some Medicinal Plants of Euphorbiaceae Family for COX Inhibitory Activity
Panchal JB, Gandhi PM, Manek RA, Sheth DB, Modi KP
Department of Pharmacology, B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India
Objectives: To screen some medicinal plants of Euphorbiaceae family for COX inhibitory activity. Materials and Methods: Four plants from Euphorbiaceae were selected for present study viz. Phyllanthus reticulates (HE-PR), Baliospermum montanum (HE-BM), putranjiva roxburgi (HE-PU) and Euphorbia neriifolia (HE-EN). Hydro-alcoholic extract were prepared by cold maceration method. Extract were screened for confirmation of anti-inflammatory potential in RBC membrane stabilization activity model. Evaluation of effect on COX enzyme was done using Prostaglandin synthesis inhibition activity (in-vitro using isolated rat uterus) & COX assay kit. Results: All plants showed statistically significant (p < 0.05) dose dependent stabilization of plasma membrane of sheep erythrocytes which was comparable with effects produced by standard further all extracts impaired amplitude and/or frequency of spontaneous contractions of the isolated rat uterus. HE-PR, HE-BM, HE-PU shown statistically significant COX-1 inhibition at higher concentration. Although, all plant extracts have shown COX-2 inhibition but HE-BM and HE-PU shown statistically significant COX-2 inhibition. And HE-EN plant shown only COX-2 inhibition. Conclusion: All the medicinal plant selected in study are having good effect on COX enzyme which may partially or fully contribute to its anti-inflammatory action. Further fractionation of extracts and isolation of phytoconstituents will give clear idea for understanding the basis for their usefulness in treatment of inflammatory disorders.
AIN-16
In vivo Investigation of Anti-inflammatory Activity of Flowers of Plant of Nyctanthes Arbor-tristis L. in Rats
Vannamalar S
Department of Pharmacology, Vinayaka Mission's College of Pharmacy, Salem, Tamil Nadu. India
Objectives: This Study is designed to evaluate the anti inflammatory activity of flowers of plant of Nyctanthes arbor-tristis.L. is investigated by in vivo method in rats. Materials and Methods: The male Wistar albino rats were divided into 6 groups of Six animals. Group I served as a control. Group II rats were administered with standard drug of Diclofenac sodium (50 mg/kg) orally. Group III, IV, V, VI animals were administered with ethonal and aqueous extracts of Nyctanthes arbor-tristis.L. (EENAT, AENAT, 200 mg/kg, 400 mg/kg respectively) orally. After 30 minutes, all group of animals were administerrd with Carrageneen 1% w/w 0.1 ml plantas region of paw. Note the initial paw volume of each rat by mercury displacement method. The right paw will serve as reference non inflammated paw for comparision. Compare the mean percentage changes in paw volume in control and drug treated animals and express as percent. Results: Ethanol and Aqueous extracts (Group III, IV, V, VI) compared to the normal control (Group I). There was a significant reduction in the level of paw volume in extracts groups and its anti inflammatory effectiveness is comparable to that of its commercial counterpart, Diclofenac sodium (Group II) showed a positive results. Conclusion: Ethonal and aqueous extracts of Nyctanthes arbor-tristis.L. (EENAT, AENAT, 200 mg/kg, 400 mg/kg) showed significant anti inflammatory activity in dose dependent manner. Aqueous extract of Nyctanthes arbor-tristis.L. found to be significant and most effective than ethanol extracts.
ANS
ANS-1
Ancient Treatment for Migraine
Devi MP, Reddy AS, Bakshi V, Kaklij RM
Objectives: My main Objectives is to give clear explanation about acupuncture treatment which treats migraine. Subjective: Migraine: A recurrent throbbing headache that typically affects one side of the head and is often accompanied by nausea and disturbed vision. Acupuncture is one of the oldest Methods of healing - focuses on stimulating specific body points. Acupuncture is a form of traditional Chinese medicines for migraines and other body alignments. During acupuncture needles are inserted up to 2 inches and remain in the body for 20 minutes. Acupuncture is also used in treating other types of headaches, labour pain, chemotherapy induced nausea and vomiting, pain from fibromyalgia, neck pain, back pain, menstrual pain, muscle pain, anxiety, insomnia, dental pain, osteoarthritis. Acupuncture involves inserting solid, thin, metallic needles into various places of the body. Acupuncture believed to stimulate the body's natural painkillers, increase blood flow, and stimulate nerves, muscles, tissues. It is believed that acupuncture stimulates muscles and releases the body's natural pain killers called endorphins. Acupuncture may also block neurotransmitters and therefore block the pain messages from being delivered to the brain.
AUT
AUT-1
Paracetamol induced Generalized Bullous Fixed Drug Eruption: A Rare Case
Aasani DS, Mistry RA, Parmar DM, Trivedi HR
Department of Pharmacology, M.P.S.M.C., Jamnagar, Gujarat, India
Fixed drug eruption (FDE) is a distinct type of cutaneous adverse reaction that characteristically recurs in the same location upon re-exposure to offending drug. It is responsible for 10% of all adverse drug reaction. Common drugs causing FDE are sulphonamides, NSAIDs (Non-steroidal anti-inflammatory drugs), tetracycline, phenytoin, doxycycline, clarithromycin, etc. Generalized bullous fixed drug eruption (GBFDE) is a very rare variant of FDE. Paracetamol is most commonly used analgesic-antipyretic drug with consistent safety profile and very low incidence of side effects when used for fever, headache, myalgia and other painful events of various origins. We hereby report a rare case of GBFDE caused by tablet paracetamol. So, culprit drug was stopped and patient was advised never to take Paracetamol in future. Patient was managed with injectable dexamethasone, chlorpheniramine maleate, ceftriaxone and local application of benzoic acid + salicylic acid ointment, betamethasone valproate + soframycin cream and recovered within 12 days. Fixed drug eruption is common with Paracetamol but generalized bullous fixed drug eruption is very rare case. So, we recommend adding this type of unique case to the list of possible side effect of above mentioned drug.
AUT-2
A Novel In silico Study of Kidney Stone Formulations Found in Shusruta Samhita: An Inception of Ayurinformatics
Johari S 1 , Sinha S 1 , Khati RS 1 , Sharma A 2 , Ghosh A 3 , Sarma BP 4
1 Centre for Bioinformatics Studies, Dibrugarh University, Dibrugarh, Assam, India, 3 Department of Botany, Guwahati University, Guwahati, Assam, India, 4 Department of Kayachikitsa, Government Ayurvedic College, Guwahati, Assam, India, 2 Laboratory of Molecular Electrochemistry, Universite Paris Diderot, Paris, France
Kideny stone (Nephrolithiasis) disease has afflicted human for many centuries affecting up to 5% of the human population, with a lifetime risk of passing a kidney stone of about 8-10%. Ayurveda is an ancient medical science which has remedies for most of the diseases, with that quest a sloka has been selected from Shusrut Samhita, Chikitsa Sthan, Sloka no. 19 which mentions a formulations to dissolve kidney stone in 7 days. In this paper an attempt has been made to study the virtual reaction of chemical constituents found in Tribulus terrestris seed honey and urine of sheep as mentioned in, Shushrut samhita, Chikitsa sthan, Verse no. 19 which can cure kidney stone in 7 days. The chemical constituents were virtually reacted and virtually synthesized chemical compound were generated. Out of which the best nineteen compounds satisfying the Dragon Consensus Score was further taken as the ligand and docked with the target receptor Tamm Horsefall Protein (THP) using GEMDOCK and AUTODOCK Vine. It was observed that out of the 19 virtually generated ligand, ligand A1 interacts more potentially with THP with 5 hydrogen bonds with binding affinity -5.6 kcal/mol. Also B1 and C4 interacted well with binding affinity 5.8 and 5.7 Kcal/mol respectively. Thus the formulations A1, B1 and C4 can be synthesized as potent drug like candidates for kidney stone.
IMP
IMP-1
ADR-A Retrospective Study on Stevens-Johnson syndrome More Details and Toxic Epidermal Necrolysis in a Tertiary Care Hospital
Harsha S, Prasath DD, Jitha S, Dhanya SP, Dhanya J, Kala KP
Department of Pharmacology, Government T.D. Medical College, Alappuzha, Kerala, India
Objectives: Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are severe cutaneous hypersensitivity reactions. This study aims at finding the incidence of SJS and TEN by various drugs in last 3 years (July 2012-July 2015) in a tertiary care hospital. Materials and Methods: ADRs collected (using CDSCO forms) in the Department of Pharmacology over a period of 3 years (July 2012-July 2015) were analysed. All patients who developed SJS and TEN were included in this study. Clinical and treatment data were collected from the Department of Dermatology. Causality, Severity and Preventability were assessed by suitable scales. Results: Of the total 602 ADRs, 345 (58.97%) had skin manifestations of which 2.66 % SJS, 0.49% TEN and 0.17% overlap were reported. Antiepileptic's (66.67%) were the main causative drugs with Carbamazepine-37.5% and Phenytoin-18.75%. Majority were in the age group 36-45 years (33.33%) and there was a female predominance (62.5%). Causality assessment showed that all of the reactions were probable. Severity analysis indicated every case to be severe. Preventability analysis showed that none of them were preventable. The causative drug was stopped. All the patients were admitted in ICU and were managed with oral Cyclosporine or IV Immunoglobulin, IV antibiotics, high dose IV steroids and supportive measures for eyes and oral mucosal erosions. There were no case fatalities. Conclusion: SJS and TEN are life threatening conditions and hence any symptoms have to be dealt with active management on an inpatient basis.
IMP-2
An Experimental Study to Evaluate the Anti-arthritic Effect of a Combination of Withania Somnifera and Omega 3 Fatty Acids in a Rat Model of Rheumatoid Arthritis
Singh S, Nath R, Pant KK, Dixit RK, Pal R, Kumar R
Department of Pharmacology, King George's Medical University, Lucknow, Uttar Pradesh, India
Objectives: To evaluate the anti-arthritic effect of combination of Withania somnifera extract (WSE) and omega 3 fatty acids in Complete Freund's Adjuvant (CFA) induced rheumatoid arthritis (RA) in rats. Materials and Methods: A total of 30 Wistar Albino rats of either sex were divided into 5 groups of 6 rats each. Baseline values of physical parameters (paw volume, paw thickness, ankle diameter, body weight) and biochemical parameters (TNF-alpha) were measured. Groups I and II served as normal controls. Arthritis was induced in rats of groups III to V by an intradermal injection of 0.2 ml of CFA in their left hind paw. After 10 days, the rats were scored for arthritic index and the parameters were measured again. Drugs were administered orally from day 11 to day 20. Groups I and II received distilled water and tween 80 respectively. Group III served as the arthritic control. Groups IV received WSE 1000 mg/kg + omega 3 fatty acids 100 mg/kg while group V received indomethacin 3 mg/kg. On day 21, the parameters were measured again. Results: The combination of WSE and omega 3 fatty acids caused a significant increase in body weight (p < 0.05) while a significant decrease in paw volume, paw thickness, ankle diameter, arthritic index and TNF-alpha (p < 0.05 for all parameters) was noted as compared to the control group, but it was found to be less efficacious than indomethacin. Conclusion: The combination of WSE and Omega 3 fatty acids can be considered as a potential anti-arthritic agent.
IMP-3
Comparative Study of Efficacy and Antimicrobial Effects of Olive Oil, Coconut Oil, Tacrolimus in AD Patients
Rai RK, Singh S, Abidi A, Fatima F, Qadeer F, Srivastava K
Department of Pharmacology, Era's Lucknow Medical College, Lucknow, Uttar Pradesh, India
Objectives: To study the efficacy and antimicrobial effects of topical Olive oil (OO), Coconut oil (CO) and their combination with Tacrolimus in patients with mild to moderate AD and Xerosis. Materials and Methods : A total of 56 patients diagnosed AD were included in the study according to inclusion and exclusion criteria. They were randomized into two groups, Group A was given Olive oil, Group B was given Coconut oil for 4 weeks and Topical Tacrolimus was added to both groups along with Oils respectively. Patients were evaluated at baseline, at 4, and 8 weeks for SCORAD (SCORing of Atopic Dermatitis) index values and Skin swabs were taken to assess Staphylococcus aureus  colonies positive/negative. Results: Both the groups showed significant reduction in SCORAD scoring. In the CO group, 47% (21/56) of patients attained moderate improvement and 46% (20/56) showed anexcellentresponse. Mean SCORAD indices decreased from baseline by 18% in the CO group and by 20% in the OO group. In the both groups, 70% (41/56) of patient's SCORAD showed improvement as from moderate grade to mild. Skin swabs assessed in both groups, showed significant reduction of colony counts in S. aureus and in CO group it also became negative at 8 th week from baseline in 38% (21/56). Conclusion: Thus, among patients with mild to moderate AD, topical application of CO for eight weeks was superior to that OO based on clinical (SCORAD) and Skin Swab assessment.
IMP-4
Immune Checkpoint Inhibitors: A New Avenue in Cancer Therapy
Agharia MAM, Gawali UP, Shah KU
Department of Pharmacology, Dr. V.M.G.M.C., Solapur, Maharashtra, India
Objectives: Surgery, radiotherapy and chemotherapy are the conventional Methods for treatment of cancers. Among the most promising approaches to activating therapeutic antitumor immunity is the blockade of immune checkpoints. Immune checkpoints are the inhibitory pathways used by the immune system to maintain self-tolerance and modulate the immune response in peripheral tissues to minimize the collateral tissue damage. It is now clear that tumours co-opt certain immune-checkpoint pathways as a major mechanism of immune resistance, particularly against T cells that are specific for tumour antigens. Most of the immune checkpoints are initiated by ligand-receptor interactions; therefore the blockade of either the ligand or the receptor with the help of the specific antibodies can suppress the activity of these immune checkpoints. Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and programmed cell death-1 (PD-1) are typical immune checkpoint molecules intimately involved in the suppression of anti-tumour immunity. A Cytotoxic T lymphocyte associated antigen 4 (CTLA4) antibodies, named Ipilimumab, was the first such immunotherapeutic to achieve US FDA approval. In this review, the important immune checkpoint pathways will be discussed along with the status of few antibodies that are being used to block the immune checkpoint pathways. Materials and Methods: Relevant articles were identified on PUBMED and Google scholar using keywords immune checkpoint inhibitors, CTLA-4 antibodies, and PD-1/PD-L1 antibodies. Results and Conclusion: Immune checkpoint inhibitors provide a new avenue in cancer therapy. Immunotherapy with checkpoint-blocking antibodies targeting CTLA-4 and PD-1/PD-L1 has improved the outlook for patients with a variety of malignancies.
BHP
BHP-1
Neonatal Anoxia Leads to Cortical Mitochondrial Dysfunction and Associated Long Term Neurobehavioral Changes
Samaiya PK 1 , Gopeshwar N 2 , Kumar A 3 , Krishnamurthy S 1
1 Department of Pharmaceutics, Neurotherapeutics Lab, Indian Institute of Technology, Banaras Hindu University, Varanasi, Uttar Pradesh, India, 2 Department of Molecular and Human Genetics, Banaras Hindu University, Varanasi, Uttar Pradesh, 3 Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India
Objectives: This study investigated the temporal effect of mitochondrial and neurological dysfunction associated with primary (day-1) and secondary (day-7) pathological insult causing cortical mitochondrial dysfunction in a non-invasive model of anoxia in neonatal rats. Materials and Methods: Rat pups after 30 h to birth (2 days) were subjected to anoxia of two episodes (10 min in each) at a time interval of 24 h by passing 100% N 2 into an enclosed chamber. Anoxia was confirmed by pulse oximetry. Behavioural activities like reflex latency and hanging latency were performed from day-1 to day-7 for the evaluation of sensorimotor deficits following anoxia. Mitochondrial bioenergetics was evaluated using a Clarke-type electrode on day-1 and day-7 following anoxia to study the alterations in different states of mitochondrial respiration and RCR. Mitochondria dysfunction was evaluated by alterations in mitochondrial transition pore opening (mPTP) and release of cytochrome-C in cytosol. Results: A significant alteration in reflex and hanging latency was observed which was proportionate to a compromised mitochondrial bioenergetics as confirmed by decrease in mitochondrial respiration, mPTP opening and release of cytochrome-C on day-1 and day-7 following anoxic injury. Conclusion: The knowledge of the time course of mitochondrial dysfunction-linked mechanisms may provide novel targets for pharmacological interventions targeting mitochondria.
BHP-2
Effects of Chronic Hypoxia on Neurobehavioral Changes and Oxidative Stress Markers in Rats: Modulation by Nitric Oxide
Sharma M 1 , Gulati K 1 , Krishnan R 2 , Ray A 1
1 Department of Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi, Delhi, India, 2 Department of Physiology, Vallabhbhai Patel Chest Institute, University of Delhi, Delhi, India
Objectives: To study the effects of chronic hypoxia on neurobehavioral changes viz. anxiety and cognition, and its possible regulation by nitric oxide (NO) in rats. Materials and Methods: Wistar rats (200-250 g, either sex) were used. Hypoxia simulating high altitude at 8000 ft (H-I) and 12000 ft (H-II) was induced in a specially designed hypoxia chamber. Elevated plus maze (EPM) and Morris Water Maze (MWM) tests were used as behavioural tests for anxiety and cognition, respectively, and oxidative stress markers were measured in brain homogenates. The effects of NO modulators (L-arginine and 7-nitroindazole) on behavioural and biochemical parameters were assessed, in both control and experimental groups and compared statistically. Results: In the EPM test, hypoxia induced intensity dependent angiogenesis which were accompanied by reductions in brain GSH and elevations in MDA. The changes induced by H-II were attenuated by L-arginine (500 mg/kg) and aggravated by 7-Nitroindazole (30 mg/kg). In the MWM test, hypoxia increased the mean escape latency time (on trial day 4) as compared to controls, and also reduced the time spent in the target quadrant in the probe trials, in an intensity dependent manner, and these effects were accompanied by reductions in brain GSH and elevations in MDA. These cognitive deficits and oxidative stress markers were also attenuated by L-arginine and aggravated by 7-Nitroindazole. Conclusion: The Results are suggestive of the involvement of oxidative stress and NO during hypoxia induced anxiety and cognitive deficits.
BHP-3
Contribution of Histaminergic Transmission in the Ethanol Induced Anti-nociceptive Effects
Verma L, Jha R, Jain NS
Institute of Pharmaceutical Sciences, G.G.V., Bilaspur, Chhattisgarh, India
Objectives: Involvement of central histaminergic transmission in the modulation of nociception-like behaviour and alteration in brain histamine levels by ethanol, prompted us to study the possible participation of the histaminergic transmission in the acute ethanol induced ant nociception-like behaviour. To study the effects of histamine analogue on ethanol inducing ant nociceptive effect. Materials and Methods: The separate groups of mice were treated with vehicle or histamine precursor, L-histidine or histamine (H1 or H2) receptor antagonists. These animals after appropriate time point were then challenged with vehicle or ethanol (0.5-2.0 g/kg, i.p.) and twenty min thereafter animals were subjected on hot plate test to note the paw licking latency and tail flick test to assess the tail flick latency time. Results: Results indicate that acute ethanol (16% w/v, 0.5-2.0 g/kg, i.p.) injection significantly increased the latency time on hot plate and tail flick, supporting its classical ant nociceptive effect. Pre-treatment of histamine precursor, augmented the effect of sub-nociceptive dose of ethanol (0.5 & 1 g/kg, i.p). On the other hand, prior administration of H1 receptor antagonist, cetirizine (1 mg/kg, i.p.) and H2 receptor antagonist, ranitidine (50 μg/mice i.c.v.) significantly reversed the potentiating effect of histamine precursor, on ethanol induced ant nociceptive effects and per se also reduced the ethanol induced effect nonciception in both the tests. Conclusion: It is reasonable to speculate that histamine might play a cardinal role in the ethanol induced behavioural effects on nociception via H1 or H2 receptor stimulation.
BHP-4
Low Dose of AM 251, a Cannabinoid Receptor-1 Antagonist Attenuate the Chronic Alcoholism induced Neuropathic Pain in Wistar Rats
Behl T 1 , Yadav HN 2 , Sharma PL 3
1 Department of Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi, New Delhi, India, 2 All India Institute of Medical Sciences, New Delhi, India, 3 Indo-Soviet Friendship College of Pharmacy, Moga, Punjab, India
Objectives: Alcohol is considered to be a major culprit in contributing neuropathic pain like state. Cannabinoid receptor has been implicated in analgesic due to inhibition of acetylate cyclase and calcium currents and presynaptic modulatory effect in the transmitter release. The over-activation of cannabinoid receptor leads to desensitization as the released end cannabinoids cause the impairment in signaling mechanism. In this study, we examined whether low dose of AM251, a cannabinoid receptor antagonist attenuate the chronic alcoholism induced neuropathic pain in Wistar rats. Materials and Methods: Mechanical allodynia and thermal hyperalgesia is measured by dynamic plantar apparatus and plantar test apparatus respectively and were taken as index for the assessment of neuropathic pain. Results: Low dose of AM 251 significantly attenuates the chronic alcoholism induced neuropathic pain in Wistar rats due to prevention of desensitization of cannabinoid receptor that occurs due to elevated level of end cannabinoids causing impairment in signaling mechanism. Conclusion: The activation of various pathways of alcoholic neuropathy Results in numerous devastations that ultimately dispose to morbidity. The selective targeting of cannabinoid receptor and protein kinase C can offer a novel approach in the management of alcoholic neuropathy.
BHP-5
Self-medication Practice and Perception of Side Effects Among Medicos: A Cross-sectional Study
Yadav SK, Gungam P, Vidyullatha B, Namala B
Department of Pharmacology, Osmania Medical College, Hyderabad, Telangana, India
Objectives: To assess practice and perception of side effects of medication among interns and PG preparing medical students. Materials and Methods: It is a cross-sectional study in which study population consisted of interns and PG preparing medical students of Osmania Medical College, Hyderabad, and Telangana, India. This study was conducted from July to August 2015. Total 550 students were enrolled. The medicos who took self-medication during last six months were included. They were given a questionnaire that included both open and close ended questions about self-medication practice and perception of side effects. Statistical Analyses: Data was analysed and presented as counts and percentages. Results: Antihistamines and Antibiotics were most commonly self-medicated followed by PPI's, NSAIDs, vitamin supplements and then anxiolytics. Side effects perceived were metallic taste, nausea, gastritis, pedal oedema, diuretic effect and drowsiness. They were of the opinion that self-medication is part of self-care. Conclusion: Self-medication is widely practiced among medical students. Although OTC drugs are safe and meant for self-medication, there can be serious implications if they are used improperly due to lack of knowledge of their side effects and interactions in this situation, we should educate the students about advantages and disadvantages of self-medication.
BHP-6
Evaluation of Docosahexaenoic Acid Supplementation on Cognitive Ability in Normal Rodents
Khare A, Kothari S
Department of Pharmacology, G.R. Medical College, Gwalior, Madhya Pradesh, India
Objectives: This study was conducted to see whether DHA supplementation has any effect on memory enhancement in normal rodents and to compare this effect with standard memory enhancing drug. Materials and Methods: Memory enhancing activity of DHA was studied using elevated plus maze apparatus in Swiss Albino mice of either sex. They were divided into four groups of six mice each. Group 1 (control group) was given 2% gum acacia suspension, Group 2 & 3 received 2% gum acacia suspension of DHA at doses of 300 mg/kg & 400 mg/kg B.W respectively and Group 4 was administered 2% gum acacia suspension of standard nootropic drug piracetam (200 mg/kg). All four groups were given 0.5 ml of solution orally for 15 days. The time taken by rodent to move from open arm to close arm with all its four paws (Transfer latency, TL) was recorded before and after the drug administration for 15 days to see any improvement in the memory. Results: DHA in both doses (300 mg/kg & 400 mg/kg) showed a decrease in TL as compared to control group but it was statistically not significant (P > 0.05). Piracetam (200 mg/kg) also showed a decrease in TL as compared to control but was also statistically not significant (P > 0.05). Effect of DHA (400 mg/kg) was comparable to that of piracetam. Conclusion: DHA & piracetam increased the memory retention in normal mice as compared to control but was not significant. This finding needs to be confirmed further by using more models of memory test and administering DHA for longer duration.
BHP-7
Evaluation of Anti-anxiety Activity of Fenugreek (Trigonella foenum-graecum) in Albino Mice
Venakatanarayana N, John P
Department of Pharmacology, Mamata Medical College, Khammam, Telangana, India
Introduction: Trigonella foenum-graecum is commonly known as fenugreek. Fenugreek is commonly used in food preparation, is assumed to possess nutritive and restorative properties and has been used in folk medicine for a wide range of diseases including diabetes, fever and abdominal colic as a poultice for abscesses, boils and carbuncles, anti-inflammation, antitumours, antidiabetic, anaemia, antiviral, antimicrobial, Hypotensive, and antioxidant activity. Trigonella Foenum-Graecum (TFG) has been used since ancient times in Indian folklore medicine for its many medicinal properties. TFG is reported to possess anxiolytic, nootropic, immunomodulatory and hypoglycaemic properties. Anxiety is a psychological and physiological state characterized by somatic, emotional, cognitive, and behavioural components. Objectives: To evaluate the anti-anxiety activity of Trigonella Foenum-Graecum in comparison with diazepam as a standard drug. Materials and Methods: Elevated plus maze model & Light-Dark Model. Diazepam is injected i.p. Drugs are administered as per the following groups. Group I - Control + Stress Induced, Group - II Stress Induced + Diazepam, Group - III Stress Induced + Test 1 (250 mg/kg), Group - IV Stress Induced + Test 2 (500 mg/kg), Group - V Stress Induced + Diazepam + Test 2 . Statistical Analysis: Analysis of the data will be done using ANOVA and Tuckey test. P values of less than 0.05 will be considered significant . Results and Conclusion: Will be interpreted statistically after the study.
BHP-8
Experimental Studies on the Time Dependent Changes in Stress Markers after Restraint Stress in Rats: Modulation by Nitrergic Agents
Prakash S, Gulati K, Ray A
Department of Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi, New Delhi, India
Objectives: The present study evaluated the time dependent changes in neurobehavioral and endocrinal markers after different durations of acute restraint stress (RS), and its modulation by nitrergic agents in rats. Materials and Methods: Inbred female Wistar rats (150-200 g) will be used. The rats will be housed under standard laboratory conditions (22 ± 2°C, 12 hour light/dark cycle - lights on at 0800 hours) with free access to food and water. Rats were exposed to 1 h or 6 h of acute restraint stress (RS), and following this, they were evaluated for the effects of RS on anxiety modulation and plasma corticosterone at different time intervals post RS. Results: Exposure of rats to 1 h RS Resulted in neurobehavioral suppression in the EPM at 0 h which was returned to near control levels after 6 h and 24 h post-RS. L-arginine pre-treatment reversed EPM effects at 0 h, and did not appreciably influence effect the 6 h and 24 h post-RS behavioural changes. Further, exposure of rats to 6 h RS also Resulted in behavioural suppression in the EPM, and this remained suppressed at 6 h and 24 h post-RS. Neither, L-arginine nor L-NAME was able to influence these RS induced changes. Conclusion: The Results suggest that acute RS induced time dependent changes in anxiety modulation in the EPM, which were not only dependent on the type/severity of the stressor but also on the time periods at which stress responses were elicited, and these effects were differentially regulated by nitric oxide.
BHP-9
Potentiation of Activity of Benfotiamine Coadministered with Thyroxine in Cisplatin induced Peripheral Neuropathy in Rats
Harshananda HM 1 , Hariprasad MG 1 , Razdan R 1 , Yasha TC 2
1 Department of Pharmacology, Al-Ameen College of Pharmacy, Bengaluru, Karnataka, India, 2 Department of Neuropathology, N.I.M.H.A.NS., Bengaluru, Karnataka, India
Objectives: To evaluate the individual and combination effects of Benfotiamine (BT) and Thyroxine (T4) in Cisplatin induced peripheral neuropathy (PN) in rats. Materials and Methods: PN was induced by administering Cisplatin 2 mg/kg, i.p twice weekly for 8 weeks. Rats were divided in to five groups: group I: normal control, group II: positive control received only Cisplatin, group III: positive control + BT (100 mg/kg p.o daily), group IV: positive control + T4 (1 mg/kg i.p twice weekly) and group V: positive control + BT and T4 for 8 weeks. At the end of study behavioural parameters like motor in coordination, thermal & cold hyperalgesia, grip strength, histopathological studies and electrophysiological properties of sciatic nerve like nerve conduction velocity were studied. Results: PN was evidenced in Cisplatin control rats as the behavioural parameters, histological features and electrophysiological properties of sciatic nerve were significantly altered (P < 0.001) compared to normal control. Treatment with BT, T4 and combination significantly improved (P < 0.001) all the above parameters when compared to Cisplatin control rats. Conclusion: Treatment with T4, BT, and combination effectively ameliorated many of the behavioural, electrophysiological and histological manifestations of Cisplatin induced peripheral neuropathy and the combination exhibited synergistic protective effect.
BHP-10
Effect of Acute and Chronic Administration of Nalbuphine on Motor Activity in Opiate Dependent Rats
Raghav R 1 , Jain R 1 , Roy TS 2 , Dhawan A 1 , Kumar P 2
1 Department of Psychiatry, National Drug Dependence Treatment Centre, New Delhi, India, 2 Department of Anatomy, All India Institute of Medical Sciences, New Delhi, India
Objectives: Nalbuphine, a κ-opiate agonist and μ-opiate partial antagonist, stimulate sκ- receptors and antagonizes the acute reinforcing/rewarding effects of morphine, has been widely used as an analgesic or an adjuvant with morphine. The aim of the present study was to compare the acute and chronic effect of nalbuphine on motor activity in opiate dependent rats. Materials and Methods: Male adult Wistar Albino rats (170-175 gms, N = 164) were made physically dependent by administrating increasing dose of morphine. Nalbuphine was co-administered acutely and chronically in variable doses (0.1, 0.3, 1.0, 3.0 mg/kg, i.p.) with morphine and saline in experimental and control group respectively. Motor activity was assessed for 25 minutes at 5 minutes interval on 0, 1 st , 3 rd , 5 th , 6 th day and animals were weighed prior monitoring. Results: Opiate dependent rats showed hyper-locomotion during withdrawal i.e., significant increase in the locomotor activity after naloxone challenge. Moreover, combination of acute dose of nalbuphine and morphine showed no effect on naloxone induced hyper-locomotion whereas chronic administration of morphine resulted in attenuation of hyper-locomotion in opiate dependent rats. Conclusion: These Results suggest that nalbuphine might be useful as pharmacological adjuncts in the treatment of opiate addiction (Supported by Indian Council of Medical Research, Govt. of India, and New Delhi).
IND
IND-1
Antilithic Activity of Citrus Medica Linn on Urinary Type's Struvite Crystals
Chauhan CK 1 , Joshi MJ 2 , Vaidya ADB 3
1 Government Science College, Gandhinagar, Gujarat, India, 2 Department of Physics, Crystal Growth Laboratory, Saurashtra University, Rajkot, Gujarat, India, 3 ICMR-Advanced Center for Reverse Pharmacology in Traditional Medicine, Kasturba Health Society, Vile Parle (West), Mumbai, Maharashtra, India
Objectives: Struvite-(NH 4 ) MgPO 4 .6 (H 2 O), ammonium magnesium phosphate hexahydrate is one of the components of urinary calculi. Struvite forms a painful urological disorder with life threatening complication known as "staghorn-calculi". Epidemiological studies report a frequency of the occurrence of struvite stones between 25% and 38%. In spite of surgical management the medical prevention of recurrent struvite calculi is greatly desirable. The need is to identify herbal formulation, which can inhibit struvite growth, in addition to high success rates, excellent safety profile and low side effect profile. Materials and Methods: In vitro single diffusion gel growth technique was used to study the growth-inhibition behavior of struvite crystals by using the juice of Citrus medica Linn. An aqueous solution of ammonium dihydrogen phosphate of 0.5 M concentration was mixed with the sodium metasilicate solution of specific gravity of 1.05 in appropriate amount to set the pH value 7.0. After the gelation took place, 20 mL supernatant solutions of pure 1.0 M magnesium acetate (control solution), and 1.0 M magnesium acetate prepared with different concentrations of the juice of Citrus Medica Linn. were gently poured on the set gels. Results: The number of struvite grown crystals and their dimensions and growth rate decreased with increasing concentrations of the juice of Citrus Medica Linn. The enhancement of dissolution rate of struvite crystals was also noticed. Conclusion: Citrus Medica Linn. Is found to have antilithic activity and proved as potent inhibitor for struvite. Results are important from reverse pharmacology point of view.
IND-2
Evaluation of Cysteine Protease Inhibitory Activity of some Antimalarial Plants
Vadalia J, Vekariya S, Sheth N, Raval M
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Cysteine proteases are responsible for many biochemical processes occurring in living organisms and they have been implicated in the development and progression of several diseases that involve abnormal protein turnover. Recent studies have shown that plasmodium expresses three papain-family cysteine proteases, known as falcipains, cysteine protease inhibitors blocked parasite haemoglobin hydrolysis and development, which is correlated with inhibition of falcipain-2, indicating that cysteine proteases play a key role in haemoglobin degradation, a necessary function of erythrocyte trophozoites. In this study methanolic and water extract of few plants having antimalarial activity (leaves of N. arbor-tristis, C. crista, A. excelsa, B. variegate, seed of. Aegyptiaca, entire plant of E. littorale, fruit of M. charantia) were screened for protease inhibitor activity. The present study was undertaken to evaluate Cysteine protease inhibitory activity of selected medicinal plants. Materials and Methods: Cysteine protease inhibition by papain inhibition assay was carried out for water and methanol extract of selected plants. Results: Comparative study of selected medicinal plants methanolic and water extract of N. arbor-tristis showed the maximum inhibition, 87.8051%, IC 50 - 13.03 μg/mL and 85.6189%, IC 50 - 16.54 μg/mL respectively. Conclusion: The present study has provided scientific validity to leaves of N. arbor-tristisagainst cysteine protease inhibition activity. Isolation of cysteine protease inhibitors may provide a lead compound for development of novel therapeutic agents.
IND-3
Pharmacological Review on Indian Wild Plant Caesalpinia Crista
Jivani P, Vadalia J, Mohaddesi B, Koradia K, Sheth N, Raval M
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Caesalpinia crista is plant growing throughout wild area of India. It is medium size plant. It is popular in indigenous system of medicine like Ayurveda, Siddha, Unani and Homoeopathy. The bitter principles Bonducin and Natin are the primary constituents of Caesalpinia crista apart from the linoleic acid, fatty acid, setasitosterol and different diterpenes which mainly believed to be responsible for its therapeutic action. In the traditional system of medicine various plant parts such as leaves, stem, root, seed and oils are used. The seeds have a long history in folklore use as anthelmintic and antimalarial. The plant has been recommended for the treatment of various diseases and disorders such as antispasmodic, malarial fever, leucorrhea, abdominal pain, rheumatoid arthritis, diabetes, cystic fibrosis, amenorrhoea, anthelmentic, febrifugal and to counteract toothache. The herb is used internally as well as externally. The present review attempts to detail information on pharmacology, traditional uses and current research prospects of the herb.
IND-4
In vivo Anti-oxidant Activity of Ethanolic Extract of Leaves of Adhatoda Vasica Nees in Dextran Sulphate Sodium induced Ulcerative Colitis in Rats
Patel J, Marsoniya Y, Chauhan R
B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India
Objectives: Present study was designed to evaluate protective effect of Adhatoda vasica Nees. In rats in an attempt to search safe, effective and economic treatment for ulcerative colitis and to study the antioxidant affect of Adhatoda vasica Nees. In homogenized colon tissue. Materials and Methods: Phytochemical screening was performed in the ethanolic extract of leaves of Adhatoda vasica Nees (EEAV). Dextran sulphate sodium (DSS) induced Ulcerative colitis model was used for present study. Rats were divided into six groups (n = 6) namely, vehical control, disease control, standard group (Sulphasalazine - 50 mg/kg) and test groups (EEAV-200, 400, 600 mg/kg). After 11 days, animals were sacrificed and evaluated for myeloperoxidase (MPO), malondiadehyde (MDA), super oxide dismutase (SOD) and catalase level in the homogenized colon tissue. Results: Phytochemical analysis of ethanolic extract of leaves of Adhatoda vasica shows presence of alkaloids, sugar, tannins, saponin, and phenols. Animal treated with EEAV were showed higher level of SOD and Catalase and lower level of MDA, MPO than that observed in disease group. These observations were comparable to that observed with standard group. Conclusion: Adhatoda vasica Nees significantly reduced the severity of the Ulcerative colitis produced by DSS. The antioxidant property might be responsible for this beneficial effect. Further studies are suggested to isolate the active principle responsible for the activity and necessary to confirm the exact mechanism of action.
IND-5
Phytochemical, Pharmacological Evaluation of Morinda Pubescens J.E.Sm. Bark Extract for Nephroprotective Activity
Jedage HD, Manjunath KP
Department of Pharmacognosy, College of Pharmacy, K.L.E. University, Hubli, Karnataka, India
Objectives: Free radical generation has a strong role in the pathogenesis of renal damage associated with the use of gentamicin. Therefore, the present study was carried out to evaluate the Nephroprotective effect of Morinda pubescens J.E.Sm. (Rubiaceae) against gentamicin induced nephrotoxicity. Materials and Methods: Nephrotoxicity was induced in male Wistar rats by intraperitoneal administration of gentamicin 100 mg/kg/day for ten days. The treatment was done with silymarin 50 mg/kg/p.o., water extract 200 mg/kg/p.o. and its ethyl acetate fractions 100 mg/kg/p.o. bark of M. pubescens was determined using parameters serum creatinine, urea, uric acid, blood urea nitrogen, albumin, protein, other parameters are kidney weight, body weight, urine volume and histopathology of kidney. Results: It was observed that the water extract and its ethyl acetate fractions bark of M. pubescens has brought back the altered levels of biochemical markers to the near normal levels in the dose dependent manner. In histopathological study the gentamicin-induced glomerular congestion, peritubular inflammation, tubular desquamation, tubular congestion, interstitial haemorrhage and odemaof the kidney cells were found to be reduced in the group receiving the bark extracts of M. pubescens along with gentamicin. Conclusion: The present study that water and its ethyl acetate fraction possessed Nephroprotective activity. The isolated fraction was found to exhibit greater Nephroprotective activity than the water extract.
IND-6
Antidiabetic and Anti-hyperlipidemic Activity of Premna latifolia Extracts in Streptozotocin-induced Diabetic Rats
Jeedi NM, Koti BC
Department of Pharmacology, K.L.E. University's College of Pharmacy, Huballi, Karnataka, India
Objectives: To investigate the antidiabetic and antihyperlipidemic effect of ethanolic extract of plant Premna latifolia leaves in Streptozotocin-induced diabetic rats. Materials and Methods: Extract was analysed for the presence of various phytoconstituents like carbohydrates, proteins, amino acids, steroids, triterpenoids, glycosides, saponin, flavonoids, alkaloids, tannins and phenolic compounds. Streptozotocin (55 mg/kg body weight, intraperitoneal) was administered to induce diabetes and hyperlipidaemia in adult rats. Extract (100 and 200 mg/kg) and glibenclamide (5 mg/kg) as standard drug were administered orally for 21 days to evaluate antidiabetic and antihyperlipidemic activity. Blood glucose, Serum content of total cholesterol, triglycerides, High Density Lipoprotein, Low Density Lipoprotein, insulin levels were estimated. Carbohydrate and lipid metabolizing enzymes like Glucose-6-phosphatase, Fructose-1, 6-diphosphatase, Phosphoglucoisomerase, Aldolase, Glucose-6-phosphate dehydrogenase, amylase and lipase level were also measured. Histopathology of pancreas was studied. Results: Experimental data indicated that extract normalizing the liver and pancreatic functions in Streptozotocin induced diabetic rats. Conclusion: Ethanolicextract of plant Premna latifolia leaves possesses both antidiabetic and antihyperlipidemic activities in the Streptozotocin induced diabetic rats. These findings support the conventional usage of Premna latifolia leaves for the treatment of diabetes.
IND-7
Evaluation of In-vitro Antimicrobial Activity of Cassia Auriculata Linn Bark.
Kumthekar A, Garge VN, Nikam SR, Kadam VJ
Bharati Vidyapeeth's College of Pharmacy, CBD Belapur, Navi Mumbai, Maharashtra, India
Objectives: Medicinal plants as potential source of therapeutic aid have secured an important role in health system all over the world in diseased conditions as well as potential Materials for maintaining proper health. Cassia auriculata has wide range of pharmacological actions hence the present study was undertaken to evaluate its efficacy against different bacterial and fungal species. The In-vitro antimicrobial activity of different extracts of Cassia auriculata Linn bark was carried out. Materials and Methods: The bark was subjected to soxhlet extraction and acetone and methanol extracts were prepared. These extracts were tested for Antibacterial activity using bacterial strains, Escherichia More Details coli Staphylococcus aureus, Bacillus subtilis and Salmonella More Details typhi. These extracts were also studied for the Minimum Inhibitory Concentration effect against Candida albicans. The agar disc diffusion Methods was used to determine Anti-microbial activity of both the extracts. Results: Minimum Inhibitory Concentration was determined and the Results were compared using different synthetic Anti-bacterial and Anti-fungal agents as reference standard. Conclusion: The present studies suggested that Cassia auriculata bark extracts have potential Anti-bacterial and Anti-fungal Activity. The inhibitory effect of the extract justified the medicinal use of Cassia auriculata bark and further study is required to find out the active component which is of utmost medicinal value against wide range of microorganisms.
IND-8
Comparative Preformulation Study of Different Formulations of Trikatu Churna
Gupta P, Nagwansi D, Gupta S
Rajiv Gandhi Institute of Pharmacy, Satna, Madhya Pradesh, India
Objectives: The present paper aims to investigate and standardize the trikatu churna formulation from different pharmacies on the basis of organoleptic characters, physical characteristics and physico-chemicalevaluation. Materials and Methods: Trikatu is a compound churna as it consists of more than one ingredient. It consists of coarse powder (sieve 40 size) of fruits of Piper longum, Piper nigrum and rhizomes of Zingiber officinale. Formulation was made by taking equal proportion of each powdered drugs. All the procured and authenticated individual drugs were dried in shade and cleaned by hand sorting. The individual drugs were then crushed using willing grinder and passed through mesh no. 40. The individual drugs were then weighed as per the quantity required. The drugs were mixed geometrically using a double cone blender (Kshitij innovations, ambala). The mixed formulation was unloaded, weighed, and packed in labelled glass bottles and standardization was done on the basis of organoleptic characters, physical characteristics and physico-chemicalevaluation. Results: The Results of various parameters obtained from the study showed that marketed formulations & In-house have comparable physical values. The flow ability of formulation was found to be poor in all formulations. There is no uniformity in preparation of formulations. Conclusion: The obtained Results could be utilized as a reference for setting limits for the reference standards for the quality control and quality assurance of these drugs.
IND-9
Effect of Kungiliya Vennai on Excision Wound Healing in Albino Wistar Rats
Bhat V 1 , Amuthan A 1 , Rosli BBM 2 , Khairuddin NAB 2 , Isa FSB 2
1 Department of Pharmacology, Melaka Manipal Medical College, Manipal University, Manipal, Karnataka, India, 2 MMMC, Melaka, Malaysia
Objectives: Kungiliya vennai (KV) is an indigenous siddha herbal formulation indicated for healing of wounds. Objectives of our study were to evaluate the wound healing property of topical application of KV in Albino Wistar rats. Materials and Methods: Three groups of eight Albino Wistar female rats each were used for the study. Under anesthesia, excision wound of 300 mm 2 size was created. Group 1 served as control. Groups 2 and 3 were applied with mupirocin and respectively daily until wound was completely healed. The wound contraction rate and epithelialization period was measured. Biopsy was taken on day 12 and after the wound healed, for histopathological examination. Results were analyzed by one-way ANOVA followed by Turkey's test, keeping p < 0.05 as statistically significant. Results: Qualitative examination of wound granulation tissue of KV treated rats showed increased vascularity, tissue eosinophils and regeneration of adnexal skin structures, which was not seen in other groups. The epithelialization period was significantly (p < 0.001) hastened in KV treated group compared to control group. Conclusion: Topical application of Promotes wound healing in rats. It additionally regenerates adnexal structures such as hair follicles, sweat glands and sebaceous glands.
IND-10
Isolation and Identification of Mastitis Causing Microorganisms from the Infected Milk and Use of Terminalia Chebula as an Alternative of Antibiotics to Treat Subclinical Mastitis in Cattle
Kher M, Bhatt V, Sheth N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Aim of the present study was to investigate isolation and identification of microorganisms from the infected cattle milk responsible for bovine subclinical mastitis and in-vitro effect of different extracts of plant Terminalia chebula against isolated microorganisms. Materials and Methods: Milk samples were collected from the affected cows from different cattle farms of Anand Agricultural University; Anand; Gujarat. Microorganisms from the milk were isolated by streak plate Methods (four flame Methods), and identified by staining technique and by biochemical tests. Extraction of Terminalia chebula fruit is carried out by using hot percolation Methods (Soxhlet apparatus Methods). Different extracts (Petroleum ether, Chloroform, n-Hexane, Ethyl acetate, n-Butanol, Methanol and Water) of Terminalia chebula fruit were tested against the isolated causative microorganism by antimicrobial assay using agar well diffusion Methods. Results: Gram positive as well as Gram negative bacteria were identified which includes Staphylococcus aureus, Streptococcus spp., Pseudomonas aeruginosa and Escherichia coli from the infected milk. Among the different extracts Ethyl acetate, Methanol and n-Butanol extract shows higher antimicrobial activity in comparison to antibiotic amoxicillin against E. coli. and P. aeruginosa. In case of S. Aureus ethyl acetate shows same activity as that of antibiotic amoxicillin. However in Streptococcus spp. A little decrease in activity observed in comparison to amoxicillin. While comparing activity of different extracts of Terminalia chebula, ethyl acetate extract show higher activity against all four isolated microorganism. Conclusion: It is concluded that Terminalia chebula possesses antibacterial activity against bacteria isolated from infected milk. The present work supports its use as an alternative herbal therapy against bovine subclinical mastitis.
IND-11
Preliminary Pharmacological Screening of Anti Cataract Activity of some Unexplored Medicinal Plants of Chhattisgarh State
Bodakhe SH, Namdeo KP
S.L.T. Institute of Pharmaceutical Sciences, G.G. Vishwavidyalaya (A Central University), Bilaspur, Chhattisgarh, India
Objectives: To investigate the anticataract activity of some medicinal plants. Materials and Methods: In this investigation anticataract activity was determined using cataract formation in ovine lens. Lenses were evaluated firstly for extent of opacity and secondly, for lens glutathione (GSH) levels. Based on traditional knowledge from local people in Achanakmar forest area of Chhattisgarh four plant namely Centella asiatica (Mandukparni), Phaseolus bilobus (Vanadrak) and Ailangium lamarckii (Akol) were collected, authenticated and air dried. Stem bark of Ailangium lamarckii, while leaves of Centella asiatica and Phaseolus bilobus were extracted with ethanol in Soxhlet apparatus. Whole-eye globes of goat removed immediately after slaughter was obtained from the local slaughterhouse in 100 ml Tyrode solution. The lens protective effect was determined by culturing freshly excised goat lenses in a Tyrode medium containing hydrogen peroxide (H 2 O 2 , 0.5 mM). Lenses were evaluated firstly for their ability to transmit light at different time intervals & by measuring the time taken for the lenses to become opaque (t op ) and secondly, for lens glutathione levels. Results: The extract of stem bark of Ailangium lamarckii prevented the opacification of the ovine lens induced by hydrogen peroxide in dose dependent manner. The extract also prevented the decline of GSH content caused by hydrogen peroxide. The extract of other plants did not show significant activity. Conclusion: The Results indicate that extract of stem bark of Ailangium lamarckii protect the cataract formation in ovine lens induced by hydrogen peroxide.
IND-12
Phytochemical and In vitro Anthelmintic Activity of Momordica Charantia Linn. Fruit Extracts
Bagada A, Gandhi V, Vadalia J, Raval M
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Momordica charantia or bitter melon, also known as balsam pear or karela, is a tropical vegetable, is a common food in Indian cuisine and has been used extensively in folk medicine as a remedy for diabetes. As per mentioned in Ayurveda it is also used as abortifacient, anthelmintic, contraceptive, eczema, antimalarial, galactagogue, gout, Jaundice, abdominal pain, kidney (stone), laxative, leprosy, leucorrhea, piles, Pneumonia, Psoriasis, Purgative, rheumatism, fever and scabies. It is mention as anthelmintic and as krimiroga in Ayurveda although no more work done on extract of Momordica charantia. Materials and Methods: In this works anthelmintic activity of methanolic and water extracts were checked on earth worms Eisenia foetida. Also the successive extraction petroleum ether, chloroform, ethyl acetate, methanol and hydroalchoholic extracts were checked at conc. 5 mg/ml and 10 mg/ml. Results: Methanolic and water extract shows death time at 139 min & 152 min respectively at 10 mg/ml dose. While in successive extraction chloroform extract shows more potent activities than any other fractions. Conclusion: Activity is probably due to presence of alkaloids and steroidal triterpenoids present in it. Hence the anthelmintic activities of Momordica charantia is proved as per mentioned in Ayurveda further need to isolate the compound which is responsible for it.
IND-13
To Evaluate Anticonvulsant Activity of Aqueous Extract of Cuminum cyminum Linn. in Albino Rats
Singh A, Khichi KK, Chouhan O, Gehlot A, Rathore R, Trehan N
Department of Pharmacology, Dr. S.N. Medical College, Jodhpur, Rajasthan, India
Objectives: To evaluate anticonvulsant activity of aqueous extract of Cumimum cymimum in Albino rats. Materials and Methods: Adult male Albino (100-150 gm) rats were used as experimental animals for Maximal Electroshock Seizure Methods (MES) to study the anticonvulsant activity and divided in to three groups under study. Group I consisting of six animals served as control and received distilled water. Group II subdivided in to II-A, II-B, II-C (n = 6) received Cumimum cymimum in the doses of 300 mg/kg, 750 mg/kg and 1000 mg/kg per orally, respectively. Group III sub divided in to III-A, III-B, III-C received Phenytoin 25 mg/kg, 40 mg/kg and 50 mg/kg p. o., respectively. Results: Cumimum cymimum decreased extension period, although the extension period was not significant (P > 0.05) in 300 mg per kg dose, while the extension period was highly significant (P < 0.001) in higher doses (750, 1000 mg per kg). Phenytoin has highly significant the extension period (P < 0.001) in all the three doses. "Student's t-test" was used to compare different groups. Conclusion: From this preliminary evaluation it can be concluded that the use of Cumimum cymimum can be used as anticonvulsant agent at higher doses (750, 1000 mg/kg p.o.). Further, detailed research is yet to be done, as it may prove to be clinically sound.
IND-14
Antimutagenic assay of some Indigenous medicinal plants
Rehman S, Latif A
Department of Ilmul Advia, Faculty of Unani Medicine, Aligarh Muslim University, Uttar Pradesh, India
Objectives: Realizing the up striking rate of mutagenic and cancer like diseases, a study plan was designed to search for some alternatives from Indigenous drugs of natural origin from Unani System of Medicine on the basis of ethno botanical and phytochemical data. A hypothesis was made to analyze their potential to kill or inhibit the growth of cells for Antimutagenic activity. Materials and Methods: Aqueous extracts of Chirayita (Swertia chirayita Linn.) whole herb, Banafshah (Viola odorata Linn.) leaves and flowers and Mamiran (Coptis teeta Roxb.) rhizome were tested for their Antimutagenic potential. The Salmonella Histidine point mutation assay of Maron and Ames (1983) was used with partial modifications as described by Kaur et al., (2000). Results: At a dose of 50 μg/0.1 ml/plate, the extracts exhibited the inhibition of His + revert ants from 36.59% to 96% against direct acting mutagen sodium Azide (NaN 3 ) induced mutagenicity in Salmonella typhimurium tester strains TA97, TA98 and TA100. However, at lower concentrations (5 and 25 μg/plate) of the plant extracts, a decrease in Antimutagenic activity was recorded. Aqueous extracts, at tested concentrations, showed no sign of mutagenicity to tester strains. Conclusion: Plant extracts exhibited potent Antimutagenic activity of Banafshah followed by Chirayita and Mamiran. Dose dependent Antimutagenic activity of the extracts is also evident from linear regression analysis of the data. Qualitative analysis reveals the presence of active photoactive constituents as flavonoids, phenols present in the tested extracts which are responsible for their Antimutagenic activity.
IND-15
Nephroprotective Activity of Elwa (Aloe Barbadensis) in Eat Models
Aslam M, Rehman S, Kalim J
Department of Ilmul Advia, Faculty of Medicine (Unani), Jamia Hamdard, New Delhi, India
Objectives: Chronic kidney disease is a debilitating condition responsible for high morbidity and mortality. Globally, CKD is the 12 th cause of death and the 17 th cause of disability, respectively. It is estimated that 1,00,000 new patients of end stage renal disease (ESRD) enter renal replacement programs annually in India. Aloe barbadensis known as Elwa in Unani system of medicine, used to cure many diseases including the treatment of renal disorders since ancient time by the Unani physicians, but no scientific data have yet been undertaken to verify these claims. The present study is an attempt to screen A. barbadensis for its Nephroprotective activity on scientific parameters. Materials and Methods: In the present study, the effect of Aloe barbadensis at a dose of 350 and 1260 mg/Kg was investigated on gentamicin-induced (100 mg/Kg) nephrotoxicity in rats, by monitoring levels of blood urea nitrogen (BUN), serum creatinine and histopathological examination of kidney. Results: The Results showed that Aloe barbadensis significantly normalized the increased blood urea and serum creatinine level indicating its protective activity. The histopathological examination reported features of renal necrosis like Glomerular congestion, glomerular infiltration, tubular cell swelling caused by gentamicin. The dried gel of Aloe barbadensis markedly prevented the histopathological features of tubular necrosis. Conclusion: The findings suggest that the Aloe barbadensis possesses marked Nephroprotective activity with minimal toxicity and could offer a promising role in the treatment of renal injury caused by nephrotoxins like gentamicin.
IND-16
Evaluation of the Clinical Effect of Poly Herbal Compound in the Management of (Bronchial Asthma) Tamakaswasa and Study the Vasaka (Adhatoda Vasica Nees) in Silico Approach
Rigom Pegu 1 , Sarma B 1 , Borua R 1 , Sinha S 2 , Johari S 2 , Ghosh A 3
1 Government Ayurvedic College and Hospital, Guwahati, Assam, India, 2 Center for Bioinformatics Studies, Dibrugarh University, Dibrugarh, Assam, India, 3 Department of Bio Technology, Indian Institute of Technology, Guwahati, Assam, India
Objectives: Tamaka Swasa (Bronchial Asthma) a syndrome characterized by airflow obstruction with reduced airflow, wheezing and dyspnoea. An open clinical trial was conducted on 60 patients of either sex between 10-70 years age to assure the clinical response of herbal compound against bronchial asthma at Department of Kayachikitsa, Govt. Ayurvedic College & Hospital, and Guwahati-14. An attempt has also been made to identify the potential drug target of Asthma followed by molecular interaction of Vasak compounds with the target protein of Asthma. Materials and Methods: Clinical trial has been conducted as per standard Ayurvedic procedures with modern investigations and molecular docking studies have been performed using AutodockVina. Results: The clinical trial Results show clinical and symptomatological improvement. Also, improvement in Peak Expiratory Flow Rate suggesting broncho-dilator effect, significant reduction of AEC and ESR was observed showing anti-allergic effect of the drug. During the course of treatment no any adverse effects were noticed. Molecular docking studies of all Screened 8 (eight) ligands out of 12 (twelve) phytochemicals of Adhatoda vasica with target protein of Asthma (IL 3, IL 4, IL 5, IL 13, TNF-α and EOTAXIN) shows Vasicinolone to be most potent ligand that binds with IL-5 at the most minimum binding affinity of -7.7 kcal/mol. Conclusion: In India we have ocean of medicinal plants and treasure of knowledge for the perfect use of that medicinal plants. Charak Samhita, Shusrut Samhita of Ayurveda States Vasak (Adhatoda vasica) as the remedy for Asthma. So a clinical and molecular level study was made to identify the potent drug candidate against Asthma.
IND-17
Evaluation of Effect of Nishamalaki on Stz and Hfhf induced Diabetic Neuropathy in Wistar Rats
Dawane J, Pandit V, Khatavkar P, Bhosle M
Department of Pharmacology, Bharati Vidyapeeth Deemed University Medical College, Pune, Maharashtra, India
Objectives: Diabetic neuropathy is one of the most common complications affecting 50% of diabetic patients. Neuropathic pain is the most difficult types of pain to treat. There is need of new effective drug tested with perfect animal model mimicking a human disease. Nishamalaki, combination of Curcuma longa and Emblica officinalis used to treat Diabetes mellitus. To evaluate the effect of Nishamalaki in STZ & HFHF induced diabetic neuropathy in type 2 diabetic Wistar rats. Materials and Methods: Group I (Control) vehicle treated consists of 6 rats. Diabetes induced in 36 Wistar rats with Streptozotocin (35 mg/kg) intra-peritoneally followed by high fat high fructose diet. 4 weeks after confirmation of development of diabetes; rats divided into six groups of (n = 6). Group II - VII Diabetic Control, NA low dose, NA High dose, Glibenclamide, Pioglitazone and Epalrestat. Animals received drug treatment for next 4 weeks. Monitoring of BSL done every 15 days & Lipid profile at the end. Eddy's hot plate and tail immersion test performed to assess thermal hyperalgesia and cold allodynia. Walking function test performed to assess motor function. Results: Diabetic rats exhibited significant (p < 0.01) hyperalgesia, increased BSL and decreased body weight compared with control rats. Dose-dependent improvement observed in thermal hyperalgesia & cold allodynia in NA groups. Results of Nishamalaki were comparable with Glibenclamide and more effective than Epalrestat and Pioglitazone. Nishamalaki improved lipid profile. Conclusion: Nishamalaki is effective in controlling hyperglycaemia and reduced neuropathic pain in diabetic rats. Nishamalaki delayed progression of diabetic neuropathy.
IND-18
Preparation and Evaluation of an Ayurvedic Formulation: Vati
Gupta S, Singh N, Gupta M
Department of Pharmaceutical Science and Technology, AKS University, Satna, Madhya Pradesh, India
Objectives: The Objectives of the present paper is to formulate and evaluate the Ayurvedic Vati on the basis of organoleptic characters, physical characteristics and physico-chemicalevaluation. Materials and Methods: The crude drugs used in preparation were purchased from the local Market and were identified and authenticated. Physico–chemical studies like total ash, acid insoluble ash, water & alcohol soluble extract, loss on drying and successive extractive values by cold maceration Methods were carried out as per the WHO guidelines. Preliminary phytochemical tests were performed as per the standard Methods. Results: The compound formulation powder is brownish, dust coloured with a characteristic spicy odour and taste. Physicochemical data was subjected to various analytical parameter average value of total ash content (5.56%), acid insoluble ash (0.985%), alcohol soluble extractive (12.35%), water soluble extractive (56.5%), loss on drying at 105°C (6.29%) and pH value (5.05). Conclusion: The set parameters were found to be sufficient to evaluate the vati and can be used as reference standards for the said formulation which will be part of the quality assurance for these formulations.
IND-19
Pharmacological Evaluation of Standardized Extract of Centella Asiatica L. Urban Leaves on Benign Prostatic Hyperplasia in Male Wistar Rats
Aswar M 1 , Aswar U 1 , Mahajan U 1 , Nerurkar G 1 , Mohan V 2 , Thakurdesai P 2
1 Department of Pharmacology, Sinhgad Institute of Pharmacy, Narhe, Pune, India, 2 Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, India
Objectives: Evaluation of standardized extract of Centella asiatica (L.) Urban leaves (INDCA) on testosterone induced benign prostatic hyperplasia (BPH) in rats. Materials and Methods: BPH was induced with testosterone (3 mg/kg, S.C.) in olive oil for 4 weeks in male Wistar rats. The rats were randomized into different groups and administered with vehicle (as BPH control), INDCA (15, 30 or 60 mg/kg, p.o.) or finasteride (10 mg/kg, p.o.) or their combinations for 4 weeks along testosterone administration. Normal group without any treatment was also maintained. The behavioural parameters were recorded on 0 th , 28 th , 42 nd and 56 th day of study. The hormonal (in serum) and biochemical parameters (in serum) and molecular parameters (in prostate tissues) were measured ex vivo. Results: Sub acute (28 days) of testosterone administration induced BPH related behavioural parameters (increased anxiety and suicidal related traits and decreased body weight and locomotor activity) in BPH control rats. BPH control rats also showed up-regulated expression of enzymes (5α reductase 1 and 2, aromatase, SGK-1), increased serum hormone (free, bound and total testosterone, DHT and cortisol) levels, decreased urinary function related biochemical (24-h urine output and creatinine clearance) parameters on day 56 of the study. Sub acute treatment of INDCA in established BPH induced rats showed amelioration of behavioural, biochemical, hormonal, and biochemical (urinary function) parameters alone and in combination with finasteride as compared to BPH control rats. Conclusion: INDCA showed good therapeutic efficacy against testosterone induced BPH in rats and can be considered for further development.
IND-20
Preventive Effect of Pimpinella Anisum in Experimental Cataract
Bhadada SV 1 , Patel S 2 , Johar K 3
1 Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India, 2 Torrent Research Centre, Ahmedabad, Gujarat, India, 3 Iladevi Cataract Research Centre, Ahmedabad, Gujarat, India
Objectives: Cataract remains the leading cause of blindness in middle and low income countries for which no efficacious medical therapy is available. Oxidative and osmotic stress Results in gradual loss of lens transparency and is implicated in senile and diabetic cataract. Essential oil of Pimpinella anisum (Aniseed oil) possesses rich content of trans-anethole which possesses good antioxidant property. The Objectives of the study was to evaluate the effect in senile and diabetic cataract by in vitro hydrogen peroxide induced cataract and in vitro aldose reductase inhibitory activity. Materials and Methods: Anissed oil was evaluated for total phenolic and flavonoid content and qualitative confirmation by HPTLC for the presence of trans-anethole. The lenses cultured with hydrogen peroxide were pre-treated with the essential oil. Its in-vitro aldose reductase inhibitory activity was also evaluated. Further, molecular docking study was performed with aldose reductase for its known constituents. Results: Cataract was developed by hydrogen peroxide and the oil showed protective effect compared with the disease control lenses as seen in the stereoscopic and transparency images. The protective effect was confirmed by the improvement in the soluble protein levels and antioxidant parameters. Also, trans-anethole showed interactions with the important active site amino acids residues of aldose reductase enzyme. Conclusion: Our data suggests that Aniseed oil may be effective in preventing the development of senile cataract in the rat lens as shown by the improvement in the oxidative stress. It also shows significant inhibition of aldose reductase enzyme and thus may be helpful in diabetic cataract.
IND-21
Evaluation of Anti Hyperglycemic Effect of Aqueous Extract of Centella Asiatica in Experimental Animals
Choudhury RS, Roy D
Department of Pharmacology, Silchar Medical College and Hospital, Silchar, Assam, India
Objectives: Diabetes Mellitus, a major health issue throughout the world, needs newer drugs to control it adequately as well as provide options for safer and more cost effective therapies. Centella asiatica (C. asiatica), from previous studies, has been found to have antihyperglycemic effects in diabetic model rats. Our study aims at further establishing the anti-diabetic property of C. asiatica. To evaluate the anti-hyperglycaemic effect of aqueous extract of Centella asiatica in alloxan induced diabetic male Albino rats. Materials and Methods: Aqueous extract of Centella asiatica was obtained. The male Albino rats were randomly divided into 6 groups, each receiving intraperitoneal injection of freshly prepared alloxan monohydrate. Three groups were treated with the test sample (C. asiatica) in three different doses (50, 100 and 200 mg/kg). Glibenclamide was taken as the standard hypoglycaemic drug for another group. A positive and a negative control were maintained. Blood glucose levels were estimated after fasting as well as following treatment with test sample/standard. All Results were expressed as the mean ± Standard Deviation and data were compared using ANOVA and paired/unpaired t-test. A confidence level of 0.05 was considered significant. Results: The aqueous extract of C. asiatica reduced blood glucose levels in all groups, with most significant reduction seen at the dose of 200 mg/kg. Conclusion: The study shows significant antidiabetic properties of aqueous extract of C. asiatica at a dose of 200 mg/kg in alloxan induced diabetic rats.
IND-22
Pharmacological, Clinical Research Based Prospective and Siddha Concepts Aiding Authentication of Cirunagapoo Used in Few Siddha Compound Formulations: An Updated Review
Deepa B
Pharmacopoeial Laboratory for Indian Medicine, Ghaziabad, Uttar Pradesh, India
Objectives: Authentication is a challenge in the prevailing and present day trend of adulteration and substitution. So, an attempt to update the Scientific research, in support of Authentication of Siddha herbal drug Cirunagapoo (Cinnamomum wighitii Meissen.-Lauraceae), has been aimed for, as it is named Naakhesaram in Sanskrit. Materials and Methods: This review- Describes: the Phytochemical, pharmacological and clinical studies conducted till date on Cirunagapoo (Cinnamomum wighitii Meissn. Lauraceae.). Sorts: the inclusion of the drug in selected Siddha Compound Formulations, in the Siddha classical texts. Correlates: The research with each of the indications prescribed for the single drug and in the selected Formulations. Compares the updates of other drugs in the name of Nagakesara namely, Mesua ferrea Linn. (Guttiferrea), Ochrocarpus longifolius Benth & Hook. F (Guttiferrea), Calophyllum inophylum Linn. (Guttiferrea) and Dillenia pentagyna Roxb. (Dilleniaceae) available in market. Research papers show evidences of Crocus sativus as a substitute for Mesua ferrea. Conclusion: For formulating officially or for standardization, authentication is the first step. But, this study justifies it in a reverse pharmacological manner, with siddha concepts, in a theoretical way of discussion to make authentication of Cirunagapoo, clear and easier admist crux. This scientific update would provide research data to fill up the lack of evidences, to meet them in future, as to strongly authenticate Cirunagapoo and in a view that the genuinity is not only in naming but also in its final target of treating the prescribed disease.
IND-23
Effectiveness of Diosgenin in Experimental Benign Prostatic Hyperplasia in Rats
Gandhi S, Patel E, Patel P, Patel B, Vyas B
Objectives: To study the effectiveness of Diosgenin in experimentally induced benign prostatic hyperplasia in rats and to find probable mechanism involved in the treatment. Materials and Methods: Benign prostatic hyperplasia in rats was induced by subcutaneous injection of testosterone (5 mg/kg) daily for 28 days. A negative control group received Arachis oil (1 ml/kg, SC), a model group received testosterone subcutaneously and a test group in addition to daily dose of testosterone received diosgenin 100 mg/kg/alternative days. On 28 th day after dosing, urine volume for 5 hr. of each rat were collected and measured. On 29 th day, rats were sacrificed and body weight, prostate weight, prostate length, prostate width, testis weight, seminal vesicle weight, serum testosterone level, total protein in prostate and biochemical parameters were measured and histological studies were carried out. Further in vitro analysis of Diosgenin on contractility of isolated rat vas deferens and prostate gland produced by exogenously administered agonists were carried out. Results: Treatment with diosgenin at alternative days for 28 days Resulted in significant inhibition of prostate growth. Diosgenin had significantly increased serum testosterone level. In histopathological analysis of prostate gland showed improvement in architecture of prostate cells in diosgenin. Diosgenin also significantly attenuated the biochemical parameters that directly or indirectly correlated with BPH. Results of in vitro experiment suggest that diosgenin had attenuated the contractile responses of isolated vas deferens to exogenously applied agonist. Conclusion: In conclusion, our data suggest that diosgenin significantly inhibited the prostate growth and shows protective effect in experimentally induced benign prostatic hyperplasia.
IND-24
Phytochemical and Pharmacological Screening of Aqueous and Ethanolic Extracts of Ficus Racemosa Linn. Stem Bark
Godinho MHS, Rivonker PC, Patkaro L
Goa College of Pharmacy, Goa, India
Objectives: To evaluate the phytochemical constituents and pharmacological activities of aqueous and ethanolic extracts of Ficus racemosa Linn. Materials and Methods: CNS activities, viz., antianxiety (Elevated plus maze, Restraint stress test), spontaneous behaviour (Opto-Varimax Auto-Track system), muscle coordination (Rotamex) and effect on learning and memory (Morris water maze), were investigated using Aqueous extract at a dose of 200 mg/kg and ethanolic extract at doses of 200 mg/kg and 400 mg/kg b.w. administered by oral route for a period of seven days. The control used was 2% Tween 80 prepared in distilled water. Diazepam (2 mg/kg) was used as standard drug. The ethanolic extract was screened for anthelmintic activity on adult earthworm, Eudrilluseuginae where albendazole and pyrantelpamoate were used as standards. Results: The rats which received the ethanolic extract at a dose of 400 mg/kg showed significant antianxiety activity. Aqueous extract at a dose of 200 mg/kg showed moderate muscle relaxant activity. Ethanolicextract of Ficus racemosa Linn. also showed cognitive improvement having effect on probe memory and significant anthelmintic activity at a concentration of 50 mg/mL by causing paralysis. Conclusion: Based on the findings of the present study, it can be concluded that the Ficus racemosa Linn. Extracts may find use in the management of anxiety, helminth infection, as a muscle relaxant and may enhance learning and memory.
IND-25
Preclinical Studies of Arogyavardhini Vati in High Fat-fructose Fed Prediabetic Rats
Waghmare RS 1 , Nakanekar A 2 , Tatke PA 1
1 C.U. Shah College of Parmacy, S.N.D.T. Women's University, Mumbai, Maharashtra, India, 2 Government Ayurved College and Hospital, Nagpur, Maharashtra, India
Objectives: Diabetes, if detected and treated at prediabetic stage can be reversed. Ayurveda, traditional medicine system of India, recommends the use of plant based medicines as well as Mineral based medicines for treating assorted disease conditions. Arogyavardhini Vati is one such formulation indicated in obesity related metabolic disorders. The present study aims at preclinical evaluation of Arogyavardhini vati in prediabetes rats. Materials and Methods: The high fat diet (HFD) comprising of approximately 65-70% fat and fructose was fed to rats for 15 weeks to induce Prediabetes. Arogyavardhini vati was given per orally at dose level of 200 mg/kg/day for 4 weeks along with continuation with feeding HFD. Pioglitazone (3 mg/kg/day) was used as the standard. Weight and fasting blood glucose levels estimated weekly. The biochemical parameters were estimated on day 0 and every month and at the end of intervention. Results: Prediabetic rats treated with Arogyavardhini vatishowed significant decrease in blood glucose levels and biochemical parameters. Reduction in lipid levels, attenuation of blood urea nitrogen, serum Creatinine and liver markers indicated that the Arogyavardhini vati also improved renal and liver dysfunction associated with prediabetic hyperglycemia. Conclusion: Arogyavardhini vati can be considered as promising candidate for treatment of prediabetic conditions. Different crude drugs and metallic constituents present in the Arogyavardhini vati contributed in the hypoglycemic effect.
IND-26
Phytochemical and Pharmacological Screening of Aqueous and Ethanolic Extracts of Moringa Oleifera Lam. Stem Bark
Noronha ED, Godinho MHS, Kudchadkar CV
Objectives: To evaluate the pharmacological effects of Moringa oleifera Lam. stem bark extract on the central nervous system of rats, investigate its anthelmintic activity and carry out preliminary screening of its phytoconstituents. Materials and Methods: The CNS activities, viz., anti-anxiety, spontaneous behaviour, muscle coordination, analgesic and effect on learning and memory, were investigated in male Wistar Albino rats, using the Elevated plus Maze, Opto-Varimex Auto-Track system, Rotamex, Hot plate analgesiometer and Morris water maze respectively. The restraint stress model was used to induce anxiety in the animals. 2% Tween 80 served as the control and Diazepam (2 mg/kg) as standard for anti-anxiety activity and muscle coordination. Pentazocine (5 mg/kg) served as standard for analgesic activity. The anthelmintic activity was carried out on a species of earthworm i.e. Eudrillus euginae. Results: The aqueous extract of Moringa oleifera showed significant anti-anxiety effect and analgesic activity when compared with the control, highest at 200 mg/kg. The aqueous extract also revealed additional anthelmintic activity at 100 mg/ml seen through the paralysis of worms. Ethanolic extract showed good muscle relaxant activity at a dose of 400 mg/kg. Conclusion: The Results suggest that the aqueous extract of Moringa oleifera has significant anti-anxiety as well as analgesic effects in rats. The ethanolic extract shows good muscle relaxant activity. Both activities could be attributed to the presence of various phytochemical constituents like flavonoids, tannins etc. The aqueous extract additionally showed anthelmintic activity, the exact mechanism of which has to be further investigated.
IND-27
Pharmacological Investigation of Aqueous and Ethanolic Extracts of Adina Cord Folia Roxb. on the Central Nervous System of Rats
Fernandes A, Joshi MP, Mendonça C
Objectives: To study the pharmacological activity of aqueous and ethanolic extract of the stem bark of Adina cordifolia Roxb. along with an isolated compound quercetin, on the central nervous system of rats. Materials and Methods: Wistar/Sprague Dawley Albino rats of either sex weighing about 150-200 g were divided into 8 groups. Aqueous and ethanolic extracts at two doses (100 and 200 mg/kg p.o.) and quercetin (50 mg/kg p.o.) which was extracted by column chromatography were used as test extracts. Diazepam and Pentazocine served as positive controls (4 mg/kg i.p. and 5 mg/kg i.p. respectively) and 1% tween 80 served as control. The study was carried out for a period of 7 days. The activities evaluated Anti-anxiety activity using elevated plus maze, locomotor activity using Optovarimex and Rotamex, and analgesic activity via Hot plate analgesiometer. Statistical analysis was carried out using one way ANOVA followed by Dennett's test. The software used was Graph Pad Instat. Results: It was found that the aqueous and ethanolic extracts showed CNS depressant, muscle relaxant activity and also to some extent analgesic and anti-anxiety activity. However Quercetin which was isolated showed higher activity than any of the groups. Conclusion: The Results show that Adina cordifolia Roxb. possesses the compound quercetin, which shows potential CNS depressant, muscle relaxant, analgesic and anti-anxiety effect. However further investigation will be required to establish this claim.
IND-28
Phytochemical and Pharmacological Screening of Ethanolic and Aqueous Extracts of Crossandra Infundibuliformis (L.) Nees Leaves
Gomes H, Godinho HMS, Nogueira C
Goa College of Pharmacy, Goa, India
Objectives: The study was aimed at screening the ethanolic and aqueous extracts of leaves of Crossandra infundibuliformis (L.) Nees for pharmacological activity and phytochemical constituents. Materials and Methods: The effect on the central nervous system of rats was investigated using the Elevated plus Maze, Rota rod, Auto track Hot Plate Analgesiometer and Morris water maze for anti-anxiety activity, muscle relaxation, spontaneous behaviour, analgesic activity and learning and memory respectively. Anthelmintic activity of ethanolic extract was evaluated, while brine shrimp lethality assay and MTT assay were performed for cytotoxic activity. 2% Tween 80 was used as the control. Diazepam (2 mg/kg) and Pentazocine (5 mg/kg) were used as standard drugs. The Results were statistically analysed using one way ANOVA by Dunnett's test. Results: The rats which received the aqueous extract at a dose of 200 mg/kg showed a Significant increase in %OAE and %TSOA in the EPM and restraint stress test. Ethanolic extract at the dose of 400 mg/kg showed a statistically significant increase in the reaction time on the Hot plateanalgesiometer. Both ethanolic and aqueous extracts did not show any significant effect on Rotamex as well as the Auto-Track system. Ethanolic extract of the leaves also exhibited anthelmintic activity at given concentration the extract was also found to be non-cytotoxic. Conclusion: The aqueous extract of leaves of Crossandra infundibuliformis (L.) Nees, administered at a dose of 200 mg/kg, shows good anti-anxiety activity. This could be due to the presence of various phytochemical constituents like flavonoids and tannins.
IND-29
Hepatoprotective Effect of Stevioside Against Lipopolysaccharide-induced Liver Injury in Wistar Rats
Perumal Y 1 , Choudhary S 2 , Ray RS 2,3 , Latha S 2
1 Department of Pharmacology, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India, 2 Department of Pharmacology, Delhi Institute of Pharmaceutical Sciences and Research, University of Delhi, New Delhi, India, 3 Dr. B.R. Ambedkar Center for Biomedical Research, University of Delhi, New Delhi, India
Objectives: Lipopolysaccharides (LPS), a bacterial endotoxin when administered systemically is capable of producing hepatotoxic response. Stevioside, diterpenoidal glycoside is abundantly found in the leaves of Stevia rebaudiana (Asteraceae) Composite family which possess antioxidant, anti-inflammatory and immunomodulatory activities. The present study investigates the hepatoprotective effect of Stevioside in lipopolysaccharide induced liver injury. Materials and Methods: Wistar Rats were challenged with single dose of lipopolysaccharide (5 mg/kg) intraperitoneally. Experimental animals were subdivided into 3 groups viz. Normal, LPS treated (5 mg/kg i.p.) and Stevioside (250 mg/kg p.o) + LPS treated animals. Results: Stevioside treatment significantly attenuated the LPS induced liver injury as evident from the altered levels of Glutathione, SOD and Catalase. Furthermore, Stevioside restores liver functions by altering the level of liver enzymes such as SGOT and SGPT indicating its hepatoprotective potential. Conclusion: Thus, Stevioside exerts excellent hepatoprotective properties against inflammatory stimulants and infectious microbes.
IND-30
Screening of Novel Specific Inhibitor for MMP1
Patra S, Patra S
Department of Biological Science and Bioengineering, Indian Institute of Technology, Guwahati, Assam, India
Objectives: Matrix metalloproteinase-1 (MMP-1) is an instigator of collagenolysis; the catabolism of triple helical collagen. The regulated collagenolysis in the extracellular matrix is an important homeostatic process. However, loss of collagen lytic control causes various disorders, suggesting that its inhibition may open therapeutic avenues. Known inhibitors are not selective, leading to undesired side effects. Thus, the understanding of the structure-function relationship in MMP1 and its inhibition by natural molecules requires further exploration. The Objectives of the present investigation are: Virtual screening of various natural compounds for their activity against MMP-1, Production docking run with the top ranked compounds and their comparison by docking of reported inhibitors to select a "better" drug. Materials and Methods: Docking was performed with 20 reported inhibitors as control. Virtual screening was performed using the aforementioned as scaffolds of 2103 derivatives from ZINC database. Raccoon and Autodock 4.2 were employed for the same. Top ten hits were selected based on their lowest free energy of binding and inhibition constant. The specificity of the selection process was further validated by molecular docking of 100 GA run through Autodock 4.2. Results: Out of 10 top hits, four compounds showed highest affinity for MMP1. By comparing the docking Results with 20 reported MMP1 inhibitors it was found that compound ZINC02436922, a phenolic compound was the best compound which showed better interaction with seven hydrogen bond formation and -10.20 of lowest free energy of binding in the active site of MMP1. ZINC02436922 also follows the drug likeness properties as per Lipinski rule of five. Conclusion: This study indicated that ZINC02436922 a derivative of compound EGCG performed better than available known inhibitors.
IND-31
Anxiolytic Activity of Lyophilized Succulent of Aloe Vera (L.) in Mice
Kothari S 1 , Singhal T 1 , Kumar R 2
1 Department of Pharmacology, G.R. Medical College, Gwalior, Madhya Pradesh, India, 2 Department of Pharmacology, S.N.B. Medical College, Jabalpur, Madhya Pradesh, India
Objectives: Aloe vera is succulent plant widely used in cosmetics and alternative medicine industries. There is little scientific evidence of the effectiveness of Aloe vera succulent for treatment of anxiety like states. Therefore present study is planned to evaluate antianxiety activity of Aloe vera succulent using animal models of anxiety. Materials and Methods: Anxiolytic activity of lyophilized succulent (LS) of Aloe vera at the dose of 100, 200 and 300 mg/kg and standard drug alprazolam 5 mg/kg were studied using elevated plus maze and light dark box. Effects were observed on (a) time spent on (b) number of entries into (c) number of stretch attend postures (d) number of head dips in arms of elevated plus, whereas total time of stay in dark and light box, number of entries and rears in light box were studied using light and dark box model. Results: Showed that LS of Aloe vera at the dose of 200 and 300 mg/kg significantly (P < 0.05) increased proportionate time spent on and number of entries into open arms number of stretch attend postures and head dips in closed arms in elevated plus maze and time of stay, number of entries and rearing in light area in light and dark box model respectively. Effects of LS of Aloe Vera at the dose of 300 mg/kg were comparable with alprazolam 5 mg/kg using both the models. Conclusion: Lyophilized succulent of Aloe vera produced dose dependent significant antianxiety activity.
IND-32
Phytochemical and Pharmacological Screening of Ethanolic and Aqueous Extracts of the Leaves and Stalks of Apium Graveolens on Rats
Joshi MP, Fernandes J, Jha MK
Goa College of Pharmacy, Goa, India
Objectives: To evaluate the phytochemical constituents and to study the pharmacological effects of the aqueous and ethanolic extracts of the leaves and stalks of Apium graveolens on rats. Materials and Methods: Aqueous extract at a dose of 200 mg/kg and the ethanolic extract at doses of 200 mg/kg and 400 mg/kg were administered to rats for seven days. Diazepam was used as the positive control for anti-anxiety activity, muscle relaxation and spontaneous behavior and pentazocine for analgesic activity. The test for learning and memory was conducted for six days. Pentobarbital Potentiation test was conducted for the ethanolic extract at a dose of 400 mg/kg and flumazenil was used to establish the mechanism of action. Tween 80 was used as the control for all the tests. Results: In the test conducted using the EPM, the rats that were administered 400 mg/kg ethanolic extract showed an increase in the %OAE and %TSOA indicatinganti-anxiety activity. All the three test groups showed a significant increase in RT, and decrease in AT and RT for spontaneous behaviour which suggested CNS depressant activity. None of the test groups showed muscle relaxant activity, analgesic activity or any improvement in learning and memory. The potentiation of pentobarbitone sleeping time showed an significant increase in the sleeping time indicating that the ethanolic extract possess sedative activity whereas, the sleeping time was comparable to the control with flumazenil suggesting that the mechanism of action of the active constituents in the extract probably act via the benzodiazepine receptors. Conclusion: Ethanolic extract of the leaves and stalks of Apium grave lens may play a role in management of Anxiety and Insomnia.
IND-33
Study to Find out Evidence Based Approach of Ayurvedic Treatment for Metabolic Disorders
Singh DK 1 , Kumar R 1 , Lakhani P 1 , Tutu S 1 , Lal M 2 , Dixit RK 1
1 Department of Pharmacology, KGMU, Lucknow, Uttar Pradesh, India, 2 Department of Dravyaguna, State Ayurvedic College and Hospital, Lucknow, Uttar Pradesh, India
Objectives: To find out evidence based approach of indigenous medicines for the management of metabolic disorders. Materials and Methods: Internet based search of review and research articles related to management of metabolic disorders published after year 2000 and onwards. The articles were critically analysed regarding uses of individual indigenous preparations as well as combination formulations. The data were compiled and analysed with the help of ayurvedic expert. Results: Allium sativum: Supplementation produced reduction in total cholesterol besides lowering blood pressure. Camellia Sinensis: It was apopular remedy for obesity in ancient times. It acts by increasing consumption of energy and triggering the oxidation of fat. Coccinia indica: Studies have suggested that its extract decreases the fasting blood glucose levels. Cynanchum Auriculatum: It has significant appetite-inhibiting effect. Garcinia Cambogia: Contributes to a feeling of satiety and subsequent weight reduction. Gymnema sylvestre: Has demonstrated hypoglycemic and hypolipidaemic effects in studies. Hibiscus sabdariffa : Clinical trials have shown reliable evidence of antihypertensive effects. Hoodia Gordonii: It inhibits appetite, alters the neuropeptide-mediated pathways of the central nervous system. Momordica charantia: It may reduce blood glucose diabetics. Panex ginseng: It has shown significant reduction in blood sugar levels and blood pressure. Trigonella foenum graecum: Human studies have confirmed the glucose and lipid-lowering effects. Conclusion: Herbal medications are the most commonly used alternative therapy for metabolic disorders. Scientific validation of several Indian plant species has provided the efficacy of these herbs. However, their safely and efficacy need to be further evaluated by well designed, controlled clinical trials.
IND-34
Study to Find out Scientific Evidences Based Indigenous Treatment for Hypertension Utilizing Web Based Information
Chandrama M, Lakhani P, Tutu S, Saxena U, Kumar R, Dixit RK
Department of Pharmacology and Therapeutics, King George Medical University, Lucknow, Uttar Pradesh, India
Objectives: To find out indigenous drugs for the treatment of hypertension and to critically collect the evidences in favour of use as antihypertensive agents. Materials and Methods: An extensive web based search of articles related to the use of indigenous drugs for the treatment of hypertension was done. The articles from the indexed journal were qualified for the study. A total of 34 articles were analysed and the data were summed. The studies with direct evidences of antihypertensive effects were segregated and analysed. Results: The study showed that there are many botanical preparations for treatment of hypertension. Some of these single preparations are Rauvolfia serpentina, Ganoderma lucidum, Hibiscus sabdariffa, VI scum album, Crataegus laevigata, Olea europaea, Withania somnifera, Nardostachys jatamamasi, Terminalia arjuana, Allium sativum. The compound formulations from the Indian Ayurvedic system were Mamsyadi kvatha, Brahmi vati, Prabhakara vati, Arjunarista, Seveta parpati, Hrdayarnava rasa etc. The evidences in favor of healthy diet, yoga and healthy life style along with natural products have been advised. Conclusion: The study finds that there are ample evidences that the botanical preparations may be very good antihypertensive drugs and may be better replacement for the synthetic compounds.
IND-35
CNS Activity of Quisqualis Indica Leaf Extract
Barve KH, Arunachalam S, Dighe A
Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, Maharashtra, India
Objectives: The leaves of Quisqualis indica contain quisqualic acid, an AMPA agonist, capable of producing excitatory effects on the Central nervous system (CNS). Thus, the plant extract can be expected to show some CNS activity. The present study focuses on screening the extract for CNS effects. Materials and Methods: The collected plant was authenticated. Aqueous extract of the leaves was subjected to phytochemical screening, fingerprinting by chromatography, acute toxicity studies and efficacy studies for CNS activity. Results: The extract revealed the presence of alkaloids, amino acids, carbohydrates, flavonoids and phenolic compounds (21.275%w/w). The chromatographic analysis revealed the presence of amino acids. Acute toxicity studies indicated that the extract was safe up to 2000 mg/kg. There was a significant reduction in the locomotor activity at the dose of 25, 50,100 and 150 mg/kg. The extract at the dose of 150 mg/kg enhanced the activity of diazepam and suppressed the activity of caffeine. The Irwin battery test showed sedation of intensity 1 at the dose of 150 mg/kg. The extract showed a significant increase in immobility time as compared to control in the tail suspension test. It was further observed that there was a significant reduction in the duration of convulsions in MES induced convulsions in the rats. Conclusion: These data indicate that the extract in spite of claiming to possess quisqualicacid, has CNS depressant activity. This effect might be due to higher phenolic content. The extract needs to be fractionated and the active constituent evaluated at mechanistic level to understand the CNS effects.
IND-36
Comparitive Analysis of Hepatoprotective Activity of Ficus Religiosa and Tridax Procubens Against Isoniazid + Rifampicin Induced Hepatotoxicity in Rats
Shrivastava V
Department of Pharmacology, Kalinga Institute of Medical Sciences, Patia, Bhubaneswar, Odisha, India
Objectives: To compare the hepatoprotective effect of methanolic extract of Tridax procumbens and Ficus religiosa (Aswatha) with standard drug i.e., Liv 52. Settings and Design: Rats were divided into five different groups (n = 6): (1) group 1 - control, (2) group 2 - toxic control receive isoniazid + rifampicin (100 mg/kg i.p. each), (3) group 3 - received tridax extract (200 mg/kg p.o) along with isoniazid and rifampicin, (4) group 4 - received ficus extract (200 mg/kg p.o) with isoniazid and rifampicin, (5) group 5 - standard group receiving LIV 52 (10 mg/kg p.o) along with isoniazid and rifampicin. Materials and Methods: After 21 days the blood was collected by retro-orbital venous plexus of the rats from each group and send for biochemical estimation. Blood samples were centrifuged for 10 min at 3000 rpm to separate the serum. ALP, ALT, AST and bilirubin levels were estimated from the serum by using standard kits. Results: As evident from our study, rats receiving Tridax shows significant improvement in all LFT parameters i.e. ALP, SGOT, SGPT, Direct Bilirubin. There is significant difference between Tridax group and Ficus group in comparison to LIV 52 group. Ficus group also shows improvement of LFT parameters but not significant compared with LIV 52 group. Conclusions: From this study it can be concluded that both Tridax and Ficus methanolic extract have got hepatoprotective effect. There is significant difference between hepatoprotective effect of Tridax as compared to ficus and Liv 52.
IND-37
Antioxidant, Free Radical Scavenging and in vitro Cytotoxic Studies of Different Solvents Extracts of Lawsonia inermis Bark
Trupesh M Pethani 1 , Mayuri M Thumar 2 , Ashvin V Dudhrejiya 2 , Shashank K Singh 3
1 Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India, 2 B.K. Modi Government Pharmacy College, Rajkot, Gujarat, India, 3 Cancer Pharmacology Division, CSIR-Indian Institute of Integrative Medicine, Jammu, Jammu and Kashmir, India
Objectives: The aim of this research was to investigate phytochemicals, antioxidant activity and cytotoxic effect of the different extracts of stem bark of Lawsonia inermis using various in vitro assay methods as well as to estimate the amount of total phenol and flavonoid contents. Materials and Methods: Antioxidant potential of various extracts of stem bark of L. inermis was determined by the DPPH, nitric oxide radical scavenging, super oxide radical scavenging and Fe 3+ reducing power assay. Cytotoxic effect was evaluated using SRB assay. Results: The order of antioxidant activity of different solvents extracts of L. inermis stem bark displayed from higher to lower level as methanol, ethyl acetate, hydro-alcoholic, chloroform, dichloromethane and n-hexane extracts. Methanolic extracts of L. inermis showed the highest amount of phenolic and flavonoid contents and reducing capacity. n-hexane and dichloromethane extracts showed pronounced cytotoxic effect against HCT-116 and A549 human cancer cell lines with 90-99% cell growth inhibitory activity, where as 40-74% cell growth inhibitory activity against Ovcer-5 human cancer cell line. The antioxidant potential of L. inermis extracts significantly correlated (p < 0.05) with the phenolic content of the different solvent extracts. Conclusion: The present study demonstrates notable anticancer activity in L. inermis bark extracts. Chemical components of L. inermis have good antioxidant capacities and this species could be used as a potential source of new natural antioxidants.
IND-38
Antinociceptive effect of berberine against CCI-induced neuropathic pain
Singh AR, Badgujar LB, Khanvilkar GR, Saraf MN
1 Bombay College of Pharmacy Kalina, Santacruz (E) Mumbai, Maharashtra, India
Objective: To evaluate the antinociceptive efficacy of berberine on CCI induced neuropathic pain in rats. Materials and Methods: Male Wistar rats (180-200 g) were operated under pentobarbital (60mg/kg i.p.) anesthesia for chronic constriction injury (CCI). Saline (3ml/kg), berberine (10 and 20 mg/kg) were administered intraperitoneally from 15 th to 28 th day after surgery. The animals were sacrificed on day 29th and sciatic nerve was isolated for estimation of NFkβ, IL1β, IL6 and TNFα.The behavioural assessment using neutral plate, cold plate, vonfrey, actophotometer was carried out on 0, 3, 7, 14, 21 & 28 th day.All the data were analysed by GraphPad Prism 5.01 for Windows. The results were expressed as means ± SEM. P value of <0.05 was considered to be significant. Results: CCI induced animals displayed significant hyperalgesia, allodynia (p<0.01) in vonfrey, neutral and cold plate when compared with sham operated animals. Berberine (10 & 20mg/kg) significantly attenuated the hyperalgesia & allodynia (p<0.05). Similarly, berberine significantly suppressed the expression of NFkβ, IL1β, IL6 and TNFα and attenuated loss of MNCV in a dose dependent manner compared to CCI animals (p<0.05). CCI and Berberine, both did not show any significant reduction in the locomotor activity when compared with sham. Conclusion: Neuropathic pain till date remains a challenging condition to diagnose & treat effectively. It is a manifestation associated with diabetes, chemotherapy, trigeminal neuralgia, spinal surgery etc. Berberine (10 and 20 mg/kg) was found to reduce the pain threshold by inhibiting NF-κB, and by reducing the expression of pro-inflammatory cytokines (TNF-α, IL-1β and IL-6) which are involved in pathogenesis of neuropathic pain in a dose dependant manner.
CEL
CEL-1
Development of In-vitro Preclinical Model of Age-related Macular Degeneration
Rana D 1 , Sarvaiya K 2 , Pethani T 2
1 Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India, 2 Department of Pharmacology, L.M. College of Pharmacy, Ahmedabad, Gujarat, India
Age related macular degeneration is very complex disorder leading to blindness in elder patients. The model for drug testing is not easily available due to complex pathophysiology of the disease and thus in-vitro model is developed. Age related macular degeneration is divided into basically two types: Geographic Atrophy and Neovascular Age related Macular Degeneration. The major cells affected in the disease are photoreceptors and RPE cells, due to inflammation in the choroidal vessels or drusen. The model involves use of cell lines of RPE cells co-cultured with vascularizing tissue. The RPE cells will be differentiated into photoreceptors using genetic engineering. The conversion of RPE cells into the photoreceptors can be done with conversion rate of as high as 80%. The media for growth of cells will be provided via vasculature and the viability of the cell lines will be maintained. The induction of disease and testing of drug will be favored by the vasculature.
CEL-2
Cytotoxicity and Anti Apototic Activity of Taxifolin
Md Wasimul Haque, Shakti Prasad Pattanayak
Departmenrt of Pharmacutical Sciences and Technology, BIT, Ranchi, Jharkhand, India
Objective: Cancer is one of the major deadly and worldwide disorder in developed as well as in developing countries. Plant-derived anti-cancer agents such as flavanoid (Taxifolin) are reported as potent antitumor phytochemicals with broad-spectrum pharmacological activities (colon, prostate and breast cancers). Many mechanisms of action have been identified, including carcinogen inactivation, ant proliferation, cell cycle arrest, induction of apoptosis and differentiation, inhibition of angiogenesis, antioxidation and reversal of multidrug resistance or a combination of these mechanisms. To study the invitro cytotoxic and antiapoptotic potential of taxifolin on MCF-7 cell lines. Materials and Methods: Cell proliferation was determined with Cell Titer 96 Aqueous. On-Radioactive Cell Proliferation Assay Kit. It was followed with trepan blue exclusion test to determine the percentage of viable cells. The study incorporated cell cycle assay to distinguish cell distribution at various cell cycle phases using Cycle test Plus DNA Reagent Kit. The apoptosis detection kit was used to determine the percentage of apoptotic and necrotic cells using flow cytometry. Results: The 50% inhibitory concentration (IC 50 ) value determined using the proliferation assay was 25 μM taxifolin. Late apoptotic cell percentage increased rapidly when treatment duration was increased to 24 h with 25 and 100 μM taxifolin. Further analysis using cell cycle assay showed taxifolin inhibition of breast cancer cell proliferation at minimal dose 25 μM and led to S phase arrest significantly at 72 h treatment. It was also noted elevation sub-G 1 peak following treatment with 25 μM taxifolin for 12 h. Increase in taxifolin to 50 μM caused G 2 phase arrest at each time-point studied. Conclusion: In general taxifolin showed sustained inhibition of breast cancer cell proliferation with long-term treatment.
CEL-3
Role of ATP-sensitive Potassium and Maxi Potassium (bk ca ) Channels in beta 3-adrenoceptors Mediated Tocolytic Effect in Buffaloes (Bubalus Bubalis)
Choudhury S, Sharma V, Nair SV, Jaitley P, Nakade UP, Sharma A, Yadav R, Garg S
Department of Pharmacology and Toxicology, College of Veterinary Science and Animal Husbandry, UP Pandit Deen Dayal Upadhyaya Pashu Chikitsa Vigyan Vishwavidyalaya Evam, Go-Anusandhan Sansthan, Mathura, Uttar Pradesh, India
Objectives: This study was undertaken to elucidate the cellular coupling mechanism of beta 3-adrenergic receptors with potassium channels in myometrium of non-pregnant buffaloes. Materials and Methods: Uteri of diestrous stage buffaloes were collected from local abattoir and myometrial strips were prepared from the mid-cornual region of uterus for measurement of isometric tension. Results: Both BRL-37344 and SAR150640, two specific agonists of β3 -adrenoceptors, produced dose-dependent inhibitory effect on myometrial spontaneity and this effect was blocked by SR 59230A, a selective β3 specific adrenoceptorantagonist. BRL-37344 was found to be more potent than SAR 150640 as the respective pD 2 values were found to be 7.22 ± 0.09 (n = 7) and 3.27 ± 2.67 (n = 6). Further, potassium channel blockers, namely-glybenclamide (10 μM), tetraethyl ammonium (1 mM) and iberiotoxin (100 nM) significantly shifted the dose response curve of BRL-37344 towards right with reduction in efficacy (R max ). However, 4-aminopyridine (1 mM) failed to alter the tocolytic effect of BRL-37344. Conclusion: Our Results suggest that beta 3-adrenergic receptors mediate an additional mechanism of myometrial relaxation in buffaloes and, besides direct involvement of β3 -adrenoceptor, their tocolytic effect is also mediated through K ATP and BK Ca channels in buffalo myometrium. Therefore, beta 3-adrenergic receptors seem to be a potential alternative target for management of pre-term labour; however, similar studies are warranted on uterus of pregnant animals.
CEL-4
Presynaptic Auto and Heteroceptors: Tools for Cutting Edge Pharmacology
Gawade SP
Sahyadri College of Pharmacy, Sangola, Solapur, Maharashtra, India
Objectives: To present significance of presynaptic auto receptors and heteroceptors in the mechanism of neurotransmission. Materials and Methods: In vitro experimental animal model using sea snake Enhydrotoxin-a and monovalent E. schistosa horse antivenin subjected to high frequency stimulation on rat neuromuscular junction and in vivo model of chronic nicotine treatment and DA antagonist, sulpiride on step down passive avoidance. The update of various presynaptic and heperoceptors from the existing literature. Results: The expression of presynaptic auto receptors and heteroceptors is based on the conditions to plastic synaptic changes that occurred in chronic degenerative diseases or to chronic exposure to drug therapies or by persistent exposure of natural/synthetic agonist and antagonist at cellular and experimental animal models. Using the concept of reverse pharmacology, presynaptic nicotinic facilitating type of auto receptors as fPTP (facilitatory post tetanic potentiation) were identified at rat neuromuscular junction. Presynaptic nicotinic heteroceptor activation at the dopaminergic nerve terminals was suggested using passive avoidance in the in vivo rat model. Besides, presynaptic muscarinic inhibitory M 2 , M 4 , adrenergic inhibitory α2A , α2C , adrenergic facilitatory β2 , serotonergic 5HT 1A , 5HT 1B , 5HT 7 and 5HT 1D , dopaminergic D 2 and D 3 , facilitating α4 /β2 nicotinic, α3β2 nicotinic, histaminergic H 3 auto receptors and presynaptic serotonergic 5HT 2A and nicotinic α7 heteroceptors were exemplified. Conclusion: Presence of presynaptic nicotinic auto receptors and presynaptic nicotinic heteroceptors on dopaminergic neurons were shown and using various pharmacological, neurophysiological and neurobiochemical techniques in cellular and experimental animal models presynaptic auto and heteroceptors were reviewed.
CEL-5
Vateria Indica Resin Asnanotechnology Based Therapy for Radiation-induced Burns in Treatment of Cancers
Mirza MA, Ramesh S, Hasan M
With the high incidence of cancer and various effective therapies which Results in side-effects like radiation burns there is an initiation to search for prophylaxis and management for post-radiation therapy induced reactions. This is likely to facilitate continuation of therapy usually interrupted by radiation burns and super infections. The new area of research which centres around creation, manipulation and application of structure in the nanometre size range (1-100 nm) coming under the general branch of nanotechnology in medicine and in particular the use of nanoparticle for drug delivery system, is covered in this research Preliminary trials on a selected number of patients by preparing vateria indica as an ointment gave an insight about its potential in healing radiation therapy burns. On this basis, a full-scale investigation was launched by insuring the botanical authenticity, of the source of resin, exudation process, stability and absorption pattern. To further enhance the role of the Sarja rasa resin i.e., Vateria indica nanotechnology Methods for topical drug delivery systems were explored.
CEL-6
An Assessment of the Phosphorylation of Ampk And Akt in L6 Myotubes by two Thiazolidine-4-One Derivatives of Nicotinamide-Nat-1 and Nat-2
Kishore A, Shetty PMS, Reddy N, Akhila HS, Nayak PG, Kutty NG
Department of Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
Objectives: Two nicotinamide thiazolidin-4-ones synthesized in our lab (designated NAT-1 and NAT-2) were reported to have anti-hyperglycaemic activity in various preclinical models. Based on indications that these molecules could be exerting their action by increasing peripheral uptake of glucose, it was decided to evaluate their effect on the activation (phosphorylation) of AMPK and Akt, two key molecules in glucose metabolism. Materials and Methods: AMPK and Akt phosphorylation was assessed using western blot. Briefly, 2 × 10 6 L6 cells seeded in T-25 flasks were incubated with 10 μM and 100 μM concentrations of NAT-1, NAT-2 and Metformin (standard) for 2 hours. Then, cell lysates were prepared and protein content determined. 25 μg of protein was resolved in 10% SDS-polyacrylamide gel and transferred to PVDF membrane. The blot was incubated with primary antibodies of AMPK, p-AMPK, Akt and p-Akt and the proteins were visualised. Results: Metformin is a known activator of AMPK, which was observed in our experiments. It increased the phosphorylation of Akt as well. NAT-1 in both the doses failed to phosphorylate AMPK but an apparent, statistically insignificant, rise in the p-Akt was observed with 100 μM doses. 100 μM of NAT-2 exhibited an apparent increase in the levels of p-AMPK whereas it significantly increased p-Akt in both the doses. Conclusion: NAT-1 and NAT-2 have shown activation of Akt, which could have could have partly contributed to their anti-hyperglycaemic activity. It is not known if the molecules are directly phosphorylating Akt or any other mechanisms are involved. Further studies are required to confirm this.
CEL-7
Cell Based In vitro Model for Drug Screening and Toxicity Study
Joshi H, Vadia N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Measurement of cell viability play a vital role in screening of new drug candidates with a main purpose of ascertains the toxic behaviour of newly synthesized/developed chemical moiety. Cell cytotoxicity study provides better and economic alternative of drug screening. Materials and Methods: Cell cytotoxicity studies are performed on various cell cultures and the molecules of the interest are examined along with related substance and their metabolite by in-vitro condition with an aim to investigate drug activity on cellular and molecular level. Results: Cytotoxicity study provides efficient drug screening technology which is comparatively fast and easy to use. This study helps to determine possible changes in cellular and molecular process in a presence of small quantities of investigated substance and provide better opportunity to understand the effect of new chemical entities on human and animal cell cultures. Conclusion: Different cell based assay provides sensitive and reliable screening method for drug candidate within a short duration of time. Such studies can act as bridge between various biochemical assay and animal tests.
NEU
NEU-1
Beneficial Effects of Gnetum Gnemon L. on Acute and Chronic Stress Induced Neurobehavioral and Biochemical Perturbations in Wistar Rats
Patowary P 1 , Barua CC 1 , Bordoloi M 2 , Barua IC 3 , Roy JD 4
1 College of Veterinary Science, Guwahati, Assam, India, 2 Natural Products Chemistry Division, CSIR-North East Institute of Science and Technology, Jorhat, Assam, India, 3 Department of Agronomy, Assam Agricultural University, Jorhat, Assam, India, 4 Division of Animal Health, Indian Council of Animal Research, Barapani, Assam, India
Objectives: The study was proposed to investigate the adaptogenic activity using n-hexane fraction of Gnetum gnemon Linn. (family Gnetaceae) leaves in rats to establish their involvement in the HPA axis. Materials and Methods: Ethanol extract of G. gnemon extracted with hexane, and three semi pure compounds isolated. Pretreatment with hexane fraction of G. gnemon leaves (50 and 100 mg/kg b.w., p.o.) were administered in forced swimming induced acute stress (3 days) and chronic stress (7 days) in animals. Organ weights, biochemical parameters, plasma corticosterone levels, antioxydant enzymes, LPO levels in cerebrum, cerebellum and cortex; catecholamine levels in hippocampus and cortex were estimated, since they are the most affected parts during stress. Results: Hexane extract of G. gnemon reverted the elevated levels of ALT, AST, plasma glucose, cholesterol, creatinine kinase and triglycerides towards normal. The atrophied spleen size and hypertrophied adrenal glands were normalized. G. gnemon treatment significantly (p < 0.05) elevated the levels of GSH, catalase, SOD, norepinephrine (NE), epinephrine (Ep) and dopamine (DA) in different regions of the brain with subsequent upsurge of plasma BDNF following treatment in the acute and chronic stress groups. Pretreatment with the fraction significantly reduced the activity of LPO enzyme and plasma corticosterone, thereby counteracting the harmful effect of free radicals. Conclusion: Finally, it can be inferred that Gnetum gnemon, a plant popularly used by tribal people of North-East India and also in other parts of Asia for its nutritive property, also possesses adaptagenic property, which can be profitably exploited for health benefits of human beings and animals to overcome stress.
NEU-2
Study of Ant Nociceptive Effect of Paroxetine in Acute Pain in Albino Rats
Yatish B, Patil MV, Ramabhimaiah S
Department of Pharmacology, Navodaya Medical College, Raichur, Karnataka, India
Objectives: Pain is the most common reason patients seek medical care. A study has shown that increased level of monoamines in synaptic cleft leads to change in pain threshold and induce antinociception. Among the various SSRI, paroxetine is the most potent inhibitor. Materials and Methods: Adult Albino rats weighing 150-200 g were used for the study. For studying analgesic activity, animals were grouped in to 5 groups of 6 each, and treated I.P as follows: Group 1 (Control) received 1 ml/kg body weight of distilled Water, Group 2 (Standard) received Pentazocine 10 mg/kg. Group 3, 4 & 5 received Paroxetine in a dose of 2.5 mg/kg, 5 mg/kg & 10 mg/kg body weight respectively. The animal was placed on a hot plate which was maintained at a temperature of 55°C throughout the test. Reaction time (RT) was recorded when the animal licks its fore and hind paws and jumped at before (0) and 15, 30, 60, 90 minutes after drug administration. One way ANOVA followed by post-hoc turkey test was used for statistical analysis. P < 0.05 is considered significant. Results: Mean RT after 60 minutes of injection of Paroxetine (10 sec) was higher than baseline value of 7 sec with SD of 1.4 means difference 1.5 ± 0.7 and is significant when compared to control. No significant difference in RT was found between paroxetine and pentazocine. Conclusion: Paroxetine, a SSRI antidepressant, has a clear antinociceptive activity.
NEU-3
Role of Melanocortin System in the Neuroprotective Effect of Miniocycline in Experimental Autoimmune Encephalomyelitis
Gote VN, Khanorkar PS, Somalwar AR, Kokare DM
Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur, Maharashtra, India
Objectives: To investigate the role of melanocortin system in the neuroprotective effects of minocycline in experimental autoimmune encephalomyletis (EAE). Materials and Methods: Encephaloantigen, myelin basic protein emulsified in complete Freund's adjuvant with pertusis toxin was injected into sub-planter region of the hind paw for the induction of EAE in Wistar rats. Animals were assessed for the clinical sign of EAE and locomotor count on eight day and treated either with saline, minocycline or melanocortin modulators for thirteen days. Results: Animals showed clinical signs of EAE which were confirmed by a significantly higher clinical score (score 0-5) and decreased locomotor activity in open filed test as compared to naïve control rats. Thirteen days treatment (from post-immunization day 8-20) with minocycline or Ro27-3225 (MC4 receptor agonist), via fourth-ventricle, in EAE rats dose-dependently decreased EAE clinical score and increased the number of crossovers as compared to EAE rats, reflecting recovery. Moreover combined treatment with sub-effective doses of Ro27-3225 and minocycline showed improvement in behavioral EAE symptoms. In histological studies, we noticed a significant increase in perivenular mononuclear cell and inflammatory cuffs in white and grey matter of the spinal cord of EAE rats. However, 13 days treatment of minocycline or Ro27-3225 attenuated these effects. The axonal loss and de-myelination was also blocked by treatment of minocycline or Ro27-3225 in EAE rats as revealed in the Bielschowsky silver staining and Luxol fast blue staining, respectively. Conclusion: Melanocortin system may mediate the effect of minocycline on locomotor function following EAE. The strategy aimed at endogenous MC4 selective agonist Ro27-3225 and activation of minocycline may facilitate neuroprotection, axonal regeneration, and prevent inflammation.
NEU-4
Evaluation of Neuropharmacological Effects of Butea Monosperma Lam. Kuntze in Experimental Animal Model
Gagarani MB, Patil PH, Agrawal NB, Surana SJ
Depaprtment of Pharmacology, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Maharashtra, India
Objectives: In the present study, Ethyl acetate fraction (EAF) and n-butanolic fraction (NBF) of methanolic extract of plant Materials was investigated for analgesic effect. Rota rod for muscle co-ordination activity. Depression was tested using Tail suspension test and while Elevated plus maze model used for accessing the effect on anxiety. Materials and Methods: Hot plate Methods was used to test analgesic potential of EAF and NBF; Swiss Albino mouse (20-25 gm.) was divided into groups and treatment, tested on heated surface 55°C to 56°C. The muscle relaxant study was performed with help of rota rod apparatus. Behavior parameter for anxiety and depression was tested by elevated plus maze. Results: Significant increase in time of latency in hot plate was observed in 200 mg/kg in NBF fraction. In rota rod Methods NBF at 100 mg/kg and higher dose (200 mg/kg) and EAF at higher dose (200 mg/kg) shows the significant Results when compare with control. In Tail Suspension for antidepressant action, NBF at higher dose level (200 mg/kg) have significant Results at 1 st & 2 nd hour of dose administration, there was significantly increase in time of immobility when compared with control group. Conclusion: From the experimental study we can conclude that the NBF of Butea monosperma possess centrally mediated weak analgesic properties, also significant effect on the motor coordination of the animals which shows the possible peripheral neuromuscular blockage.
NEU-5
Omeprazole Down-regulates Proinflammatory Cytokines and Oxidative Stress in the Chronic Constriction Injury-induced Neuropathic Pain in Rats
Walke AK, Chanchal SK, Mahajan UB, Goyal SN, Patil CR
Department of Pharmacology, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra, India
Objectives: To study the effect of oral omeprazole (50 mg/kg/day for 14 days) in the rat model of chronic constriction injury (CCI) induced neuropathic pain. Materials and Methods: Neuropathic pain was induced in rats by placing four loose ligatures around the sciatic nerve. Mechanical cold and thermal allodynia were estimated by behavior Methods such as Von Frey filaments, cold-plate and evaluated on days 3, 7, 11 and 14 after surgery, respectively. In addition, SOD, GSH Catalase and MDA were measured to evaluate anti-oxidation activity and measured cytokines level for inhibitory effect on release of cytokines in neuropathic pain. Results: The intensity of neuropathic pain was estimated as paw withdrawal latency and withdrawal pressure threshold against thermal and mechanical stimuli. Estimation of the motor nerve conduction velocity and histological examinations of the longitudinal sections of the nerve revealed the extent of CCI-induced damage. Oxidative stress in nerve tissue was determined as levels of GSH, catalase and SOD, lipid peroxidation. Omeprazole treatment significantly decreased the mechanical and thermal hyperalgesia, and attenuated the levels TNF-α, IL-1 β and IL-6 in the sciatic nerve. It inhibited the CCI induced histological perturbation and restored the motor nerve conduction velocity. Conclusion: These effects of omeprazole indicate its protective effects against neuroinflammatory conditions. Further investigation is warranted to delineate the mechanism of antineuropathic and neuroprotective effects of omeprazole.
NEU-6
Are Bacoposides in Bacopa Monnieri Solely Responsible for Improving Memory Function?
Arora R, Kumar R, Gupta YK
Department of Pharmacology, All India Institute of Medical Science, New Delhi, India
Objectives: To study the effect of normal, bacoposides enriched and free extract of Bacopa monnieri in scopolamine induced amnesia model in rats. Materials and Methods: Male Wistar rats (200-250 g) were divided in five groups (n = 6), I: Vehicle control; II: Scopolamine only; III-V: Bacopa monnieri extracts i.e. Normal (BM) enriched (BME) and free (BMF), along with scopolamine respectively. All the extracts were given at dose of 100 mg/kg orally, and scopolamine at 3 mg/kg, i.p., once, 30 min before assessment. The neurobehavioral parameters were assessed using elevated plus maze (EPM), passive avoidance (PA) and Morris water maze (MWM) test. Results: In scopolamine only group, the retention latency (EPM) and latency to reach target quadrant (MWM) was increased (40.5 ± 4.5 s, 18.6 ± 2.4 s; p < 0.01), while escape latency (PA) was decreased (45.2 ± 12.0 s; p < 0.05) significantly, as compared to vehicle control group (15.8 ± 1.9 s, 6.7 ± 1.3 s, 264.9 ± 14.1 s), indicating amnesia. Pre-treatment with all three extracts had significantly improved retention latency (EPM & PA) and latency to reach target quadrant (MWM) as compared to scopolamine only group. However, there was no significant difference in between the extract groups. Conclusion: The total bacoposides content was significantly different in BME (75.1% w/w) and BMF (0.11% w/w) as compared to BM (41.9 % w/w), but no significant difference was found in their activity. BMF has also been found to significantly (p < 0.05) improve scopolamine induced amnesia, indicates that constituents other than bacoposides, have potential role on learning and memory.
NEU-7
A Prospective Study of Epileptic Patients to Evaluate the Efficacy, Safety and Tolerability of Newer Antiepileptic Drugs in Patient's Refractory to Conventional Antiepileptic Drugs
Shabbir SA, Mulkalwar S
Department of Pharmacology, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune, Maharashtra, India
Objectives: To evaluate efficacy of newer AEDs in epileptic patient's refractory to conventional AEDs. To evaluate safety and tolerability of newer AEDs . To assess the Quality of life . To assess cost effectiveness of newer AEDs. Materials and Methods: This was a prospective study conducted at Dr. D. Y. Patil Medical College, Pune & Nobel Hospital, and Hadapsar after obtaining permission from Institutional Ethics Committee. 100 epileptic patients of all age and either sex who were diagnosed epilepsy andon treatment for atleast one year were included in the study after taking written informed consent. All the information was obtained by using pre-printed proforma and by discussion with the patient and his/her family members. The cost of the drugs was calculated by using Drug Index. P < 0.05 was considered statistically significant. Results: 31 patients were on conventional monotherapy, 10 on newer monotherapy and 59 on combination therapy (23 on conventional conventional and 36 on conventional + newer). Valproic acid was the most commonly used AED for all types of seizures followed by carbamazepine, which was used mostly as combination therapy either with conventional or newer AEDs. Oxcarbazepine was most commonly used newer antiepileptic as a monotherapy. Topiramate was most commonly used newer antiepileptic as a combination therapy. We found more seizure freedom and >50% reduction in seizure frequency in patients on newer monotherapy as compared to conventional monotherapy, though the difference was not statistically significant. In combination therapy, number of patients with seizure freedom in conventional plus newer combination group was significantly more as compared to conventional plus conventional combination group. The effectiveness of newer AEDs when used in combination could be because of its different mechanism of action, broad spectrum activity and lack of enzyme induction. The overall incidence of adverse events was not very high in our study and mostly seen with the combination therapies. Carbamazepine and valproic acid contributed to most of the ADRs. Overall, the AEDs were well tolerated. Improvement in quality of life was comparable in all three treatment groups which could be attributed to reduction of seizure frequency and few adverse events of newer AEDs. Conventional monotherapy was found to be cost effective as compared to newer monotherapy and combination therapy. Newer monotherapy and combination therapy were almost 2.4 to 3 times costly as compared to conventional monotherapy. Conclusion: The newer AEDs are safe, well tolerated and effective when used alone or in combination for seizure control in patients with refractory epilepsy. Though costly, it provides rapid seizure control and good quality of life.
NEU-8
Treatment of Stroke: An Herbal Perspective
Buch P, Airao V, Sharma T, Shukla R, Patel R, Parmar S
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Stroke is a global health problem and morbidities and mortalities due to stroke endanger the socio-economic aspects of developing countries. Indeed, stroke is the second commonest cause of death and fourth leading cause of disability worldwide. Stroke is no longer a disease of developed countries: In India, ICMR estimate in 2004 indicated that stroke contributed 41% of deaths and 72% of disability adjusted life years amongst the non-communicable diseases. Thrombolytic therapy is the only approved therapy in management of stoke. Moreover, the plethora of failed clinical trials with neuroprotective drugs and side effects related to existing acute stroke treatments have raised justifiable concerns and warranted detailed preclinical evaluation of novel neuroprotective agent. In order to develop safe and effective therapy for stroke, herbal drugs may represent an ideal source. In fact, varieties of herbal drugs have been described for the treatment of stroke. However, the strength of evidence to support the use of these herbal drugs is unclear. This review primarily focuses on mechanism underlying the beneficial effects of herbal drugs in patient with stroke and the possibility to increase the therapeutic time window in patients with stroke.
NEU-9
Studies on the Neuroprotective Role of Agmatine in Neonatal Rats Following Germinal Matrix Haemorrhage
Bisen A, Upadhya M, Taksande B
Shrimati Kishoritai Bhoyar College of Pharmacy, New Kamptee, Maharashtra, India
Objectives: The germinal matrix haemorrhage has beeninflicted to neonates either in pre or post term of gestational supposed to destruct germinal vasculature of the brain. Affliction due to traumatic conditions which pretend to hamper the developmental milestones essential to normalize the behavior primarily on a ground sphere of action dealing with the cognition and locomotion. So, the attempts were made to monitor the neurodeficit count which was surgically induced in the caudate nucleus junctional site for sensorimotor pathway amongst basal ganglia having adherence with the germinal centres. Induced impairment recovery status was investigated by agmatine, a polyamine neuromodulator which is featured with multifacet activity and enrolled as a neuroprotective agent for the recovery and managenment of impaired mental condition which targets the study design. Materials and Methods: Neonates Post-natal day-7 Sprague Dawley rats were subjected to GMH by means of clostridial collagenase type VII - S (Sigma Aldrich) using stereotaxic surgery. Pups were subjected to their respective dams along with treatment groups of 10, 20 and 50 mg/kg of agmatine. After 3 rd and 4 th week of the study pups were proceed to have there locomotor and cognitive assessment (Shrimati Kishoritai Bhoyar College of Pharmacy, New Kamptee, and Pharmacology Research Laboratory 441002). Results: Neurodeficit count scores, Rota rod test, T-maze and Grip traction studies evidently shown that agmatine may have neuroprotective activity. Agmatineconfers its potent neuroprotective activity in treatment group of 50 mg/kg. Results have shown pronounced recovery status in neuromotor deficits and compensatively enhanced the memory in all assessment parameter. Conclusion: Agmatine has been evidently elicits its potential as neuroprotective agent which creates a spark for its implementation in clinical manifestations such as mental retardation, cerebral palsy, leukomalacia etc.
NEU-10
Neuroprotective Activity of Narirutin Rich Fraction from Citrus Paradise Against Global Cerebral Ischemia in Rats
Bhatt LK, Patel P
SVKM's Dr. Bhanuben Nanavati College of Pharmacy, Vile Parle (West), Mumbai, Maharashtra, India
Objectives: The objectives of present study is to evaluate neuroprotective effect of narirutin rich fraction from Citrus paradisi against global cerebral ischemia/reperfusion injury in rats. Materials and Methods: The induction of cerebral ischemia was performed by occluding bilateral common carotid arteries (BCCAO) with clamps for 30 min followed by 24 h reperfusion. To evaluate the efficacy animals were treated with narirutin rich fraction (150 & 300 mg/kg) for 7 days prior to injury. Behavioral and biochemical levels of lipid peroxidation, superoxide dismutase, catalase, and glutathione were estimated and histological study of brain coronal sections were performed. Results: BCCA occlusion, followed by reperfusion Resulted in alteration in behavioral tests, increase in lipid peroxidation and decrease in superoxide dismutase, catalase, and glutathione. Pretreatment with narirutin rich fraction showed significant attenuation in these parameters. Further histological studies showed neuroprotection by the treatment. Conclusion: The Results of the present study confirm neuroprotective effect of narirutin rich fractions from Citrus paradise against global cerebral ischemia in rats.
NEU-11
Effects of s-Nitrosoglutathione on Experimentally Induced Cognitive Dysfunction in Rats
Dubey H, Gulati K, Ray A
Department of Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi, New Delhi, India
Objectives: The aim of this study was to investigate effects of the NO donor, S-Nitrosoglutathione (GSNO) in experimentally induced cognitive dysfunction in rats S. Materials and Methods: Male Wistar rats (n = 5/group) were divided into three groups and were treated with intracerebroventricular (ICV) injection of streptozotocin (STZ, 3 mg/kg) or control group (artificial CSF). The STZ treated group received either GSNO (50 μg/kg,) or saline, ip, for 4 weeks. Cognitive function was assessed by Morris water maze (MWM) test and Passive avoidance test. Results: In the MWM test, STZ + saline treated rats showed increase in acquisition latency as compared to controls (by 135%) on day 4. However, during probe trial control rats spent more time in the target quadrant as compared to STZ + saline treated rats. Pretreatment with GSNO attenuated the delay in acquisition and the GSNO treated rats took lesser time (by 27%) when compared to STZ + saline treated group on day 4. In the probe trial, the GSNO treated rats spent more time (by 17%) in the target quadrant as compared to STZ + saline group. In the passive avoidance test, GSNO pretreatment increased the latency (by 18%) of entry into the dark chamber as compared to saline+ STZ group. Conclusion: It is inferred that, the NO donor, GSNO attenuates experimentally induced cognitive dysfunction as assessed by MWM and passive avoidance tests.
NEU-12
Neuroprotective Potential of Naringin Against ICV Collagenase-induced Neurological, Behavioral and Biochemical Alterations
Marwaha L, Singh N, Bansal Y, Bhandari R, Chopra K, Kuhad A
Pharmacology Research Laboratory, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India
Objectives: The present study was designed to explore the protective effects of naringin against ICH-COL induced behavioral, neurological and memory deficits in rats. Materials and Methods: ICV-ICH was induced by single unilateral intrastriatal infusion of collagenase (1 IU in 2 μL, ICV) over 10 minutes. From 2 nd day onwards, naringin was administered (10, 20 and 40 mg/kg; p.o.), till 27 th day Animals were subjected to a battery of behavioral tests to access behavioural changes, including neurological scoring tests (cylinder test, spontaneous motility, righting reflex, horizontal bar test, forelimb flexion), act photometer, rota rod, Randall Sellito and von Frey. Post stroke depression was estimated using forced swim test (FST) on 14 th day. Memory deficits were monitored using Morris water maze test. Results: Post stroke depression, neurological and cognitive deficits as assessed by force swim test, neurological scoring test and Morris water maze test respectively were mitigated dose dependently by naringin administration. Naringin administration also attenuated the nitro-oxidative stress and restored TNF-α and endogenous anti-oxidant levels. Conclusion: Our research demonstrates that naringin has a protective effect against ICH inducedneuro-cognitive deficits, along with mitigation of oxido-nitrosative and inflammatory stress.
NEU-13
Targeting Orphan Nuclear Receptor Rora as a Therapeutic Option for Autism Spectrum Disorder
Dwivedi S, Alokam R, Racharla S, Bafna P, Sriram D, Yogeeswari P
Department of Pharmacy, Birla Institute of Technology and Science, Pilani, Hyderabad, Telangana, India
Objectives: Autism Spectrum Disorder (ASD) is a complex neurodevelopmental disorder of early onset, highly variable in its clinical presentation. Several studies suggest that expression of retinoid related orphan receptor alpha (RORA) is altered in brain tissue with ASD. In association to RORA the nuclear factor kappa B (NF-κB) and localized inflammation of the central nervous system may also contribute to the development of autism and are suggested to be the markers of altered RORA gene expression. The present study was initiated to investigate the effect of novel candidates from BITS database on valproic acid (VPA) altered RORA expression, evaluated by the RORA associated inflammatory mediators in IMR32 cell lines and rat brain slices . Materials and Methods: Initially 2500 compounds from BITS database were subjected to in-silico screening using Schrodingerdrug discovery package and only the promising candidates were investigated in-vitro and ex-vivo models for markers of RORA. Results: Findings from study suggested that VPA leads to overexpression of RORA in IMR-32 cells as well as in rat brain slices. The NF-κB and cytokines i.e. IL-6, IL-1β, TNF-α were also found to be overexpressed probably due to involvement of RORA. One candidate (RB-12) from BITS database was able to reduce NF-κB and cytokines expression significantly in VPA treated IMR32 cells and rat brain slices which were supposed to occur through RORA modulation. Conclusion: Thus we postulated that targeting RORA pathway could yieldcandidate drugs for ASD treatment but still need to be extended in-vivo validation.
NEU-14
Application of Pharmacogenomics in Neuropathologies
Acharjya M, Dey A, Kumar V
Department of Pharmaceutics, Neuropharmacology Research Laboratory, Indian Institute of Technology (Banaras Hindu University), Varanasi, Uttar Pradesh, India
Neurological disorders including neurodegenerative diseases and psychiatric disorders have gained recent attention in the field of pharmacogenomics and personalized medicine. Although conventional pharmacological therapies for neurological diseases are available, but treatment often remains problematic due to inefficacy of drug response, development of tolerance, occurrence of adverse drug reactions (ADRs) and suboptimal dosing, which are largely unpredictable in individual patients. Individual drug responses are the Results of interactions of multiple environmental and genetic factors. The effectiveness and toxicities of medications used in cerebral stroke, dementia, seizures, multiple sclerosis, Alzheimer's and Parkinson's disease are all influenced by genetic polymorphisms. Therefore, in neurology, there is an urgent need to develop newer strategies that allow conceptualization of therapies to increased efficacy and minimize toxicity. Pharmacogenomics is one such tools, which revealed the relationship between human genome sequence variation and differential drug responses. Pharmacogenomics strategies have been concentrated on drug candidates to know the relationship between drugs pharmacokinetic parameters related genes, and potential drug targets. However, only few pharmacogenomics agents used in neuroimmunology and neurodegenerative diseases have been incorporated successfully into clinical practice. Further, large numbers of studies are still required in neurology, which really needs to progress on several fronts, including better-standardized phenotyping, collection of appropriate sample sizes and use of new advanced technologies such as genome-wide approaches, next generation gene-sequencing and systems biology. Thus, there still possibilities are exists to establish biomarkers or new drugs that could help to select for cost efficient neurological therapies with an optimal benefit to risk relationship.
NEU-15
Rutin Protects Against Doxorubicin Induced Neuronal Damage In vitro and Cognitive Dysfunction In vivo
Nandakumar K, Ramalingayya GV, Reddy N, Cheruku P, Shoja MH, Rao CM
Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
Objectives: Cancer survival rates have been improved remarkably due to advances in treatment strategies. Despite of this, chemotherapy induced cognitive dysfunction progressively become major concern (Chemo brain/Mental fog). Hence, the Objectives is to evaluate rutin (RUT), a flavonoid glycoside for its neuroprotective potential against doxorubicin (DOX) induced neurotoxicity in human neuroblastoma (IMR-32) cells and to prevent the episodic memory deficits associated with DOX induced chemo brain in Wistar rats. Materials and Methods: MTT assay, AO/EB staining, flowcytometric analysis, ROS analysis and neuritogenic assays were carried out to evaluate neuroprotective potential in IMR-32 cells. Behavioural study was conducted to assess episodic memory by using object recognition task. Histopathological and biochemical analysis was also accomplished. Results: Prior exposure with RUT at 100 μM protected IMR-32 cells against DOX (1 μM) neurotoxicity. DOX had increased apoptosis, intracellular ROS generation with inhibition of neurite growth in differentiated IMR-32 cells which was significantly ameliorated by rutin pre-treatment. Flowcytometric analysis showed that RUT was able to reduce DOX induced alterations noticed in cell cycle progression. Doxorubicin administration (10 cycles at 2.5 mg/kg, i.p.). Significantly decreased discriminative and recognition indices indicating impaired episodic memory. Daily treatment with RUT (50 mg/kg, p.o.) significantly prevented DOX induced episodic memory deficits without influencing locomotion. Rutin protected from DOX produced histopathological abnormalities of major organ systems. Conclusion: Rutin may be a possible adjuvant intervention to alleviate cognitive complications associated with DOX chemotherapy so as to improve the QOL in cancer survivors.
NEU-16
Role of Endogenous Opioidis in Stress Adaptation During Repeated Immobilization Stress Exposure in Mice
Bali A, Jaggi AS
Department of Pharmaceutical Sciences and Drug Research, Punjabi University Patiala, Punjab, India
Objectives: The present study was designed to identify the role of endogenous opioids in stress adaptation during repeated immobilization stress exposure in mice. Materials and Methods: Mice were subjected to immobilization stress for 120 minutes. A single episode of immobilization stress was employed to induce acute stress, while animals were repeatedly exposed to homonymic stressor for 5 day to induce stress adaptation. Stress-related behavioral alterations were assessed using the act photometer, whole board, open field and social interaction tests. The serum corticosterone levels were assessed as a marker of the HPA axis. Results: A single exposure of immobilization stress produced the significant behavioural and biochemical alterations that were subsequently restored following repeated stress exposure, indicating the development of stress adaptation. Administration of naloxone (5 mg/kg), a specific antagonist of opioid receptors, did not modulate acute stress-induced behavioural and biochemical alterations in stress-subjected mice. However, naloxone selectively attenuated stress adaptive effects (at behavioural and biochemical level) on the 5 th day in stress-subjected mice. Conclusion: Opioids may not play a major role during acute stress exposure, however during repeated stress exposure; a significant rise in endogenous opioids may possibly contribute in inducing stress adaptation.
NEU-17
Diffusion Kurtosis Imaging Detects a Very Early Alpha-synuclein Accumulation Induced Changes in Transgenic Mouse Model of Parkinson's Disease Overexpressing Alpha Synuclein
Khairnar A 1 , Kucerova JR 2,3 , Drazanova E 3,4 , Nikoletta Szabó 5 , Latta P 6 , Arab A 2,3 , Paier BH 7 , Sulcova A 2 , Zenon Starcuk JR 4,6 , Rektorova I 1
1 Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Brno, Czech Republic, 2 Experimental and Applied Neuropsychopharmacology Group, Central European Institute of Technology, Masaryk University, Brno, Czech Republic, 3 Department of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic, 4 Institute of Scientific Instruments, Academy of Sciences of the Czech Republic, Brno, Czech Republic, 5 Department of Neurology, Faculty of Medicine, Albert Szent-Gyorgyi Clinical Centre, University of Szeged, Szeged, Hungary, 6 Multimodal and Functional Imaging Laboratory, Central European Institute of Technology, Masaryk University, Brno, Czech Republic, 7 QPS Austria GmbH, Grambach, Austria
Objectives: Current challenge in Parkinson's disease (PD) is to develop neuroprotective agent which may halt or reverse the progression of PD. Unfortunately there is no validated diagnostic biomarker which may detect PD at early stage to test neuroprotective drug. Therefore, the second challenge in PD studies is to develop early diagnostic biomarker. The aim of the present study was to evaluate whether diffusion kurtosis imaging (DKI) an advanced MRI Methods could able to detect earlier changes induced by alpha synuclein (α-Syn) accumulation in 3 month old transgenic mice overexpressing α-Syn (TNWT-61). We hypothesize that the presence of α-Syn aggregates would create more water diffusion barriers, resulting in an increase in kurtosis. Materials and Methods: TNWT-61 and wild type (WT) mice underwent behavioural studies to detect motor impairment and DKI scanning using 9.4 T Bruker systems in vivo. Region of interest (ROI) and tract based spatial statistics (TBSS) was used to detect gray and white matter abnormalities respectively. Results: TNWT-61 mice showed significant progressive impairment of motor coordination compared to WT mice. As expected TNWT-61 showed a significant increase in mean kurtosis metric as compared to WT littermates in striatum and thalamus with ROI analysis. TBSS analysis did not show any significant change. Conclusion: The current study provides evidence that DKI is sensitive for ealry in vivo detection of the microstructural changes in TNWT-61 mice induced by α-Syn accumulation. DKI may potentially improve the early detection of PD and help in monitoring its progression.
NEU-18
Adverse Drug Reactions Due to Antiepileptic Drugs in a Tertiary Care Hospital
Prasath DD, Harsha S, Jitha S, Dhanya J, Kala KP
Department of Pharmacology, Government T.D. Medical College, Alappuzha, Kerala, India
Objectives: Adverse drug reactions (ADRs) are shown to cause 40% treatment failure in the use of Antiepileptic drugs (AEDs). Aim of this study was to analyze the ADRs with use of AEDs in a Government tertiary care hospital, Kerala. Materials and Methods: ADRs were collected using Central Drug Standard Control Organization (CDSCO) forms. All patients who developed ADRs with AEDs during July 2014 -July 2015 were included in this study. Data was analysed and expressed using descriptive statistics. Results: Of the total 254 ADRs 21 (8.2%) were due to AEDs. The male to female ratio was 1.63:1. Majority belonged to mean age group 31-60 years (42.85%) with minimum age of 9 years and maximum 78 years. The major AEDs accounted for ADR were Phenytoin (42.8%) followed by Carbamazepine (23.8%). The organ system mainly involved were Skin and Mucous Membrane (76%) followed by Central Nervous System (19%). The most common ADR was maculopapular rash (52.38%). Three cases of Stevens Johnson Syndrome were reported. Causality assessment by Naranjo's Algorithm showed that 81% of the reactions were probable and 19% were possible. In all patients the offending drug was stopped and alternative treatment was provided. The ADRs were managed conservatively. Conclusion: This study showed that ADRs involving skin and mucous membrane were common with the use of AED; some of which required interventions and prolonged hospital stay. Early detection and prompt reporting of ADRs to Pharmacovigilance centres can ensure drug safety and thereby helps to improve the overall quality of life.
NEU-19
Evaluation of Zinc Oxide as Anti-depressant in Albino Mice
Annavarapu S, Naidu CDM, Sree KP, Rao YV
Department of Pharmacology, Kamineni Institute of Medical Sciences, Nalgonda, Telangana, India
Objectives: To evaluate the role of Zinc as anti-depressant in Albino rats using forced swim test. Materials and Methods: Swiss Albino mice were exposed to increasing doses of Zinc Oxide (5 mg/kg, 10 mg/kg, and 20 mg/kg) intra peritoneally to evaluate anti-depressant effect of Zinc using despair swim test. Standard drug used as control was fluoxetine (10 mg/kg, 20 mg/kg) intra peritoneal. A combination group (Zinc 10 mg/kg + Fluoxetine 10 mg/kg) is also present. Immobility time is noticed and analysed using SPSS 19.0 version. Results: Zinc at a dose of 10 mg/kg (76.00 ± 1.52 sec), 20 mg/kg (69.66 ± 2.57 sec) significantly reduced the immobility time when compared to the control, normal saline (174.50 ± 5.16) in the forced swim test and hence showing the antidepressant effect. Zinc at a dose of 5 mg/kg potentiated the antidepressant activity of low dose fluoxetine by reducing the immobility time. Conclusion: The present study reveals the antidepressant effect of Zinc after single administration and is equally efficacious to fluoxetine. However, further studies are required to confirm the Results of present study.
NEU-20
Stereo Isomeric Specific Anti-cholinesterase and Anti-amnestic Activity of 4-[(3H, 3aH, 6aH)-3-phenyl)-4, 6-dioxo-2-phenyldihydro-2H-pyrrolo (3, 4-D) isoxazol-5(3H, 6H, 6aH)-Yl] Benzoic Acid Derivatives
Anand P 1 , Singh B 2
1 Department of Chemistry, Khalsa College, Patiala, Punjab, India, 2 Department of Chemistry, Punjabi University, Patiala, Punjab, India
Objectives: The present study was aimed to designed to evaluate the stereo isomeric specific anti-cholinesterase and anti-amnestic activity of pyrrolo-isoxazole benzoic acid derivatives. Materials and Methods: The synthesis of pyrrolo-isoxazole benzoic acid derivatives involved ring opening cyclization of p-amino benzoic acid with maleic anhydride to yield maleanilic acid, which in turn afforded N-arylmaleimide via ring closed cyclization. Azomethine-N-oxides were obtained by condensation of N-aryl hydroxylamine with differently substituted Benz aldehydes followed by refluxing of N-arylmaleimide with differently substituted azomethine-N-oxides to yield cis- and trans-stereoisomers of pyrrolo-isoxazole benzoic acid. These compounds were evaluated in vitro for AChE inhibitory activity in rat brain homogenate with donepezil as standard AChE inhibitor. Thereafter, the most potent test compound was evaluated for butyrylcholinesterase inhibitory activity and in vivo memory evaluation in scopolamine (0.4 mg/kg)-induced amnesia in mice by employing Morris water maze test. Results: All pyrrolo-isooxazole benzoic acid derivatives demonstrated potent AChE inhibitory activity. The cis isomers of synthesized compounds exhibited AChE inhibitory activity similar to donepezil and four of them (7h, 7i, 8i, 8h, IC 50 = 19.1 ± 1.9-17.5 ± 1.5 nM) displayed higher inhibitory activity as compared to donepezil (21.5 ± 3.2 nM) with compound 8i (IC 50 = 17.5 ± 1.5 nM) being the most active one. The test compound 8ia also ameliorated scopolamine-induced amnesia in mice in terms of restoration of time spent in target quadrant (TSTQ) and escape latency time (ELT). Conclusion: Pyrrolo-isoxazole benzoic acid derivatives exhibit stereoisomer specific anti-cholinesterase and anti-amnestic activity.
NEU-21
Cycloserine Induced Psychosis: A Case Report
Paserkar GL, Gupta MC
Department of Pharmacology, PGIMS Rohtak, Haryana, India
Objectives: To carry out pharmacovigilence activity at PGIMS Rohtak. Materials and Methods: This pharmacovigilence activity was conducted in chest and tuberculosis outpatient department PGIMS, Rohtak. Twenty four year old male patient was diagnosed with pulmonary tuberculosis and prescribed with Category-I ATT (isoniazid, rifampicin, pyrazinamide, ethambutol and pyridoxine). He took medicines irregularly and reported as MDR-TB, and then he was prescribed inj. kanamycin, tab. levofloxacin, and cap. Cycloserine, Tab. ethambutol, tab. pyrazinamide, Sachet PAS, Tab. Pyridoxine. After taking the regimen for two months the patient and his relative reported back with persistent psychotic complaints like insomnia, irrelevant talk, delusion and suicidal ideation. Physician suspected cycloserine as a cause of psychotic manifestation and omitted cycloserine from the regimen. Results: After omitting cycloserine from the regimen psychotic manifestations regressed slowly. This indicates that cycloserine is responsible for observed psychotic symptoms in this patient. Conclusion: In this case we conclude that cycloserine causes psychosis in patient of MDR-TB, so there is need of awareness and close monitoring of psychiatric adverse events of ant tubercular agents.
NEU-22
Case of Toxic Epidermal Necrolysis Due to Carbamazepine in Paediatric Patient
Agrawal P 1 , Purohit G 1 , Srivastava B 1 , Singh N 2 , Bhardwaj R 1 , Gaur S 1
1 Department of Pharmacology, Government Medical College Haldwani, Nainital, Uttarakhand, India, 2 Department of Paediatrics, Government Medical College, Haldwani, Nainital, Uttarakhand, India
Objectives: Toxic epidermal Necrolysis is a serious and life threatening idiosyncratic mucocutaneous reaction characterized by acute hypersensitivity due to viral infections, malignancies and drug leading to denudation of skin. Carbamazepine is widely used in treatment of generalized tonic clonic seizure, Trigeminal neuralgias, Bipolar disorder, and Diabetic neuropathy. Case Report: The clinical presentation of the patient with blisters and denuded skin involving more than 30% of body surface area following Tab. Carbamazepine, favors clinical diagnosis of Toxic Epidermal Necrolysis. As per WHO Uppsala Monitoring center (WHO UMC) standardized case causality assessment criteria and Naranjo Algoithm this case was considered as a certain reaction due to Carbamazepine. Conclusion: Carbamazepine is a widely prescribed drug for Seizure and Trigeminal Neuralgias, physician should be aware with its adverse and life threatening side effects and drug should be prescribed judicially.
NEU-23
Intravenous Transplantation of Human Derived Dental Pulp Stem Cells Improves Diabetic Neuropathy in Rats
Bari N 1 , Shahani P 2 , Majumdar D 3 , Sowmithra 3 , Razdan R 1 , Datta I 3
1 Al Ameen College of Pharmacy, Bengaluru, Karnataka, India, 2 Manipal Institute of Regenerative Medicine, Bengaluru, Karnataka, India, 3 National Institutes of Mental Health and Neurosciences, Bengaluru, Karnataka, India
Objectives: The study was conducted to investigate the effect of human derived dental pulp stem cells (DPSCs) transplantation in Streptozotocin (STZ) induced diabetes type 1 model. Materials and Methods: DPSCs were isolated from teeth of adult human beings. They were cultured, characterized and labelled for the administration to diabetic rats. Diabetes was induced in male Wistar rats by single intraperitoneal injection of STZ (55 mg/kg). After confirmation of diabetic neuropathy at 6 week, DPSCs (1 × 10 6 cells i.v.) were transplanted. Simultaneously positive and negative control rats were kept for the study. After 8 weeks various behavioural, biochemical and nerve conduction velocity studies (invasive and non-invasive) were performed in rats. Results: Body weight and serum blood glucose levels were seen to be improved as compared to vehicle-treated DN animals. Moreover, significant improvement was noted in tail flick, grip strength and muscle co-ordination in DPSCs treated DN rats. An improvement on the inflammatory milieu of DN was observed. Plasma levels of secretory TNF-α were seen to be significantly reduced after DPSC treatment, indicating an anti-inflammatory effect of DPSCs. This effect was confirmed by improvement in mRNA levels of IL-6, TNF-α and TGF-β, and thus reversal of inflammation. Improved nerve conduction velocity in DPSCs treated group indicates its neuroregenerative effect on sciatic nerve. Conclusion: Our Results strongly indicate that intravenous transplantation of DPSCs could be promising treatment for DN.
NEU-24
Evaluation of Neuroprotective Potential of Thymoquinone in Animal Model of Parkinson's Disease
Thoria PN, Parmar SK
Department of Pharmaceutical Science, Saurashtra University, Rajkot, Gujarat, India
Objectives: Parkinson's disease (PD) is a chronic progressive neurodegenerative disorder, primarily characterized by profound loss of nigrostriatal neurons. Some plant isolates have goodneuroprotective as well as anti-inflammatory, antioxidant activity. Nigella sativa have good neuroprotective action and its main constituent is thymoquinone (TQ), so this study was undertaken to evaluate neuroprotective potential of Thymoquinone in animal model of Parkinson's disease. Materials and Methods: Per group 8 animals (Male Wistar rat) were taken. Group I: Sham (without treatment); Group II: Disease control (surgery performed, vehicle administered, Group III: TQ (5 mg/kg), Group IV: TQ (10 mg/kg), Group V: TQ (15 mg/kg). After stereotaxic surgery 6-hydroxydopamine (6-OHDA) lesioned rats were daily treated orally with TQ (Group III, IV and V) at respective doses. Body weight, total locomotor activity and behavioral study were performed on day 1, 7 and 14. On day 15 Blood collection and dissection performed for biochemical parameters as well as histopathology evaluation. Results: Activity of superoxide dismutase (SOD) and Glutathione peroxidase (GPX) reduced in the Disease control group. TQ pretreatment significantly improved behavioral and locomotor effect as compared to Disease control group. SOD and GPX levels also increased in TQ treated group as compare to disease control group. Conclusion: These Results suggest that TQ have neuroprotective effect against 6-OHDA induced neurotoxicity in rat model of Parkinson's disease.
NEU-25
In vitro Neuroprotective Effect of Catechin Against Doxorubicin and Glutamate Induced Neurotoxicity in IMR-32 Cell Lines
Kumar N, Rao CM, Cheruku SP, Nandakumar K, Biswas S
Department of Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
Objectives: The present study was designed to evaluate neuroprotective effect of catching against doxorubicin and glutamate induced neurotoxicity on IMR 32 neuroblastoma cell line. Materials and Methods: IMR 32 cell line was procured from NCCS, Pune, India and used for neuroprotection study by cell viability assay. The pre-treatment of catechin were given for one hour followed by exposure of doxorubicin (1 and 2 μg/ml) for 24 h which showed a significant increase in percentage viability compared to doxorubicin. Retinoic acid supplementation produced neuronal differentiation in IMR-32 cell lines, Resulted in the extension of neurites, a neuronal cholinergic phenotype. Glutamate (0.5 mM) and doxorubicin (1.5 μg/ml) were selected as toxicant to produce neurotoxicity in cells and investigated for the neuroprotective effect of catechin (40 μg/ml). Flow cytometry study was done to assess its effect on cell cycle against doxorubicin induced toxicity. Results: The cells clearly appeared to be degenerated, rounded and detached due to glutamate and doxorubicin induced toxicity. This degeneration caused due to the toxicants were reversed by treatments with catechin. Similar effect was observed on neurite length which was decreased significantly due to exposure of both toxicants and significantly protected by the pre-exposure of the treatments. Conclusion: Catechin showed neuroprotection against doxorubicin and glutamate induces toxicity on IMR-32 cell line.
NEU-26
Prognostication of Traumatic Brain Injury Patients in a Tertiary Care Hospital in India
Yadav BS, Priyanka K, Arundathi M, Bhavyaka G, Krishna DN, Roy PK
School of Pharmacy, Anurag Group of Institutions, Ghatkesar, Hyderabad, Telangana, India
Objectives: To evaluate the improvement in outcome of Traumatic Brain Injury (TBI) patients with adherence to the Brain Trauma Foundation (BTF) guidelines 2007. Materials and Methods: A Retrospective analysis study is underway in a tertiary care hospital by assessing the following parameters in TBI patients. (1) Blood pressure - Systolic blood pressure <90 mmhg during stay in hospital is avoided. (2) Glasgow coma scale score - on admission and during stay. (3) Pupillary response and size - on admission. (4) Oxygenation SPO 2 <90% is avoided. (5) Age - 0-30 years, 30-60 years, >60 years. (6) Anti seizures prophylaxis. (7) Sedatives and paralytics during first 2-3 days. (8) Infection prophylaxis- antibiotic administration. (9) Deep vein thrombosis prophylasis either by low molecular weight heparin (LMWH) or Pneumatic compression devices. (10) Adequate calorie supplementations. Each patient is given a score out of 10 and comparision of outcomes based on mortality at Day 7, Day 14, and Day 30 due to all causative reasons will be evaluated. Results: A statistical analysis of the Results would be done by October 2015 to evaluate a scoring system to predict outcomes from TBI patients. Conclusion: The expected outcome is adherence to the BTF guidelines may be useful means for increasing the score and improving the outcome of patients with Traumatic Brain Injury.
NEU-27
Asiatic Side (INDCA) Ameliorate Cognitive Impairment in Chronic Mild Stress Model in Wistar Rats
Aswar M 1 , Yanna V 1 , Aswar U 1 , Thakur DP 2 , Mohan V 2
1 Department of Pharmacology, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India, 2 Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, India
Objectives: Objectives of the present study was to assess the attenuation of impaired cognition induced by chronic unpredictable mild stress (CMS) model in Wistar rats. Materials and Methods: Adult Wistar rats were subjected to six different low grade mild stressors (tilted cage, food and water deprivation, restricted access to food, exposure to empty bottle, wet cage, continuous illumination) for 7 weeks. These stressors were randomly scheduled over one week period and repeated throughout 7 weeks to maintain the aspect of unpredictability. At the end of every week sucrose consumption test and body weight of all animal was measured. Treatment either with standard or INDCA (3, 10, 30 mg/kg) was started during the last two weeks of stress period. Object recognition test (ORT), Object location test (OLT) was carried out to assess cognitive performance and open field test (OFT) performed to determine locomotion. At the end of the study anti-oxidant biochemical parameters were also performed. Results: Control rats showed gradual reduction in consumption of sucrose demonstrating anhedonia whereas INDCA significantly increased the intake of sucrose solution. Exposure to ORT, OLT and OFT, impaired cognition was observed but INDCA significantly increased exploration time towards novel object. Affected locomotion CMS control group was significantly reversed by INDCA treatment. Conclusion: INDCA administration from 5 th week significantly reverses anhendonia and improves cognitive performance in ORT and OLT. Significant alterations in anti-oxidant biochemical parameters were also observed. INDCA could be functional and supportive treatment for depression and to improve cognition in depression.
NEU-28
Impact of Neurosteroids on the Brain, Sexdifferences and Therapeutic Potentials: An Overview
Zilate SR, Gosavi D
Department of Pharmacology, MGIMS, Sevagram, Maharashtra, India
Neurosteroids are synthesized within the brain and rapidly modulate neuronal excitability. They are classified like pregnane neurosteroids such as allopregnanolone and allotetrahydrodeoxycorticosterone, and androstane neurosteroids, such as and rostanedioland etiocholan one. Neurosteroids such as allopregnanolone are positive allosteric modulators of GABA-A receptors with powerful antiseizure activity in animal models. Neurosteroids increases both synaptic and tonic inhibition. They are endogenous regulators of seizure susceptibility, anxiety and stress. Sulfated neurosteroids such as pregnenolone sulfate, which are negative GABA-A receptor modulators, are memory-enhancingagents. Sex differences in susceptibility to brain disorders could be due to neurosteroids and sexual dimorphism in specific structures of the human brain. Synthetic neurosteroids having better bio availability and efficacy and drugs that enhance neurosteroid synthesis have therapeutic potential in anxiety, epilepsy and other brain disorders. Clinical trials with the synthetic neurosteroid analog ganaxolone in the treatment of epilepsy have been hopeful. Neurosteroidogenic agents that lack benzodiazepine-like side effects show promise in the treatment of anxiety and depression.
NEU-29
Protective Role of Losartan During Aluminium-induced Neurotoxicity
Shetty M 1 , Shenoy S 2 , Nagendra K 3 , Amin N 3
1 Department of Pharmacology, Melaka Manipal Medical College, Manipal University, Manipal, Karnataka, India, 2 Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India, 3 Department of Biochemistry, Kasturba Medical College, Manipal University, Manipal, Karnataka, India
Objectives: To investigate neuroprotective effects of losartan against alluminium chloride induced neurotoxicity in rat hippocampus. Materials and Methods: In this study, 18 male Wistar rats were designated into 3 groups of 6 each and treated for 84 days as follows: Group I: vehicle. Group II: alluminium chloride (30 mg/kg) along with rivastigmine 5 mg/kg, Group III: alluminium chloride (30 mg/kg) along with losartan (2.5 mg/kg). At the end of the study, the animals were sacrificed and their brain homogenates were evaluated for acetyl cholinesterase activity and malondialdehyde (MDA) levels. Data was analysed using one way analysis of variance (ANOVA) followed by Tukey's post hoc test using GraphPad Instate software, version 3.06. Results: Losartan supplementation to aluminium chloride treated animals caused a significant decrease in the activity of acetyl cholinesterase (P < 0.05) and increase in the levels of MDA (P < 0.05). Group III showed better Results compare to group II. Conclusion: The study suggests that losartan can be used as a neuroprotectant during alluminium chloride induced neurotoxicity. Further evaluation of brain histopathology, behavioural and neurochemical indices are required to strengthen our current Results.
NEU-30
Current Trends in the Treatment of Multiple Sclerosis
Majumdar S, Sarmah D
Department of Pharmaceutics, Indian Institute of Technology (Banaras Hindu University), Varanasi, Uttar Pradesh, India
Multiple Sclerosis (MS) is an inflammatory autoimmune disease of the central nervous system where an autoimmune attack takes place against the axonal myelin sheath, leading to the breakdown of salutatory conduction, axonal destruction and irreversible neuronal cell death. Along with being a complex disease, MS has a highly varied clinical picture, with the pattern of sensory and motor disturbances varying from individual to individual. Effective therapies for MS include approaches which allow CNS repair by inhibition of inflammation and/or simultaneously protecting neurons from damage. Pharmacological treatment for MS includes the use of steroids, immunosuppressants and immunomodulatory. Cyclophosphamide and azathioprine are commonly used immunosuppressant's, shown to have variable degree of benefit. Other drugs available for MS include Dimethyl fumarate, dalfampridine, alemtuzumab, natalizumab etc. Interferon beta was found to be effective in cases of relapsing-remitting MS. Recent works by researchers have shown that erythropoietin (plays a role in erythropoiesis) and methotrexate in low doses is effective against certain inflammatory diseases. It was found that treatment with erythropoietin and methotrexate significantly improved neurological function recovery, reduced inflammatory infiltrates and demyelination. However, clinical significance of the combination is yet to be established. Although many of the drugs available have failed as treatment for progressive MS, management of MS therefore solely aims to minimize symptoms and to improve function. The aim of this review is to highlight the current scenario with regard to MS in the health sector and to summarize the pharmacological options available for MS.
NEU-31
Study of Change in Salivary Cortisol Levels in Treatment Resistant Depression
Kavita, Hishikar R, Sahu MK, Khodiyar PK
Pt. JNM Medical College, Raipur, Chhattisgarh, India
Objectives: To observe the changes in the salivary cortisol levels in the treatment resistant depressive patients. To study the effects of antidepressant drugs given in treatment resistant patients and its association with cortisol. Materials and Methods: The present study will be a prospective cohort study to be carried out in the psychiatric OPD in the DrBRAM Hospital Raipur and Pt. J. N. M Medical College, Raipur. During the study, the participants will be the treatment resistant depressive patients who attend the psychiatric OPD, who are taking antidepressant medications but not responding to the treatment for a long time. The samples of saliva are taken from them and the levels of the salivarycortisols are measured by the salivary cortisol kit in our department of biochemistry. The samples from the patients taking antidepressant medications are measured and after 2 months also and then the follow up done. Inclusion Criteria: Patients diagnosed as case of treatment resistant depression; Age group 18 years and above. Exclusion Criteria: Patients having hormonal disorders; Patients having other psychiatric disorder; Pregnant and lactating mothers; Patients having substance abuse disorders. Results: Out of 50 patients, 35 are having significant increased salivary cortisol levels as compared to their baseline and 15 patient's levels are almost near to baseline. Conclusion: Depression is one of the widespread diseases in the world. Dysregulation of the hypothalamic pituitary adrenal axis has been hypothesized to be one of the cause of illness which is concomitant with a high level of cortisol.
NEU-32
Epirisone Hydrochloride Induced Maculopapular Rash
Balaraddiyavar N 1 , Bhushan A 1 , Kinatot BC 1 , Huggi G 2
1 Department of Pharmacology, BIMS, Belagavi, Karnataka, India, 2 Department of Dermatology, BIMS, Belagavi, Karnataka, India
Objective: Epirisone Hydrochloride is an antispasmodic and an analgesic drug which is indicated in most of the spastic diseases like spastic paralysis in cerebrovascular diseases, cervical spondylosis, cerebral palsy, periarthritis etc and also being tried for hypertension. Drug is marketed in most of the Asian countries including India but its legal status is not licensed. Studies show the history of hypersensitivity in other countries but it is the first of reported case in India. Here, we report the case of a patient who developed maculopapular rash with epirisone hydrochloride.
NEU-33
Anti-epileptic Drug and Sleep Quality: A Prospective Study
Bhattacharjee A 1 , Verma S 1 , Gupta MC 1 , Dabla S 2
1 Department of Pharmacology, Pt. B. D. Sharma Post Graduate, Institute of Medical Sciences, Rohtak, Haryana, India, 2 Department of Medicine, Pt. B. D. Sharma Post Graduate, Institute of Medical Sciences, Rohtak, Haryana, India
Objectives: Disturbed sleep is common in patients with epilepsy. Antiepileptic drugs (AEDs) used for seizure control can modulate sleep quality. The current study was aimed to evaluate effects of AED therapy on sleep quality in adult patients with epilepsy. Materials and Methods: A prospective, observational, questionnaire based study was carried out amongst 90 treatment naive adult epileptic patients who received various antiepileptic drugs like valproic acid, phenytoin, carbamazepine, levetiracetam, and lamotrigine or combination therapy. Three scales namely Pittsburgh Sleep Quality Index (PSQI) questionnaire, Epworth Sleepiness Scale (ESS) and Insomnia Severity Index (ISI) were used to see the overall influence of AEDs on sleep. Patients were subjected to the questionnaires before the start of treatment and followed up at 4 and 8 weeks. Statistical analysis was done using repeated measures ANOVA. Results: 64 cases out of 90 patients were considered for final evaluation. At 4 weeks, maximum deterioration in sleep quality as assessed with PSQI score, was seen with phenytoin and combination therapy: 2.14 ± 0.22, 2.77 ± 0.29 respectively, which continued at 8 weeks. ESS score showed maximum increase in daytime drowsiness with phenytoin (4.21 ± 0.03), carbamazepine (2.78 ± 0.2) and combination therapy (5.14 ± 0.07), wile ISI score showed increase in insomnia with phenytoin (4.69 ± 0.32) and combination therapy (4.45 ± 0.04). Levetiracetam showed improvement in sleep on all the three scales, whereas lamotrigine and valproate had no significant effect. Conclusion: AEDs have differing effects on sleep structure, which can be beneficial or detrimental. Consideration of these potential effects is important in maintaining optimal sleep quality in patients with epilepsy.
NEU-34
Benefits of D-cycloserine in Psychiatric Diseases: Review
Praviraj PV, Kiran UP
Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India
Objectives: Cycloserine has been in use for 30 years as a broad spectrum antibiotic for tuberculosis. Its main side effect is drug induced psychosis. The D-Cycloserine stereoisomer has been recently found to have cognition enhancement effect at low doses from 15 mg to 100 mg. Currently the role of drugs for cognition enhancement in psychiatric diseases is minimal, though numerous drugs are being used and many are under trial. To review the benefits of D-cycloserine in psychopharmacology for its cognitive enhancement effects in various psychiatric diseases. Materials and Methods: Review of international scientific papers published from 2004 to till date. Only original studies published in peer reviewed journal are included in this review. Results: 50 studies reviewed, first such study by Ressler et al. exposure therapy combined with DCS Resulted in significantly larger reductions of acrophobia symptoms (Ressler et al.), Chasson et al. DCS accelerates the gains of exposure in OCD. It was shown by Tsai et al. short-term D-cycloserine treatment exerts a cognitive enhancing effect for Alzheimer's disease patients when given at a dose of 100 mg/day. The studies reported negligible side effects with single pill administration. No studies regarding long term benefits and side effects of DCS. Conclusion: D-cycloserine acts as a partial agonist at the glycine modulatory site at the glutaminergic NMDA receptor (Ressler et al.). After almost 10 years since the discovery of cognitive enhancement action of D-Cycloserine it has been tried out for various psychiatric diseases and found to have beneficial effects for few of them. The reason for no studies published in India regarding this concept may be due to lack of awareness among the psychiatrists and high cost of the drug.
NEU-35
A Prospective Study on the Use of Local Anaesthetic Agents in Modern Surgical Practices at a Tertiary Care Hospital in Duke
Ganguly D, Herle M, Rajshekhar D, Kokila BN
Department of Pharmacology, K.V.G.M.C.H., Sullia, Dakshina, Karnataka, India
Objectives: To study the trend and pattern of use of local anaesthetic agents for various surgical procedures with respect to the appropriateness and rationality and also to monitor complications, if any. Materials and Methods: A prospective, observational study was carried out for a period of 6 months. 174 case records were collected from department of anaesthesia at K.V.G. Medical College Hospital, Sullia. The data was recorded in a speciallydesigned case reporting form comprising information about indication, type of operative procedure, type of anaesthetic procedure, name of anaesthetic agents, adjuvants used and complications if any. Descriptive statistics and Fischer's exact test were applied for the analysis of data. Results: The mean age was 42.98 ± 1.2. Out of 174 cases there were 46% males and 54% females. The mean no. of anaesthetics used per procedure was 1.26 ± 0.03. Most commonly employed procedure was Sub-arachnoid block (SAB) (75.28%) and the most common agent used was bupivacaine (59%) as a single agent. There was significant association found (P < 0.05) between the no. of anaesthetic agents used and the type of anaesthetic procedure performed and also between the concerneddepartment and the type of anaesthetic procedure performed. Hypotension (45%) and bradycardia (20%) were the most frequently encountered complications. Most commonly used adjuvant was ephedrine (30.48%) followed by opioid analgesics (24.39%). Conclusion: Strong association found between choices of anaesthetic agent with the technique of induction and it is bupivacaine for SAB in majority. The utmost use of single anaesthetic agent sufficed the procedures in majority rather than combinations.
NEU-36
Phenytoin Induced Fatal Erythroderma: Case Report
Tandon S, Kotinatot BC
Department of Pharmacology, BIMS, Belagavi, Karnataka, India
Phenytoin is an antiseizure drug which is shown to be effective with frequent side effects that are rarely fatal. It is frequently prescribed antiseizure drug due to its high efficacy. Here, we report case of a 14 year old patient who developed erythroderma during the course of treatment with phenytoin that Resultsed in death of the patient. Noranjo's causality scale and WHO-Uppsala monitoring centre (UMC) causality criteria was used to determine a causal relationship between erythroderma and treatment with phenytoin.
NEU-37
A Prospective Observational Study to Evaluate Safety Reporting of Antidepressants at King George Hospital in Visakhapatnam, India
Lalitha K, Sudha J, Reddy SA, Padhy S, Lakshmi S
Department of Pharmacology, Andhra Medical College, Visakhapatnam, Andhra Pradesh, India
Objectives: This is a prospective observational study conducted in the department of psychiatry, KGH, from May-August 2015. Adverse drug reactions encountered with patients taking anti-depressant drug were mentioned. Materials and Methods: Randomly selected patients prescribed with at least one antidepressant and monitored for ADR's, irrespective of their age and gender. Results: 350 patient were reviewed out of which 223 patients received at least one anti-depressant, 96 patients experienced 146 adverse drug reactions. SSRI's (82 [56.16%]) was the most common therapeutic class of drugs associated with adverse drug reactions. Gastrointestinal system (34 [23.28%]) was most common affected. Dry mouth (n = 20) and diaphoresis (n = 14) were the most common. Among all adverse drug reactions majority are mild in their severity [n = 131 (89.72%)] and 19.18% are preventable. Conclusion: In this study incidence of adverse drug reactions to anti-depressants was 43.04%. SSRI's were the most common implicated drug group for the adverse drug reactions.
NEU-38
Comparison of Marble Burying Behaviour of Three Different Withania Somnifera Extracts in Stressed Mice
Dey A 1 , Chatterjee SS 2 , Kumar V 1
1 Department of Pharmaceutics, Neuropharmacology Research Laboratory, Indian Institute of Technology (Banaras Hindu University), Varanasi, Uttar Pradesh, India, 2 Stettiner Str. 1, Karlsruhe, Germany, Willmar Schwabe GmbH and Co., KG, Karlsruhe, Germany
Objectives: To compare oral efficacies of different parts of the Ayurvedic Rasayana herb Withania somnifera (Ashwagandha or Indian Ginseng) in a model for obsessive compulsive disorders in stressed mice. Materials and Methods: Groups of male mice were treated with stress resistance promoting oral doses (10 mg/kg/day) of a medicinally used Withania somnifera root extract (WSR), or with an extract of its aerial parts (WSA) or of its stem (WSS), or with their vehicle for 12 consecutive days. They were subjected to foot shock stress induced hyperthermia test on the 1 st , 5 th , 7 th , and 10 th , and to marble burying tests on the 11 th and 12 th days of treatments. Stress triggered alterations in bodyweights and temperatures were quantified on all observational days. Results: Body weight losses and elevations in basal core temperature triggered by occasional exposures to 50 seconds of foot-shock stress in the vehicle treated groups, were not observed in the extract treated groups. Transient stress induced hyperthermic response, as well as marble burying behaviour were also significantly (p < 0.05) suppressed by all the three extracts. Observed efficacies of WSA were somewhat higher than those of WSR or WSS. Conclusion: Repeated daily 10 mg/kg oral doses of root, stem or aerial part extracts of Withania somnifera are high enough for prevention of obsessive compulsive behaviour in mice. Extracts of the stems and roots of the plant are somewhat less enriched in adaptogenic plant metabolites than its entire aerial parts. The bioassay procedure used is a convenient one for pharmacologically standardization of adaptogenic herbal extracts.
NEU-39
Neurotoxicity Mitigation by Hesperidin in Wistar Rats
Naseem M, Parvez S
Department of Medical Elementology and Toxicology, Jamia Hamdard (Hamdard University), New Delhi, India
Objectives: We evaluated the role of hesperidin (HP) in ameliorating neurotoxicity induced by carbon tetrachloride CCl 4 . Materials and Methods: Rats were equally divided into 4 groups for the assessment of neuroprotective effect of HP. Group I animals received normal salinefor 8 days and a single injection of olive oil through s.c.route. Group II animals received HP (200 mg/kg b.w., oral) for a period of 8 days. Group III animals received normal saline for 8 days and a single injection of CCl 4 on 7 th day. Group IV animals received both HP (200 mg/kg b.w., oral) for 8 days + CCl 4 (2 ml/kg b.w., S.C.) on 7 th day. To evaluate the protective effect of HP we performed various enzymatic, non-enzymatic and neurotoxicity biomarker parameters as well. Results: In our study CCl 4 caused a significant increase in the oxidative markers, viz., lipid peroxidation (LPO) levels and protein carbonyl (PC) content. There was also marked inhibition of antioxidants and neurotoxicity markers. HP was shown to ameliorate the enzymatic, non-enzymatic antioxidants as well as neurotoxicity biomarkers in brain tissues of rats at the cellular level. Conclusion: Our Results demonstrated that HP had a potent antioxidative and neuroprotectiveeffectimplying its key role in protecting regions of brain against various types of insultsinduced by neurotoxicants.
NEU-40
Stem Cell Technology - A Boon in the Treatment of Neurodegenerative Diseases: An Overview…!!
Kirde SS, Varma S
Department of Pharmacology, MGIMS, Sevagram, Wardha, Maharashtra, India
Human neurodegenerative diseases such as Parkinson's disease (PD), Huntington's disease (HD), amyotrophic lateral sclerosis (ALS) and Alzheimer's disease (AD) are caused by progressive loss of structure, function or number of neurons, including death of neurons in brain or spinal cord. As a rule, dead neurons in adult CNS are neither substituted nor can their terminals redevelop when their axons are damaged. Unfortunately, the current available treatment options neither pharmacological nor neurosurgical are efficient in arresting the progression of the neurodegenerative processes. Stem cell therapy has developed the field of medicine over the past few decades. Today, stem cell therapy offers promising faith for almost all forms of neurodegenerative diseases including PD, Huntington's disease (HD), Alzheimer's and amyotrophic lateral sclerosis (ALS). Stem cells therapy not only empowers regeneration of new neurons and replace damaged neurons, but also modulates the immune system. Stem cell therapy is probably the only potential treatment modality which offers 'cure' for neurodegenerative diseases. In this review, we have summarized the types of stem cells, principles of using therapy, evolving concept of stem cell therapy, clinical applications, recent advancement and potential future prospects of stem cell therapy in various neurodegenerative disorders.
NEU-41
Effect of Risedronate on Depression Paragidms in Male Swiss Albino Mice and Wistar Rats: An Experimental Study
Amitha N, Torgal SS
Department of Pharmacology, Jawaharlal Nehru Medical College, Belgaum, Karnataka, India
Objectives: To study the influence of Risedronate on depression paradigms in male Swiss Albino mice and Wistar rats by Forced swim test (FST) and tail suspension test (TST) and compared with the standard (Amitryptilline). Materials and Methods: Three groups of healthy male Wistar Rats (6 in each group) were subjected to FST (Training on day 1 and tested for immobility time on day 2). Three groups of healthy male Swiss Albino mice (6 in each group) were subjected to TST (tested for immobility time when suspended by the tail).
Results: FST in Rats and TST in mice: The mean immobility time (seconds) in group II and group III was significantly reduced as compared to group I. However group II reduced the mean immobility time more than group III but the difference was not significant. Conclusion: Treating post-menopausal osteoporosis is known to reduce depression in patients. Risedronate, a bisphosphonate, showed anti- depressant activity probably due to inhibition of certain mediators of depression which are currently being explored. Further studies are suggested to confirm this activity.
NEU-42
Cholinergic Antagonists Elicits Behavioural Imapirment and Memory Dysfunction via Cholinergic Breakdown in Mouse Model of Global Cerebral Ischemia Reperfusion Injury
Ray RS, Katyal A
Dr. B.R. Ambedkar Center for Biomedical Research, University of Delhi, New Delhi, India
Objectives: Global cerebral ischemia induced reperfusion injury (GCI/R) in humans is clinically evidenced in situations like cardiac arrest, asphyxia, drowning or severe systemic hypotension during a surgical procedure. Materials and Methods: In the present study, we investigated the effects of scopolamine (0.1 mg/kg i.p.) and mecamylamine (0.5 mg/kg i.p.) oncholinergic system and memory function in mouse model of global cerebral ischemia/reperfusion injury. Results: Cholinergic blockade by scopolamine and mecamylamine displayed altered learning and memory functions and behavioral dysfunction, evident from behavioral studies. Furthermore, treatment with cholinergic antagonists displayed significantly altered muscarinic and nicotinic receptor expression and AChE and ChAT levels thereby confirming the crucial involvement of cholinergic system in memory performances following GCI/R. Conclusion: The correlation of altered learning and memory performances with thecholinergic markers confirms the functional importance of both muscarinic and nicotinic receptor and association of cholinergic hypofunction and memory dysfunction following GCI/R injury. The outcomes of present study together with earlier reports highlights the importance of cholinergic integrity and preservation of both muscarinic and nicotinic receptor functions in maintaining memory functions following GCI/R injury.
NEU-43
Effect of Ganoderma Lucidum in Anterograde Amnesia Induced in Male Wistar Rats by Diazepam an Experimental Study
Savithasree S, Hogade AP
Department of Pharmacology, Jawaharlal Nehru Medical College, Belgaum, Karnataka, India
Objectives: To study the effect of Ganoderma lucidum on induction of anterograde amnesiain male Wistar rats by Diazepam. Materials and Methods: Threegroups (n = 10), of healthy rats (150-180 grams) weretrained for searching a hidden platform in Morris water maze for 4 daysandtested for retrieval of that task on the 5 th day. IAEC is obtained and all guidelines of CPSCEA have been followed.
Results: The Mean Escape Latency Time was significantly reduced on day 4 compared to day 1 in groups me and III. Rats in groups II spent lesser time in the target quadrant than of Group I. Index of retrieval in group III was significantly more than that in group I. Conclusion: Ganoderma lucidum ameliorated induction of anterograde amnesia by diazepam. This may be possibly due to its anti-oxidant property.
NEU-44
Clinical Pattern of the Adverse Drug Reactions of Antiepileptic Drugs in a Tertiary Care Hospital
Thomas M, Badyal DK, Pandian JD
Department of Pharmacology, Christian Medical College and Hospital, Ludhiana, Punjab, India
Objectives: To evaluate the clinical pattern of the adverse drug reactions of antiepileptic drugs in patients visiting tertiary care hospital. Materials and Methods: ADRs (Adverse Drug Reactions) occurring in department of neurology over a period of three months in the patients visiting outpatient department in a tertiary care hospital were analysed. Patients receiving antiepileptic drugs namely phenytoin, sodium valproate, carbamazepine, lamotrigine, oxcarbazepine and levetiracetam were evaluated for any suspected drug related cause using adverse drug reaction checklist and spontaneous reporting. Severity of ADRs and outcomes were noted. Causality was assessed using causality assessment scale as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria. Results: In 60 patients evaluated, 131 ADRs were observed. The ADRs noted were sleepiness (19%), irritability (17.5%), headache (11.4%), weight gain (10.6%) and poor memory (9.16%). Hair loss (8.39%), difficulty in concentration (7.6%), acne (6.10%), tremors 5.34%) were also noted. Out of total ADRs swollen gums accounted for 3.05% while skin rash and excessive hair growth accounted for 0.76% each. The ADRs reported were mild to moderate in severity and all patients recovered. The causal relationship of the reactions was probable as per WHOM causal relationship scale. Conclusion: The most common adverse drug reaction reported was sleepiness and the least common was skin rash and excessive hair growth. The commonest drug causing adverse drug reactions was phenytoin.
NEU-45
Evaluation of Antiepileptic Activity of Fructose-1, 6-diphosphate and Vitamin C Combination
Samariya B, Shah G
Department of Pharmacology and Clinical Pharmacy, K.B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India
Objectives: To assess the antiepileptic effects of fructose-1,6-diphosphate, vitamin C and their combination in intravenous pentylenetetrazole kindling model and intracranial carbachol kindling model. Materials and Methods: Pentylenetetrazole kindling was induced by intravenous infusion of PTZ (10 mg/ml; infusion rate: 1 ml/min) to rats. For carbachol kindling, intracranial administration of carbachol (1 μl; 5 μg/ml) was done at well-spaced intervals by introducing maximum three injections per day and maximum nine administrations till stage 5 epileptic convulsions were produced. The treated group animals received FDP, vitamin C or both, 28 days prior to the kindling. During kindling, time latency to reach a seizure stage, frequency of stimulation and percentage protection were recorded whereas the brain homogenate parameters included: measurement of levels of neurotransmitters, GSH and MDA. Results: The slowing of seizure progression, increase in seizure threshold and required number of stimuli to reach to stage 5 convulsion was highest with FDP and Vitamin C combination followed by FDP and Vitamin C alone treatment. EEG data during the PTZ infusion indicated ictal epileptiform in disease control group, in contrast to the treatment groups which showed no difference from the background activity. The test drugs either alone or in combination did not alter glutamate and aspartate levels in brain but increased the GABA and GSH whereas reduced MDA levels. The effect was most prominent in the combination, followed by FDP. Conclusion: It can be concluded from the above data that both FDP and Vitamin C has beneficial effects in chemical induced kindling and their combination shows synergistic effects.
NEU-46
Efficacy of Oligosaccharides Based Standardized Fenugreek Seed Extract in Partial Sciatic Nerve Ligation Induced Peripheral Mononeuropathy in Rats
Thakurdesai P 1 , Kandhare A 2 , Zambare G 2 , Bodhankar S 2 , Vishwaraman M 1
1 Department of Scientific Affairs, Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, India 2 Department of Pharmacology, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Erandwane, Pune, Maharashtra, India
Objectives: To evaluate the efficacy and probable mechanism of oligosaccharides based standardized fenugreek seed extract (SFSE-OS) in animal model of peripheral mononeuropathy. Materials and Methods: Peripheral mononeuropathy was induced in male rats through unilateral partial sciatic nerve ligation (PSNL). After 48 h of recovery period, the rats were administered orally with vehicle (Sham and PSNL control groups), pyridoxine (PD, 100 mg/kg) or SFSE-OS (3, 10 and 30 mg/kg) for next 28 days. The measurements on hyperalgesia, tactile allodynia, motor in-coordination, and motor nerve conduction velocity (MNCV) were recorded at baseline and end of treatment period of 28 days. Subsequently, the biochemical, histological and molecular measurements were performed in the isolated sciatic nerve homogenate. Results: Sub-acute oral treatment of SFSE-OS showed dose-dependent reversal from PSNL induced hyperalgesia, tactile allodynia, motor in-coordination, decreased MNCV. The SFSE-OS treated rats showed significantly reduced levels of neural calcium, nitric oxide and inflammatory mediators (TNF-α and IL-1 β), increased levels of neural Na-K-ATPase and lesser inflammatory and necrotic changes in sciatic nerve as compared with PSNL control rats. Conclusion: The subacute oral treatment of SFSE-OS showed promising efficacy against PSNL induced mononeuropathy in rats by reducing inflammatory pain and improving neuro-conduction.
NEU-47
Naringin Offers Protection Against Post-stroke Depression in Mice: Possible Involvement of Nitric Oxide Mechanism
Aakriti, Aggarwal A, Gaur V, Kumar A
Division of Pharmacology, UGC Centre of Advanced Study, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India
Objectives: The present study was designed to explore the nitric oxide mechanism in the protective effect of naringin against I/R induced neurobehavioral alterations including depression, oxidative damage and mitochondrial dysfunction in mice. Materials and Methods: Laca mice (25-30 g) were subjected to BCCAO occlusion (5 min) twice at the interval of 10 min, followed by 96 h reperfusion. Naringin (50 and 100 mg/kg) was administered for 10 days, starting 7 days before the animals were subjected to I/R injury. On day 10, various neurobehavioral parameters followed by biochemical parameters and mitochondrial enzyme complex activities were assessed. Results: Ischemia reperfusion injury caused significant neurobehavioral changes (increased immobility period, neurological score and decreased locomotor activity), oxidative damage (increased lipid peroxidation and nitrite concentration and depleted reduced glutathione, glutathione-S-transferase, superoxide dismutase and catalase) and altered mitochondrial enzyme complex activities (complex I to IV) as compared to sham treatment. Naringin (50 and 100 mg/kg) treatment significantly attenuated neurobehavioral alterations, oxidative damage and restored mitochondrial enzyme complex activities as compared to control (ischemia reperfusion) group. Further, protective effect of naringin (50 mg/kg) was attenuated by L-arginine (100 mg/kg) or sildenafil (5 mg/kg) pretreatment. L-NAME (10 mg/kg) or 7-NI (10 mg/kg) pretreatment with naringin (50 mg/kg) significantly potentiated their protective effect as compared to their treatment alone. Conclusion: The study suggests the involvement of nitric oxide mechanism in the protective effect of naringin against post-stroke depression induced neurobehavioral, biochemical and cellular alterations in mice.
NEU-48
Decreasing Severity of Diabetic Neuropathy in Rats by Phloroglucinol
Keerthi S, Bhadri N, Razdan R
Depatment of Pharmacology, Al-Ameen College of Pharmacy, Bengaluru, Karnataka, India
Objectives: Experimental diabetic neuropathy (DN) is marked by impaired nerve conduction velocity (NCV) and metabolic abnormalities including hyperglycemia, abnormal fatty acid metabolism and oxidative stress. So the purpose of the present study was to evaluate the neuroprotective potential of phloroglucinolin Streptozotocin (STZ) induced diabetic rats. Materials and Methods: Diabetes was induced in male Wistar rats by single intraperitoneal injection of STZ (55 mg/kg). Diabetic rats were divided into four groups namely Diabetic control treated with normal saline (DC) and test group treated with 150, 200 and 250 mg/kg (per oral, daily) of phloroglucinol for 8 weeks. A group of normal rats (n = 6) treated with normal saline were used as negative control. After 8 weeks biochemical parameters in serum (fasting glucose and lipid profile) were determined. The severity of neuropathy was determined by performingnerve conduction velocity. Antioxidant activity was also carried out on the isolated sciatic nerves to assess total oxidative stress. Results: Serum glucose, total cholesterol, triglycerides & LDL levels were increased and HDL was significantly decreased in DC group (P < 0.001) compared to NC group. Phloroglucinol treatment significantly decreased serum glucose, total cholesterol, triglycerides & LDL and significantly increased HDL in dose dependant manner. Phloroglucinol treatment also showed significant increase in superoxide dismutase, catalase activity, and decrease in Malondialdehyde (MDA) in the sciatic nerve homogenate. The sciatic nerve conduction velocity was improved in phloroglucinol treated group compared to DC group. Conclusion: Phloroglucinol exhibited neuroprotective effects in STZ induced diabetic ratsdue to its antihypoglycemic, hyperlipidemic and antioxidant potential.
NEU-49
Study of Antianxiety Activity of Hydro-alcoholic Extract of Hibiscus Rosa-sinensis Flower in Swiss Albino Mice
Mundale NS, Varma S
Department of Pharmacology, MGIMS, Sevagram, Wardha, Maharastra, India
Objectives: To evaluate anti-anxiety activity of hydro-alcoholic extract of Hibiscus rosa-sinensis flower (HRSF) in swiss-Albino mice. Materials and Methods: After obtaining Institutional Animal Ethical Committee approval, Swiss Albino mice of weighed 25-35 gm, either sex were randomly divided into four groups of six animals each. Flowers were allowed to dry, powdered and extract was prepared by using soxhlet apparatus. 10 gm of yield was obtained from 40 gm of powder. Control group received distill water, standard group received diazepam (2 mg/kg) and test groups were received HRSF extract (100 mg/kg &200 mg/kg) body weight respectively, by oral feeding. The anti-anxiety effect was assessed by using light and dark model in mice. Results: In Light and Dark model, it implied that HRSF (200 mg/kg) extract showed highly significant increase in time spent in Light box when compared to control. Number of crossing were significantly (**p < 0.5) increases at HRSF 100 mg/kg extract and highly significant (***p < 0.001) increases at 200 mg/ kg . Conclusion: Current study demonstrates that statistically significant antianxiety activity of HRSF .
NEU-50
Nitric Oxide Modulation in Protective Role of Antidepressants Against Chronic Fatigue Syndrome in Mice
Kaur A, Kumar A, Garg R, Gaur V, Kumar P
Division of Pharmacology, UGC Centre of Advanced Study, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India
Objectives: Chronic fatigue syndrome (CFS) is a heterogeneous disorder of unknown etiology, characterized by persistent and relapsing fatigue, neuropsychiatric symptoms, and various other somatic complaints. Headache, joint pain, gastrointestinal disturbance, cognitive dysfunction, visual disturbance, paresthesia, and neuropsychiatric problems, including anxiety-like behavior are the common complaints of CFS patients. Exact pathological mechanism behind CFS is unknown. However, recent studies demonstrated that mitochondrial dysfunction and hypothalamus pituitary adrenal dysfunction, leading to CFS, is associated with elevated peroxynitrite level. Experimental animal models suggested the anxiolytic and antidepressant effect through inhibition of nitric oxide synthase. The present study was designed to elucidate the possible nitric oxide (NO) mechanism in the protective effect of antidepressants using mice model of chronic fatigue syndrome (CFS). Materials and Methods: Animals (male Albino laca mice) were forced to swim for each 6 min session for 7 days and immobility period was measured on every alternate day. After 7 days various behavioural tests (locomotor, mirror chamber and plus maze tests for anxiety) and biochemical estimations on mice brain (nitrite levels, reduced glutathione, lipid peroxidation and catalase activity) were performed. Animals were pre-treated with citalopram (5 and 10 mg/kg) and imipramine (10 and 20 mg/kg) daily for 7 days. Results: Six minutes continued forced swimming for 7 days caused chronic fatigue-induced anxiety-like behavior as assessed in mirror chamber, plus maze tests, and impairment in locomotor activity followed by oxidative damage (as evidenced by increased lipid peroxidation, nitrite levels, depleted reduced glutathione, and catalase activity) in animals. Seven days pre-treatment with citalopram (5 and 10 mg/kg) and imipramine (10 and 20 mg/kg) significantly improved behavioural and biochemical alterations. Further, L-nitro-arginine methyl ester (L-NAME, 5 mg/kg) and methylene blue (MB, 10 mg/kg) pre-treatment with citalopram (5 mg/kg) or imipramine (10 mg/kg) potentiated their protective effect. However, l-arginine (100 mg/kg) pre-treatment with citalopram (5 mg/kg) or imipramine (10 mg/kg) reversed their protective effect as compared with their effect per se (P < 0.05). Conclusion: The present study suggests that protective effect of citalopram and imipramine might be due to its NO modulation against chronic fatigue induced behavioural and biochemical alterations.
NEU-51
Protocatechuic Acid Supplementation Prevents the Development of Streptozotocin Induced Neuropathic Pain in Rats
Upaganlawar A, Sanklecha D, Upasani C
SNJB's Shriman Sureshdada Jain College of Pharmacy, Chandwad, Maharashtra, India
Objectives: The present study was designed to evaluate the protective effects of Protocatecheuic acid in streptozotocin induced neuropathic pain. Materials and Methods: Male Albino rats were used in the present study. Diabetes was induced in the rats by single intraperitonial dose of Streptozotocin (60 mg/kg, in chilled citrate buffer). Protocatecheuic acid (40 mg/kg, p.o) was administered for 21 days after the confirmation of neuropathic pain. Blood was collected for the estimation of glucose level. Neuropathic pain was assessed by using Von fray filament test, hot plate test and cold allodynia. At the end of treatment period rats were sacrificed and sciatic nerve was excised to measure the level of endogenous antioxidants (lipid peroxidation and reduced glutathione) and nitric oxide contents. Results: Treatment with Protocatecheuic acid for 21 days in neuropathic pain induced rats showed a significant prevention of altered body weight and glucose level. Protocatecheuic acid supplementation showed a significant (P < 0.05) reduction in paw withdrawal threshold in Von fray filament test, hot plate test and cold allodynia. The level of Lipid peroxidation and nitric oxide was found to be significantly reduced whereas level of reduced glutathione was significantly (P < 0.05) increased in treatment group as compared to diseased group. The observed effect might be due to the strong antioxidant activity of protocatecheuic acid.
NEU-52
Impact of Comorbid Conditions on Stroke Occurrence and Outcome
Sharma Tejas, Airao Vishal, Buch Prakruti, Parmar Sachin
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Stroke is a global health problem and morbidities and mortalities due to stroke endanger the socio-economic aspects of developing countries. Indeed, stroke is the second commonest cause of death and fourth leading cause of disability worldwide. Stroke is no longer a disease of developed countries: In India, the ICMR estimates in 2004 indicated that stroke contributed 41% of deaths and 72% of disability adjusted life years amongst the non-communicable diseases. Now a day's rt-PA is the only therapy approved to treat acute ischemic stroke in USA and edaravone in Japan. It has been documented that comorbid conditions such as diabetes, hypertension and/or dyslipidemia can worsen the stroke outcome and give rise to acute ischemic attacks as well. Data suggests that hypertension, diabetes and smoking increase the risk of stroke by 42%, 35% and 12%, respectively. Moreover, the plethora of failed clinical trials with neuroprotective drugs have raised justifiable concerns with respect to role of associated comorbid conditions on stroke outcome. Therefore, to address the aforesaid gaps between preclinical and clinical stroke research, the Stroke Therapy Academic Industry Roundtable (STAIR) committee suggested a detailed preclinical and clinical evaluation of novel neuroprotective agents in young, healthy subjects and further studies in females, aged populations, and subjects with co morbid conditions such as hypertension, diabetes, and hypercholesterolemia.
NEU-53
Cerebroprotective Potential of Alstonia Scholaris Against Ischemia/Reperfusion-induced Brain Injury in Experimental Rats
Airao Vishal, Sharma Tejas, Buch Prakruti, Parmar Sachin, Vaishnav Devendra
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: In the traditional systems of medicine India, Alstonia scholaris and its components have been prescribed by traditional healers to treat brain related disorders such as epilepsy and depression. The present study was designed to investigate neuroprotective potential of standardized ethanol extract of A. scholaris (EEAS) against ischemia/reperfusion (I/R)-induced cerebral injury in rats. Moreover, the presence of phytochemicals has been studied by HPTLC. Materials and Methods: Global cerebral ischemia was induced in male Wistar albino rats by bilateral common carotid artery (BCCA) occlusion for 30 min followed by reperfusion for 60 min. The levels of lipid peroxidation (LPO) and nitric oxide (NO) were estimated as a measure of oxidative stress markers. Moreover, the levels of endogenous enzymatic and non-enzymatic antioxidants such as superoxide dismutase (SOD), catalase (CAT), glutathione (GSH) and total thiol (T-SH) were assessed along with cerebral infarction area and histopathological studies. Results: Pre-treatment with EEAS (100, 200 and 400 mg/kg) ameliorated the levels of LPO and NO, whereas the activity of SOD, CAT, GSH and T-SH were restored back to normal when compared to I/R group. EEAS-treated groups showed marked reduction in cerebral infarction as compared to I/R group. Histopathological study revealed reversal of brain damage in EEAS-treated groups as compared to I/R group. Conclusion: A. scholaris showed potent neuroprotective activity against global I/R-induced cerebral injury and is mediated through its free radical scavenging activity.
CHM
CHM-1
Clinical and Biochemical Evaluation of Adverse Drug Reaction of Chemoradiation on Nasopharynx and Laryngeal Carcinoma Patients in a Tertiary Care Hospital of Assam
Jiban JT, Das S
Department of Pharmacology, Assam Medical College, Dibrugarh, Assam, India
Objectives: To assess the occurrence of ADR on chemo radiation in nasopharynx and laryngeal carcinoma patients and to assess their causal relationship. To assess chemotherapeutic drug induced changes in biochemical parameters. Materials and Methods: A prospective observational study as carried out from January 2015 to August 2015, after getting approval from human ethical committee, among the indoor patients who received chemoradiation in the department of Radiotherapy, Assam Medical College and Hospital. The patients were followed up to track for ADR and changes in haematological parameters following chemoradiation. Results: Out of total 70 patients, 64 given consent to participate in the study, while 54 patients completed the treatment. All the patients had developed one or more ADRs. Causality assessment revealed 84% of ADRs to be probable and 16% to be possible according to WHO Uppsala Monitoring Centre causality assessment scale. The ADRs that commonly occurred were alopecia, nausea, vomiting, anorexia, rise of temperature, peripheral tingling sensation, tinnitus. In haematological parameters, there was decrease in haemoglobin level, total leucocyte count, and neutrophil and platelet count after treatment. There was also change in blood urea level and serum creatinine following first 3 cycles of chemoradiation from baseline with cisplatin and carboplatin. Conclusion: Although cancer chemoradiation is associated with numerous side effect it can be reduced by Proper monitoring better anticancer agents having better efficacy with minimal side effects.
CHM-2
Rare Adverse Event Manifestation of Commonly Used Antimalarial Drug Chloroquine in Tertiary Care Center of Telangana State
Deenadayalan K, Sam PG, Pushpalatha C
Department of Pharmacology, Chalmedaanandrao Institute of Medical Sciences, Karimnagar, Telangana, India
Objectives: Exanthematous pustulosis is a severe acute pustular skin reaction induced by drugs. Adverse effects of antimalarial drugs usually are nausea, vomiting, dizziness, headache, urticaria, blurred vision, retinopathy and hypotension, but Chloroquine induced Exanthematouspustulosis is a veryrare entity. Case Report: A 31 year old male came with complaints of severe maculopapular rash all over the body after taking two ampoules of Inj. Chloroquine IM, when diagnosed of suffering from malaria. On examination-The rash was diffuse symmetric exanthematous rash with fine pustular eruptions between them, particularly more on trunk and extremities which started approximately after 24 hours of taking Chloroquine injection. Results: Complete blood picture-Absolute Neutrophilia. Histopathology-A punch biopsy of the lesion shows infiltrations of neutrophils, eosinophils and plasma cells. Treatment: IV Corticosteroids, IV Anti-histaminics and topical Corticosteroids. Conclusion: Though exanthematosis pustulosis is a rare and serious manifestation of Chloroquine induced drug reaction, immediate diagnosis and prompt treatment prevents further worsening of condition.
CHM-3
To Study the Occurrence and Pattern of Adverse Drug Reactions Associated with Anti Tubercular Drugs in Tuberculosis Patients During Intensive Phase of Therapy
Pathak D, Patel SB, Dhodi DK, Pathak D, Patel SB, Dhodi DK
Department of Pharmacology, Grant Government Medical College and Sir J. J. Group of Hospitals, Byculla, Mumbai, Maharashtra, India
Objectives: Adverse drug reactions (ADRs) due to antitubercular therapy (ATT) are mostly found during intensive phase of treatment and may lead to decrease in patient compliance. As good patient adherence to the treatment regimen is the foundation stone to effective antitubercular therapy, so close monitoring of ADRs and their effective management is required. This study therefore aims to explore the occurrence and pattern of ADRs associated with ATT drugs in TB patients during Intensive phase of treatment. Materials and Methods: A prospective observational study was performed from March 2014 - February 2015. The patients diagnosed with TB visiting OPD or admitted to the ward of Pulmonary Medicine Department of JJ hospital were included and followed up for two months. The suspected ADRs were recorded. Results: Out of 200 tuberculosis patients, 108 (54%) patients reported occurrence of ADR. The majority case of adverse drug reactions is gastrointestinal reactions in 82 (41%) patients followed by hepatotoxicity in 44 (22%) patients. Total 26% of ADRs were reported by the age group 21-30 years. Most cases of ADRs (63%) had a good clinical outcome. Conclusion: The occurrence of ADRs due to antitubercular therapy during intensive phase is high and this study was found useful for the prevention, early detection of ADRs and their 0 appropriate management.
CHM-4
Study of Drug Utilization Pattern in Neonatal Intensive Care Unit
Neeta C, Singh S, Gumma KM
Bidar Institute of Medical Sciences, Bidar, Karnataka, India
Objectives: Newborn infants form a highly vulnerable group. Compared to adults they are more prone to adverse drug events. Exposure to multiple drugs is also known to be a leading factor in their well-being. Many advances have been made in this area, yet there is a paucity of information to guide rational prescribing in newborns. This study was conducted to evaluate the drug prescribing trends in a neonatal intensive care unit (NICU) of a tertiary care hospital in Bidar, North Karnataka Region, India. Materials and Methods: A prospective study was undertaken, over a period of 3 months at the government teaching hospital, Bidar. Neonates of either sex admitted to NICU were included. Data collection was done by scrutinizing the inpatient case sheets and investigation reports. Results: A total of 100 neonates were admitted and 11 deaths were noted. Most common cause for admission was septicaemia. The total number of drugs prescribed was 488. The average number of drugs per prescription was 4.9. Antimicrobials were the commonest agents prescribed and intravenous route was the commonest route of drug administration. Most of the drugs were prescribed by generic names. Conclusion: In our study it was observed that polypharmacy is commonly observed practice in NICU patients. Most of the antibiotics were prescribed empirically . The dose and frequency of administration was mostly as per the standard guidelines.
CHM-5
Evaluation of Anti-oxidant and Anti-tumor PROPERTIES of Clerodendrum Indicum L. Kuntze by In vitro Methods and DMH Induced Model of Colorectal Cancer
Priya KB 1 , Pai KSR 1 , Shetty MM 2
1 Department of Pharmacology, Manipal University, Manipal, Karnataka, India, 2 Department of Pharmacognosy, Manipal University, Manipal, Karnataka, India
Objectives: The plant Clerodendrumindicum (L.) Kuntze which belongs to the family Lamiaceae has shown cytotoxic activity in the routine brine shrimp assay. But no further investigation has been carried out to confirm its activity. The extracts of plant has also shown the presence of flavonoid content which might stand as a base for its anti-oxidant property. Hence, in order to evaluate the cytotoxic and anti-oxidant properties of the plant, the study has been conducted by various in vitro Methods and DMH induced in vivo model of colorectal cancer. Materials and Methods: Soxhlet extraction process followed by partitioning into petroleum ether (PEF), ethyl acetate (EAF) and aqueous fractions was done. To evaluate the anti-oxidant property, in vitro assays like DPPH and ABTS were performed. To study the cytotoxic properties, MTT assay was performed on various cell lines followed by fluorescent microscopy based assays like AO/EB staining, anti-metastasis assay and flow cytometry. Based on these Results, in vivo DMH model of colorectal cancer was selected and various anti-oxidant and anti-cancer parameters were evaluated. Results: PEF and EAF had IC 50 values of 31.33 and 72.83 μg/ml respectively. The standards used in the study were doxorubicin and 5-fluorouracil. The activity was found to be as a Results of apoptosis through AO/EB staining assay and G o -G 1 phase arrest was observed in flow cytometry. In vivo study has shown a significant decrease in the count and incidence of colon tumors. Lipid peroxidation and nitrite levels were decreased in the test groups. Conversely, the anti oxidant enzyme levels were found to be increased in the disease control group which were reduced in the test groups. Flavonoid content by AlCl 3 Methods was found to be 300.37 and 235.14 μg Quercetin/mg fraction. HPLC peak corresponding to Quercetin in the ethyl acetate fraction was observed. Conclusion: The fractions have shown significant cytotoxic anti-cancer activity in vitro and in vivo. Futher investigations could be carried out to find the exact mechanism of action and the possible factors for increase in anti-oxidant enzyme levels in vivo could demonstrated.
CHM-6
Excoriating Maculopapular Skin Rash Caused by Antitubercular Drugs: A Case Report
Modi RS 1 , Desai SV 1 , Singh K 2 , Naxane A 3
1 Department of Pharmacology, Dhiraj General Hospital, Pipariya, Vadodara,Gujarat, India, 2 Department of Respiratory Medicine, Dhiraj General Hospital, Pipariya, Vadodara,Gujarat, India, 3 Department of Nephrology, Dhiraj General Hospital, Pipariya, Vadodara,Gujarat, India
Adverse cutaneous drug reactions (ACDR), mostly bizarre type (Type B), are caused by a number of drugs including the anti-tubercular drugs. The ACDR may manifest in a variety of ways and may be of different severity grades. A 64 year old male patient, a known case of diabetes mellitus, hypertension, renal dysfunction and with the past history of myocardial infarction was on treatment for all these conditions for last 10 years with no issues. During last 1 year, the patient developed left pleural effusion repeatedly which was tapped on 4 occasions. Testing of pleural fluid did not confirm tuberculosis. However, patient was put on presumptive anti-tubercular treatment as per revised RNTCP guidelines, comprising of INH (600 mg), Rifampicin (450 mg), Pyrazinamide (1500 mg) and Ethambutol (1200 mg) given 3 times a week, on 11 th February, 2015. On next day patient developed skin rashes with itching which progressed to excoriating maculopapular skin rashes with bulla while the AKT continued. Patient was admitted to hospital on 23 rd February, 2015 and AKT was immediately stopped. Patient was treated with topical antibiotics and corticosteroids. Fresh skin lesions stopped and the residual skin lesions improved over next 5 days. This was a case of ACDR of Type B, probably caused by anti-tubercular drugs. The ADR measured as "Possible" in WHO causality scale and "Possible ADR" with score of 4 by Nariño's scale. ACDR are common with anti-tubercular drugs which need to be identified and treated appropriately. Such approach shall strengthen the Pharmacovigilance Programme of India (PvPI).
CHM-7
Pattern of Adverse Drug Reactions Due to Cancer Chemotherapy in Tertiary Care Teaching Hospital in Central India
Chakraborty D, Kale RS
Department of Pharmacology, MGIMS, Sevagram, Maharashtra, India
Objectives: 1. To find the drug or drug regimens responsible for frequent Adverse Drug Reaction (ADR). 2. To assess the pattern of ADRs in patients receiving cancer chemotherapy.3. To assess the distribution of cancers for which the chemotherapeutic drugs are used. Materials and Methods: Adverse drug reactions in terms of human suffering constitute a major clinical problem and increases health care cost. Thus the present study planned and conducted in Radiotherapy department of tertiary care teaching hospital in central India from May- August 2015, a hospital based prospective, observational study. The ADR reporting forms by Central Drug Standard Control Organisation (CDSCO) were used. After inclusion and exclusion criteria, total 64 diagnosed cancer patients were enrolled receiving cancer chemotherapy. The data collected by ADR reporting and analysed by using Microsoft excel in simple frequency and percentage. Results: 58 (91%) patients out of 64 of the total patients receiving cancer chemotherapy develop ADRs. Breast cancer is the most common followed by oral cancer. Out of 58 patients who develop ADRs, 30 patients (51.7%) were suffering from alopecia followed by anorexia (44.8%) and anaemia (39.7%). Cisplatin is the most common single drug causing ADR. Regimen of Paclitaxel, Cisplatin and 5 fluorouracil were found causing most ADRs. Conclusion: Adverse drug reactions are very common during cancer chemotherapy. This study helps to know prevalence of cancer in that area and to detect which drug or drug combinations causing more ADR.
CHM-8
Cycloserine Induced Psychosis in Patients Suffering from Multidrug Resistent Tuberculosis
Golla S, Pradeep Y, Mamatha D, Rajeswaramma G, Sonia SS
Department of Pharmacology, Kurnool Medical College, Kurnool, Andhra Pradesh, India
Adverse drug reactions and toxicity inevitably accompany all treatment courses for drug resistant tuberculosis. Our cases underscore the importance of awareness regarding neuropsychiatric adverse reactions due to MDR-TB therapy and reversible nature of it. Cycloserine induced psychosis with suicidal tendencies is the most life threatening complication and sometimes could be fatal. We report two cases of cycloserine induced psychosis.
CHM-9
Case Reports with Sulfone Syndrome Induced by Dapsone
Shaik AH, Rajanikanth M, Alahari S, Sharon SS, Swarnalatha K
Department of Pharmacology, Kurnool Medical College, Kurnool, Andhra Pradesh, India
Objectives: To report a case of sulfone syndrome, seen in patient prescribed Dapsone for Lepromatous Leprosy. Results: A 28 year old female, known case of Lepromatous Leprosy on MB-MDT since 15 days, presented with 5 days history of Rash all over the body, painful oral erosions and fever. A diagnosis of Sulfone syndrome was made on patient's treatment history, presence of fever, Pruritic maculopapular rash and clinical findings. Conclusion: Our case report highlights the importance of awareness regarding adverse events with MB-MDT and the reversible nature of the adverse events on drug withdrawal.
CHM-10
Lichenoid Drug Eruption Induced by Pyrazinamide: A Case Report
Pradeep Y, Shireesha G, Prasadu MVS, Rajesh P, Sharon SS
Department of Pharmacology, Kurnool Medical College, Kurnool, Andhra Pradesh, India
Pyrazinamide is largely bacteriostatic but can be bacteriocidal in actively replicating TB bacteria. Side effects are infrequent. Here we report a lichenoid drug eruption on the sun exposed areas which appeared 3 weeks after commencement of treatment. Lichenoid drug eruption resolved dramatically upon withdrawal of the drug.
CHM-11
A Rare Case Report of Teicoplanin Induced Anaphylactic Shock
Alahari S, Rajinikanth M, Hussain A
Department of Pharmacology, Kurnool Medical College, Kurnool, Andhra Pradesh, India
Teicoplanin induced anaphylactic shock is a rare side effect. It is important that clinicians are made aware of this potential side effect of teicoplanin. We report a case of teicoplanin induced anaphylactic shock leading to cardiac arrest and patient was revived successsfully.
CHM-12
Prescription Audit in Indoor Patients of Paediatric Ward of a Tertiary Care Teaching Hospital
Siddiqui WA, Chincholkar A
Department of Pharmacology, MIMER Medical College, Talegaon, Pune, Maharashtra, India
Objectives: The present study was undertaken to know the prescribing trends of drugs in indoor patients of paediatric wardof a tertiary care hospital. Materials and Methods: A prospective prescription audit was conducted for a period of 4 months from July 2014 to October 2014 at Paediatric ward and data was analyzed using WHO indicators/guidelines for antimicrobials. Results: The total number of prescriptions analyzed was 443. Average number of antimicrobials per prescription was 3.5. Most commonly prescribed antimicrobial agent (95%) each were Cotrimoxazole and Gentamicin. Mean duration of hospitalisation was 4-5 days. Conclusion: Antimicrobial agents were found to be prescribed by the proprietary name in significant number. The high incidence of their can be modified by a feedback to the prescribers.
CHM-13
A Retrospective Study to Analyse Prescription Pattern and Cost of Anti Malarial Drugs in Indoor Malaria Patients at a Tertiary Care Teaching Hospital
Modi JP, Singh AP, Mundhava SG, Lalwani US, Shah SS
Department of Pharmacology, P. D. U. Government Medical College, Rajkot, Gujarat, India
Objectives: To analyze prescription pattern of drugs and its cost in indoor malaria patients in year 2013-14 at tertiary care teaching hospital. Materials and Methods: A record based retrospective, observational study was carried out in which prescription pattern of drugs and its cost in indoor malaria patients of the year 2013-14 were analyzed. Results: Out of 100 patients, 59 were infected with Plasmodium falciparum (59%) and 38 with Plasmodium vivax (38%). Most of the complicated cases were found from Plasmodium falciparum (n = 29) than Plasmodium vivax (n = 2). In prescriptions, total 2238 drugs were prescribed to treat 100 cases out of which 69 were successfully treated. 67.42% of the drugs were prescribed by parenteral route (n = 1509). The average number of drugs per encounter was 6.11. Total 432 antimalarial and 259 antimicrobials drugs were used in this study. 59.02% ofdrugs were prescribed by generic name (n = 1322). 8.40% of drugs were prescribed from outside (n = 188). Majority of the drugs (96.20%) were from EML. Average drug cost to treat complicated P. falciparum case (485.68 INR) was found to be higher than uncomplicated P. falciparum (297.35 INR). Same applies in case of P. vivax. Conclusion: This study showed that irrational use of anti-malarialdrugs was high and it did not follow the treatment guidelines by NVBDCP, India. This causes increase in cost of treatment and in long term may even contribute to drug resistance. Interventions are necessary to improve rational drug use in our facility.
CHM-14
An Observational Study of Antibiotic Use in Neonates Suffering From Sepsis in a Tertiary Care Hospital
Bhattacharyya S 1 , Mohanty M 2
1 Department of Pharmacology, Hi-Tech Medical College, Rourkela, Odisha, India, 2 Department of Pharmacology, KIMS, Bhubaneswar, Odisha, India
Objectives: Evaluation of antibiotic utilization and sensitivity/resistance pattern in patients of neonatal age-group suffering from sepsis . Materials and Methods: A prospective observational study was done including 34 neonates suffering from sepsis in a tertiary care hospital. Results: Among the 34 patients, in 30 neonates treatment was started with empirical combination of β-lactam + Aminoglycosides, among them Cefotaxime and Amikacin (20.7%), Piperacillin and Amikacin (14.7%), Amoxicillin and Amikacin (11.7%) were continued till discharge. Anti-MRSA like Linezolid/Vancomycin or Carbapenem/Imipenem had to be added in 16 (47%) patients afterwards. Anti-fungals were given to 20.5% patients. Ionotropes (44%), Anti-convulsants (26.4%), Inj Ca-gluconate (17.6%) were used as supportive treatments. Gram +ve septicemia (91.7%) has been more frequent than gram -ve septicemia (8.3%) in our study. In gram-positive bacteria higher resistance was found against first line drugs like penicillin ± bli (90.5%), macrolide (75%), Cephalosporins (71%), aminoglycoside (68%). However, Linezolid, vancomycin and tigecycline have shown 100% sensitivity. Conclusion: Results were compared with similar studies and expected to contribute in formulating treatment protocol of sepsis patients.
CHM-15
Chemotherapy Induced Nausea and Vomiting: Six Months Assessment in a Tertiary Care Teaching Hospital
Nongkynrih BS 1,2 , Wahlang JB 1,2 , Devi LP 1,2 , Kumar R 1,2 , Brahma DK 1,2 , Lahon J 1,2
1 Department of Pharmacology, NEIGRIHMS, Shillong, Meghalaya, India, 2 Department of Oncology, NEIGRIHMS, Shillong, Meghalaya, India
Objectives: To study the pattern of Chemotherapy induced nausea and vomiting (CINV) in Oncology department, NEIGRIHMS and to carry out associated causal relationship with the suspected offending drug. Materials and Methods: The present study is a hospital based prospective observational study to monitor CINV associated with different Anti-cancer drugs used in Cancer (Ca.) Chemotherapy in Oncology department of NEIGRIHMS after obtaining approval from Institute Ethical Committee. Results: Total of 67 cases receiving chemotherapy at tertiary teaching Institute, NEIGRIHMS after due valid consent has been obtained from the concerned patient. Types of cancer observed include oesophageal cancer of fourteen patients (20.8%), Ca. lung, Non-Hodgkins lymphoma, Ca. Rectum, Ca. Ovary, Ca. Cervix, Ca. Breast, Ca. Stomach, Ca. Gall bladder, Ca. Oropharynx, Ca. Nasopharynx, Ca. colon, CML, Neuroblastoma. Out of 67 patients, the observed adverse drug reaction of nausea and vomiting were in 17 patients (25.37%). The suspected anti-cancer drugs were Cisplatin, Paclitaxel, and topside, Ifosfamide, Cyclophsphamide, Doxurobucin, Vincristine, Oxaliplatin, and Gemcitabine. Among these drugsCisplatin and Paclitaxel commonly caused CINV. Premedication drugs were Injection Ranitidine, Dexamethasone, Granisetron, Pheniramine maleate. All these patients were managed by InjectionPantoprazole andLidocainegel. Conclusion: Chemotherapy induced nausea and vomiting is a common adverse effect with anticancer drugs involving various neurotransmitters. Premedicationwith appropriate drugs can counter the activation of these neurotransmitters and can prevent CINV.
CHM-16
Anti-cancer Potential of Interferon Inducer in Dmba Induced Breast Cancer Model
Bakrania AK, Patel SS
Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India
Objectives: The aim of present study was to investigate the anti-cancer potential of an interferon inducer DEAE-dextran in DMBA induced breast cancer model to develop new strategies for the treatment of breast cancer. Materials and Methods: 3-5 week old female SD rats were randomly divided into 8 groups. DMBA (25 mg/kg, s.c.) was administered in the mammary gland to induce breast cancer. After 8 weeks, animals were sacrificed and tumors dissected out and evaluated for tumor size, tumor incidence, SOD, Catalase, GSH, LDH, GGT, ELISA measurement of β-interferon, Immunohistochemistry, Histopathology and gene expression studies for VEGF, Notch-1 & PEA3. Results: In present Study DEAE-dextran administration for period of 8 weeks showed release of β-interferon (170 mcg/100 mg tissue). We have found that DEAE-dextran produced a significant inhibition of incidence of tumor and its growth in DMBA induced animals. Treatment also produced significant suppression of cancer biomarkers such lactate dehydrogenase, gamma glutamyl transferase and inflammatory markers such as C-reactive protein, compared to disease control group. Histopathological analysis also showed that DEAE-dextran was able to inhibit tumor development by inhibition of hyperplastic lesions. Anti-oxidants were found to be significantly improved in treated groups as compared to disease control animals. IHC of CD-31 showed improvement in treated animals compared to disease control. Various gene expression studies showed promising Results. Conclusion: DEAE-Dextran showed a promising anti-cancer agent for breast cancer by inducing interferon which showed antiangiogenic activity.
CHM-17
Evaluation of Effects of Various Doses of Indinavir on Lipid Profile in Wistar Albino Rats
Kantanavar KA, Nayak NIM, Gupatha Bmhrk, Pooja M, Dasaraju R
Department of Pharmacology, K. S. Hegde Medical Academy, Mangalore, Dakshina, Karnataka, India
Objectives: To evaluate the effects of 5 different doses of indinavir on lipid profile in Wistar Albino rats. Materials and Methods: Thirty six Wistar Albino rats of either gender were divided in 6 groups of 6 animals each. Group I was normal control and received citric acid plus distilled water. Group II, III, IV, V and VI received indinavir at the doses of 500 mg/kg, 1000 mg/kg, 1500 mg/kg, 2000 mg/kg and 2500 mg/kg respectively by mixing with citric acid and distilled water. All the doses were administered orally once a day for 21 days. Fasting lipid profiles were done before the administraon of first dose of indinavir and on 22 nd day. Paired-t test and One-Way ANOVA were used for analysing the data. Results: In all the test groups, there was significant (P <0.05), dose dependent increase in total cholesterol, LDL, VLDL and triglyceride levels with the exception of HDL levels which were decreased. Conclusion: Indinavir causes dose dependent dyslipidemia in Wistar Albino rats.
CHM-18
Chemopreventive Effect Terminalia Chebula Fruit Extract Against 7, 12 Dimethaylbenz(a)Anthracene Induced Mammary Cancer in Rat
Jannu AK, Puli VK, Jayalakshmi U, Talla V
Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, India
Objectives: Chemoprevention is good approach to reduce the cancer incidence. Many medicinal plant extracts used indigenously are having this effect. Methanolic extract of Terminalia Chabula (T.C) fruit has shown good anti cancer activity in breast cancer cell lines. In present study its in vivo efficacy was studied in combination with doxorubicin to determine the chemo preventive effect of T.C fruit extract on DMBA induced mammary cancer in rats. Materials and Methods: Methonolic extract in two doses (200 and 400 mg/kg) were tested for DMBA induced mammary carcinoma in female Spargue Dawley rats in terms of tumor incidence, tumor volume, life span, histological variation and oxidative stess against the reference drug doxorubicin. The pharmacokinetics of doxorubicin was studied in presence of 400 mg/kg body weight dose of T.C extract. Results: Moderate increase in the plasma concentration of doxorubicine is observed in the presence of extract when campared to doxorubicin alone. At 200 mg/kg body weight dose of the plant extract exhibits reduction of tumor incidence (50%), tumor volume (69.8%) was observed. It was further confirmed by histopathological investigation of breast tissue. After treatment with T.C fruit extract a significance (p < 0.001) decrease in lipid peroxidation and significant (p < 0.001) increase in GSH, catalase, superoxide dismutase were observed. The life span and body weight also increased in extract treated. Dose dependent improvement in all parameter is observed at high dose (400 mg/kg body weight) of extract. Conclusion: It is inferred that the fruit extract of the plant T.C. possesses significant potential for chemo preventive efficacy against DMBA- induced mammary carcinogenesis through its antioxidant activities and has shown synergistic effect in presence of doxorubicin by sparing its plasma concentration at high dose level.
CHM-19
Amoxicillin Clavulanic Acid Resistance in Pus Samples Sent for Culture Sensitivity: The Scenario in a Tertiary Care Hospital, Ballari
Prashanth SP, Murgesh JV, Lakshminarayana K, Vinitha K, Vishwanath M
Department of Pharmacology, VIMS, Ballari, Karnataka, India
Objectives : To evaluate the pattern of resistance to Amoxicillin Clavulanic Acid among organisms isolated from pus samples sent for culture sensitivity. Materials and Methods : Amoxicillin Clavulanic Acid is a broad-spectrum antibacterial that has been available for clinical use in a wide range of indications for over 20 years. Emergence of resistant bacteria such as β-lactamase producing P. aeruginosa and ESBL, penicillin resistant S. pneumoniae and macrolide resistant S. pyogenes, has complicated the empirical therapy of these infections in several countries. A retrospective, cross sectional observational study was taken up in the Dept of Pharmacology, to evaluate the resistance pattern of culture isolates of pus samples from various departments. The culture and sensitivity reports obtained by Kirby Bauer Disc diffusion Methods of pus samples during last 6 months were collected from the Department of Microbiology. Samples not yielding growth, contaminated or with no isolates were excluded. The data obtained were tabulated and analysed using relevant statistical Methods. Results : A total of 245 reports were analysed (n = 245). Most common organism isolated and its percentage resistance was Staphylococcus (Isolated: 46.53%; Resistant: 61.4%), followed by E. coli (I: 19.59%; R: 87.5%), Pseudomonas (I: 14.29%; R: 62.85%), Klebsiella (I: 11.43%; R: 85.71%), Citrobacter (I: 3.27%; R: 100%), Streptococci (I: 2.04%; R: 0%), Proteus (I: 1.63%; R: 75%), Enterobacter (I: 0.82%; R: 50%) and Acetobacter (I: 0.4%; R: 0%). 69.4% of sample culture isolates were found to be resistant to Amoxicillin Clavulanic Acid. Conclusion: Most of the organisms (nearly 70%) causing purulent infections were resistant to Amoxicillin Clavulanic Acid. Of the first four common isolates E. coli was the most resistant followed by Klebsiella, Pseudomonas and Staphylococcus.
CHM-20
Adverse Drug Reactions Pattern Due to Chemotherapy in Cancer
Parmar SP, Trivedi HR
Department of Pharmacology, M. P. Shah Medical College, Jamnagar, Gujarat, India
Objectives: To assess adverse drug reactions pattern in patients receiving cancer chemotherapy drugs in tertiary care hospital Jamnagar. Materials and Methods: A prospective, observational study was carried out for duration of 12 months (July 2014 to June 2015). All the patients who underwent cancer chemotherapy at the government G.G. hospital, Jamnagar during the study period were included. Clinical and treatment data were collected from the inpatient case records. CDSCO forms were used to record the ADRs. Causality, severity and preventability were assessed by WHO causality assessment scale and Naranjo scale, & Shumock and Thornton scale respectively. Results: Total of 53 patients who were given cancer chemotherapy developed ADR. From the total of 53 patients who developed ADR 24 were females (45%) and 29 (55%) were males. The most commonly affected System organ classification was blood and lymphatic system 41 (77%), followed by gastrointestinal tract 11 (20%). Carboplatin 19 (35%), Cisplatin 18 (33%) and Gemcitabin 7 (13%) were most common drug classes responsible for ADRs. According to causality most of the ADRs were "possible" 50 (94%), followed by probable" 3 (6%) and "By Naranjo scale ADR were possible" 39 (74%). "Probable" 14 (26%), & "Shumock and Thornton scale shows 53 (100%) were "not preventable" and 0 (0%) were "preventable". Conclusion: Early detection of drug toxicity helps to treat the patient and modify the doses or the drug regimen to minimize toxic effects.
CHM-21
Metabolic Adverse Effect Profile of Second Line Antiretroviral Therapy in Adult Aids Patients in a Tertiary Care Hospital in Eastern India
Mandal A, Kumari M, Chakraborty B, Mukherjee A, Adhikari B, Chatterjee S
Department of Pharmacology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India
Objectives: Requirement for second line ART is progressively increasing in India. Despite the high propensity to cause adverse effects, there is limited published data on their safety profile. The aim of our study was to profile the metabolic adverse effects with second line ART in patients attending SSKM-ART centre, Kolkata. Materials and Methods: This record based cross-sectional observational study reviewed past clinical and followup records of all registered adult patients onsecond lineART. Demographic characteristics, treatment regimens, substitutions/switch, WHO clinical staging, CD 4 count, laboratory parameters were collected by reviewing the NACO White Card. Results: Out of 18 registered cases, majority were on tenofovir, lamivudine, ritonavir boosted atazanavir regimen. Commonmetabolic abnormalities observed were raised serum triglyceride and cholesterol levelsin 56% and 33.3% cases respectively and hyperbilirubinemia (>2 ULN) without significant AST, ALT elevation was noted in 14 (77.7%) of cases. These patients were mainly on ritonavir boosted atazanavir based regimens and were non-reactive for Hepatitis B and C and not on antitubercular drugs. Peak mean serum total bilirubin was 5.05 ± 2.13 mg/dl. Causality assessment was done using WHO UMC criteria. The suspect drugs for hyperbilirubinemia were atazanavir and lopinavir, while lopinavir, atazanavir were implicated for dyslipidemia. Drug withdrawal was not undertaken but interclass switching was required. Conclusion: This study indicates that hyperbilirubinemia is the commonest metabolic adverse effect noted which is comparablewith other global published studies. Small size of the study cohort and incomplete laboratory data were our main study limitations.
PKN
PKN-1
Development and Validation of Bioanalytical Methods Using LC-MS/MS for Detection of (−)-epicatechin in Human Plasma
Vasoya R, Panchni H, Pethani T, Sheth N
Department of Pharmaceutical Science, Saurashtra University, Rajkot, Gujarat, India
Objectives: Development of reliable, precise and reproducible bio-analytical Methods for estimation of (-)-Epicatechin as per US -FDA guideline. Materials and Methods: The analyte were extracted by liquid- liquid extraction and separation by C8 column (150 mm × 4.6 mm, 5 μm) with a gradient mobile phase acetonitriale: 2 mM ammonium acetate (pH-3) (90:10) and flow rate was 0.5 ml/min. Results: Themass to charge ratio m/z 289.0 → 109.2 (for (-)-Epicatechin) and m/z 296.1 → 205.3 (for Hydrochlorothiazide, the internal standard). The linear response range was 1-200 ng/ml in human plasma, with correlation coefficient (r 2 ) = 0.996 and lower limits of quantification of 1 ng/ml. Run time was 5 min. The Intra- and inter-day precisions were within 5%. The accuracy was more than 90.00%. Methods was validated according to the biological Methods validation guidelines of the Food and Drug Administration and proved acceptable. Conclusion: This Methods has a higher sensitivity and good accuracy and precision and reproducibility. This Methods allow quantification of (-)-Epicatechin the 1-200 ng/mL. In additional, this Method has a short run time.
PKN-2
Advances in Pharmacology of Isoflavones-Genistein Bioavailability (Minireview)
Joshi JV, Agashe SV, Vaidya RA, Amonkar AJ, Vaidya ADB
Kasturba Health Society Medical Research Centre, Mumbai, Maharashtra, India
Objectives : Soya and Isoflavones (ISFs) like genistein are phytoestrogens (PE), and are commonly used as health supplements by postmenopausal women. These isoflavones (ISFs) act on the β-receptors of 17-β estradiol, without consequences like breast cancer/heart disease caused by α-receptor activation; the former helps in prevention of osteoporosis, heart disease, menopausal symptoms and cancer. Amidst several ISFs/ PEs, genistein is the most bioactive and maximally studied. This review summarises the recent advances in kinetics of genistein, for the understanding of its use in therapy. Materials and Methods: The citations in PubMed (N = 103) from 2005 to 2015 have been covered. The differences in models and Methodsology - analytical, volunteer factors, settings etc. have been reviewed. Besides Soya, other Ayurvedic, Japanese and Chinese plants, which do have genistein are also reviewed. Results: Major advances in kinetics of genistein have contributed to its rational pharmacotherapy. Enriched ISF in Soya foods, beverages and novel delivery systems have challenged the kinetic studies. Fermented products yield higher plasma concentrations of the genistein rather than the glycoside - genistin. Processed Soya flour can reduce genistein availability due to proteinaceous content. Faze I and II metabolism of genistein occurs in the intestine and its mucosa and liver predominantly by CYP1A1, CYP1A2 and CYP2E1. The p450 system has also been demonstrated in non-hepatic cells like the breast tumour cells, and lung tissue. The metabolites conjugated in liver viz. glucuronides and sulfates, circulate in blood and are excreted in bile and urine. The colonic microbiome can induce some variations in kinetics of genistein due to enterohepatic circulation; active metabolites like equol have been reported. Conclusion: The variability of bioavailability of genistein and its active metabolite equol suggests the need of individualization of the dosage, frequency and intervals of the formulations and fortified items of foods etc.
PKN-3
Analgesic Activity of Paracetamol in Microsomal Enzyme-induced Wistar Rats
Mahdi MA 1 , Umar AA 1 , Malami S 1 , Maje IM 1 , Tanko Y 2 , Labaran KS 3
1 Department of Pharmacology and Therapeutics, Faculty of Pharmaceutical Sciences, Ahmadu Bello University, Zaria, Nigeria, 2 Department of Human Physiology, Faculty of Medicine, Ahmadu Bello University, Zaria, Nigeria, 3 Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmaceutical Sciences, Ahmadu Bello University, Zaria, Nigeria
Objectives: This study investigated the analgesic effect of paracetamol using two animal models for analgesia. These models were thermal - induced pain stimulus and acetic acid writhing test in Wistar rats. The Objectives of the experiment is to determine the analgesic effect of paracetamol after enzyme induction with an anticonvulsant agent. Materials and Methods: Twelve adult rats divided into two groups of six rats per group were used. Group one served as control and was given oral paracetamol solution at three dose levels i.e. 5 mg/kg, 10 mg/kg and 100 mg/kg. Each of the dose was given to two rats in this group respectively. Group two rats received a pretreatment with 30 mg/kg oral phenobarbitone for seven days. Subsequently, they were given paracetamol by the oral route at same doses and manner as in group one. Drug preparation and administration was similar for both models. Jumping off the plate or licking of paw served as response for the hot plate test and the reaction time was noted. Results: Results obtained indicated that there was no statistical difference (P < 0.05) in mean reaction time of test (1.95 ± 0.83 min.) compared with control group (1.15 ± 0.44 min) at 10 mg/kg paracetamol. However, the delay in response to thermal pain at this dose was 69.23%. Paracetamol (p.o.) at 5 and 100 mg/kg Resultsed in shorter mean reaction time and lower protection. Contrarily, the difference in decrease in mean frequency of writhing of test rats was significant (P < 0.05) compared with control at 5 and 100 mg/kg oral paracetamol. The mean frequencies were; 25 ± 7.07 (test) and 7.5 ± 3.54 (control) at 5 mg/kg and 16 ± 2.12 (test) and 12 ± 0.1 (control) at 100 mg/kg. Inhibition of writhing (70%) was highest at a dose of 5 mg/kg paracetamol. Conclusion: The Results of this study suggest that enzyme induction enhance the analgesic activity of paracetamol.
PKN-4
Floating Drug Delivery System
Awari B, Kale R, Zilate S, Kumar R
MGIMS, Sevagram, Wardha, Maharashtra, India
Recent technological and scientific research has been devoted to the development of rate controlled drug delivery systems to overcome physiological adversities such as short gastric residence times and unpredictable gastric emptying times. Differences in gastric physiology such as gastric pH and motility exhibit both intra and inter subject variability demonstrating significant impact on gastric residence time and drug delivery behavior. This triggered an increased interest towards formulation of novel delivery systems which retained in stomach for prolonged and predictable period of time. Several approaches such as floating drug delivery systems (FDDS), swelling and expanding systems, bioadhesive systems, modified shape system, high density systems or other delayed gastric emptying devices have been discovered till now. FDDS are of particular interest for drugs that are locally active and have narrow absorption window in stomach or upper small intestine, unstable in the intestinal or colonic environment, and exhibit low solubility at high pH values. Floating Drug Delivery System is one amongst the Gastro Retentive Dosage Forms (GRDFs) used to achieve prolonged gastric residence time. The presentation will give an detailed information on the pharmaceutical basis of their design, classification, advantages, limitation, floating mechanism, factors affecting floating system, drug candidates suitable for floating and application of the system.
PKN-5
Comparative Pharmacokinetic Study of Novel Multiunit Capsule and Market Product of Quetiapine Fumarate
Mehta D, Parejiya P, Patel H, Trivedi P, Shelat P
K.B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India
Objectives: A novel modified release oral dosage form of poorly soluble drug Qutiapinefumarate (QF) was fabricated as pH independent and patient compliant delivery system. Materials and Methods: Techniques of gastro-retention and mechanism of microenvironment pH modulation were combined to achieve pH independent delivery of QF. Multiunit modified release system was developed as capsule dosage form. The developed novel system was evaluated for in vitro parameters. Pharmacokinetic study was performed in New Zealand rabbits using single-dose cross-over study. It was compared with immediate release market product. Collected blood samples were analysed using HPLC Methods. Pharmacokinetic parameters including Cmax, tmax, AUC0-t, AUC0-∞, t 1/2 and MRT were determined from plasma profile for both formulations. Results: In vitro evaluation of developed system followed set criteria for the tested parameters. Plasma concentration - time profiles of both the formulations revealed that the formulated novel system was having higher t max (6 h) and lower C max (190 ng/dl) as compared to t max (5 h) and C max (242 ng/dl) of market product. In contrast, effective plasma concentration was maintained for prolonged period by novel delivery system. AUC0-∞of developed delivery system was 1.36 times higher as compared to market product. Conclusion: It was concluded from the Results that the multiunit delivery system was successfully developed as an effective sustained release dosage form with better control of plasma drug concentration and improved bioavailability as compared to immediate release market product. Additionally, once daily dosing requirement can also prove. Reduced dosing frequency and improve patient compliance are additionaladvantages of the developed delivery system.
PKN-6
Pharmacokinetics of Flucloxacillin in Cisplatin Induced Chronic Renal Failure in Goats
Mishra A 1 , Dewangan G 2 , Sar TK 1 , Chatterjee US 3 , Mandal TK 1
1 Department of Pharmacology and Toxicology, West Bengal University of Animal and Fishery Sciences, Nadia, West Bengal, India, 2 Department of Pharmacology and Toxicology, College of Veterinary Science and Animal Husbandry , Mhow, Madhya Pradesh, India, 3 Consultant at Park Clinic, Kolkata, India
Objectives: To study pharmacokinetics of flucloxacillin in cisplatin induced chronic renal failure in goats. Materials and Methods : Pharmacokinetics of flucloxacillin (10 mg kg -1 , i.v.) was studied in both healthy and chronic renal failure (CRF) female black Bengal goats. Cisplatin (30 mg m -2 ) was administered intravenously, once daily consecutives for seven days to induce chronic renal failure (CRF) grade I. The pharmacokinetic parameters were calculated in both cases. Results : CRF grade I caused significant changes in the determined variables of flucloxacillin. The C max and C min of FLX observed at 0.08 and 12 h in healthy goats were 77.76 ± 7.50 and 0.34 ± 0.11 μgml -1 respectively, while the same in CRF grade I goats at 0.08 and 24 h were 115.51 ± 4.12 and 0.21 ± 0.05 μgml -1 respectively. CRF grade I condition caused significantly increased t 1/2β (3.61 ± 0.030 h), t 1/2α (0.06 ± 0.01), AUC (166.14 ± 5.18 μg ml -1 h) and significantly decreased V darea (0.31 ± 0.03 L kg -1 ), V dss (6.45 ± 1.11 L kg -1 ) and Cl B (90.36 ± 5.30 L kg -1 h -1 ) values of flucloxacillin (FLX) compared to healthy goats. Conclusion: Kinetic behavior of FLX was altered between healthy and grade I CRF goats and the dosage schedule can be used in field of FLX may be reduced in nephropathic goats.
PKN-7
Development of Bio-analytical Method of Eslicarbazepime Acetate by LC-MS/MS Method
Sherathia BK, Thumar KN, Vadia N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objective: The objective of the proposed work is to develop LC-MS/MS method for estimation of Eslicarbazepine acetate (ESL) in human plasma. Material and Methods: The proposed method was developed with C18 G; 150 × 4.6 mm, 5.0 μ columnwith the mobile phase of methanol: formic acid (80:20 % v/v). The develop method was validated according to ICH guideline. Result: The develop method was found to be linear in a concentration range of 2-25 μg/ml and 0.6-48.50 and % recoveries was found to be 99059-100.22% and 92.97-93.41% respectively. Conclusion: The Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of ESL in tablets and as well as in human plasma. The develop method can be used for the pharmacokinetic study of ESL in routine clinical and quality control laboratory.
PKN-8
Development and Validation of Bioanalytical Method Using LC-MS/MS for Detection of Gymnemagenin in Rat Plasma and its Application to Pharmacokinetic Study Using Gymnema Sylvestre Extract
Thumar K 1 , Pethani T 1 , Chaniyara N 1 , Trivedi P 2 , Sheth N 1
1 Saurashtra University, Rajkot, Gujarat, India, 2 Kadi Sarva Vishwavidyalaya, Gandhinagar, Gujarat, India
Gymnemagenin, a triterpene sapogenin from gymnema sylvestre is a naturally antidiabetic agent. A rapid and sensitive high performance liquid chromatography tandem mass spectrometry method has been developed and validated for the determination of the active component gymnemagenin (hydrolysed product of gymnemic acids), in rat plasma after oral administration of aqueous Gymnema sylvestre extract. The plasma samples were pretreated using liquid-liquid extraction with tetra-butyl methyl ether and 0.1 N sodium hydroxide which maintain the bufferic condition. Chromatographic separation was achieved on a Kromasil, C 18 column (100 mm × 4.6 mm, 5 μm) with isocratic elution using a mobile phase consisting of 0.1% Formic acid and methanol (30:70, v/v) at a flow rate of 0.6 ml/min. The detection was accomplished by a triple quadrupole tandem mass spectrometer in multiple-reaction monitoring (MRM) scanning via an Electro spray ionization source operating in the positive mode. The calibration curve exhibited good linearity (r 2 > 0.99) over a range of 1.00 - 500 ng/ml for gymnemagenin. The Lower Limit of quantification (LLOQ) was 1.00 ng/ml. The validated method was successfully applied to investigate the pharmacokinetics of gymnemagenin after oral administration of Gymnema sylvestre extact in rats.
CLP
CLP-1
To Assess the Knowledge, Attitude and Practice of Obesity in General Population of Rajkot City, Gujarat
Shah P, Bhalodiya P
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: To find the occurrence of overweight and obesity in the general population of Rajkot. To survey the knowledge, attitude and practice on obesity. To bring general awarenessamong general population with respect to obesity, its risk factors, complications and management. Materials and Methods: The present study was an observational cross-sectional study. The study was carried out in general population within Municipal Corporation limits of Rajkot city of Gujarat. The study period was betweenMarch to June 2014. Data were collected in a semi-structured questionnaire by interviewing subjects through house-to house visits after getting their informed consent. The questionnaire included information regarding demographic data, knowledge assessment, attitude and practice assessment of obesity and presence of another diseases condition. Results and Conclusion: The occurrence of overweight and obesity was 21% and 17% respectively in general population of Rajkot city. Occurrence was found to be higher in women was overweight (13%) and obese (11%) as compared to men overweight (8%) and obese (6%). Maximum number of overweight and obesity were found similar 7% in age group 31-40 years. The persons with high intake of fast-food and oily vegetables had highest occurrence of overweight and obese. It seems that annual income also affects the health status. Most of people consider sedentary lifestyle, unhealthy diet and stress as a risk factor for obesity. Obesity may be controlled by doing exercise and dietary modification. In dietary modification they would be preferred less fatty foods and more fruit/fruit juice.
CLP-2
An Evaluative Study of the First Line Regimens Used for the Treatment of HIV Infected Adult Patients Attending the Art Centre
Bhattacharjya S, Gohain K, Kotokey RK
Assam Medical College, Dibrugarh, Assam, India
Objectives: To evaluate the effectiveness, adverse effects and treatment failure to the first line regimens used for the treatment of the HIV infected adult patients in a tertiary care hospital. Materials and Methods: After taking the permission from the institutional human ethical committee and the written consent from the patients, all the HIV infected patients >18 years of either sex who were started with either of the two first line regimens (ZLN/ TLN - Zidovudine/ Tenofovir + Lamivudine + Nevirapine) were enrolled in the study for duration of 1 year. The exclusion criteria were patients with tuberculosis, hepatorenal insufficiency, diabetes, pregnancy and prior exposure to ARV. Results: A total of 54 patients along with 13 treatment failure cases were evaluated in the study. There was increase in the CD4 count and weight following 6 months of therapy along with manifestations of self limiting adverse effects like nausea, vomiting, rash, pallor and fatigue etc mainly in the first few weeks. 13 treatment failure cases presented with both clinical and immunological treatment failure. Non adherence was found to be the most important cause of TF. Results details will be presented during the conference. Conclusion : Both the regimens were found to be effective for treatment of HIV-naïve patients. Causes of non-adherence should be evaluated and strategies should be planned accordingly.
CLP-3
Prospective Study on Pharmacological Management of Hemorrhagic Stroke and Treatment Cost Analysis in a Tertiary Care Hospital
Sahiti K, Prathyusha TVS, Babu AN, Kumar MS, Rao NR
Department of Pharmacology, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India
Objectives: To evaluate the pharmacological management of haemorrhagic stroke & treatment cost analysis in a tertiary care hospital. Materials and Methods: (1) Source of data: Data was collected from case sheets, of patients who are admitted in stroke unit in tertiary care hospital, Guntur. (2) Study site: tertiary care hospital, Guntur. (3) Study duration: The study will be carried out for a period of 9 months. (4) Study Design: "A community based prospective study". (5) Study Criteria: The study was carried out by considering the inclusion and exclusion criteria. (6) Parameters evaluated: demographic characteristics, family history, risk factors, neurological examination findings, diagnostic data, and the type of treatment. Results: Mainly brain stroke can be managed using anti-hypertensives, anti-thrombolytic and anti-platelets. The average cost for the emergency treatment of a brain stroke patient is almost about 2000 - 10,000 for medicinal treatment and 3,200 per day for non-medicinal treatment. Conclusion: Immediate identification of stroke within 3 hours is very important in the management of stroke.
CLP-4
Drug Induced Nutritional Deficiencies in Children
Singh A, Vijay R, Vyas A, Jangir S
Department of Pharmacology, S. P. Medical College, Bikaner, Rajasthan, India
Drug Induced Nutritional Deficiencies (DINDs) are an important yet poorly recognized field. Good clinical practice not only involves diagnosis and treatment but nutrients deficiency should also be taken care of. There are several drugs which may lead to various vitamin deficiencies like mineral oils, phenytoin, neomycin, isoniazid, valproic acid, etc. affecting several biochemical reactions and ultimately development of children. Enhanced folate deficiency is the Results of therapy with methotrexate in patients with an inherited methylenetetrahydrofolate reductase deficiency. Increased risk of pellagra with isoniazid therapy in cases of N-acetyl transferase deficiency is other examples. Tetracyclines can chelate calcium ions which get incorporated into teeth, cartilage and bone Resultsing in discoloration of both primary and permanent dentition. Fluoroquinolones primarily affect the cartilages and there is joint involvement in young children. Chronic use of corticosteroids Results in calcium malabsorption and cystic fibrosis. Zn supplements decrease copper absorption leading to sideroblastic anaemia, and thiazide diuretics increase excretion of Zn leading to chronic liver diseases. Imipramine, methylphenidate and dextroamphetamine are the drugs in children with known associations of decreased appetite and slowed growth. In nutshell, improved child development relies on physicians' awareness. Nutrients deficiency should not be a price for effective drug therapy by them.
CLP-5
Observational Study on Comparison of Efficacy and Eradication Rate of Two Anti H-Pylori Regimens in Patients with Acid Peptic Disorder
Kagarana B, Aghara R, Bhalodia P
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Lafutidine is a novel H2-receptor antagonist with gastro protective activity that includes enhancement of gastric mucosal blood flow. The aim of the present study was to compare the effectiveness of 14-day, Lafutidine-Clarithromycin-Amoxicillin therapy with the Esomeprazole-Clarithromycin-Amoxicillin therapy for H-Pylori eradication. Materials and Methods : Ninety patients with H-Pylori-infected APD were randomly enrolled from gastro care clinic and endoscopy centre for two regimens Esomeprazole (20 mg b.i.d.), Clarithromycin (500 mg b.i.d.), and Amoxicillin (1000 mg b.i.d.) and Lafutidine (10 mg b.i.d.), Clarithromycin (500 mg b.i.d.) and Amoxicillin (1000 mg b.i.d) for 14 days. The effectiveness among the two regimens were compared by faces pain scale, endoscopic grading, and symptoms scoring and eradication rate was checked by rapid urease test. Statistical analysis was done by willcoxon matched pair test. Results: Eradication rate of H-Pylori was higher in LFT group (81.48%) as compared to EPZ group (77.77%) which may be due to higher potency and long lasting anti-secretory effect of Lafutidine. Furthermore, the acid peptic disease cure rate and symptom response rate were almost similar in the EPZ and LFT groups at the end of the 14 days treatment; however, symptomatic relief in most cases was observed earlier at 7 th in LFT group patients. Conclussion: The Results of this study showed that Lafutidine-Clarithromycin-Amoxicillin therapy was equally safe and effective as Esomeprazole- based triple therapy for the eradication rate of H-Pylori, but had earlier response and thus could be considered as an alternative treatment option.
CLP-6
Clinical Evaluation of an Ayurvedic Formulation Medohar Ark in Dislipidemia and in Obese Patients
Bhalodiya P, Rajyaguru C
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Study aims, to investigate the efficacy of MEDOHAR ARK in obesity & Dislipidemia, And to take prevalence of Hypertension, Diabetes and Dislipidemia associated with Obesity at Saurashtra University campus. Materials and Methods: Awareness Seminar on Obesity and Related Complications" and medical check-up campaign was arranged and patients were diagnosed for hypertension, diabetes, dyslipidemia and obesity. According to inclusion exclusion criteria they were divided in Group 1 (follows diet + drug) and group 2 (Diet). Patient follow-up at 1 st , 15 th , 28 th and day was done for taking details of symptoms of obesity. Study ends with collecting require data by doing laboratory testing and result analyzed by applying paired t-test. Results: Hypertensive Patients were more found at Saurashtra University campus and more Chances of develop cardiovascular risk, diabetes and dyslipidemia with obesity and Overweight. Men are more prone to develop obesity compare to women and after age of 45 yrs more chances to increase weight in both. It was also found with hereditary, eating Habit, diet and sedentary lifestyle. Drug and diet both are helpful to reduce symptoms of Obesity as well as BMI. Conclusion: Medohar Ark was found helpful to reduce symptoms of obesity and overweight, Increase the HDL level significantly in body and reduce BMI. Significant improvement couldn't be seen in case of LDL, TC and TG level in 8 week study. Further study can be possible with this drug by recruiting large number of volunteers for a longer duration to get the better results.
CLP-7
Wheatgrass Improves Quality of Life in Patients with Thalassemia Major
Shah PI 1 , Goyal RK 2 , Tripathi C 3 , Gosai M 3 , Ghori V 1
1 Shantilal Shah Pharmacy College, Bhavnagar, Gujarat, India, 2 Sri Ramchandra Medical Centre, V ClinBio Labs, Chennai, Tamil Nadu, India, 3 Government Medical College, Bhavnagar, Gujarat, India
Objectives: Wheatgrass juice and its formulation has been shown to produce beneficial effects in thalassemia major patients. In the present investigation we studied the effect of wheatgrass juice and capsules and the probable mechanism of action in patients with thalassemia major. Materials and Methods: It was prospective, open labeled, non-randomized, parallel design and no controlled clinical study in 28 patients with thalassemia major. Results: Treatment with wheatgrass formulations in thalassemia major patients produced decrease in serum ferritin, serum iron, and total iron binding capacity. There was normal excretion of urobilinogen in the urine of patients with thalassemia. Bilirubin, bile salts, leukocytes, nitrites, protein, and glucose were absent in the urine sample of thalassemia major. Universal CAS assay also showed the presence of phytosiderophore in wheatgrass capsules and juice. The FTIR spectroscopy also confirmed the presence of various functional groups in the chemical structure of phytosiderophore. In-vitro Iodometric titration and standard test for identification of Iron chelation also supports the iron chelation by wheatgrass capsules and juice. Conclusion: In conclusion our data provides sufficient evidence that wheatgrass can produce decrease in iron over load possibly by virtue of phytosiderophore present in wheatgrass formulations.
CLP-8
A Cross-sectional Study of use of Iron Chelating Agents in Transfusion Dependent Thalassaemia Major Patients
Santra S 1 , Mukhopadhyay T 2 , Das P 3 , Mishra SS 4
1 Department of Pharmacology, IMS and SUM Hospital, SOA University, Bhubaneswar, Odisha, India, 2 Blood Transfusion Unit, Thalassaemia Society of India, Kolkata, West Bengal, India, 3 Department of Anatomy, IMS and SUM Hospital, SOA University, Bhubaneswar, Odisha, India, 4 Department of Hematology, IMS and SUM Hospital, SOA University, Bhubaneswar, Odisha, India
Objectives: To study and describe the utilization pattern of iron chelating agents among 73 transfusion-dependent thalassaemia major patients. Materials and Methods: Transfusion dependent thalassaemia major patients above the age of 2 years managed by various haematologists and Thalassaemia specialists were studied. The administration of iron chelators namely Desferrioxamine (DFO), Deferiprone (DFP) and Deferasirox (DFX) were evaluated. 47 (64%) of the thalassaemics had serum ferritin level below 2500 ng/dl, of whom 20 (27%) patients have ferritin level below 1000 ng/dl. 55 (75%) of 73 patients who were treated with a single chelating agent consisted 50 patients only on DFX. 8 (67%) patients were on DFO + DFP and 4 (33%) are treated with DFX + DFP. Results: The mean age was 19 and mean serum ferritin level was 2280 ng/dl among the thalassaemia major patients. DFX was used 68% of patients as monotherapy and 5% patients in combination therapy with DFP. DFX in the dose of 30-40 mg/kg/day was prescribed in 52% of patients. Mean dose of 15 mg/kg/day of DFX was been administered in combination with DFP (75 mg/kg/day) in 5% patients. DFO + DFP were preferred by 8 patients, out of which 6 were aged above 25. Cost of monotherapy is twice that of combination therapy. Conclusion: These data demonstrates the ferritin status and present scenario of utilization of chelating agents among thalassaemia major patients on repeated transfusions. The dosing of new drug, Deferasirox and the cost analysis of various chelating regimen has also been dealt. Individualization rather than rationalization of chelation therapy should be focussed upon in managing iron overload in thalassaemia.
CLP-9
Utilization of Antibiotics for Bronchopneumonia in Pediatric Age Group Between 1-5 Years in Two Tertiary Care Hospitals of East Sikkim on the Basis of Age and Gender
Endow A, Sharma C, Dutta S, Sharma U
Sikkim Manipal Institute of Medical Sciences, Gangtok, Sikkim, India
Objectives: To study the utilization of Drugs for Bronchopneumonia in Pediatric Age Group between 1-5 years in two Tertiary Care Hospitals of East Sikkim on the basis of Age and Gender. Materials and Methods: Data was collected over a period of six months (July, 2014-December, 2014) from all new in-patients and outpatients coming to the Pediatric Department of these two hospitals, who fell in the age group of 1-5 years, presenting with cough, fever and respiratory distress. A Case Record form incorporating Socio-demographic profile of the patients and drug utilization data was used. The latest edition of the Indian Drug Review was referred, for the generic names/chemical names of various drugs. Statistical analysis was done using the SPSS (Statistical Package for the Social Sciences) Version 20.0 and Microsoft Excel 2007. Results: The study recorded 155 patients, who fell in the inclusion criteria. Out of this 57 (36.7%) patients were in-patients. 59 (38%) patients were diagnosed to be suffering from Bronchopneumonia out of which 32 (54.2%) were Male. 56 (94.9%) patients were prescribed antibiotics and Inj. Taxon (Ceftriaxone) was most commonly used (30 cases). Conclusion: Most of the patients (59) suffering from Broncopneumonia were Males (32) and most of them were inpatients (57). Cephalosporins (Ceftriaxone) was the most commonly used Antibiotic.
CLP-10
Phenytoin Induced Steven-Johnson Syndrome: A Case Report
Ashwini PS, Radhika MS, Bhandari PR, Kavitha VD
S.D.M College of Medical Sciences and Hospital, Sattur, Dharwad, Karnataka, India
Objectives: Steven Johnson Syndrome (SJS) is a serious systemic disorder in which there are vesicobullous lesions involving skin and mucous membrane. It can Results as an immune response to an antigen or as a drug reaction. To report a case of Phenytoin induced SJS. Materials and Methods: A 36 year old male patient undergoing treatment for alcohol deaddictionwith Tab Disulfiram 250 mg from past 3 months during this he developed a seizure and the physician changed his antiepileptic medication to oral Phenytoin 200 mg OD. After 20 days of Phenytoin use he developed multiple purpuric macule all over body with erythema of oral cavity, oedema of face, periorbital puffiness; later which was diagnosed by dermatologist as SJS. An audio-visual consent was obtained by patient. Results: The WHO-UMC causality assessment is basically combined assessment taking into account the clinical-pharmacological aspect of the case and the quality of documentation. The causality was assessed as "possible" as per WHO criteria. Conclusion: Phenytoin could be the causative drug as noted by the causality assessment.
CLP-11
Ornidazole Induced Bullous Purple Patches: A Case Report
Kavitha VD, Bhandari PR, Radhika MS, Ashwini PS
S.D.M College of Medical Sciences and Hospital, Sattur, Karnataka, India
Objectives: To report a case of ornidazole induced purple patches. Materials and Methods: A 44 year old female patient admitted for multiple fibroids, underwent total abdominal hysterectomy with pre-operative antibiotic coverage with Inj. Ornidazole and Inj. tramadol. On the 2 nd post-operative day she developed violaceous patches on the left hand, right knee, buttocks and lips. Violaceous patches with erythematous halo with bullae on the right forearm. Dry lips with scaling was also present which was diagnosed by a dermatologist as fixed drug eruption secondary to ornidazole. An audio-visual consent was obtained from the patient. Results: The WHO-UMC causality assessment is basically a combined assessment taking into account the clinic-pharmacological aspects of the case and the quality of documentation. The causality assessed as "possible" as per the WHO criteria. Conclusion: Ornidazole could be the causative drug as noted by the causality assessment.
CLP-12
Evaluation of Compliance to Treatment in Patients Receiving Antidepressant/Antiepileptic Drugs by Therapeutic Drug Monitoring Using LCMS/MS Methods: A Cross-sectional Observational Study
Parmar S 1 , Thakre 2 , Turankar A 1 , Dakhale G 1 , Pawar S 1 , Shinde V 1
1 Department of Pharmacology, GMC, Nagpur, Maharashtra, India, 2 Department of Psychiatry, GMC, Nagpur, Maharashtra, India
Objectives: Epilepsy is relatively common condition characterised by tendency for recurrent seizures due to disturbance of spread of electrical discharge of the cortical neurons. Noncompliance to medical treatment is common, limits treatment efficacy, increases morbidity & mortality, reduces quality of life. Monitoring levels of drugs & their metabolites in plasma helps to check compliance to treatment as well as pharmacokinetic peculiarities. Aim of study is to assess compliance to treatment in epileptic & depressive patients. Materials and Methods: Cross sectional, observational study carried out from Nov. 2014-March 2015 in patients attending psychiatry OPD, patients diagnosed as a case of depression/epilepsy & on antidepressants/antiepileptics for at least 1 month. Blood collected from patients & analysed by LCMS/MS to find plasma concentration. Results: Out of 52 patients, 28 were on antidepressant & 24 were on antiepileptic therapy. Average adherence score of patients on antiepileptics was 3.54 (SD 1.76) & 2.5 (SD 1.42) on antidepressants. Most commonly used antidepressant was Escitalopram (n = 16/24), & antiepileptic was Carbamazepine (n = 16/28). Better adherence score was noted in patients taking Escitalopram in comparison to others. Average drug levels of Carbamazepine & Escitalopram were 8.37 & 6.95 respectively. Conclusion: Overall, Morisky adherence score for all drugs is above 2 (less than low). Factors affecting low adherence needs to be investigated in separate studies. Amongst antidepressant, Escitalopram is better adhered drug in comparison with other drugs. Therapeutic drug levels observed in case of Carbamazepine found to be in prescribed therapeutic range, whereas Escitalopram levels are below prescribed levels.
CLP-13
Evaluation of Potential Drug-drug Interactions in Patients of Emergency Medicine Department at Atertiary Care Teaching Hospital: A Prospective Study
Trivedi VD 1 , Barot PK 2 , Malhotra SD 3 , Patel V 4
1 Department of Pharmacology, Smt. N.H.L. Municipal Medical College, Ahmedabad, Gujarat, India, 2 Department of Pharmacology, GMERS Medical College, Himmatnagar, Gujarat, India, 3 Smt. N.H.L. Municipal Medical College, Ahmedabad, Gujarat, India, 4 Dr. Jivraj Mehta Smarak Health Foundation, Ahmedabad, Gujarat, India
Objectives: A Drug Drug Interaction (DDI) is defined as a pharmacokinetic or pharmacodynamic influence of drugs on each other, which may Results in desired effects, reduced efficacy and effectiveness or increased toxicity. Our study Objectives were to evaluate potential drug-drug interactions (p DDI), to identify nature and mechanism of potential drug drug interaction, and also to identify common drug groups involved in potential drug drug interaction. Materials and Methods: A prospective observational, cross sectional study was carried out over period of 2 months in the emergency medicine department after obtaining written approval by Institutional Review Board. All patients admitted to emergency medicine department were enrolled in the study after taking written informed consent from the patient/legal guardian. Data was analyzed for potential drug-drug interaction by using online Medscape drug interaction checker software, textbooks & reference books. Drug interactions judged by the Medscape drug interaction checker. Fischer exact test and Pearson correlation coefficient test were used to assess the relationship between quantitative variables. Results: In our study, prescriptions of 156 patients admitted in the emergency medicine department were collected for first 48 hrs and analyzed. The mean age was 53.38 ± 16.84 years. Male: Female ratio was 1.9:1. Total 156 patients received 1635 drugs, number of drugs prescribed per patient being 9.99 ± 2.55 (Mean ± SD). About 96% prescriptions had potential for drug drug interactions. The total number of potential drug interactions was 1191 with mean number of drug interactions 7.63 ± 3.53. The association between pDDIs and number of drugs prescribed more than 5 was statistically significant (p < 0.0001). About 70% of p DDI was either significant or serious. Conclusion: More than 95% patients had potential for drug-drug interactions. Safeguards need to be introduced to prevent patients from receiving medications that have the potential to cause adverse drug interactions in the emergency medicine department.
CLP-14
Surgical Chemoprophylaxis and Surgical Site Infection in Cesarean Section and Hystrectomy at Tertiary Care Teaching Hospital
Rajgadhi HD 1 , Bhatt KM 1 , Malhotra SD 1 , Patel VJ 2
1 Department of Pharmacology, Smt. N.H.L. Municipal Medical College, Ahmedabad, Gujarat, India, 2 Dr. Jivraj Mehta Smarak Health Foundation, Ahmedabad, Gujarat, India
Objectives: To evaluate the use of antimicrobials and to check rationality and cost of the antimicrobials for surgical chemoprophylaxis in Obstrectic and Gynecology department. Materials and Methods: A prospective, observational, longitudinal, non-interventional study was carried out in the Obstetrics and Gynecology department of a tertiary care teaching hospital after seeking approval from IRB. All patients admitted in obstetrics and gynecology wards for cesarean section and/or hysterectomy were enrolled in the study after written informed consent. Rationality was checked by standard international guidelines. Results: A total of 270 patients who were admitted to the Obstetrics and Gynecology wards for cesarean Section and/or hysterectomy were enrolled in the study during a period of 1 year. Out of these 77.40% prescriptions belong to patients who have undergone cesarean section, 22.58% cases were operated for abdominal/vaginal hysterectomy. The most frequently prescribed preoperative antibiotic was single dose of injection Cefotaxime in 247 (91.48%) cases, Post operative antibiotic was injection Gentamicin 252 (93.33%). Patients who developed with SSI had prolonged post-operative hospital stay of 8.5 ± 1.71 days as compared to cases without SSI (5.24 ± 0.72 days). A significant (P < 0.0001, U = 99) higher cost of drug therapy among cases with SSI. None of the prescriptions adhered to standard guidelines for preoperative prophylaxis. Conclusion : The most frequently prescribed single dose preoperative antibiotic was injection Cefotaxime. Post-operative antibiotic treatment was given with more than one antibiotic for the period of 3 days. The cost of therapy and duration of stay was significantly higher in those who developed the SSI. Measures to implement standard guidelines should be emphasized to all prescribers to promote rational prescribing.
CLP-15
Analysis of Prescription Quality of Patients with Chronic Respiratory Disorders at a Tertiary Care Teaching Hospital
Thakkar KK 1 , Bhadiyadara SN 1 , Malhotra SD 1 , Patel VJ 2
1 Department of Pharmacology, Smt. N.H.L. Municipal Medical College, Ahmedabad, Gujarat, India, 2 Dr. Jivraj Mehta Smarak Health Foundation, Ahmedabad, Gujarat, India
Objectives: To determine the quality of prescribing in patients of chronic respiratory disorders attending medicine outpatient department at a tertiary health care teaching hospital using the Prescription Quality Index (PQI) tool and to assess the reliability of this tool. Materials and Methods: A prospective, cross-sectional, non-interventional study was carried out for over periodic of 12 months at medicine outpatient department patients of chronic respiratory disorders at tertiary care teaching hospital. Total and criteria wise PQI scores were derived according to Hassan's criteria for each prescription. Prescriptions were categorized as poor (score of ≤31), medium (score 32-33), and high quality (score 34-43) based on PQI total score. Data were analyzed using Statistical Package for Social Science 20.0 and Cronbach's α. Results: Most common respiratory disorders were COPD (66.5%) and Bronchial Asthma (49.4%). A total of 120 prescriptions were collected and evaluated for quality of prescribing using PQI tool. Out of 120 approximately 53%, 39% and 8% were of high, medium and low quality respectively. The PQI score ranges from maximum (40) to minimum (13). Mean PQI score for COPD and Bronchial asthma was 32.12 ± 6.28 and 31.51±6.16 respectively. Most commonly affected age was 31-50 Years. Most common drug prescribed was Theophylline and Etofylline. Cronbach's α for the entire 22 criteria were 0.73. Conclusion: PQI was found to be a comprehensive, valid and reliable tool for assessment of prescribing quality and further studies in different health care settings and in conditions other than chronic respiratory disorders can be carried out using PQI for assessment of prescribing quality in different therapeutic situations.
CLP-16
Nevirapine-induced Toxic Epidermal Necrolysis in a HIV Infected Patient: A Case Report
Godavarthi R 1 , Ghosh A 2 , Panja B 1 , Pal P 1 , Sen S 1 , Roy K 3
1 Department of Pharmacology, ICARE Institute of Medical Sciences and Research, Haldia, West Bengal, India, 2 Department of Pharmacology, MGM Medical College and LSK Hopsital, Kishanganj, Bihar, India, 3 Department of General Medicine, ICARE Institute of Medical Sciences and Research, Haldia, West Bengal, India
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are the most severe cutaneous adverse reactions (SCARs) which mainly caused by exposure to drugs and having significant morbidity and mortality. TEN represents an immunologic reaction to a foreign antigen and is most often caused by drugs. Nevirapine (NVP), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is an important component of highly active antiretroviral therapy (HAART). It is sometimes associated with life-threatening adverse reactions. Here, we report the fatal case of 75 years old male who developed TEN secondary to intake of nevirapine. The causality assessment as per the Naranjo algorithm and WHO- UMC criteria revealed the ADR to be Probable (Naranjo score 8). Assessment of causality by using the algorithm of drug causality for epidermal necrolysis (ALDEN) was also used. Despite meticulous supportive care and withdrawal of all drugs, his situation worsened and died after 7 days of hospital admission. This case report will increase awareness among treating physicians for careful monitoring of patients on NNRTI-based antiretroviral therapy and better counseling of the patient on NVP regimen for early identification and reporting of SCARs so that fatalities due to adverse drug reactions can be prevented with timely intervention.
CLP-17
Simvastatin and Ezetimibe, a Synergistic Combination therapy in Hypercholesterolemia: Review of Updates on Recent Trends in Pharmacokinetics, Pharmacodynamics, Adverse Reactions and Analytical Methods
Babu SM 1,2 , Kumar RV 2 , Reddy PBB 2 , Rao VS 3 , Sharma HK 3
1 Department of Pharmaceutical Sciences, J.N.T. University, Kukatpally, Hyderabad, Telangana, India, 2 Axis Clinicals Limited, Miyapur, Hyderabad, Telangana, India, 3 Aurobindo Pharma Research Center, Bachupalli, Hyderabad, Telangana, India
Hypercholesterolemia is one of the important risk factors for coronary artery disease and also a major cause of death in the industrialized and highly developed countries. The lowering of low-density lipoprotein cholesterol (LDL-C) is the primary target of therapy in the primary and secondary prevention of coronary artery diseases. Although statin therapy is the mainstay for LDL-C lowering, a significant percentage of patients prescribed these agents either does not achieve targets with statin therapy alone or have partial or complete intolerance to them. For such patients, the use of adjuvant therapy capable of providing incremental LDL-C reduction is advised. Simvastatin (SV) is a cholesterol-lowering agent, hydrolyzes to form a β, Δ-dihydroxy acid, which is an active metabolite, structurally similar to β-hydroxy-β-methylglutaryl coenzyme A (HMG-Co A), a key inter- mediate in cholesterol biosynthesis. Hydrolyzed Simvastatin competes for HMG-CoA reductase, this leads to decrease in cholesterol biosynthesis. Ezetimibe is the first in a new class of cholesterol lowering agents known as cholesterol absorption inhibitors. Ezetimibe (EZE) localizes in the small intestine and acts at the brush border, thus inhibits the passage of dietary and biliary cholesterol across the intestinal wall and thereby keeps the cholesterol in the intestinal lumen for excretion. Co-administration of EZE and SV Resultsed in a dose dependent reduction of low density lipoprotein (LDL) and total cholesterol with no effect on high density lipoprotein (HDL) cholesterol and triglycerides. Thus combination therapy exerts synergistic effect by different mechanisms in reducing serum cholesterol derived from different routes. This review describes a brief overview of the chemistry, pharmacokinetic, pharmacodynamic and adverse effects of Ezetimibe and Simvastatin. This review also focuses distinctly on comprehensive update of various analytical Methods for the quantification of Ezetimibe and Simvastatin in various formulations and biological fluids.
CLP-18
Study of Adverse Drug Reactions and Treatment Outcome in Multidrug Resistant TB Patients in a Tertiary Care Hospital, Dibrugarh, Assam
Juri D, Gohain K
Department of Pharmacology, Assam Medical College, Dibrugarh, Assam, India
Objectives: To determine the frequency and types of Adverse drug reactions (ADR) and to evaluate the treatment outcome in patients with multidrug resistant tuberculosis (Mdr TB). Materials and Methods: A Retrospective Analysis was done of 39 patient's with Mdr TB registered in DOTS PLUS centre from the period of JUNE 2013 to AUG 2015 in Assam Medical College, Dibrugarh, Assam. Results: ATotal of 39 patients were evaluated of which 28 patients were resistant to both Isoniazide(INH) and Rifampicin (R) and 11 patients were resistant only to Rifamipicin which were registered as Mdrtb as per RNTCP guideline. Twopatients were eventually diagnosed to be case of XDR. Age group of study people was between 16 years to 65 years. Diagnostic criteria for most of the patients(17 no) were sputum '+'at diagnosis, re-treatment case. Among the patients 1 was declared cured (2.6%), 3 default (7.7%) and 3 died (7.7%). 31 patients are undergoing treatment. 20 of total 39 patients showed ADR. 3 patients were having psychosis (7.69%), for which cycloserine was stopped in 2 patients, one defaulted. 10 patients complained of joint pain (25.64%), two vomiting (2.56%), two skin rashes (2.56%), three complained of hearing disturbances (7.69%). Conclusion: Treatment outcome for MDR-TB remains poor in patients taking DOTS-PLUS therapy which is furthercompounded by high drug toxicity, long duration of treatment, and default from treatment. Our main aim should be the prevention of emergence of Multidrug resistant strains which can beattained by prompt diagnosis and effective treatment of all TB cases.
CLP-19
Evaluation of Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting by Prescribers in a Teaching Hospital in North Karnataka
Uppin V, Khot A, Wali RS, Naikawadi AA
Department of Pharmacology, Shri B.M. Patil Medical College, Bijapur, Karnataka, India
Objectives: Spontaneous reporting (2) of adverse drug reactions is an immense responsibility of health care professionals, especially prescribers. Therefore, the present study was undertaken to evaluatethe Knowledge, Attitude and Practice towards ADR reporting among prescribers. Though health care professionals think that, ADR reporting is very important, but because of lack of sensitization and knowledge of Pharmacovigilance and ADRs, underreporting is very common. Therefore, second Objectives of the study was to get an insight into causes of underreporting of ADRs. Materials and Methods: A cross sectional study has been done on 120 prescribers of Tertiary care hospitals in Vijayapur, by using pretested structured questionnaire . Statistical analysis: Descriptive statistics like mean and standard deviation has been calculated. Results were tabulated & analyzed by using SPSS 20 software. Results: Among 120 prescribers, 52% of were aware of the existence of ADR reporting system in India; and only (79%) of respondents were aware of existing suspected ADR form for health care professionals, (82%) felt that all ADRs should be reported. However, only 30% have reported ADRs. Reasons cited for lack of reporting were did not know where (26%), how (40%) to report and the lack of access to reporting forms (21%). Conclusion: Prescribers knowledge was adequate, but did not know where & how to report. Hence they feel organizing CME or workshops will improve reporting practices.
CLP-20
Study of Prevalence of Self-medication Pattern Among Medical Students for Primary Dysmenorrhea
Madhavi P, Sankar K, Ramana VV, Chandrakala K
Department of Pharmacology, Siddhartha Medical College, Vijayawada, Andhra Pradesh, India
Objectives: To study the prevalence of self-medication by using over the counter drugs and non pharmacological Methods for primary dysmenorrhoea. Materials and Methods: A Cross sectional descriptive study using a self-developed, validated, Objectives and structure questionnaire as a tool, was conducted among medical students with Dysmenorrhoea and in the age group of 18-22 yrs. Statistical analysis was done using Chi-Square test. Results: Out of 203 respondents 30% were self medicated by using over the counter drugs and 70% were treated themselves by non-pharmacological Methods like taking rest, applying hot fomentation on abdomen. Among the over the counter drugs 56% of them used single drug and 44% used combination of drugs. Most commonly used single drug was Mefenamic acid and most commonly used combination of drugs was mefenamic acid + dicyclomine hydrochloride. Out of those respondents taking OTC only 5% seeked gynaecologist advises. Significant number of students were taking rest [Chi-square value = 66.84 p < 0.01 highly significant] losing attendance in their academics. Conclusion: Primary Dysmenorrhoea is affecting young girls irrespective of regularity of cycles. The prevailing self-medication pattern is inappropriate, substantial proportion of girls have inadequate knowledge regarding treatment and need of gynaecologist consultation.
CLP-21
An Evaluation of Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting in a Tertiary Care Teaching Hospital of Sikkim ADR Reporting: A KAP Questionnaire Study
Datta S
Department of Pharmacology, SMIMS, Gangtok, Sikkim, India
Objectives: Spontaneous voluntary ADR reporting is paramount to the success of the Pharmacovigilance Programme of India. There has however been minimal and sporadic voluntary reporting of ADR's at the ADR Monitoring Centre (AMC) Gangtok, Sikkim. Knowledge, perception, attitude and awareness of health professionals are determinants of reporting practices. This Questionnairestudy aims at evaluating these indicators in the teaching hospital attached to the medical institute and find out Methods to improve existing reporting practices. Methods: This is a cross sectional questionnaire based observational study carried out in the medical, surgical and pathology departments of the teaching hospital, Gangtok, Sikkim over a period of 2 months. The questionnaires were filled by the respondents and returned back to us within the next 24 hours. Data obtained from filled questionnaires was thereby analyzed. Results: The overall correct response rate to the knowledge based questions was 56.3%. While 97% of respondents were of the view that ADR reporting was necessary, 35% of the respondents felt that difficulty in deciding the causality of an ADR discouraged them from reporting. 79% of the respondents were not aware of the presence of an ADR Monitoring centre affiliated to the hospital and 87% of the respondents admitted that they were not sending filled ADR forms to the ADR monitoring centre. Conclusion: The study indicates that the respondents have an average knowledge and positive attitude towards ADR reporting and pharmacovigilance. There is however a lack of awareness and poor ADR reporting practices. Efforts are required to enhance awareness and aptitude towards pharmacovigilance and ADR reporting.
CLP-22
A Study to Assess Awareness Amongst Pregnant Women About the Effects of Drugs on the Fetus and Self-medication
Banzal N, Saxena K, Dalal M, Srivastava SK
Department of Pharmacology and Obstretics and Gynaecology, SMIMER, Surat, Gujarat, India
Objectives: A study was carried out on 200 pregnant women visiting obstretics & gynaecology Department SMIMER Surat to assess their awareness about effect of medication & self-medication. Materials and Methods: It was a prospective, observational cross sectional study based on the Questionnaire, provided to 200 pregnant women. All the pregnant women attending antenatal clinic in SMIMER Hospital Surat, willing to participate in the study were included. Results: About 99% were not aware about the effect of medication on the health of foetus and did not even inquire about it. At the time of survey, 74% pregnant women were on some medication. More than 80% were not aware about the duration of medication about 51%. Conclusion: There is a lack of awareness amongst the pregnant women regarding the effect of drugs on foetus. However, there was a good awareness that during pregnancy drug should be taken based on clinician's prescription rather than self-medication.
CLP-23
A Retrospective Analysis of Adverse Drug Reaction Reported in Tertiary Care Hospital
Saxena K, Tailor C, Mehta C, Gajera P, Srivastava SK
Department of Pharmacology, SMIMER, Surat, Gujarat, India
Objectives: The adverse drug reactions (ADRs) reported to pharmacovigilance center in tertiary care hospital were analyzed to find out the incidence and causality. Materials and Methods: This was a retrospective study to analyze the ADR reported at pharmacovigilance center after ethical clearance from Institutional Ethic Committee (IEC). ADR data were analyzed and ADRs were categorized as department-wise, system affected and causative drug. The causality of each ADR was assessed by WHO-UMC scale. Results: The majority of patients who had suffered from ADRs were between 19-64 years of age (94.2%) and male patients (58.6%) were affected more than female (41.4%). Pulmonary medicine department has reported highest number of ADR followed by dermatology department. Skin (46.5%) was most affected system followed by gastrointestinal (30.45%), CNS (21.26%), respiratory (9.0%) and remaining systems. Rifampicin (13.79%) shows the largest numbers of ADR followed by zidovudine (13.21%), nevirapine (12.64%) and diclofenac sodium (8.0%). The maximum ADRs reported were probable (94.8%) followed by possible (5.2%). Conclusion: In conclusion, the skin was most affected system followed by gastrointestinal, central nervous and respiratory system. Rifampicin has caused maximum ADRs followed by zidovudine, nevirapine and diclofenac sodium. The causality analyses showed that majority of ADRs were probable (94.8%) while remaining falls in possible (5.2%) category.
CLP-24
Educational Intervention to Improve Knowledge, Attitude and Practice of Pharmacovigilance Among Nursing Staff in Tertiary Care Hospital
Hingorani S, Mehta C, Gajera P, Srivastava SK
Department of Pharmacology, SMIMER, Surat, Gujarat, India
Objectives: The present study was planned to assess the knowledge, attitude and practice among nursing staff and to evaluate the effect of educational intervention. Materials and Methods: The questionnaire related with knowledge, attitude and practice (KAP) were given to nursing staff before and after the educational intervention in a tertiary care hospital. The data obtained were subjected to statistical analysis. Results: The training given in different sessions has improved KAP among nursing staff. Ninety six percent of them responded correctly regarding who can report ADR as compared to pre training session (69%). Regarding pharmacovigilance as purpose of safe use of medicines was responded by 71% after training as compared to 54% before training. In questions related to PvPI, 94% of nursing staff responded correctly about the scale to be used for causality assessment in comparison to 79% before training. Majority of them were of opinion that only unknown and serious ADR should be reported whereas after training they answered that all the ADR should be reported. A significant improvement has been noticed in questions related to attitude and practice. Conclusion: The educational intervention to improve KAP among nursing staff has Resultsed in significant improvement.
CLP-25
Complementary and Alternative Medicine CAM Use in Chidren with Haematological Disorders
Shinde V, Sontakke S, Motghare V, Pimpalkhute S, Bajait C
Department of Pharmacology, GMC, Nagpur, Maharashtra, India
Objectives: To assess prevalence of complementary and alternative medicine (CAM) use in paediatric patients suffering from thalassemia and to compare CAM use in paediatric patients of thalassemia and sickle cell disease(SCD). Materials and Methods: This was cross sectional, questionnaire based survey conducted in tertiary care teaching hospital after approval of institutional ethics committee. Patients suffering from thalassemia or SCD, of either gender attending sickle cell clinic and paediatric OPD were included after obtaining informed consent. Parents accompanying patients were interviewed and information obtained was entered in self-developed, semi structured, pretested questionnaire. Data was analysed using Graph Pad Prism version 6.0. Results : Use of CAM as reported by parents was 34.78% and 30.13% in thalassemia and SCD respectively (p=0.476). Ayurveda (78% and 71%) and homeopathy (22% and 29%) were most common CAM used in both diseases. Most of the parents didn't disclose CAM use to their doctor (84.37% & 85.50%). Significantly more parents of SCD children reported to have benefitted from CAM (p = 0.0122). Benefits obtained from CAM were similar in both groups: symptomatic improvement, increased haemoglobin, reduced blood transfusion. Reasons for stopping CAM were similar in both groups such as no relief with treatment, adverse effects & high cost. Conclusion : Results of this study indicate that CAM use is similar in SCD and thalassemia. The matter of concern is that many patients, who used CAM along with conventional medicines, didn't disclose CAM use to their doctors, this increases possibility of potential interactions and avoidable problems.
CLP-26
Antimicrobial Utilization and Sensitivity Pattern in Indoor Patients with Positive Urine Culture: An Observational Study
Shah U, Shah S
Department of Pharmacology, Government Medical College, Baroda, Gujarat, India
Objectives: This observational cross-sectional study was planned to study the antimicrobial prescribing pattern and analyze the antimicrobial sensitivity pattern of organisms. Materials and Methods: The study was undertaken for a period of 6 months during which antimicrobial usage data in terms of timing, frequency, dosage, route, duration of therapy of 300 indoor patients with positive urine culture report were collected. Results: From 17 samples 2 organisms were isolated and from 283 samples single organism was isolated, so in total 317 organisms were isolated from 300 samples. Total 33 different antimicrobials were used in 300 patients. Most commonly prescribed antimicrobials before Results of culture reports were cephalosporins (81.66%), aminoglycosides (38.33%) and penicillins (26%). Most common pathogen isolated was E. coli(48.58%, 154 patients), which was sensitive to norfloxacin (81.62%), ofloxacin (73.53%) and cefoperazone + sulbactam (69.12%). In these patients, after culture report, ofloxacin and cefoperazone + sulbactam were most commonly prescribed. Second common organism isolated was Enterococcus (16.72%, 53 patients), which was sensitive to linezolid (92.45%) and vancomycin (81.13%). In these patients, after culture report, linezolid and vancomycin were most commonly prescribed. Other organisms isolated were Klebsiella, Pseudomonas and Acinetobacter. Conclusion: Commonly used antimicrobials in our setup are not tested routinely for sensitivity and not used in accordance with the antimicrobial sensitivity pattern of organism. The antimicrobials prescribed routinely should be included in culture sensitivity testing. Antimicrobial prescriptions for empirical treatment should be changed from time-to-time according to culture sensitivity data, so thatantimicrobial to which most organisms are sensitive can be chosen.
CLP-27
Drug Utilisation Study in Ophthalmology Outpatients Department of a Tertiary Care Teaching Hospital
Luhar H, Shah P
Department of Pharmacology, Government Medical College, Baroda, Gujarat, India
Objectives: This observational cross- sectional study was planned to study the prescribing pattern of drugs in the out-patients Department of Ophthalmology. Materials and Methods: The study was planned for a period of 6 monthsduring which drug usage data in terms of dosage formulation, frequency, route, duration of therapy of 200 outdoor patients(of 3 months) were collected. Results: Prescriptions of 200 patients were analyzed by the WHO prescribing indicators. It showed that the total number of drugs prescribed was 419, average number of drugs per encounter was 2.09 and the number of drugs per prescription ranged from one to six. Percentage of drugs prescribed by generic name was 16.22%. Percentage of encounters with antibiotics and with injections prescribed were 85% and 1% respectively. Percentage of drugs prescribed from National List of Essential Medicines (NLEM) was 54%. Antimicrobial agents (64.91%) were the most commonly prescribed drugs followed by anti-inflammatory and anti-glaucoma drugs. Fluoroquinolones were the most common (71.69%) of all antimicrobial drugs, of which ciprofloxacin (72.82%) was the most frequently prescribed drug. The maximum number of drugs prescribed, were in the form of eye drops (67.5%), followed by ointments and tablets. The study is in progress and in oral presentation the data of 6 months will be included. Conclusion: The prescriptions were satisfactorily complete indicating the information of drug formulation, frequency and duration of treatment. The study suggests a need for improvement in encouraging the ophthalmologists to prescribe by generic name and selection ofdrugs from National List of Essential Medicines (NEDL).
CLP-28
A Study on Adverse Drug Reaction Occurring in Department of Paediatrics in a Tertiary Care Hospital
Gupta A, Singh SP, Agrawal P, Rao YK, Kushwaha V, Singh A
Department of Pharmacology, GSVM Medical College, Kanpur, Uttar Pradesh, India
Objectives: To study and analyze adverse drug reactions (ADRs) in pediatric patients. Materials and Methods: Study was conducted in department of paediatrics at LLR Hospital, GSVM Medical College, Kanpur over a period of six months. Spontaneous ADR reporting technique was used for data collection. All indoor and OPD patients of both sexes who encountered ADR were included in our study. TO classify ADRs expended Rawlins and Thompson's classification was used. For Causality assessment Naranjo's Probability Scale, for predictability modified guidelines by the council for International Organizations of medical Sciences, and for severity Modified Hartwig severity scalewas used. Seriousness was assessed as per WHO criteria. Results: A total of 30 ADRs (47% male, 53% female) reported during the study period. Out of total ADRs 40% were found in 0-1 year, 23% in 1-5 years and 37% in 5-15 years age group. All the reported ADRs were of type B. The most common ADR was rash(50%) followed by red man syndrome (20%). Most common drug responsible for ADRs was antimicrobials (77%). On causality assessment 63% ADRs were found probable and 37% possible. Most of ADRs were of mild type (57%) on severity scale. Most of ADRs were of non- serious type (70%). Conclusion: Maximum burden of ADRs were found in 0-1 year age group. Antimicrobials were found responsible for most of the ADRs. So antimicrobials should be prescribed cautiously with direction to monitor ADRs rigorously in paediatric patients.
CLP-29
Drug Utilization Pattern of Antibiotics in Acute Respiratory Tract Infections in the Paediatrics Department of Gauhati Medical College and Hospital: A Prospective Study
Mousum SA, Lahkar M, Singha B
Department of Pharmacology, Guwahati Medical College and Hospital, Guwahati, Assam, India
Objectives: To study the drug utilization pattern of antibiotics in acute respiratory tract infection in Pediatrics Department of Gauhati Medical College and Hospital. Materials and Methods: The study was a prescription based cross-sectional study. Prescriptions of patients having acute respiratory tract infections who were prescribed antibiotics were observed. Demographic characteristics such as age, sex and indications along with dosage and route of administration were also recorded. The data were analyzed for the utilization pattern of different groups of antibiotics and their route of administration along with dosage in acute respiratory tract infections. Results: Out of 200 prescriptions for acute respiratory tract infections who were prescribed antibiotics it has been observed that 120 were suffering from severe pneumonia 20 only pneumonia, 14 with bronchiolitis, 36 acute tonsilitis and 10 with acute bronchial asthma. The different groups of antibiotics were amoxicillin-clavulinic acid combination, cefotaxim and amikacin. Pneumonia was the most common condition where antibiotics were prescribed. Almost all the prescriptions were within the age group of 6 months to 3 years age group. Conclusion: This study shows that pneumonia is the single major indication where antibiotics are being used uniformly. The other acute respiratory tract infections include acute tonsillitis, bronchiolitis and acute bronchial asthma;however in acute bronchial asthma antibiotics were used in a few prescriptions. Majority of the prescriptions of acute bronchial asthma and some with acute bronchiolitis were without any antibiotics.
CLP-30
Study of Cutaneous Adverse Drug Reactions in a Tertiary Care Hospital
Manjunatha R, Pundarikaksha HP, Vijendra R
Department of Pharmacology, Kwmpegowda Institute of Medical Sciences, Bengaluru, Karnataka, India
Objectives: To study the incidence, clinical spectrum and severity of cutaneous adverse drug reactions (ADRs). Materials and Methods: This Retrospective study was conducted by retrieving the case records with cutaneous ADRs from the medical records section, KIMSH&RC, Bangalore. Case records between May 2011 and April 2012 were collected. Cutaneous ADRs were recorded in the ADR reporting proforma and causality was assessed using WHO causality scale. Cases were analysed for the incidence, drugs commonly implicated, clinical spectrum and severity of the cutaneous ADRs (Hartwig severity severity scale). Results: Of the 40 cases of cutaneous ADRs recorded, most of them were maculopapular rash and/or pruritis (82.5%) and the rest forming the remaining 17.5%. The most common drug causing cutaneous ADR were NSAIDs (22.5%) followed by anti retroviral drugs (17.5%), cephalosporins (15%), piperacillin-tazobactem and fluoroqinolones (7.5% each). Nevirapine had a wide clinical spectrum of ADRs with maculopapular rash (28.6%), pruritis (28.6%), Steven Johnson syndrome (SJS), vesiculobullous eruption and exfoliative dermatitis (14.3% each) whereas NSAIDs related ADRs were Maculopapular rash + pruritis (89%) and Fixed drug eruptions (19%). Percentage of cases with mild, moderate and severe cutaneous ADRs was 62.5, 32.5 and 5 respectively. Conclusion: A wide clinical spectrum of cutaneous ADRs from maculopapular rash to serious SJS were observed, the most common being maculopapular rash. The most common drug causing cutaneous ADR was NSAIDs. Nevirapine had the widest clinical spectrum of ADRs and most of the cases of cutaneous ADRs were mild in severity.
CLP-31
A Comparative Study of Efficacy of Drugs Used in Patients with Benign Prostatic Hyperplasia with and without Metabolic Syndrome
Panigrahy PK 1,2 , Ramani YR 1,2 , Panigrahy B 1,2 , Maharana CS 1,2
1 Department of Pharmacology, MKCG Medical College, Berhampur, Odisha, India, 2 Department of Urology, MKCG Medical College, Berhampur, Odisha, India
Objectives: To study the efficacy of uroselective drugs in patients of benign prostatic hyperplasia (BPH) with and without Metabolic Syndrome (MetS). Materials and Methods: A total of 187 adult males diagnosed to be suffering from BPH were screened for MetS and were grouped into 2 groups as MetS (+Ve) and MetS (-Ve) and received selective α1 blockers, 5-α reductase inhibitors or a combination of both as treatment. The study medications were administered in standard dose and treatment responses were monitored at Baseline and at 4 wks, 12 wks and 24 wks of follow-up. Both the groups were given same treatment. Results: The International Prostate Symptom score showed a significant (p < 0.001) improvement at 24 weeks of α1 blockers (3.26 ± 3.38); 5 α reductase inhibitor (3.38 ± 3.40) and combination (6.63 ± 7.85) when compared with baseline value of each group (14.2 ± 7.6); (12.92 ± 7.8) and (20.85 ± 7.8) respectively. The Quality Of Life score also showed a significant improvementThere was more improvement in signs & symptoms in patients without MetS as compared to patients with MetS. There was significant improvement in glycemic profile of patients with MetS. Conclusion: α1 blockers, 5 α reductase inhibitors, are comparable in efficacy in the management of moderate to BHP. Presence of MetS has a significant negative impact on the responsiveness to α1 blockersin patients with BHP. Similarly 5 α reductase inhibitors showed a mild difference in metabolic profile with slight amelioration of glucose metabolism regulation.
CLP-32
Adverse Drug Reactions and Culture Sensitivity Pattern of Organisms in Patients Receiving Anti-microbial Agents in Medical Intensive Care Unit of a Tertiary Care Teaching Hospital
Biswas M 1,2,3 , Rege NN 1,2,3 , Karnik ND 1,2,3 , Nataraj G 1,2,3 , Dhediya RM 1,2,3
1 Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India, 2 Department of Medicine, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India, 3 Department of Microbiology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
Objectives: To find and analyze the incidence, presentation, causality, severity, predictability, preventability of Adverse Drug Reactions (ADR) and to document the culture-sensitivity (C & S) pattern in patients receiving Anti-microbial agents (AMAs) in Medical Intensive Care Unit (MICU). Materials and Methods: Following IEC approval and written informed consent, 600 patients receiving AMAs were enrolled from June 2014 to May 2015 and followed up daily till they were in MICU. Demographic data, diagnosis, investigations, treatment and details of ADRs were recorded. ADRs were analyzed using various standard scales/scoring systems. Detailed descriptive statistical analysis of collected data was done. Results: Of 600 patients (35.1 ± 14.8 years; M:F = 1:1.1), 72 developed AMA related ADRs; maximum involvement was of skin & appendages followed by vascular and gastro-intestinal system (WHO-ART coding). ADRs were mainly 'probable' (62% WHO-UMC, 69% Naranjo) and 'possible' (32% WHO-UMC, 25% Naranjo). 68% ADRs were 'mild' (modified Hartwig-Siegel), 57% 'not preventable' (Schumock-Thornton), 24% 'serious' and 44% 'predictable'. 82% ADRs resolved after withdrawal of suspected drug. Linezolid was found to cause maximum ADRs (19%), followed by anti-tubercular drugs and Cephalosporins. No drug interaction causing ADR was detected. Most commonly sent specimen for C&S was Broncho-alveolar lavage (48%). Main isolated organisms were Pseudomonas (30%), Acinetobacter (23%) and Klebsiella (16%). Microbial resistance was high with Aminoglycosides, Cephalosporins, Fluoroquinolones, Penicillins and Cotrimoxazole; most were sensitive to Colistin, Polymyxin-B and Tigecycline. Conclusion: The study documented 12% incidence of ADRs due to prescribed AMAs and high microbial resistance in our MICU setup. Careful selection and due precautions are warranted to strengthen rational AMA use and improve patient care.
CLP-33
An Analysis of Correlation and Regression Between the Treatment Outcome Measures in the Management of Rheumatoid Arthritis
Bhatt KA, Girish K, Ravish VN
Department of Pharmacology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India
Objectives: To assess the correlation between the treatment outcome measures in the management of RA with methotrexate, sulfasalazine and leflunomide. Materials and Methods: 90 subjects with RA randomized into three groups of 30 each to receive methotrexate, sulfasalazine or leflunomide. The study medications were given in the standard dose and the treatment response was monitored during the follow-up visits at 2, 4, 8, 12, 16, 20 and 24 weeks. A correlation and linear regression analysis was performed between the outcome measures like Clinical Disease Activity Index (CDAI) and Disease Activity Score-28 (DAS-28) at each visit. Results: CDAI scores correlate highly positively with DAS-28 scores (r > 0.97, p < 0.001). But, excellent correlation was observed between baseline CDAI and change in CDAI from baseline at the end of study (r > 0.29, p < 0.01), however, the correlation was moderate to poor between baseline DAS-28 and change in DAS-28 (r < 0.08) in all three study groups at various follow-up visits. Both baseline CDAI and baseline DAS-28 showed positive correlation with improvement in quality of life (r > 0.34, p < 0.001) and (r > 0.36, p < 0.001). Conclusion : Higher CDAI scores are better predictors of improvement in disease activity than DAS-28 scores. Both CDAI and DAS-28 can be considered comparable for assessment improvement in quality of life. This suggests that CDAI is a more reliable tool in assessing the treatment outcome of Disease Modifying Anti-Rheumatoid Drugs (DMARDs).
CLP-34
Pharmaco-prophylaxis of Deep Vein Thrombosis for In-patients in a Tertiary Care Hospital - An Observational Pilot Study: Preliminary Results
John S 1 , Faruqui AR 1 , Umesh S 3
1 Department of Pharmacology, St. John's Medical College Hospital, Bengaluru, Karnataka, India, 2 Department of Medicine, St. John's Medical College Hospital, Bengaluru, Karnataka, India
Objectives: To determine the pattern and rates of pharmaco-prophylaxis among hospitalized patients, at high risk for developing deep vein thrombosis (DVT) and report adverse drug reactions (ADR) seen in them. Materials and Mathod: We conducted a prospective study among inpatients of St. John's Medical College Hospital, representative of surgical & medical departments, who were at high risk of DVT (based on Padua risk prediction score). Chi-squared test and independent't' tests were used for comparisons. Results: Among 206 patients screened, 100 (48.5%) were enrolled (Padua score ≥4). Of these 55 (55%) were medical and 45 (45%), surgical patients. Mean age (SD) was 54.58 (± 18.3), 55 (55%) were women and 21 (21%) had a BMI ≥30. Of 100 high risk patients, only 24 (24%) received pharmacoprophylaxis (13 [23.6%] medical patients, compared to 11 [24.4%surgical patients], p = 0.89). Low molecular weight heparin was used in 19 (82.6%) patients. Among patients who received pharmacoprophylaxis, mean duration of hospital stay was 10.04 (±4.7) days compared to 6.7 (±3.5) days in those who did not receive (p = 0.003, 95% CI-5.4, −1.2). In these patients, no adverse reaction was reported with any of the anticoagulants used. However, steroid use, for other indications did report most of the reactions. Conclusion: Despite a large proportion of hospitalized patients being at high risk for DVT (as per Padua score), the rates of pharmacoprophylaxis was low. Our data emphasize the significance of routine risk assessment of patients for DVT & administering appropriate prophylaxis to those at risk.
CLP-35
PPI Induced Hypomagnesaemia
Patel D, Patel C, Patel D, Zala AF
Department of Pharmacology, Government Medical College, Surat, Gujarat, India
PPIs are one of the most widely and chronically used class of drugs in clinical practice for the prevention and treatment of peptic ulcer, esophagitis, gastritis and gastro esophageal reflux. They are the mainstay therapy for all acid peptic diseases because they are the most potent inhibitors of acid secretion. PPIs can affect the gastrointestinal absorption of magnesium. Hypomagnesemia has been recognized as a side effect of PPIs in recent times. Hypomagnesemia can cause several symptoms; some of which being potentially serious to CNS and CVS. Here we report a case of symptomatic hypomagnesemia in medical ICU which was resolved only after the PPI was stopped.
CLP-36
Phenytoin Induced Steven Johnson Syndrome
Patel D, Kantharia ND, Patel D, Samanta R
Department of Pharmacology, Government Medical College, Surat, Gujarat, India
Steven Johnson Syndrome (SJS), a form of Toxic epidermal necrolysis (TEN), is a rare (one to two/100,000 population/year) but life threatening skin condition. The syndrome is thought to be a hypersensitive complex that affects the skin and the mucous membranes. The most well-known causes are certain medications, infections and contact with chemicals. Drugs commonly encountered are antiepileptics, antimicrobials and non-steroidal anti-inflammatory drugs (NSAIDS). Amongst antiepileptic's; carbamazepine and phenytoin are the major culprits. Here we report the case of SJS occurred after phenytoin administration in a case of road traffic accident which was managed with phenytoin withdrawal and supportive management for skin lesions.
CLP-37
Steven-Johnson Syndrome Induced by Lamotrigine: A Case Report
Kashyapa H, Verma L
Department of Pharmacology, Dr. Vaishampayan Memorial Government Medical College, Solapur, Maharashtra, India
Stevens-Johnson syndrome (SJS) is an immune-complex mediated hypersensitivity reaction and has been linked as an adverse side effect to many drugs. This case is about a 25 year old woman who had Lamotrigine-induced Stevens-Johnson syndrome which is known to occur but is rare. Lamotrigine, an anticonvulsive medication and also a commonly used mood stabilizer was prescribed to the patient to treat symptoms of anxiety and depression. The patient developed Stevens-Johnson syndrome one month after start of therapy. This case is discussed for its relevance to the use of Lamotrigine which is currently prescribed very commonly in psychiatric practices.
CLP-38
A Case Report of Actinomycetoma Over a Rare Site in a Patient with Diabetes Mellitus; Favourable Clinical Response to Welsh Regimen
Vinitha K 1 , Lakshminarayana K 1 , Murthy SC 2 , Vatsala S 2 , Prashanth SP 1
1 Department of Pharmacology, VIMS, Bellary, Karnataka, India, 2 Department of Dermatology, VIMS, Bellary, Karnataka, India
Introduction: Mycetoma, is a chronic progressive infectious dermatosis caused by actinomycetes or by eumycetes. The condition usually occurs over lower limbs and is difficult to treat. We report a patient with diabetes mellitus with occurrence of mycetoma over a rare site (i.e, upper back), successfully treated with Welsh regimen. Case Report: A 45 year old male patient with uncontrolled diabetes mellitus presented to us with multiple discharging swellings over the upper back for the last five years. The patient was treated with multiple drugs including surgery without improvement. Cutaneous examination showed multiple non tender nodules and discharging sinuses. A clinical diagnosis of mycetoma was considered. Routine blood investigations were normal, culture showed growth of gram negative bacilli. Histopathological examination was consistent with mycetoma. The patient was started on Welsh regimen i.e., Inj. Amikacin 15 mg/kg/day in divided doses for 3 weeks with Tab. Cotrimoxazole 1.5 mg/kg twice daily for 5 weeks constituting one cycle. The patient was treated with 3 cycles of the regimen, with excellent clinical response. Conclusion: Reports on treatment of mycetoma are limited, although it is a common condition worldwide. Mycetoma occurring over upper back is uncommon. Our patient showed favourable clinical response to Welsh regimen.
CLP-39
Effects of Yoga on Pulmonary Functions, Fractional Exhaled Nitric Oxide and Quality of Life Parameters in Patients of Bronchial Asthma
Babita 1,2 , Ray A 1,2 , Menon B 1,2 , Gulati K 1,2
1 Department of Pharmacology, Vallabhbhai Patel Chest Institute, University of Delhi, New Delhi, India, 2 Department of Pulmonary Medicine, Vallabhbhai Patel Chest Institute, University of Delhi, New Delhi, India
Objectives: To study the effects of yoga as an adjunct therapy on pulmonary function test (PFT), fractional exhaled nitric oxide (FeNO) and Quality of Life parameters in patients of bronchial asthma. Materials and Methods: It was a randomized, prospective, parallel design study. The study recruited patients with clinical diagnosis of mild to moderate bronchial asthma as per GCP guidelines. They were randomized into Group 1 (control group, taking c onventional drug treatment) and Group 2 (Yogic intervention for 1 hour daily with conventional drug treatment). Pulmonary functions viz. FEV 1 (forced expiratory volume in 1 sec), FVC (force vital capacity), FEV 1 /FVC ratio, and FeNO were measured and Quality of Life was evaluated by using Asthma Quality of Life Questionnaire (AQLQ) in all patients at baseline and then were followed up for 2 months. Results: Yogic intervention in patients (Group 2) showed a significant improvement in pulmonary functions as compared to the control group (Group 1). Further, the levels of FeNO, a marker of inflammation in respiratory tract, were found to be significantly decreased in Yoga group which was accompanied with significant improvement in quality of life as measured by AQLQ. Conclusion: Adjunct Yoga therapy improves lung functions and quality of life which may be due to reduction of airway inflammation in patients of bronchial asthma.
CLP-40
Steven-Johnson Syndrome Following Use of Ofloxacin in HIV Positive Patient: A Case Report
Raghute L, Dakhale G, Pimpalkhute S, Motghare VM, Shinde V
Department of Pharmacology, GMC, Nagpur, Maharashtra, India
Objectives: Steven Johnson Syndrome (SJS) is characterized by blisters and epidermal detachment Resultsing from epidermal necrosis in the absence of substantial dermal inflammation. It is an immune Complex mediated hypersensitivity Complex that typically involves the skin and mucous membrane. Incidence of SJS is 1-2 cases per 1 million populations. Fluoroquinolones have rarely been implicated in cases of SJS. Case Report: Here we report a 43 years old Indian male received ofloxacin and ornidazole combination 4 days before starting the symptoms for bacterial infection for 3 days. He experienced a diffuse exfoliating erythema with generalized bullous eruptions that involved face, trunk and both extremities which was diagnosed as a SJS. The patient was hospitalized and improved after taking symptomatic treatment. He was also a known case of HIV infection for which he was on nevirapine, lamivudine and zidovudine combination therapy since 2008. Conclusion: So, in order to avoid the morbidity and mortality associated with SJS, it is of utmost significance to be vigilant while giving drugs known to cause SJS. We hope that this case report create awareness to the healthcare professionals that ofloxacin can cause SJS.
CLP-41
Sulphonamide Induced Toxic Epidermal Necrolysis (TEN) Complicated by TB with Pleural Effusion
Khamkar A, Motghare VM, Sontakke S, Raghute L, Tathod Y
Department of Pharmacology, GMC, Nagpur, Maharashtra, India
Objectives: TENis potentially life-threatening dermatologic disorder characterized by widespread erythema, necrosis and bullous detachment of the epidermis and mucous membrane Resultsing in exfoliation and possible sepsis or death. It involves >30% of body surface area. It is most commonly idiosyncratic. Commonly implicated drugs are antimicrobials like sulphonamides & fluoroquinolones. No lab test is able to confirm a specific drug etiology. Case Report: 20 year old female admitted in dermatology department of tertiary Care teaching Hospital with multiple reddish raised lesions over face, trunk, extremities and oral cavity. Patient had taken sulphonamides prior to onset of reaction. She was known case of TB on anti TB medication which was stopped after the onset of reaction. She was diagnosed a case of TEN and treated with injectable steroids(prednisolone) 10 mg per day for 15 dayswith anti-histaminics. Symptomsgradually subsided saving the patient from a possibly fatal condition. Conclusion: Diagnosis of TEN is often challenging. It is thought to be mediated by an immunological mechanism. Clinicians and patients need to be aware of the signs and symptoms. In this case management involvedearly identification, withdrawal of the culprit drug and rapid initiation of supportive therapies. Hence, we see that prompt diagnosis and treatment helped save the patient's life.
CLP-42
Quantitative and Qualitative Analysis of Prescriptions at a Tertiary Health Carehospital
Ghataliya K, Shah S, Desai M
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India
Objectives: To analyse the medicine use pattern and completeness of prescriptions at a tertiary health care teaching hospital. Materials and Methods: Aprospective, cross sectional study was conducted at the outpatient department (OPD) of the Civil Hospital, Ahmedabad from December 2014 to February 2015. The data was collected from ENT, paediatrics, psychiatry and skin OPD. "First Encounter Prescriptions" of patients at the dispensing pharmacy were included by systematic random sampling. The data was analysed using WHO core prescribing indicators. Qualitative evaluation was done using variables indicating completeness of prescriptions. Results: Out of 650 prescriptions, 636 were analysed. The average number of drug prescribed per prescription was 4 ± 1.4. Out of 2533 drugs prescribed, 1624 (64.1%) were prescribed by generic name, 2326 (91.8%) were listed in Essential Drug List (EDL) of Gujarat State, 2012-2013. Out of 636 prescriptions, antimicrobials were prescribed in 399 with an average of 0.62 antimicrobial per prescription. Fixed dose combinations (FDCs) were most commonly prescribed in paediatrics (155, 32.8%) and psychiatry (149, 31.5%). Majority of the prescriptions mentioned route (624, 98.1%), frequency (611, 96%) of administration and duration of treatment (610, 95.9%) while dose and instructions to patient was mentioned in 362 (56.9%) and 286 (44.9%) prescriptions, respectively. Conclusion: A substantial number of medicines lack prescription with generic name, appropriate dosage schedule and proper patient instructions. This calls for need of prescription audit and undertaking educational training for the prescribers or health care professionals.
CLP-43
Critical Analysis of Non-steroidal Anti-inflammatory Drugs and Hematinic Fixed Dose Combinations Available in Indian Market
Mendhe PP, Shah SP, Desai MK
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India
Objectives: To analyze the rationality of non-steroidalanti-inflammatory drugs (NSAIDs) and hematinicsfixed dose combinations (FDCs) available in Indian market. Materials and Methods: NSAIDs and hematinicFDCsenlisted in Indian Drug Review (IDR) 2014 and 2015 were analyzed by a pretested validated eight point criteria tool. Each FDC was assessed for number of active pharmacological ingredients (API), approval by regulatory authority, listing in WHO Essential Medicine List (EML) or National EML. Efficacy, safety, pharmacokinetic and pharmacodynamic interactions and advantages of each FDC were analyzed by evidence based literature search. The total score of the tool was 12 and score ≥7 was considered as rational. Results: Out of 220 FDCs, 93 were NSAIDs and 127 werehematinics. Out of these, 32 NSAIDs and 15 hematinic FDCs were approved by DCGI. The mean rationality score was 4.85 ± 1.19 (95% CI, 6.04-3.66). Out of 220, only 9 (4.0%) FDCs were rational and 1 was listed in WHO EML, 2015. Out of 93 NSAIDs FDCs, 2 (2.1%) were rational havingmefanamic acid plusdicyclomine and aceclofenac plus drotaverine. Out of 127 hematinic FDCs, 7 (5.5%) were rational mainly with combination of various iron salts plus folic acid. The irrational FDCs in NSAID group were diclofenac plus serratiopeptidase or omeprazole or famotidine orparacetamol. Majority of irrational hematinic FDCs were iron salts combinedwith vitamin B complex and micronutrients. Conclusion: Majority of FDCs available in Indian drug market are irrational. This calls for strengthening the regulatory approval of these formulations.
CLP-44
Intra-articular Glucocorticosteriod Hydrocortisone Hemisuccinate induced acne: A Rare Case Report
Sharanabasappa, Kanaki A, Patil BV, Vardhamane SH, Jeevangi SR, Kunnoor N
Department of Pharmacology, M.R. Medical College, Kalburgi, Karnataka, India
Acne is a chronic inflammatory disease of the pilosebaceous unit, characterized by the formation of comedones, erythematous papules and pustules, less frequently nodules or cysts, and in some cases scarring. S teroid acne is an acneoform eruption induced by steroids use. Steroid acne is relatively common dermatological problem, causing great cosmetic disfigurement. The precise mechanism of glucocorticosteroids to provoke an acneoform reaction is uncertain. Glucocorticosteroids do not affect the number of surface bacteria, but do induce cornification in the upper part of the pilosebaceous duct. So hypercornification is responsible for steroid acne. Intra-articular glucocorticosteriods are used in management of Osteoarthritis, Rheumatoid Arthritis, and Juvenile Idiopathic Arthritis & Synovitis. Typically, Acne occurs with therapy using intravenous, oral, topical and inhaled glucocorticosteroids. In this article we describe a patient with synovitis who was treated with intra-articular steroid injection and presented with steroid induced multiple acnes on the chest and the face after 10 th day. Hence we would like to present here a rare case of intra-articular glucocorticosteriod injection induced acne in a 40 years aged female.
CLP-45
Comparative Study of Efficacy and Safety of Intramuscular Aceclofenac and Diclofenac in Management of Postoperative Pain in Patients Undergoing Composite Resection for Oral Cancer
Ganashree P, Sarala N, Mohiyuddin ASM
1 Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India, 2 Department of Otorhinolaryngology and Head and Neck surgery, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India
Objectives: To study the efficacy and safety of aceclofenac and diclofenac in management of postoperative pain using Face Legs Activity Cry Consolability (FLACC) scale and Visual Analogue Scale (VAS) score following composite resection for oral cancer. Materials and Methods: Seventy six patients who underwent composite resection for oral cancer at R.L. Jalappa Hospital and Research Center from February 2014 to June 2015 were randomly assigned to receive either injection aceclofenac 150 mg or diclofenac 75 mg intramuscularly at 0, 12, 24, 36, 48, 60 and 72 hours post operatively. FLACC score was assessed at 2, 4, 8, 12 and 24 hours and VAS score at 24, 36, 48, 60 and 72 hours. Rescue analgesic, tramadol 100 mg (IV) was given if FLACC or VAS score was >3. Patient's satisfaction score was assessed at 72 hours. Results: There were 61 female patients and mean duration of surgery in aceclofenac and diclofenac groups were 450.00 ± 116.00 and 416.84 ± 130.63 minutes. Mean FLACC scores between the two groups was not significant. Patients receiving diclofenac had significant reduction in mean VAS score (p = 0.005) at end of 72 hours compared to 24 hours. Between groups there was no significant difference in mean VAS scores at any time interval. Amount of rescue analgesic required in both groups was similar (p = 0.34). At 72 hours, 31.57% patients graded their satisfaction score as good in aceclofenac and 34.21% in diclofenac groups. Nausea and dyspepsia were common adverse effects seen in both groups. Conclusion: Aceclofenac and diclofenac were both effective in reducing postoperative pain following composite resection for oral cancer. However diclofenac had better pain control at the end of 72 hours.
CLP-46
Evaluation of Health Related Quality of Life in Metabolic Syndrome and Type 2 Diabetes Mellitus Patients
Rani M 1 , Kumar R 2 , Krishan P 1
1 Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India, 2 Rajindra Medical College and Hospital, Patiala, Punjab, India
Objectives: To assess and compare the health related Quality of life in metabolic syndrome and type 2 diabetes mellitus patients. Materials and Methods: A descriptive & comparative study, consisted of 100 patients, categorized into two groups, Group 1, n = 50 : Metabolic syndrome (MetS) patients, Group 2, n = 50: Type 2 diabetes mellitus (T2DM) patients was carried out in a tertiary care hospital. To assess HRQOL, SF-36 questionnaire was used. The MetS was defined according to the revised National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria. Results: Subjects with MetS displayed significantly higher impairment of short form-36 (SF-36) as compare to T2DM patients. The most important predictors of impaired HRQOL seem to be female gender, diabetic complications and long history of diabetes in T2DM. Older age, lower education and associated components of MetS like obesity, hypertension and hyperlipidaemia also seems to be associated with impaired HRQOL in MetS patients. Domain-wise poor physical functioning was an important factor of impaired HRQOL as compared to mental health/ functioning. To find out significant factors of the variance in SF-36 subscales, especially physical and sociodemographic variables, an appropriate statistical approach is to be carried out to confirm the expected outcome. Conclusion: Our findings suggest that patients with MetS may have more impaired health related quality of life due to clustered components, like obesity, hypertension, and dyslipidemia as compare to T2DM patients.
CLP-47
Assessment and Correlation of HS-CRP and NOx Metabolites in Subclinical Hypothyroid Patients
Krishan P 1 , Kumar R 2 , Kaur R 1
1 Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India, 2 Rajindra Medical College and Hospital, Patiala, Punjab, India
Objectives: To assess the serum levels of high sensitivity C-reactive protein (hs-CRP) and nitric oxide metabolites (NOx) and to find out the correlation between hs-CRP and NOx in patients with subclinical hypothyroidism. Materials and Methods: A comparative study in a tertiary care hospital, consisted of 60 subjects, categorized into two groups, Group 1: Persons with normal TSH level, 0.45-4.50 μIU/L (Control group), Group 2: Patients with increased TSH, above 4.50 μIU/L but normal T3 and T4 level (subclinical hypothyroid) was carried out. Primary outcomes included serum C-reactive protein (hs-CRP) and nitric oxide metabolites (NOx) levels in both groups. Secondary outcome included the correlation between hs-CRP and NOx in patients with subclinical hypothyroidism. Results: Serum hs-CRP (mg/L) levels were found to be increased significantly (p < 0.05) in subclinical hypothyroid group (group 2) while no change was observed in the control group (group 1). Moreover, serum NOx (μmol/L) levels were decreased (p < 0.05) in group 2 as compared to group 1. By regression analysis, a linear relationship was found between serum hs-CRP and NOx in group 2 (y = −3.279x + 34.195). Also a significant correlation was found between hs-CRP & TSH and NOx & TSH in subclinical hypothyroid patients as compare to non significant correlation in control group. Conclusion: Our findings suggest that increased hsCRP i.e., low grade inflammation may be one of the contributing factors of endothelial dysfunction in subclinical thyroid patients.
CLP-48
Pattern of Use of Analgesics in Post-operative Pain Management in Adults Undergoing Laparotomy Surgery: A Prospective Observational Study
Toro MM 1 , Faruqui AR 1 , Nair SN 2
1 Department of Pharmacology, St. John's Medical College, Bengaluru, Karnataka, India, 2 Department of Pain and Palliative Care, St. John's Medical College Hospital, Bengaluru, Karnataka, India
Objectives: To study prescription pattern of analgesics in adult patients undergoing laparotomy surgery. Materials and Methods: A prospective observational study, conducted in patients with laparotomy surgery from departments of General Surgery and Obstetrics and Gynaecology at St. John's Medical College Hospital. Datawere collected on patient characteristics, type of surgery, anaesthesiaand analgesics prescribed up to day 3. Results: Among 250 patients, 161 (64.4%) were females, 134 (53.6%) were from surgery department. Mean age was 37.29 ± 14.9 years, prior surgerywas done in 76 (30.4%) andemergency surgery in 108 (43.2%) patients. Most common surgical procedure performed was Caesarean section 85 (73.27%) followed by Meshplasty 46 (34.3%). Spinal anaesthesia was used in 154 (61.6%) and General anaesthesia in 71 (28.4%). On the day after surgery the most common analgesic was Inj. Tramadol 100 (40%). Most were changed to oral analgesics on day 2, diclofenac and serratiopeptidase on day 2 (68, 27.2%) and (54, 21.6%) on day 3 were most common. Epidural analgesia (bupivacaine with fentanyl) was used in 31 (12.4%) patients. 2 or more analgesics, 24 hrs after surgery, were given to 82.7% in Surgery department and 17.3% in OBG department (Pearson χ2 = 54.705 p 0.000). The mean time to first analgesic after surgery was 2.85 ± 2.33 hrs. 55.5% in surgery and 44.5% in OBG department received first analgesic <6 hrs after surgery (Pearson χ2 = 2.535, p 0.111). Conclusion: Use of injectable and oral opioids was as expected but newer modalities of pain control like epidural analgesia was limited and patient control analgesia was not seen.
CLP-49
To Study the Pattern of Adverse Drug Reaction in a Tertiary Care Teaching Hospital of Jorhat, Assam
Bakal B, Chaliha M
Department of Pharmacology, Jorhat Medical College and Hospital, Jorhat, Assam, India
Objectives: (1) To record the various types of adverse drug reactions related to drug used in OPD and IPD in a tertiary care hospital in Jorhat, Assam. (2) To find out the causality, severity and preventability of adverse drug reaction related to drugs. Materials and Methods: A cross sectional observational open label study will be carried out for a period of 3 months in indoor & outdoor patients of Jorhat Medical College. The causality of the adverse drug events will be assessed as per WHO-UMC scale. The severity of the adverse event will assessed by HARTWIG SCALE. The preventability of the adverse events was assessed by SCHAUMOCK AND THRONTON SCALE. Institutional ethics committee approval will be taken prior to study. Results: The Results will be analysed using appropriate statistical Methods. Conclusion: This study will offer a representative profile of ADR to be expected, its causality, severity and preventability in a tertiary care hospital in Jorhat, Assam.
CLP-50
A Study to Assess the Knowledge, Attitude and Practices of Pharmacovigilance and Adverse Drug Reaction Reporting Among the Postgraduate and Undergraduate Medical Students in a Tertiary Care Hospital in CENTRAL INDIA
Kulmi M, Tiwari A, Reddy P, Goyal C
Department of Pharmacology, Sri Aurobindo Medical College and Post Graduate Institute, Indore, Madhya Pradesh, India
Objectives: Adverse Drug Reactions (ADRs) are one of the underestimated causes of morbidity and mortality and contributory to the ever increasing health care costs. The present study was designed to assess the awareness of pharmacovigilance and to get an insight into the practices of ADR reporting among healthcare professionals. Materials and Methods: The study was carried out using a semi-structured questionnaire which was distributed among participants. The questionnaire consisted of three sections of questions assessing the knowledge, attitude and practices of pharmacovigilance and ADR reporting. Results: It was observed that the knowledge of the participants regarding reporting responsibilities, type of adverse event and the reporting mechanisms was deficient. Majority of the respondents felt that ADR reporting is necessary and is a professional obligation but should be voluntary. The practice of reporting ADRs to the adverse drug reaction monitoring centre (AMC) of the institute was practiced by very few healthcare professionals. Most of the undergraduate students had correct understanding regarding pharmacovigilance but lacked awareness regarding the role of pharmacovigilance in identifying the safety of drugs. Conclusion: The study concluded that participants of study were only moderately aware of pharmacovigilance and ADRs reporting. This can be corrected by imparting knowledge and awareness of pharmacovigilance and through implementing regular sensitization programs for the healthcare professionals.
CLP-51
A Study on the Awareness and Perception of Pharmacovigilance Among Doctors in a Teaching Hospital in South India
Kokila BN, Ameena KK
Department of Pharmacology, K.V.G. Medical College and Hospital, Sullia, Dakshina Kannada, India
Objectives: To assess the awareness of adverse drug reactions and pharmacovigilance practices among doctors in a tertiary care teaching hospital. Materials and Methods : This is a descriptive type of research used to determine the extent of pharmacovigilance awareness among doctors at KVG Medical College and Hospital for a period of 1 month. A pre-designed validated questionnaire suitable for assessing the awareness and perception of pharmacovigilance was administered to 140 doctors. Filledquestionnaires were analysed on Microsoft excel 2013. Results: The response rate was 83.5%. Senior faculty members (Professor and Associate Professor) constituted 39% and junior faculty members 61% (assistant professor, senior-resident and junior-resident). 40.3% of the doctors had good awareness about ADR reporting and 59.7% had less awareness. 76.1% were unaware of existence of a pharmacovigilance cell in the institutionand 33.6% felt that one pharmacovigilance centre in a city should be sufficient. 72.8% of themfelt that reporting should be done only if ADRs were unusual/serious. Only 19.4% of the doctors had the willingness to report ADRs voluntarily and the others felt reporting was an obligation. 62.3% of the doctors were aware about National Pharmacovigilance Programme. The most common difficulty the doctors faced in reporting ADRs was that majority of them (41.7%) did not know how and where the ADRs have to be reported. Conclusion: Inadequate knowledge and expertiseseem to be the main reasons for not reporting ADRs. Re-enforcing knowledge with regular training and CMEs would likely improve ADR reporting among doctors.
CLP-52
A Randomized, Open Label, Balanced, Two-treatment, Single Dose, Two-periods, Two-Sequences, Crossover Bioequivalence Study of Triamterene and Hydrochlorothiazide Capsules in Healthy Male Volunteers
Zalavadia V, Kalkani V, Parmar SK
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Primary Objectives was to establish bioequivalence of hydrochlorothiazide + triamterene capsules USP 25 mg + 37.5 mg and the reference product DYAZIDE ® (hydrochlorothiazide 25 mg and triamterene 37.5 mg) Capsules in healthy, adult, male human beings under fasting condition. Secondary Objectives was to evaluate the safety and tolerability of a single oral dose of triamterene + hydrochlorothiazide capsules USP 37.5 mg + 25 mg in healthy male volunteers. Materials and Methods: A randomized, open label, balanced, two treatment, two period, single-dose, two sequence, crossover study with a 07 days washout period was conducted in 14 healthy, adult, male human subjects. Plasma samples for the analysis of triamterene and hydrochlorothiazide were collected up to 48.00 hours after drug administration. Plasma concentrations of triamterene and hydrochlorothiazidewere determined by validated LC-MS/MS analytical Methods. Pharmacokinetic parameters, including C max , AUC 0-t and AUC 0-inf were determined by using SAS or higher version. ANOVA was carried out using log-transformed C max , AUC 0-t and AUC 0-inf and the mean ratios and their 90% CIs were calculated. The safety profiles and tolerabilities of the two formulations were also assessed based on laboratory tests, 12-lead ECGs, vital signs and physical examinations. Results: Of the 14 subjects initially enrolled, 14 subjects completed both treatment periods. In the study no significant differences in pharmacokinetic parameters between the two formulations were observed. The mean age of theparticipants were 31.21± 07.69 years. The geometric mean ratios (90% CI) between the two formulations of triamterene were 107.37 (96.36% - 119.63%) for C max , 104.19 (96.04% - 113.03%) for AUC 0-t and 104.01 (95.94% - 112.76%) for AUC 0-inf . The geometric mean ratios (90% CI) between the two formulations of hydrochlorothiazide were 105.13 (97.08% - 113.86%) for C max, 104.13 (97.66% - 111.02%) for AUC 0-t and 104.06 (97.91% - 110.60%) for AUC 0-inf . There were no deaths or significant adverse events during the conduct of this study. Conclusion: It can be concluded from the present study that the generic version of triamterene + hydrochlorothiazidecapsules of test formulation is bioequivalent with Innovator's reference formulation Dyazide capsules in healthy, adult, male human subjects under fasting condition.
CLP-53
Impact of Antimicrobial Stewardship Program on Prescribing Pattern of Cephalosporins in Department of Surgery
Kumbhani U, Joshi A, Ganguly B
Department of Pharmacology, Pramukhswami Medical College, Karamsad, Gujarat, India
Objectives: E valuation of Cephalosporins prescribing pattern, prior to and after implementation of ASP. Cephalosporins are one of the widely prescribed antibiotics. Despite several years of its clinical use little is known about their prescribing pattern in reference to Antimicrobial stewardship program (ASP). Materials and Methods: This was a prospective and retrospective, one year, observational study conducted in surgery wards at a tertiary care teaching hospital. Data was collected from surgery case files and analyzed for demographic details, Cephalosporin prescribing pattern and its appropriateness in relation to ASP. Results: A total of 300 surgery case files (n = 150 each of year 2012 & 2014) were evaluated. Mean age of patients was 42.23 in 2012 while 38.38 in 2014. Overall there were 68% males and 32% female patients. According to generations Cephalosporins were prescribed as follows 1 st in 34.7%, 2 nd in 1.3%, 3 rd in 63.3%, 4 th 0.7% in year 2012 while 55.3%, 0.7%, 44% & 0.0% in 2014 respectively. Prophylactic treatment was advocated in 73.3%, empirical in 26.7% while none were rendered definitive treatment in 2012. In 2014, 91.3% patients treated prophylactically, 6.7% were treated empirically & 2.0 % were on definitive therapy.77.3% patients were switched over from parental to oral in 2012 & 78% in 2014. The data revealed significant impact of ASP P value < 0.05, in terms of appropriate prescribing of Cephalosporin's i.e. 13.3% in 2014 and 6.7% in 2012 respectively. Conclusion: Successful implementation of ASP can improve Antibiotic prescribing.
RDU
RDU-1
Evaluation of Prescription Prescribed to Pediatric Patients in a Tertiary Care Teaching Hospital
Kothari N, Bhatia R
Department of Pharmacology, and Pediatrics, Pacific Medical College and Hospital, Udaipur, Rajasthan, India
Objectives: The present study was conducted to study prescribing patterns and errors in pediatric OPD prescriptions in a tertiary care teaching hospital. Materials and Methods: The study was a cross-sectional survey. It was be conducted in Pediatrics outpatient department of Pacific hospital, a tertiary care teaching hospital in Udaipur, Rajasthan. The permission was taken from the Institutional Ethics Committee. The prescribing doctors were kept unaware about the study. A copy of the original prescription was used for the analysis of basic drug use and of medication errors. The informed written consent was taken from the parents/guardians of the participant. All the drugs related details like dose, route, dosage form, frequency of administration, indications for which prescribed, and duration of therapy was recorded in the case record form. Prescription analysis was done on the basis of WHO drug use indicators and the WHO model list of essential medicines for children. Results: Total 500 prescriptions were collected. Sixty percent drugs were prescribed by brand name. Twenty percent drugs were NSAIDs while 8 % were multivitamins. In 18% prescription antibiotics were prescribed. Conclusion: High degree of irrational prescribing going on in pediatric patients which needs to be rectified.
RDU-2
Drug Utilization Study-pattern of Use of Anti-microbial Drugs Among Post Operative Patients in Department of General Surgery of C. U. Shah Medical College and Hospital, Surendranagar
Patel D, Chhaiya S, Mehta D, Trivedi M, Acharya T, Solanki S
Department of Pharmacology, C.U. Shah Medical College and Hospital, Surendranagar, Gujarat, India
Objectives: The Objectives of this study was to assess the current trends of prescribing antibiotics amongst the patients of General surgery postoperative unit of C.U. Shah Medical College and Hospital, Surendranagar. Materials and Methods: An observational study was done amongst 200 patients admitted in the General surgery postoperative ward of a C.U. Shah Medical College & Hospital, Surendranagar over a period of 6 months in accordance with the ethical principles of the ethics committee guidelines. Data were analyzed using Microsoft Office Excel 2007 and values were presented descriptively in percentiles. Results: The average number of antimicrobials per encounter was 4.98. The most common surgeries in the postsurgical unit were urological procedures 61 followed by incision and drainage 40. Most of the patients were in the age group of 35-60 yrs. Higher utilization of cephalosporins 161 (80.5%) and fluoroquinolones 76 (38%) was noticed followed by 44 (22%) patients were prescribed with Pencillins. 80 (40%) patients were prescribed with aminoglycosides. 46 (23%) patients were prescribed with Nitroimidazole antibiotics. Conclusion: The present study provides valuable insight about the overall pattern of anti-microbials used in postoperative patients in a tertiary care hospital. It is intended to be a step in broader evaluation of safety and efficacy of drug as well as for improving prescribing habits among the fraternity and minimizing incidence of resistance to antimicrobials in surgical wards of a teaching hospital.
RDU-3
A Survey to Assess the Awareness of Adverse Drug Reactions and Pharmacovigilance Practices Among Healthcare Professionals in a Tertiary Care Hospital
Mondal A, Singh S, Budania N, Bharadwaj V, Yadav V, Sharma P
Objective: To conduct a study to know the awareness of Pharmacovigilance among health professionals of our institute. Material and Methods: This was a cross-sectional, non-interventional, observational, questionnaire-based study, carried out at SHKM Govt. Medical College, Nalhar, Mewat, Haryana. All the healthcare professionals of SHKM Govt. Medical College, Nalhar will be randomized and 20 % from these were selected for the study. The study instrument is a predesigned, validated questionnaire which was designed based on the similar previous studies. Results: Most of the subject (80%) knows about the Pharmacovigilance but only 41% are aware about the purpose of PV and PvPI. 90% subject think that ADR reporting is necessary & 79% think it should be taught in details. 40% subject have experienced ADR in their professional practice but only 15% reported the ADR. In our study most common barriers for reporting ADR are -How to report by 53% subjects, where to report by 30% & 7% subject concern about professional liability. Most of the subject suggested that ADR reporting is improved by conducting CME & various teaching programme. Conclusion: There is lack of awareness among health care professional toward pharmacovigilance & ADR reporting. So, it should be rectified by means of awareness creating programme such as CME, Workshop & by conducting various studies.
RDU-4
Evaluation of Antibacterial Prescription Pattern in Medical and Surgical Intensive Care Units of a Tertiary Care Hospital
Saache SAG, Divhare SA, Ghongane BB
Departmentof Pharmacology, B. J. Government Medical College and SGH, Pune, Maharashtra, India
Objectives: This study assess the prescribing pattern of Antibacterial agents in Medical and Surgical ICU of a tertiary care hospital in Maharashtra and suggests necessary modifications to achieve rational therapeutic practices. Materials and Methods: In this prospective observational study data of first 1000 eligible consecutive prescriptions of patients admitted toICUin 1 year were taken and recorded in proforma, analyzedusing Microsoft Excel 2013. Results: 74.1% and 25.9% prescriptions were from Medical and Surgical ICU respectively. Among 55.9% males and 44.1% females, mean agewas 46.97 ± 18.33 years. Majority of prescriptions showed cardiovascular (31.2%) and respiratory system (15.9%) dysfunctions. Polypharmacy was observed i.e., 6.67 drugs per prescription. 86.5% Antibacterials were from national list of essential medicines. Average number of Antibacterials prescribed per patient was 1.625. Metronidazole (41%) and Ceftriaxone (36.9%) were the most frequently prescribed Agents. Most Antibacterial prescriptions (72.2%) were made without bacteriological culture and sensitivity testing evidences. Brand names (96.62%) and parenteral route of administration (79.2%) were preferred by the physicians for prescribing the Antibacterials. Conclusion: Majority of Antibacterial prescriptions were rational as per WHO drug use indicators. But most of the prescriptions were not supported by culture and sensitivity reports, as it was not done in many patients of ICU. The number of Antibacterials prescribed by generic names was low in the ICU and efforts must be taken to encourage prescribing by generic names. Prescribing guideline is required to reduce the prevalent polypharmacy and to promote appropriate use of antibacterial drugs based on the culture and sensitivity reports.
RDU-5
Information in Package Inserts: A Study in Eastern India
Mishra H, Dikshit H, Mohan L, Kumar M, Pathak A, Manjhi P
Department of Pharmacology, IGIMS, Patna, Bihar, India
Objectives: Present study was designed to assess the presentation and completeness of clinical information provided in the presently available PIs for anti-diabetic, antihypertensive and hypolipidemic drugs in Patna. Materials and Methods: 93 PIs were collected from different pharmacies of Patna. All PIs were analyzed on criteria mentioned in Schedule D of Drug and Cosmetic act 1945. Score of 25 is assigned to each based on 25 criteria. Presence or absence awarded as '1' & '0'respectively. PIs with presence of more than 20 criteria will be graded as 'A'; 10-20 criteria as 'B', and less than 10 as 'C'. Results: Out of 93 PIs 37 were anti-hypertensives, 34 were anti-diabetics, and 22 hypolipedemics. Out of them, 40 (43%) belonged to Grade 'A' (including all injectable preparations) and remaining 53 (57%) to Grade 'B'. No PIs belongs to Grade 'C'. Main deficiency found were lack of generic names of incipient, information regarding unwanted effects, paediatric and geriatric use, and guidelines for therapeutic use of the drugs. Conclusion: It is hard time to refine the contents of the PIs to make them more relevant, reliable and up to mark. Patient compliance and thus the effectives of the therapy will surely be improve and can be seen a leap forward for ethical and effective dissemination of healthservices to our population.
RDU-6
Students' Attitudes on P-drug selection Exercise in Writing Prescription
Kumar M, Mohan L, Dikshit H, Pathak A, Manjhi P, Mishra H
Department of Pharmacology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar, India
Objectives: This study was conducted to develop a Methods to teach P-drug selection and to evaluate undergraduate medical student's attitude regarding P-drug concept in prescription writing. Materials and Methods: This was a questionnaire study involving fifth semester undergraduate medical students. In first phase, students were taught regarding P-drug selection and current guidelines for the treatment of type 2 diabetes mellitus by using power point slides, standard text books and handouts with drug costs. In second phase students were asked to derive a P-drug. In third phase questionnaire were given containing 12 statements to know student's attitude regarding P-drug selection exercise (scoring from 1 to 5) and responses were tabulated. The quantitative data were expressed as median and interquartile range (IQR). Results: Students selected biguanide (metformin) as a P-drug in terms of efficacy, safety, cost and convenience. 95% responded in the questionnaire, out of which 92 % scored ≥4 and median score was 4 (IQR 4-5). Opinion of 88% students was that P-dug selection teaching helped them to understand pharmacology better. Majority were in favor of introducing the process of selection of P-drug in undergraduate pharmacology curriculum. Conclusion: P-drug selection exercise helped students to understand the differences between various drugs used for the treatment of a common disease condition. Teaching P-drug selection will give them a strong foundation for developing rational use of the medicine in their future career as doctors. Also it will be helpful in modifying undergraduate pharmacology teaching pattern.
RDU-7
A KAP Study of Fixed Dose Combination Among Junior Doctors of at a Tertiary Care Hospital
Rupa AK, Radhika MS
SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India
Objectives : To assess knowledge, attitude, & practice of fixed dose combination (FDC) among junior residents (JR) and interns (INT) working at tertiary care hospital. Materials and Methods: A cross-sectional study was carried out using pretested & predesigned 10 item questionnaire among the JRs & INTs of SDM hospital to assess knowledge, attitude, & practice of FDC. Results: The study surveyed 71 JRs & 63 INTs out of which 27 (66.66%) JRs & 16 (66.66%) INTs have knowledge score of less than 70% & while only 17 (25%) JRs & 14 (25%) INTs have attitude score of 25%. 70.42% of JRs & 73% of INTs says that their UG knowledge of FDC is not sufficient for prescribing rational FDCs. 37 (52.11%) JRs & 39 (61.90%) INTs think that FDCs are not always advantageous. 47 (66.19%) JRs & 26 (41.26%) INTs are not aware that WHO decides whether a FDC is rational or irrational. Conclusion: There is a large dearth in the knowledge & attitude of the junior doctors regarding FDCs. A thorough curriculum to train the students and junior doctors with help of practical sessions during their graduate days and workshops during the internship is the need of the hour.
RDU-8
Pantoprazole Induced Acute Angioedema with Urticaria a Case Report
Muhammed A 1 , Karthik B 1 , Anasuya S 1 , Priyadharshni R 1 , Pradeep S 1 , Gangadhar R 2
1 Department of Pharmacology, Government Medical College, Trivandrum, Kerala, India, 2 Department of Pharmacology, Sree Mookambika Institute of Medical Sciences, Kanyakumari, Tamil Nadu, India
Objectives: Skin reactions like angioedema and urticaria due to pantoprazole are seldom reported in the post marketing surveillance. Here we are going to discuss a case of pantoprazole induced acute angioedema with urticaria. Materials and Methods: Case report: 8 years 3 month old female child weighing 20 kg came with complaints of abdominal pain, vomiting, loose stools 2-3 episodes of 6 hour duration. On examination epigastric tenderness was present. Duty doctor prescribed her injection pantoprazole half vial i.e. 20 mg as stat medication and advised oral fluids. After 6 hours of admission urticarial rash developed on her forehead. Duty doctor stopped pantoprazole and prescribedInj. Hydrocortisone 100 mg Q6H, Tab Ranitidine 150 mg ½-0-½. She was reviewed after 24 hours of admission (New op sheet was taken) by new duty doctor planned for a discharge and again prescribed; Tab PANTOP 20 mg 1-0-1 * 1 week (half hour before food) She was discharged, took pantoprazole at night (mother reported events). She became restless and developed erythematous lesions all over body along with edema around her eyes. Came to emergency department MCH next day morning and she was admitted. Results: The causality was confirmed as "CERTAIN" according to WHO-UMC causality assessment criteria, due to readministration of drug. Naranjo probability scale - score is >9 and hence it is a definite ADR. Conclusion: In this case report we have found that management of patients in observation room while changing duty of concerned doctors went wrong. New doctor failed to make out that the drug was stopped and he/she reintroduced it. Electronic data recording can help in this situation as data involving drugs prescribed will be entered in same site. Angioedema with urticaria due to pantoprazole is a rare ADR and it should be predicted early and wisely managed.
RDU-9
Prospective and Observational Study of Antimicrobial Drug Utilization in Medical Intensive Care Unit in a Tertiary Care Teaching Hospital
Drupad HS 1 , Nagabushan H 1 , Prakash GM 2
1 Department of Pharmacology, Mandya Institute of Medical Sciences, Bengaluru, Karnataka, India, 2 Department of Medicine, Mandya Institute of Medical Sciences, Bengaluru, Karnataka, India
Objectives: The Objectives of this study was to assess the prescribing patterns of anti-microbial drugs. Rationality of drug use in the medical ICU of a tertiary care hospital. Materials and Methods: After taking approval from the Institutional ethical committee, study was undertaken over a period of 6 months. A prospective observational study was conducted to assess the prescription pattern of antibiotic usage in the medical ICU. Standard Proforma was used to collect the information regarding antibiotics, its dose, duration, first line of antibiotics and second line of antibiotics and adverse drug reactions. Data was analysed using descriptive statistics with help of SPSS software. Results: Total 202 cases were admitted to the ICU during study period. Respiratory conditions (33.2%), febrile illness (15.3%), poisoning (15.3%) and CNS (12.9%) illnesses were commonly reported to ICU. Cephalosporins (81.7%) were commonly prescribed followed by Nitroimidazoles (30.2%) and Penicillins (16.3%). Ceftriaxone (43.1%) and Cefotaxime brand Taxim (38.6%) were commonly used followed by Pipercillin and Tazobactum combination (9.4%). No adverse reactions were reported during the study period. Conclusion: In conclusion, a wide spectrum of clinical diagnoses and a variety of drugs were utilized from various drug classes. Results showed that Cephalosporins were extensively used in ICU. The number of drugs prescribed by generic names was low in the ICU and effort must be made to encourage prescribing by generic names. Rational usage of antimicrobial agents in ICU should be encouraged by following strict Hospital antimicrobial policy.
RDU-10
Study of Drug Prescribing Pattern for Anti-asthmatic Drugs in Outpatient Department of Paediatrics in HIMS, Barabanki, Uttar Pradesh
Goel R, Bansal U, Khare AK, Ansari NA
Department of Pharmacology, Hind Institute of Medical Sciences, Barabanki, Uttar Pradesh, India
Objectives: Prescription pattern studies are done to see the prescribing of medications, their administration and adverse effects. Bronchial asthma is one of the most common chronic diseases among pediatric patients (9.6 million) worldwide which accounts for about 1 in every 250 deaths worldwide. To evaluate drug prescribing pattern of antiasthma drugs in Pediatric age groups. Materials and Methods: This observational, prospective study was done in Hind Institute of Medical Sciences, Barabanki, U.P. 240 patients of both Sexes (age: 0-12 yrs) with diagnosed asthma, attending outdoor of Pediatric department were included for the study. The study was approved by Institutional Ethical Committee. After taking informed consent by the patients or their guardians, demographic details (age, sex, weight and address) were collected. Data was obtained from patient's prescription regarding severity of asthma & its exacerbation, drugs prescribed, dose, frequency, route of drug administration, & duration of treatment. Results: Among all of them, 37.1% patients had intermittent asthma and 62.9% had persistent asthma. Among asthma patients with exacerbation (intermittent), highest number of patients were of moderate severity (51.6%), followed by mild (33.1%) & severe (15.3%). Overall this study showed that Salbutamol in exacerbation & inhalational corticosteroids (ICS) in persistent asthma were the drugs of choice. Persistent asthma was treated mainly by low to moderate doses of inhaled corticosteroids. In moderate persistent asthma long acting β2- agonist were added to inhaled steroids. Conclusion: Practitioners are following National Asthma Education and Prevention Program (NAEPP) guidelines to treat patients. More emphasis should be given on drug prescribing by their generic name.
RDU-11
A Study on Prescribing Patterns of Antihypertensive in Adult Patients Attending in a Tertiary Care Hospital of Assam
Sikidar P, Tigga R, Purkayastha A
Department of Pharmacology, Silchar Medical College and Hospital, Silchar, Assam, India
Objectives: Hypertension is one of the most common chronic medical problems prompting visits to health care providers. It has been estimated that hypertension accounts for 13% of deaths worldwide. The main Objectives of the present study was to assess the prescribing patterns for antihypertensive in a tertiary care centre located in southern part of Assam. Materials and Methods: Prospective, observational, non-interventional, hospital based study was carried out for the period of three months in an out-patient department. Adult patients of either sex who have been diagnosed with hypertension as per JNC-8 guidelines with or without co morbidities and patients receiving or prescribed with antihypertensive drugs were included. Results: The most common drug classes involved in the study was Angiotensin II receptor antagonists followed by calcium channel blocker. The most common anti-hypertensive fixed dose combination therapy involved in the study was angiotensin II receptor antagonist + thiazide diuretics. Conclusion: Our study shows that the most commonly prescribed drug classes involved were Angiotensin II receptor antagonists followed by calcium channel blocker and the anti-hypertensive drug combinations among hypertensive patients were considerable and this practice positively impacted on the overall blood pressure control.
RDU-12
To Study the Prescription Pattern of Corticosteroids in Dermatology OPD in a Tertiary Care Hospital of Assam
Sonowal P
Department of Pharmacology, Basic Science Building, Assam Medical College and Hospital, Dibrugarh, Assam, India
Objectives: To study the prescription pattern of corticosteroids in dermatology OPD in a tertiary care hospital of Assam. Materials and Methods: A prospective study was carried out by preparing specific proforma. A total of 100 prescriptions were analysed for 2 months. The prescriptions of both genders and all age groups attending dermatology OPD receiving corticosteroids were included. The parameters assessed were type of corticosteroids used, route, whether prescribed in brand name or generic name, duration of therapy. Results: The majority of cases were males (64%) in the age groups 20-40 years. The present study showed Mometasone was prescribed in 38%, Clobetasone in 25.5%, Fluticasone in 19%, Flucinolone acetonide in 12.67%, Betamethasone in 6% and tablet prednisolone in 7.83% of prescriptions. Topical corticosteroids (85%) were the most common prescribed drug. However, in 15% of prescriptions oral prednisolone was used. Most of the drugs were prescribed on an average for 2 weeks. Conclusion: In summary I have found clinicians mostly prescribed topical corticosteroids. In some cases oral prednisolone was used. They rarely used injectable and oral corticosteroids to avoid systemic side effects. However, prescription by brand name was a mater of concern.
RDU-13
Prescription Pattern in Psychiatry OPD of Tertiary Health Centre
Jagdhani RS 1 , Dudhgaonkar S 1 , Bende MM 2
1 Department of Pharmacology, Shri VNGMC, Yavatmal, Maharashtra, India, 2 Departmentof Pharmacology, GMC, Chandrapur, Maharashtra, India
Objectives: The Objectives was to determine prescribing patterns and utilization of drugs used in Psychiatric illnesses on OPD basis. Materials and Methods: It was retrospective observational study of drugs dispensed during period from July 2015 to August 2015 in psychiatry OPD in tertiary care centre. Total 300 psychiatric prescriptions were scrutinized according to WHO drug use indicator. Results are mentioned as Percentage of each parameter. Results: (i) Prescription containing more than 4 drugs: 8.33%, (ii) No. of generic drugs: 51.31%, (iii) No. of Fixed dose combinations which are irrational: 36.11%, (iv) No. of drugs from Essential drug list : 53.94%, (v) No of costly drugs in prescription: 50%, (vi) No. of prescription with improper dose, duration and frequency: 4%, (vii) Prescriptions with bad handwriting : 0%, (viii) Prescriptions written in capital letters: 0%, (ix) Prescription without Diagnosis written : 61.11%, (x) Use of more than one drug from the same group: 5.55%. Conclusion: The Prescription pattern was not according to WHO drug use indicator. Prescribing branded, costly, not affordable drugs, irrational fixed dose combinations was the trend. Treatment was symptom based as diagnosis was not written on 60% of prescription. Not a single prescription in capital letters was found. To lessen this, physicians should be sensitized by doing regular prescription audit.
RDU-14
Analysis of Prescription Pattern of Antimicrobial Agents Used in Urinary Tract Infection
Choudhari SR, Dudhgaonkar S, Bachewar NP
Department of Pharmacology, Shri VNGMC, Yavatmal, Maharashtra, India
Objectives: Urinary tract infection is one of the common infections at community level. In order to assess the adequacy of the empirical therapy current prescription pattern in our tertiary care government teaching hospital was evaluated. To analyse drug prescription pattern in the treatment of urinary tract infections and co-relate it with culture sensitivity reports. Materials and Methods: In this record based, retrospective study, total 1000 prescriptions were scrutinized from March 2015 to August 2015, out of which randomly selected 100 prescriptions were analysed according to WHO drug user indicators. Results: Average number of drugs per prescription were 2.5. Percentages of drugs prescribed by generic name, brand name and from the essential drugs list were 89.09%, 10.91% and 72.72% respectively. The percentage of prescriptions having FDCs were 18.18% and percentage of drug not needed were 6%. Costly drugs account for 15%. Thirty percent of prescriptions did not mention diagnoses. Most commonly used FDC was Cotrimoxazole 90% and other antimicrobials (AMA) prescribed were amoxicillin 6%, metronidazole 4%. Organisms were mostly resistant to fluoroquinolones (41.17%) followed by cephalosporins (32.34%). Out of 100 urine samples analysed, 85 were positive for bacterial infections. Commonly isolated organisms were Klebsiella 40% followed by, E. coli 21.7%. Conclusion: The prescription pattern was not according to WHO drug use indicators. Regular prescription audit and sensitization of prescriber is necessary to minimize irrational prescribing. The isolated bacteria were resistant to AMA commonly used in clinical practices. Hence culture sensitivity testing is advisable before initiating AMA to achieve cure and to prevent resistance.
RDU-15
An Evaluation of Gastrointestinal Drug Promotional Literature Using WHO Guidelines
Shenoy KG, Bhandarkar AP, Shetty M, Devi V
Department of Pharmacology, Melaka Manipal Medical College, Manipal University, Manipal, Karnataka, India
Objectives : This study was conducted to evaluate the drug promotional literature (DPLs) pertaining to drugs used in gastrointestinal diseases as per World Health Organization (WHO) criteria for ethical medicinal drug promotion (1988). Materials and Methods: A total of 54 DPLs pertaining to drugs used in gastrointestinal diseases were collected from the Department of Gastroenterology and Department of Medicine, Kasturba Hospital, Manipal. These promotional literatures were tested against WHO criteria for the ethical medicinal drug promotion. Results: Analysis of these DPLs showed that none of them fulfilled all the WHO criteria. All the Materials mentioned International Non-proprietary Name (100%) and the brand name (100%) of the product. The criteria presented to the least extent were information about other ingredients known to cause problems (0%), references to scientific literature (5.5%), and major drug interactions (27.7%). Information on approved therapeutic uses; precautions and warnings; contraindications; name and address of the manufacturer and distributor were missing in most DPLs. Conclusion: None of the DPLs contained all the information as per WHO criteria for ethical medicinal drug promotion. Inappropriate and incomplete information leads to irrational prescribing, if physicians do not have any other information to follow.
RDU-16
Drug Utilization Pattern of Fixed Drug Combination of Antipyretic and Analgesic in Paediatrics Department of Gauhati Medical College and Hospital
Singha B, Mousum SA, Borah A, Lahkar M
Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India
Objectives: To study the drug utilization pattern of fixed drug combination of antipyretic and analgesic compared to paracetamol in Paediatrics department of Gauhati Medical College and Hospital. Materials and Methods: The study was a prescription based cross-sectional study. Prescriptions with fixed dose combination of antipyretic and analgesic and prescriptions with paracetamol were observed. Demographic characteristics such as age, sex and indications were also recorded. The data were analysed for the utilization pattern of antipyretic and analgesic combination and compared with prescriptions with paracetamol alone without any other analgesic combination. The various conditions where antipyretic-analgesic combinations were given preference over paracetamol was also observed. Results: Out of 266 prescriptions screened 110 were prescribed with fixed dose antipyretic- analgesic combination while 156 were prescribed with paracetamol alone. The antipyretic- analgesic combination was composed of paracetamol and ibuprofen. This combination was prescribed in most of the post-operative cases and in cases with pain for various causes. Fever was the most common condition where only paracetamol and no other analgesic was prescribed. Percentage of combination prescribed was highest in children between 10-14 years of age and least in infants. Conclusion: This study shows the increase utilization of antipyretic-analgesic combinations in various conditions and the preference of fixed dose combination over paracetamol increases with increase in age of the paediatric patients.
RDU-17
Challenges in Providing Quality Use of Medicines in Patients with Limited English Proficiency in Australia
Arora D 1,2 , Mey A 1 , Maganlal S 1 , Khan S 1,2,3
1 School of Pharmacy, Griffith University, Gold Coast, Queensland, Australia, 2 Griffith Health Institute, Griffith University, Gold Coast, Queensland, Australia, 3 Mater Research Institute, University of Queensland, South Brisbane, Queensland, Australia
Objectives: The number of individuals with limited English proficiency (LEP) in Australia is large and rapidly growing. Consequently, addressing language and cultural barriers in access to pharmaceutical care is becoming ever challenging for pharmacists. Community pharmacists play an important role in increasing patient understanding of medication use. To develop a standardised questionnaire based on preliminary findings and to evaluate the current practices used by the pharmacists' for communicating with LEP patients. Materials and Methods: A standardised questionnaire based on preliminary findings was administered to practicing Pharmacists in South-East Queensland region in Australia. Descriptive statistics and thematic analysis was applied to evaluate the current status of pharmaceutical care provided by practicing Pharmacists to patients with LEP. Results: A total of 20 Community Pharmacies were selected based on their ready access to Patients and Carers with LEP in South-East Queensland. Fifteen practicing Pharmacists were included for analysis. The key findings of our study were: (1) Frequency of providing PC to LEP patients was high (> 90%). (2) Dispensing to patients with LEP took relatively longer time (>90%). (3) Majority of the Pharmacists were either unaware or unsure of the existing facilities for interpreting services (60%) and only 1 out of 14 respondents accessed these facilities. (4) Patients accompanied by interpreters posed challenge in communication. (5) This issue needs more awareness and ready to access services. Conclusion: Language and communication barrier pose significant challenge in Pharmaceutical care. Lack of easily accessible resources to facilitate communication with non-English speaking patients was commonly observed. Present study highlighted the barriers encountered by Pharmacists to cater the need of geographical location where immigrant population with LEP is dense.
RDU-18
Study of Prescribed Dose Calculation in Pediatric Patients
Tank ND, Bhansali NB, Karelia BN
Department of Pharmacology, P.D.U. Government Medical College, Rajkot, Gujarat, India
Objectives: To evaluate appropriateness and accuracy of the prescribed drug dose using Body Surface Area (BSA) as a parameter in pediatric patients. Materials and Methods: The present study was cross sectional, observational, and prospective one, conducted on an outpatient basis in pediatric patients. A total of 500 prescriptions were randomly collected and used to analyse prescribed dose. Calculation of standard dose according to BSA of individual patients of each drug was done by using formula: Individual dose = BSA (m 2 )/1.7 × average adult dose and compared with the prescribed dose of that particular drug. The BSA of an individual can be calculated from Dubois Raymond's formula. Results: The 500 prescriptions were included in the study. Total of 1216 drugs; out of which 362 (29.76%) drugs were in under dose, 245 (20.15%) drugs were in appropriate dose and 609 (50.08%) drugs were in overdose compared to their standard doses. Conclusion: In this study, around 80% of prescribed drugs were either under dose or overdose which highlights the continuing crisis of dose calculation error among prescriptions of pediatric patients.
RDU-19
Knowledge and Awareness About the Drug Package Inserts in Medical Interns
Wankhede SY, Pardeshi ML, Ghongane BB
Department of Pharmacology, B.J. Government Medical College and SGH, Pune, Maharashtra, India
Objectives: The main Objectives of this study was to assess the knowledge and awareness of the medical interns about the drug package inserts. Materials and Methods: This study was done among interns of two medical colleges of Maharashtra. A questionnaire based on package insert's contents and its importance for doctors and patients were formulated. These questionnaire were distributed to the interns for responses. Results : Total 250 medical interns answered the questionnaires, out of which 70% of them don't know the meaning of the drug package inserts. 42% of them read it most of the time, 28% read sometimes and 30% never read. It should be in regional language was the opinion of 66% interns. 75% opined, its font size should be large. 90% confirmed, it is useful from patient's point of view but when asked how, nobody was able to explain.70% were in favour that package inserts in India needs improvement but they fail to explain how it can be improved. Lastly nobody was knowing about the rule by which package inserts are governed. When compared between two colleges, 10.2% of college 1 and 42.76% of college 2 interns knows the definition of drug package inserts.97% of college 1 and 85% of college 2 agreed that they are useful from patient's point of view. Conclusion: The knowledge and awareness about the drug package inserts in medical interns is very poor, especially in college 1. Hence, there is a need to highlight its importance in their undergraduate curriculum.
RDU-20
Drug Utilization Study of Antipsychotic Drugs in the Psychiatry Outpatient Department of Tertiary Care Hospital
Shah A, Verma R, Yadav P, Vaghasiya K, Kantharia ND
Department of Pharmacology, Government Medical College, Surat, Gujarat, India
Objectives: Prescribing pattern of antipsychotics has changed over the decade. Hence, this study was carried out to analyse the utilization pattern of antipsychotics at our hospital. Materials and Methods: A retrospective study of case records of patients receiving antipsychotics was carried out in the Psychiatry OPD of New Civil Hospital, Surat for 6 months. Pattern of antipsychotic prescription, WHO prescribing indicators, defined daily dose (DDD)/1000 inhabitants/day and the ratio of prescribed daily dose (PDD) to DDD was assessed. Results: A total of 2115 drugs were prescribed in 631 prescriptions, out of which 804 (38.01%) were antipsychotics. Schizophrenia was the most common diagnosis (55.31%). Atypical antipsychotics were more commonly prescribed - olanzapine: 47.39%, risperidone: 27.49%. The average number of antipsychotics/prescription: 1.29±0.53;prescribing of antipsychotics by generic name: 95.02%; prescribing from WHO essential medicines list (EML): 43.66%; prescribing from National EML: 47.89%; prescribing for injections of antipsychotics: 0.62%; prescriptions of fixed-drug combinations: 0.50%. DDD/1000 inhabitants/day of antipsychotics: 0.014 mg. PDD/DDD for risperidone and haloperidol was 1, for olanzapine and aripiprazole >1, while for trifluoperazine, ziprasidone, amisulpride and clozapine it was <1. Conclusion: The second-generation antipsychotic olanzapine was the most commonly prescribed antipsychotic. The prescriptions were complete and followed principles of rational prescribing.
RDU-21
Prescription Audit in a Tertiary Care Teaching Hospital Attached with a Medical College
Vaghela JP, Sukhlecha AG, Trivedi HR
Department of Pharmacology, M. P. Shah Government Medical College, Jamnagar, Gujarat, India
Objectives: To generate information on World Health Organization (WHO) core prescribing indicators, to detect frequently prescribed drugs and prepare an essential medicines list for the hospital. To articulate measures to improve prescription practices. Materials and Methods: Data collection was done retrospectively from January-2014 to December-2014. Case papers of discharged indoor patients were received from medical record section of the hospital. A Case record form was used to collect demographic data. Data were assessed according to WHO core indicators like average number of drugs per prescription, percentage of drugs prescribed by generic name, percentage of prescriptions with an antibiotic prescribed, percentage of prescriptions with an injection prescribed and percentage of drugs prescribed from the essential drug list. Results: A total of 313 prescriptions were studied. Majority of prescriptions (137, 43.8%) were collected from medicine department, followed by paediatrics department (52, 16.6%). Maximum number of drugs were prescribed for diseases of digestive system (46, 14.7%). Average number of drugs per prescription was 8.62. Drugs prescribed by generic names were 62.9%; and 12.7% were fixed-dose drug combinations. Injections and antibiotics were prescribed in 273 (87.2%) and 54 (17.3%) prescriptions, respectively. Vitamins were prescribed in 45 (14.4%) prescriptions. 75.3% of the single ingredient formulations were prescribed as per Essential Drug List: 2014-15 (Gujarat). Conclusion: Majority of the drugs were prescribed as generic names and from Essential Drugs List. Majority of prescriptions were rational. Comparing the current usage of drugs with the standard treatment guidelines may enhance the effectiveness of treatment and render it cost effective.
RDU-22
Prescription Audit in an Outpatient Departments of Tertiary Care Teaching Hospital: A Cross-sectional Study
Acharya HR, Paliwal NP, Barvaliya MJ, Tripathi CB
Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India
Objectives: To evaluate the prescription from various out-patient departments of a tertiary care teaching hospital. Materials and Methods: This prospective cross-sectional study was conducted from November 2014 to June 2015. Prescriptions from the outpatient departments of tertiary care teaching hospital were collected randomly and analyzed for rationality, average number of drugs prescribed, use of medicines from essential drug list, fixed dose combinations, completeness of prescription and proportion of generic medicines prescribed. Descriptive statistics was used. Results: Total 1035 prescriptions were evaluated. 4593 total drugs were prescribed with 75% drugs with generic name. Average number of drugs prescribed was 4.5. Among all these drugs, 7.1% drugs were antimicrobials and 9.5% fixed dose combinations were prescribed. 64.9 And 86.6% drugs were prescribed from WHO and Indian essential drug lists, respectively. Multivitamin (6.7%) was the most commonly prescribed drug followed by famotidine (6.1%), chlorpheniramine (5%), omeprazole (4%) and folic acid (4%). 90% drugs were prescribed by oral route of administration. Completeness of prescription was lacking in all the prescription. Conclusion: Multivitamin and other adjuvant drugs are widely prescribed in out-patient departments. Writing of complete prescription with legible writing should be practiced.
RDU-23
Prescription Auditing and Drug Utilization Pattern in Indoor Patients of Paediatrics Department
Neha P, Shreya S, Pratik A
Department of Pharmacology, Government Medical College, Baroda, Gujarat, India
Objectives: To analyse the rationality status of prescriptions and drug utilization pattern in indoor patients of paediatrics department. Materials and Methods: The present observational prospective study was undertaken in paediatrics indoor patient department for a period of six months during which data of 100 patients was collected. The prescriptions were analysed for rationality score and rationality status ( rational, semi-rational, irrational) using Phadke's criteria; a 30 point score system in which choice of drugs and their dose, unnecessary drugs, irrational drugs/combinations and use of hazardous drugs were taken into consideration. Data was also analysed for drug utilization pattern using WHO-prescribing indicators. Results: Data of total 100 patients was analysed, of which 69 were male and 31 were female. Rationality scores of 100 prescriptions were in range of 30 to 19, with mean rationality score of 28.4%. Of 100 prescriptions, 91 were rational and 09 were semi-rational. Main reason for getting less score were improper dose and use of second choice drug or wrong selection of drug. Average number of drugs used was 6.01 per patient. 54.76% drugs were prescribed by generic name, 33.33% by brand name and 11.90% by both. Drugs prescribed from WHO-EML for children were 48.81%. Antimicrobials were prescribed for 93 patients, of which most common were amoxicillin + clavulanicacid, ceftriaxone and cefotaxime. Conclusion: Though the Results reflect rational prescribing in paediatrics department of our set up, there is still scope of improvement in areas of dosage calculation, proper documentation, prescribing drugs by generic name and from WHO-EML for children as far as possible.
RDU-24
Assessment on the Prevalence of Polypharmacy and Co-morbidity in Geriatric Patients and Their Effects
Boorugu V, Chandana, Bharadwaj S, Kaklij R, Bakshi V
School of Pharmacy, Agicultural, Ghatkesar, Telangana, India
Objectives: Geriatrics is the branch of medicine which aims to promote health by preventing and treating diseases and disabilities in older adults. The term polypharmacy generally refers to the use of multiple medications by a patient. Polypharmacy is a problem of growing interest in geriatrics with the increase in drug consumption in recent years, particularly among people aged >65 years. The main reasons for polypharmacy are longer life expectancy, co-morbidity and the implementation of evidence-based clinical practice guidelines. The aim of the study is to assess and evaluate the prevalence of polypharmacy among geriatric inpatients in a multi-speciality hospital. To assess the drug usage pattern among geriatric patients and to assess the presence of any drug related problems in geriatrics with polypharmacy. Materials and Methods: It is an ongoing prospective study that is being carried out in the different departments of a multi-speciality hospital like general medicine, cardiology, and neurology. Results and Conclusion: A regular medication chart review is suggested for geriatric patients with polypharmacy to discontinue unnecessary medication use. It is also necessary to improve the geriatric care as this age group possesses risk for more diseases and medication use.
RDU-25
A Study of Potential Drug Interactions Among Geriatric Patients Through Prescription Analysis in a Tertiary Care Teaching Hospital in Southern Odisha
Panigrahy A, Behera JP, Ramani YR, Maharana CS
Department of Pharmacology, MKCG Medical College, Berhampur, Odisha, India
Objectives: Drug usage patterns in geriatric patients change due to increasing age related co-morbidities and the tendency for polypharmacy by physicians. Various pharmacological changes associated with ageing expose the elderly to higher risks of potential drug interactions. This study aims to look into the prevalence, severity, significance of potential drug-drug interactions (pDDIs) and the management requirements for the documented pDDIs amongst geriatric patients. Materials and Methods: A cross-sectional study was carried out from May to August 2015 in Medicine department of a tertiary care teaching hospital of southern Odisha. In a specially designed case record form, data was collected after getting written informed consent from the patients. PDDIs were checked for using online drug interaction checker and stockley's Drug interactions. The severities of the interactions were assessed and categorized as major (causing permanent damage or life risk), moderate (causing harm and treatment is required) or minor (causing small or no clinical effect, no treatment required). Descriptive and univariate analysis were used to report the findings. Results: A total of 156 prescriptions were analysed, of which 72 (46.15%) prescriptions had 178 pDDIs. Majority of the pDDIsi.e 122 (69.69%) were of the moderate severityand 27 (15%) major interactions were observed. Dosage adjustment was the most popular management requirement (28%) for the documented pDDIs. Conclusion: The prevalence of pDDIs was 46.15% amongst geriatric patients which is higher than previously reported studies from India. This study highlights the necessity of effective monitoring and the need for sensitisation of practicing physicians regarding drug-drug interactions in the elderly.
RDU-26
Antibiotic Drug Use Pattern in Neonatal Sepsis
Raut A, Godha I, Jacob J, Thomas R, Pawar A
1 Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
Objectives: This study focuses on the etiological factors, risk factors, clinical characteristics and the antimicrobial drug use pattern in neonatal sepsis. Materials and Methods: This prospective observational study enrolled 27 patients from neonatal intensive care unit during 6 months period. Patients with age group of 0-28 days confirmed or suspected with sepsis were included. Data collected from the cases included demography, etiology, diagnosis and the treatment. Results: The mean age of neonates admitted in neonatal intensive care unit with sepsis was 10.40 days in which male admissions were 20 (74.07%) and female were 7 (25.90%). Common etiologies were pneumonia, meningitis, urinary tract infection (UTI) and invasive procedures. The most common gram-negative organisms were Klebsiella, E. coli and gram-positive organisms were MRSA, Enterococcus. On the basis of the onset of sepsis the patients were classified into early onset sepsis with (11.11%) and late onset sepsis (14.81%). Sepsis with septic shock was the most prominent clinical characteristic. The majority of neonates (85.18%) were prescribed 2 to 5 antibiotics and 3.70% of neonates were prescribed 10 antibiotics. Most frequently used antibiotics were: Amikacin (74.07%), Piperacillin + Tazobactum (51.85%), Meropenem (37.03%), Colistin (22.22%), Cefotaxime (22.22%), Vancomycin and Linezolid (11.11%). For fungal sepsis (Candida species) Amphotericin Band Fluconazole were given. The mean duration of antibiotic therapy was 10 days and minimum of 5 days. Conclusion: Male dominance was seen more than females. From the antibiotics given, Amikacin and Piperacillin+Tazobactum remain to be the first line drugs for sepsis. As mean antibiotics are more, length of antibiotic therapy is more.
RDU-27
A Study on Prescribing Pattern of Antimicrobial Prophylaxis for Caesarian Section at a Tertiary Care Hospital
Deenadayalan K, Chinnam P, Sam PG
Department of Pharmacology, Chalmeda Anand Rao Institute of Medical Sciences, Bommakal, Karimnagar, Telangana, India
Objectives: To evaluate antimicrobial administration pattern for prophylaxis in caesarian section patients in a tertiary care hospital. Materials and Methods: A retrospective study of medical records of 230 women underwent caesarian section was conducted from March to August 2015. Age group included was 18 to 35 years. The analysis was done for the core indicators like - Average number of antimicrobials used for prophylaxis, prescribing dose, frequency and duration of each drug. Results: The average drug prescription of antimicrobials in each prescription was 3. Preoperative antimicrobial prophylaxis was given to 166 patients, whereas all patients received postoperative prophylaxis. Antimicrobial drugs used for preoperative prophylaxis were Ceftriaxone 59.9% and Amoxicillin + Clavulanic acid 11.7%. For Postoperative prophylaxis the percentage of antimicrobials prescribed were Metronidazole 80%, Amikacin 76%, Gentamicin 20%, and fixed dose drug combinations -Ceftriaxone +Tazobactum 66%, Amoxicillin + Clavulanic acid 12% and Piperacillin +Tazobactum 11%. The rate of infection with pre- and post-operative prophylaxis was 6.5% and with only postoperative antimicrobial prophylaxis was 13.8%. It was noticed that the prescriptions by the brand names were 97.8%. Conclusion: From the present study it may be concluded that the most commonly prescribed drug for pre-operative prophylaxis was third generation cephalosporin i.e. Ceftriaxone and for post-operative prophylaxis was Metronidazole. The rate of infection with pre- and post-operative antimicrobial prophylaxis was less than only post-operative prophylaxis. Prescriptions with brand name were more than generic name. Data prescribed here will be useful in future extensive drug utilization studies.
RDU-28
Cost Analysis of Anti-fungal Drugs Available in India: A Pharmacoeconomic Study
Tiwari A, Kulmi M, Goyal C
Department of Pharmacology, Sri Aurobindo Medical College and Post Graduate Institute, Indore, Madhya Pradesh, India
Introduction: Fungal infections are common and treatment imposes economic burden on the patients. The compliance of the patient may be significantly dependent on the cost of the prescribed medicines, especially in developing countries like India. Therefore this study was conducted to analyse price variation of drugs used for fungal infections. Objectives: To evaluate the cost of different brands of anti-fungal drugs available in India, and to analyse the variations in cost of same dosage of different brands of the same active drug. Materials And Methods: Cost of a particular drug that is manufactured by different companies, in the same strength, number and dosage forms was obtained from Current Index of Medical Specialties, July-October 2015 and Drug Today, July-September 2015 and were compared. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and percentage variation in price was calculated. Results: In single drug therapy, fluconazole 150 mg (5537.23%) has maximum percentage variation while griseofulvin 250 mg (54.44%) has minimum percentage variation. In combination therapy, fluconazole and tinidazole combination shows the maximum variation up to 163.47%. Conclusion: The present study shows wide variation in the price of the same drugs manufactured by different companies. This adds to the economic burden for the patients. Hence, the stakeholders should aim at decreasing the price variation while maintaining the therapeutic efficacy. Ideally, generic drugs should be prescribed to save the patient's money and to enhance the compliance.
RDU-29
A Study to Evaluate Awareness About Significance of Pharmacological Knowledge Among Clinical Postgraduates of Tertiary Care Hospital
Rani BD, Kiran PU
Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India
Objectives: The aim of study is to evaluate awareness, attitude about significance of pharmacology and suggesting possible ways of improving knowledge about ADRs, Drug interactions, and antibiotic usage among clinical PGs in Tertiary Care Hospital. Materials and Methods: The study was prospective, prevalidated questionnaire based, conducted in tertiary care hospital having both open and closed questions. Questionnaire was distributed to 50 clinical PGs, One day time was given to answer and four of them did not return the questionnaire. Results: A total of 20 questions were considered for analysis with a response rate of 92%. 78.2% know about pharmacovigilance, 34.7% know whom to report ADR; 95.6% have knowledge about Drug interactions; 82.6% know Rationale of Antibiotic prescription, 73.91% know measures to prevent resistance for antibiotics; 78.2% know importance of patient compliance; 95% know importance of pharmacogenomics & all are interested to attend CMEs, workshops on pharmacological aspects and therapeutics. Conclusion: Clinical postgraduates have knowledge about principles of pharmacology but they lack knowledge about ADR reporting, Rationale of antibiotic prescription & prevention of antibiotic resistance. So increasing awareness in the form of CMEs & Workshops on pharmacovigilance and pharmacoeconomics is necessary as part of current Pharmacological trends.
RDU-30
Prescribing Pattern in Chronic Blepharitis in a Tertiary Care Hospital
Ramya J, Prasad KVS, Kiran UP, laxmi DV
Department of Pharmacology, Rangaraya Medical College, Kakinada, East Godavari, Andhra Pradesh, India
Objectives: Blepharitis, defined as inflammation of the eyelids, is one of the most common ocular conditions and affects both children and adults. There are five main classes of chronic blepharitis: staphylococcal, seborrheic, primary Meibomitis More Details, Meibomian gland More Details dysfunction and others. Mainstay of therapy are mechanical manoeuvres, there is less role of antibiotics in chronic blepharitis. To investigate the effectiveness of various types of interventions in the treatment of chronic blepharitis. Materials and Methods: It Isa Prospective observational study conducted in ophthalmology unit in a tertiary care hospital, Kakinada, Andhra Pradesh for a period of 3 months. Total number of patients included are 100. All antibiotics prescribed were recorded including dosage form, frequency and duration and prescribing pattern is analysed. Results: Out of 100 chronic blepharitis patients, 55 are of staphylococcal, 28 are seborrheic and 17 are primary meibomitis. Commonly prescribed drugs are fluoroquinolones (52.84%), followed by aminoglycosides (20.32%), broad spectrum antibiotics (14.6 %.) and steroids (12.1%). Mechanical interventions like maintaining eyelid hygiene and application of warm compresses was observed among 23 cases. There was no significant difference observed among the medical and non-medical interventions and p > 0.05. Conclusion: No difference is observed in terms of remission between the medical and non-medical interventions. Interventions to rectify problem of inappropriate use of antimicrobial agents are needed to make therapy more rational and cost effective.
RDU-31
Prescribing Pattern in Asthma Therapy in a Tertiary Care Hospital
Suresh K, Kiran UP, Prasad KVS, Lakshmi DV
Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India
Objectives: This study was conducted to monitor and establish drug prescribing trend of anti-asthmatic drugs in tertiary care hospital, Kakinada. Materials and Methods: Prospective observational study conducted in TBCD departmentin a tertiary care hospital for a period of 3 months. Total number of patients studied were 100. All drugs prescribed were recorded including dosage form, frequency and duration and prescribing pattern is analysed. Results: The Results reveal that β-agonists (40%) were the most frequently prescribed anti-asthmatic drug followed by Methylxanthines (27%), corticosteroids (25%), leukotriene antagonist (4.4%) and anti-histamines (3.6%) were the least prescribed. Analysis of prescription revealed that multiple drug therapy (81%) was opted for a significant number of patients as compared to single drug therapy (19%). Oral dosage form tablets (56.3%) were preferred over inhalation (33.8%). Conclusion: It is concluded that the present prescribing pattern of anti-asthmatics in tertiary care hospital does not completely meet the standard guidelines of treatment of asthma. Hence the physicians are suggested to follow the guidelines in treating asthma.
RDU-32
A Study on Self-medication Practice and Perceptions Among Post Graduate Medical Students in a Tertiary Care Hospital
Subba PVR, Annapurna, Kiran PU, Lakshmi DV
Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India
Objectives: To determine the attitudes and pattern of self-medication among post graduates. Materials and Methods: The study was done among post-graduates of Rangaraya Medical College, Kakinada on self-medication. This study was prospective, prevalidated questionnaire in 100 medical post graduate students. Out which 10 incomplete questionnaires were excluded and 90 were analysed. Results: A total of 10 questions were given for analysis with a response of 90%. The principal morbidity for seeking self-medication was cold and cough as reported by 60% students. Antibiotics were most commonly self-medicated as reported by 30% students, out of which only 15% students completed the full course of antibiotic regimen. Only 40% students opined that self-medication is part of self-care. Conclusion: Self-medication is widely practiced among post graduate medical students. In this situation, we should educate them about advantages and disadvantages of self-medication and try to avoid as far as possible.
RDU-33
Rational Use of Drugs at Hospital Discharge: A Retrospective Study in Indoor Unit of Medicine Department in a Tertiary Care Hospital, Jorhat, Assam
Baruah R, Saikia H, Chaliha M
Department of Pharmacology, Jorhat Medical College and Hospital, Jorhat, Assam, India
Objectives: Despite immense success and popularity of drugs, there has been growing concern for many years of inappropriate use. This apparent irrational use is concerning because of mounting evidence of potential side effects and drug interactions among patients in various age groups. In light of this, the aim of my study is to analyse appropriateness of drugs. Materials and Methods: Retrospective study of 2400 patients above 18 years admitted in medicine ward of Jorhat Medical College and Hospital from 15 May 2015 to 15 Aug 2015. Institutional Research and Ethics Committee clearance were obtained. Results: Pattern of drug prescribing was not always based on WHO criteria for rational use of drugs. Drugs prescribed from EML were average with prevalence of antibiotics, analgesic-anti-inflammatory agents and multivitamins. Prevalence of generic prescription was average (54.05%) which needs improvement. The notable observation pertaining to the choice of antibiotic was the use of fluoroquinolones. Most commonly prescribed analgesic anti-inflammatory agent was NSAID. Average number of drugs per prescription was 4.09, number of antibiotics per prescription is 1. Analgesic anti-inflammatory use was 80%. Multivitamin use was 75%. Conclusion: Analysis of prescribing patterns gives an insight into the problem of poly pharmacy as well as drug overuse and may bring greater awareness to this problem, the present study could serve as aplatform upon which further studies in prescription analysis can be undertaken to investigate the scope for further improvement in prescribing practices.
RDU-34
An Observational Study to Evaluate Drug Utilization Pattern Among Antenatal Care Patients in an Outpatient Department of Tertiary Care Hospital
Pati RN, Bhagat SB, Gambre RS
Department of Pharmacology, GGMC and Sir J.J. Group of Hospitals, Mumbai, Maharashtra, India
Objectives: Pregnant females require pharmacological treatment for a various acute, chronic and pregnancy-related conditions. Pregnancy affects the pharmacokinetics of drugs and also certain drugs ingested for various conditions can affect the growing foetus. Therefore study was planned to evaluate drug utilization pattern among antenatal care females. Materials and Methods: It was an observational, cross sectional descriptive study where prescriptions of 600 females visiting ANC OPD of our tertiary care hospital over 1 year were analysed. The prescribed drug were noted in a prepared study form, compiled and analysed. Results: Most of the pregnant females were in 3 rd trimester of pregnancy and visited mainly as a part of their routine check-up. Average drugs prescribed per person were 3.87 and most common drugs prescribed were hematenics & nutritional supplements followed by antacids and antibacterial. Most of the drug were prescribed by generic name and were from the WHO and National essential drug list. Most of the drug prescribed belongs to FDA category B and C. Conclusion: The drug utilization was as per WHO recommendation. No deviation in prescription was found which was harmful to mother or foetus. Though polypharmacy was found but it was necessary as per the condition of patients.
RDU-35
Prescriptional Audit of Drugs Prescribed in a Tertiary Care Hospital for Neurological Disorders
Giri RK, Prasad KVS, Prayaga UK, Kumar RK, Reddi H, Venugopal K
Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India
Objectives: To study the prescribing pattern in terms of effectiveness, cost and rationality in neurological disorder in a tertiary care hospital with an emphasis on the drugs included in National List of Essential Medicines. Materials and Methods: The current study is a prospective observational study by using the patient care indicators. A proforma was designed in accordance with WHO core prescribing indicators. The data was collected from prescription forms and case sheets of patients attending Neurology Department at Government General Hospital, Kakinada for one month. The data related to prescription patterns was then analysed by using the descriptive statistics. Results: Total 830 prescriptions were statistically analysed. 53.97% of the patients attending neurology department were males and 46.02% were females. About 55.46% percent of the prescriptions contained only one diagnosis. The average number of drugs per prescription was 2.5. About 95 percent of the drugs were prescribed by generic names and about 16.42% of the prescribed drugs were in combination. About 10.24% percent of the prescriptions contained at least one injection, while 5.84%contained at least one antibiotic. In 30.46% of the prescriptions a vitamin or tonic was prescribed. About 78 percent of the single ingredient formulations were as per the WHO 2003, Essential Medicines List (EML). Polypharmacy was seen in 32% of prescriptions. Antiepileptic's were the most commonly prescribed class of drugs (55%) followed by NSAID'S (40%) and methylcoba (34%) All of the prescriptions were appropriate in terms of strength, dose, form, frequency and duration. Conclusion: Polypharmacy was high among CVA patients and hence there is need to increase awareness regarding potential hazards of polypharmacy among these patients. 78% of the drugs prescribed were from National essential list of medicines and this can be improved. Brand names was used for 5% of drugs but most of drugs being chronic disorder this adds up the price burden the patient.
RDU-36
Efficacy of Levetiracetam as an Adjuvant Therapy in Pediatric Epilepsy
Raut A, Mathew S, Phadke A, Mehernoush C, Taskhedkar S
Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India
Objectives: The objective was to study efficacy of Levetiracetam in pediatric patients with refractory epilepsy. Materials and Methods: A prospective observational study was performed in Bharati Hospital and Research Centre. Pediatric patients who were on Levetiracetam therapy were identified and their 2 follow ups were taken for determining efficacy of therapy. Results: Levetiracetam is a novel AED that has recently been approved as add-on treatment for various seizure types in epilepsy populations that include children. 50 Pediatric patients with refractory epilepsy and who were on LEV therapy were included. Among them 33 (66%) were males and 17 (34%) were females. Observed prevalence of epilepsy in our hospital was 7.18 per thousand persons. It was observed that 48% had partial seizures while 52% patients had generalized seizures. There was no statistically significant difference in responder rates in different age group. Our study showed that LEV was effective in controlling seizures in 70.82% of patients having partial seizures and 57.68% of patients having generalized seizures. No statistical difference was found in two groups. Levetiracetam was most effective as 3 rd line followed by 2 nd line and lastly as 1 st line. Conclusion: The occurrence and prevalence of epilepsy in our hospital was similar to that of available epidemiological studies. Prevalence is found to be higher in males than females. Our study found that LEV was effective in controlling both partial and generalized seizures but it was more effective in partial onset seizures. Levetiracetam therapy was most effective as 3 rd line of treatment.
CVS
CVS-1
Protective Effect of Ursolic Acid in Doxorubicin Induced Cardiac Toxicity
Awachar NS, Kumavat VS, Mahajan UB, Goyal SN, Patil CR
Department of Pharmacology, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra, India
Objectives: To evaluate the importance of ursolicacidin doxorubicin induced cardiac toxicity in rats by persistent hemodynamic, biochemical and histopathological changes. Materials and Methods : Cardio toxicity was induced in Wistar rats with single intravenous injection of doxorubicin at dose of 67.75 mg/kg i.v for 48 hrs. At 12 hrs of interval following Dox administration the cardioprotective effect of ursolic acid (1.5 mg/kg, i.v.) and Amifostine (AMF) (90 mg/kg i.v, single dose prior 30 min) were evaluated. Results: Induction of cardiotoxicity was confirmed by increase in systolic, diastolic, mean arterial pressures, maximal positive rate of developed left ventricular pressure (+LVdP/dtmax, an indicator of myocardial contraction), maximal negative rate of developed left ventricular pressure (−LVdP/dtmax, a meter of myocardial relaxation) and an increase in left ventricular end-diastolic pressure (LVEDP, a marker of pre-load). Cardiac markers in such as CK-MB, LDH and alterations in ECG. Dox administration showed alteration in Biochemical parameters and endogenous antioxidants. Conclusion : Administration of UA Showed maximal protection against Dox induced cardiac toxicity as observed by reduction in blood pressure, prevention of left ventricular function and attenuation of biochemical and antioxidant parameters. Hence UA can be used as an adjuvant with Dox therapy in treating cancers.
CVS-2
Protective Effect of Apigenin in Isoproterenol Induced Myocardial Injury via Boom of Antioxidant Defence System
Patil PD, Buwa CC, Mahajan UB, Patil CR, Goyal SN
Department of Pharmacology, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra, India
Objectives: To evaluate the consequence of Apigenin (AP) administration on isoproterenol (ISO)-induced oxidative stress and myocardial infarction in rats through examination of the hemodynamic, biochemical and histopathological alterations. Materials and Methods : A total of 40 Wistar rats were randomly allocated to five treatment groups (n = 8) as, normal control; ISO-Induced MI group and three AP-treated MI group receiving 25, 50 and 75 mg/ kg/day of AP by i.p. route for a period of 14 days. The MI was induced by two subcutaneous injections of 100 mg/kg ISO administered on the 13 th and 14 th day at an interval of 24 hours. Results: ISO-Induced MI group rats showed evidence of significant decrease in the systolic and diastolic arterial pressures, and maximal positive rate of developed left ventricular pressure. In this group, a noteworthy diminution in the activities of creatine kinase-MB isoenzyme, reduced glutathione, superoxide dismutase, catalase along with rise in malondialdehyde content were observed. The shielding function of AP against the ISO-induced myocardial damage was observed as attenuation of all the endogenous parameters and the membrane-bound enzymes. The protective effect of AP was further confirmed by the histopathological examinations. The observed protective effect of AP was dose dependent and statistically significant at the doses of 50 and 75 mg/kg. Conclusion: Current study thus provides a confirmation that the intraperitoneally administered AP exerts protective effects against the ISO-induced MI in rats.
CVS-3
Study of Alteration in Serum Lipids by Lisinopril and Perindopril in Albino Rabbits
Chandra S 1 , Agarwal NK 2 , Khanchandani R 3 , Prajapat R 4 , Jain IP 5 , Singh SP 5
1 Department of Pharmacology, JIIU's Indian Institute of Medical Sciences and Research, Badnapur, Jalna, Maharashtra, India, 2 Department of Pharmacology, Himalayan Institute of Medical Science, Dehradun, Uttarakhand, India, 3 Department of Pharmacology, Government Medical College, Haldwani, Uttarakhand, India, 4 Department of Pharmacology, Geetanjali Medical College and Hospital, Udaypur, Rajasthan, India, 5 Department of Pharmacology, G.S.V.M. Medical College and Hospital, Kanpur, Uttar Pradesh, India
Hypertension with dislipidemia is becoming a common morbidity, since ACE inhibitors are the first line of antihypertensive drugs so present study was undertaken with the aim to evaluate the possible effects of ACE inhibitor on lipid profile in Albino rabbits. The study was conducted in the Deptt. Of Pharmacology & Therapeutics, GSVM Medical college, Kanpur. Rabbits were divided into 2 groups with 12 in each group. After 2 weeks of adaptation rabbits were given cholesterol rich diet for 8 weeks. After that animals of group I were continued with the same cholesterol enriched diet along with Lisinopril (0.25 mg/kg/day PO) and group II were fed with cholesterol enriched diet along with Perindopril (0.20 mg/kg/day PO) for 6 weeks more. Lipid profile estimation (Serum Total cholesterol, serum HDL, serum LDL, serum Triglycerides and serum VLDL) was done at day 0, 60 and day 102 respectively. Statistical analysis was carried out by using paired 't' test. Serum total cholesterol, triglycerides, HDL, LDL and VLDL cholesterol, were increased significantly (P < 0.05) in both the groups after 60 days of cholesterol feeding. Group I (Lisinopril) showed significant decrease in serum total cholesterol and LDL levels. HDL and Triglycerides levels increased significantly. The VLDL levels were also found to be increased but not found significant. Same Results were obtained by Rabbits of group II (Perindopril). It was concluded that ACE inhibitor e.g. Lisinopril, Perindopril had a favourable effect on serum lipid profile by decreasing total cholesterol, increasing serum HDL level and decreasing LDL levels by inhibiting ACE enzyme and various other mechanisms.
CVS-4
Investigation of an Ayurveda Formulation Comprising Arjuna Bark and Gaumutra on Cardiomyopathy and Nephropathy in Experimental Model
Patel S, Davra K, Rabadiya S
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: (1) Evaluation of an Ayurvedic formulation comprising Arjuna Bark and Gaumutra on Cardiomyopathy and Nephropathy in experimental model. (2) To compare the activity of combination of Arjuna bark and Gaumutra with marketed formulation of Arjuna. Materials and Methods: The female Wistar-Albino rats (200-300 g, age eight week) were divided into 4 groups, Group I is Normal control, Group II is Diabetic control (Streptozotocin 35 mg/kg, i.v), Group III is Diabetic rats treated with the 0.5 ml of test formulation of arjuna bark and gaumutra, Group IV is Diabetic rats treated with 50 mg/kg of marketed formulation of arjuna tablet, furthermore various blood, serum, tissue sample were collected and estimations of biochemical, Hemodynamic, hypertrophy, oxidative stress parameters were done. Results and Conclusion: Data suggests protective activity of Arjuna bark and gaumutra in cardiovascular and renal complication which is justified by decreased levels of cardiac and renal markers and also increased anti-oxidant enzyme levels.
CVS-5
Investigating the Involvement of Thromboxane A 2 in Remote Hind Limb Preconditioning-induced Cardio Protection
Jaggi AS, Sharma R, Randhawa PK, Singh N
Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India
Objectives: Remote hind limb preconditioning (RIPC) is a protective strategy in which short episodes of ischemia and reperfusion in a remote organ (hind limb) protects the target organ (heart) against sustained ischemic reperfusion injury. The present study was designed to investigate the possible role of thromboxane A 2 in mediating RIPC-induced cardio protection in rats. Materials and Methods: Remote hind limb preconditioning was performed by four episodes of 5 min of inflation and 5 min of deflation of pressure cuff. Occlusion of the hind limb with blood pressure cuff is most feasible, non-invasive, clinically relevant and safe Methods for inducing RIPC. Isolated rat hearts were perfused on Langendorff apparatus and were subjected to global ischemia for 30 min followed by 120 min reperfusion. The levels of lactate dehydrogenase (LDH) and creatine kinase (CK) were measured in coronary effluent to assess the degree of myocardial injury. The extent of myocardial infarct size along with the functional parameters including left ventricular developed pressure (LVDP), dp/dt max , and dp/dt min were also measured. Ozagrel (thromboxane synthase inhibitor) was employed as pharmacological modulator of thromboxane A 2 . Results and Conclusion: Remote hind limb preconditioning significantly attenuated ischemia/reperfusion-induced myocardial injury and produced cardioprotective effects. However, administration of ozagrel completely abolished the cardioprotective effects of RIPC suggesting the key role of thromboxane A 2 in RIPC-induced cardio protection.
CVS-6
Involvement of Mechano Sensitive Ion Channels in the Shielding Effect of Remote Hind Limb Preconditioning
Randhawa PK, Jaggi AS
Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India
Objectives: Remote hind limb preconditioning is an on-invasive treatment approach whereby alternate cycles of preconditioning ischemia and reperfusion to the hind limb afford cardio protection against sustained ischemia-reperfusion injury. The current study was designed to investigate the possible involvement of mechanosensitive ion channels in mediating remote hind limb preconditioning-induced cardio protection. Materials and Methods: In the present study, thirty six animals were divided into six groups: control, sham, remote hind limb preconditioning, gadolinium 7.5 mg, gadolinium 15 mg and vehicle. Remote hind preconditioning model was developed using a standard tourniquet and 4 alternate cycles of inflation and deflation (5 min each) of the blood pressure cuff served as the remote hind limb preconditioning stimulus. Using Langendorff's system, the heart was perfused and subjected to sustained ischemia. Results: Remote hind preconditioning significantly reduced infarct size, LDH release, CK release and improved coronary flow rate, hemodynamic parameters including left ventricular developed pressure, +dP/dt and -dP/dt. However, both doses of gadolinium significantly attenuated remote hind limb preconditioning-induced cardio protection. Conclusion: This suggests that brief episodes of remote hind preconditioning stimulus possibly induces back flow of blood and elicits cardioprotective effects via opening of mechanosensitive ion channels.
CVS-7
Comparative Study of Efficacy and Adverse Effect of Telmisartan versus Enalapril Maleate in Patient of Hypertension with Diabetes Mellitus
Yadav SK, Zaman ZA, Sinha HK
Department of Pharmacology, Jawaharlal Nehru Medical College, Bhagalpur, Bihar, India
Objectives: Hypertension is the most common cardiovascular diseases particularly past middle age. It is a disease itself but is an important risk factor for cardiovascular mortality and morbidity. Hypertension when associated with diabetes mellitus increases this risk. To prevent this we need appropriate antihypertensive agent with better compliance. By virtue of selective inhibition of angiotensin II type I receptor, Telmisartan reduces blood pressure throughout the day with high tolerability. Materials and Methods: A longitudinal and interventional study was undertaken including both male and female patients within the age group of 30-55 years with clinically diagnosed hypertension associated with type 2 DM. Total 80 patients were enrolled in this study. They were divided into two group i.e. hypertension group as A and hypertension associated with DM group as B with 40 patients in each group. Again a group was divided into two subgroups (A1 & A2) and B into (B1 & B2) with 20 patients in each group. A1 & B1 subgroups received tab Telmisartan 40 mg OD, A2 & B2 subgroup received tab Enalapril Maleate 5 mg OD. Total period of the study was 5 months. Results In this study both Telmisartan and Enalapril Maleate reduced systolic and diastolic blood pressure in A & B groups at 3 weeks 7 weeks and 14 weeks almost equally with no statistical significance. But in terms of adverse effect, persistent dry cough and rash was observed in A2 & B2 groups than A1 & B1 subgroups. Conclusion: Telmisartan is effective, better tolerated than Enalapril for the treatment of hypertension.
CVS-8
Prescription Pattern of Fixed Dose Drug Combination in Cardiology Department in a Tertiary Care Hospital
Mohan L 1 , Manjhi PK 1 , Dikshit H 1 , Singh BP 2 , Kumar M 1 , Pathak AK 1
1 Department of Pharmacology, Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India, 2 Department of Cardiology, Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India
Objectives: To evaluate the prescribing pattern of fixed dose combination of drugs and those fixed dose combinations of drugs (FDCs) included in list of WHO approved, in the department of cardiology in a tertiary care hospital. Materials and Methods: The case records of patients with cardiovascular disorders who attended the outpatients department of cardiology were studied after approval of Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Patna and following data was collected - patient demographics, diagnosis, the total number of drugs and fixed dose combinations of drugs prescribed, composition of the FDC, whether FDC prescribed is approved by World Health Organisation (WHO). A descriptive analysis of data was done. Results: Out of 210 patients, 94 received fixed dose combination of drugs. Of these, 91.3% patients were suffering from more than one disease. Prescription of FDCs was most common (82%) in patients above 50 years of age. The commonly prescribed FDC was aspirin with clopidogrelfollowed by telmisartan with hydrochlorothiazide. Of the prescribed FDCs, 70 % were WHO approved. Conclusion: Polypharmacy was common due to presence of multiple diseases. Though use of FDCs can ensure patient adherence to therapy, irrational use should be avoided.
CVS-9
Adherence to Treatment Guidelines in Hypertension: A Prospective Study at a Tertiary Care Teaching Hospital
Kharadi DB, Kalani PN, Patel KP, Malhotra SD
Department of Pharmacology, Smt. N. H. L. Municipal Medical College, Ahmedabad, Gujarat, India
Objectives: To analyse the prescription pattern of antihypertensive drugs and adherence to treatment according to Joint National Committee (JNC 7) guidelines on hypertension. Materials and Methods: Total 400 prescriptions from 400 patients with hypertension were collected and entered in Microsoft Excel 2007 spread sheet. The trend of prescription and adherence to treatment guidelines was analysed using Anatomical Therapeutic Chemical (ATC) classification of antihypertensive drugs, Joint National Committee-7 (JNC-7) guidelines and Guideline Adherence Index-4 (GAI-4) drugs. Data were analysed using SPSS version 21.0. Results: Mean age of patients was 55.96±8.73 years. Male: Female ratio was 2.41:1. A total of 2054 drugs were prescribed to 400 patients. Mean number of drugs prescribed per patient was 5.16 ± 1.88. The prescription trend of antihypertensive drugs was Angiotensin Receptor Blockers (70.0%), Beta blockers (61.8%), Calcium channel blockers (43.5%), Thiazide diuretics (30.8%) and Angiotensin converting enzyme inhibitors (21.0%), while that of Non-antihypertensive drugs was antiplatelets (66.5%), hypolipidemics (65.5%), nitrates (41.5%), proton pump inhibitors (34.8%) and biguanides (20.5%). Prescription quality adherence assessment revealed that 84.8% patients received drugs as per the JNC-7 guidelines, while 11.25% of the patients were over-prescribed and 4.0% were under prescribed. On assessment of adherence to the standard dose range, 86.0% patients received recommended dose range. Total adherence to top four classes of antihypertensive drugs (ARBs/ACEIs, BBs, CCBs and Thiazide diuretics) was 81.0%. Telmisartan + Hydrochlorothiazide was most commonly prescribed drug combination. Conclusion: The prescribing pattern and physician adherence to treatment was in accordance to that of JNC-7 recommendations and GAI-4 drugs.
CVS-10
Pharmacological Evaluation of g-Oryzanol for Anti-atherothrombotic Effect in Rat
Panchal SS, Bhatt A, Mishra N, Jha AB, Butani SB
Institute of Pharmacy, Nirma University, Sarkhej, Ahmedabad, Gujarat, India
Objectives: Hyperlipidemic and thrombotic events are the most common risk factor for cardiovascular death. Prevailing study aimed to evaluate effect of g-Oryzanol (OZ) on atherothrombotic animal model. Materials and Methods: Swiss Albino male mice were taken for study and divided in to four groups. Animals were treated with atorvastatin 2 mg/kg p.o. as the standard and OZ aqueous suspension 175 mg/kg p.o. up to 3 days. On third day poloxamer-407 at the dose of 500 mg/kg was administered through i.p. to induce hyperlipidemia. Thrombotic plaque was induced using FeCl 3 (50%). Animals were sacrificed after 24 h from induction period of hyperlipidemia. Further, lipid profile, coronary disease risk factors, blood coagulation parameters i.e. APTT and PT, and oxidative stress parameters were estimated. The effect of therapy on thrombus formation was observed by histopathology of coronary artery. Results: Treatment was found to improve the serum lipid profile, reduce coronary risk factors and oxidative stress. Adding to this, carotid artery endothelial layer damage was found to be restored in histopathological examination in treatment group, indicated its beneficial effect against thrombotic risk in the body. It also prolonged APTT and PT time. Conclusion: Obtained outcomes reveal that OZ may be therapeutically efficient in hyperlipidemic and atherosclerotic risk management.
CVS-11
Cardioprotective Effect of Rosa Centifolia Against Doxorubicin-induced Myocardial Toxicity in Albino Rats
Nimbal SK, Koti BC
Department of Pharmacology, KLEU's College of Pharmacy, Huballi, Dharwad, Karnataka, India
Objectives: To study the preventive role of ethanolic extract of flower petals of Rosa centifolia (EERC) against doxorubicin (Dox) induced myocardial toxicity in rats. Materials and Methods: Cardio toxicity was produced by cumulative administration of Dox (15 mg/kg for two weeks). EERC (100 and 200 mg/kg, po) was administered as pre-treatment for two weeks and then Dox in alternative day for two weeks. The general observations, mortality, histopathology, biomarker enzymes like lactate dehydrogenase (LDH), Creatine kinase (CK-MB) and Troponin-I (cTnI), biochemical parameters such as aspartate aminotransferase (AST) alanine aminotransferase (ALT) and alkaline phosphatase (ALP), antioxidant enzymes such as glutathione (GSH), superoxide dismutase (SOD) catalase (CAT) and lipid peroxidation were monitored after three weeks of last dose. Results: The repeated administration of Dox induced cardiomyopathy associated with an antioxidant deficit and increased level of biomarkers. Pre-treatment with the EERC (200 mg/kg) significantly protected myocardium from the toxic effects of Dox by reducing the elevated level of biomarker enzymes like LDH, CK-MB and absence of cTnI and biochemical parameters such as AST, ALT and ALP back to normal. EERC increased the reduced level of GSH, SOD and CAT and decreased the elevated level of malondialdehyde (MDA) in cardiac tissue. Conclusion: The biochemical and histopathological reports support the cardioprotective effect of EERC which could be attributed to its antioxidant property.
CVS-12
Comparison of Protective Effect of Oral Iron Chelator Deferiprone and Antioxidant Vitamin E in Post Ischemic Myocardial Reperfusion Injury in Albino Rabbit
Gambhir G, Gupta A, Agrawal P, Kushwaha V, Singh A
Department of Pharmacology, GSVM Medical College, Kanpur, Uttar Pradesh, India
Objectives: The main Objectives of study was to compare the protective effects of oral iron chelator (Deferiprone) and antioxidant (vitamin E) in myocardial reperfusion injury in Albino rabbit. Materials and Methods: Eighteen Albino rabbits of either sex weighing 1.5-2.0 kg were selected for study and were housed in standard laboratory conditions at 25°C, in standard pellet diet and ad libitum. Rabbits were divided into three groups Group 1 (control group), group 2 received oral deferiprone (100 mg/kg/day) for 1 week, and group 3 received vitamin E 100 IU OD for 1 week prior to ischemia. Experiment was performed by isolated heart perfusion using langendorff apparatus in 3 phases 15 min of perfusion followed by 15 min of ischemia followed by 15 min of reperfusion. Coronary perfusion in ml/min/gm of wet weight and LDH levels in mU/ml/g wet weight in perfusion and reperfusion phases were measured and compared as indicators of reperfusion injury. Data were presented as the mean± SEM (Standard error of mean). All comparisons were made with analysis of variance by Bonferroni's Methods. P < 0.05 was considered as statistically significant. Results: Measurements of LDH release during reperfusion showed a significant protective pattern with L1 (deferiprone) and no significant protection with vitamin E as compared to control. No differences in coronary perfusion were found between the various groups. Conclusion: Oral iron chelator deferiprone provided significant protection against myocardial reperfusion injury while protection provided by Vitamin E was insignificant as compared to control.
CVS-13
Anti-hyperlipidemic Potential of Emblica Officinalis in High Fat-fed Rats: Up-regulation of LDLR
Variya BC, Patel SS, Bakrania AK
Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India
Objectives: The present investigation, was undertaken to evaluate the anti-hyperlipidemic potential of fruit juice of Emblica officianalis and to identify the molecular mechanism of action. Materials and Methods: Wistar rats weighing in range of 200-250 gm were randomly divided into 6 groups. Hyperlipidemia was induced by feeding a high-fat diet for eight weeks and simultaneously fruit juice and fenofibrate treatment was given to the respective groups. We have also identified the possible mechanism of action using various molecular techniques. Results: The Results of the study demonstrated that total cholesterol level was found to be significantly increased without alteration in triglyceride level in disease controled rats as compared to control rats and these were significantly diminished by treatment with fruit juice of Emblica officinalis. This models didn't show any alteration on glucose homeostatis. Histo-architectural study of liver and aortic arc also showed oil infiltration with significant inflammation. Immunohistological study also showed up-regulation of surface LDL receptors. Conclusion: The fruit juice contains numerous identified phytoconstituents which are responsible for the biological action. In lieu of these observations, our findings indicate that fruit juice of Emblica officinalis showed decrease in cholesterol level probably having potential to up-regulate LDL receptor on hepatic cells. Fruit juice of E. officinalis can be beneficial for the suppression of hyperlipidemia and LDL receptor might be the molecular target which provide a better understanding of the potential mechanism of Emblica officinalis.
CVS-14
Drug Induced Nutritional Deficiencies in Children
Vijay R, Vyas A, Singh AP, Jangir S
Department of Pharmacology, S. P. Medical College, Bikaner, Rajasthan, India
Drug Induced Nutritional Deficiencies (DINDs) are an important yet poorly recognized field. Good clinical practice not only involves diagnosis and treatment but nutrients deficiency should also be taken care of. There are several drugs which may lead to various vitamin deficiencies like mineral oils, phenytoin, neomycin, isoniazid, valproic acid, etc. affecting several biochemical reactions and ultimately development of children. Enhanced folate deficiency is the Results of therapy with methotrexate in patients with an inherited methylene tetra hydrofolate reductase deficiency. Increased risk of pellagra with isoniazid therapy in cases of N- acetyl transferase deficiency are other examples. Tetracyclines can chelate calcium ions which get incorporated into teeth, cartilage and bone Resultsing in discoloration of both primary and permanent dentition. Fluoroquinolones primarily affect the cartilages and there is joint involvement in young children. Chronic use of corticosteroids Results in calcium malabsorption and cystic fibrosis. Zn supplements decrease copper absorption leading to sideroblastic anaemia, and thiazide diuretics increase excretion of Zn leading to chronic liver diseases. Imipramine, methylphenidate and dextroamphetamine are the drugs in children with known associations of decreased appetite and slowed growth. In nutshell, improved child development relies on physicians' awareness. Nutrients deficiency should not be a price for effective drug therapy by them. Key words: Child development, good clinical practice, nutrient deficiency.
CVS-15
Role of LCZ696 (Valsartan/Sacubitril) - A First in Class Angiotensin Receptor-nephrilysin Inhibitor in Cardiovascular Diseases: A Systematic Analysis of Published Clinical Trials
Lahiry S, Bala M, Sil A
Department of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India
Objectives: To evaluate the role of LCZ696, a recently FDA-approved ACE-Nephrilysin inhibitor (ARNi) in the management of cardiovascular diseases from online available medical literature. Materials and Methods: Clinical trial data on LCZ696 was assessed using PubMed search using key words "LCZ696, cardiovascular diseases". Titles, abstracts were assessed. RCTs directly comparing LCZ696 to other drugs or placebo, having total mortality or vascular events as their primary or secondary outcome were accessed in full-text. Retrieval was limited to 'human' and 'English' language. Quality of RCTs assessed following CONSORT guidelines. Incomplete Methodsology, Results in abstract form, duplicate publications were excluded. Two reviewers (SL and AS) independently screened RCTs. Data extraction forms were used to obtain uniform quality of data. Results: Out of 4, 3 were active controlled trials (2 on heart failure; PARAMOUNT, PARADIGM-HF & 1 on hypertension) and one placebo-controlled trial on hypertension were assessed. LCZ696 revealed a statistically significant 20% reduction in death/hospitalization rates for HF, 16% reduction in rate of all-cause death compared to enalapril at 3.5 years of follow-up (PARADIGM-HF; n = 8442). Angioedema is notably absent with LCZ696. Decrease in high sensitivity Troponin-T, improvement in N-terminal-pro-BNP, left atrial size suggested LCZ696 may reduce myocardial injury in HF (PARAMOUNT trial; n = 298). 398 Asian patients enrolled in a placebo-controlled trial and a double-blind RCT (n = 1215) showed a reduction in blood pressure. Conclusion: Systematic analysis of trial data reveals clear evidence of using ARNi (in place of ACE inhibitors) in HF and hypertension. Its role in other cardiovascular conditions needs further assessment.
CVS-16
The Impact of Iron Supplements on the Incidence of Re-hospitalization in Post-MI Patients with Persistent HAA
Kumar S 1 , Srivastava RK 1 , Sharma R 1 , Lalar K 2 , Kataria SP 3
1 Department of Pharmacology, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India, 2 Department of Cardiology, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India, 3 Department of Clinical Pathology, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India
Objectives: Post-MI patients discharged with mild to moderate persistent HAA are susceptible to the worst clinical out-comes and poorer status of health amounting frequent re-hospitalization. The present study was to find out whether iron supplement to post-MI patients having persistent HAA would affect on the frequency of re-hospitalization. Materials and Methods: 40 post-MI patients with moderate persistent HAA were enrolled following inclusion, exclusion criteria and written consent from patients. Two groups were made, each group had 20 patients. One group of patients received iron supplement daily while other group did not receive iron supplement for six months. All patients were on prescribed medication for post- MI and were followed up in Cardiology OPD at one month, 3 months and 6 months. Clinical assessment, status of health and hematological examination were recorded. Results: The patients who were on iron supplements achieved normalization of HAA. There was increase in hemoglobin concentration to a normal levels and improved the status of health and clinical outcomes. This reflected no re-hospitalization in iron treated patients compared to untreated patients who required re-hospitalization for the management of cardiac complications including recurrence of myocardial infarction, cardiac failure, hypertension, and renal failure. Conclusion: Our study revealed the need of iron supplements to post-MI patients with persistent HAA to protect re-hospitalization.
CVS-17
Protective Effect of Dietary Polyphenols of Macrotyloma Uniflorum Seeds in Cardiac Abnormalities Associated with the Metabolic Syndrome in Rats
Shinde P, Panda V, Desai Y
Prin. K. M. Kundnani College of Pharmacy, Colaba, Mumbai, Maharashtra, India
Objectives: The present study evaluates the protective effects of a hydro alcoholic extract of the seeds of Macrotyloma uniflorum (MUSE) and ferulic acid in fructose induced cardiac abnormalities associated with the metabolic syndrome in rats. Macrotyloma uniflorum seeds (horse gram) are rich in antioxidant phenolic acids, ferulic acid being the most potent one. Materials and Methods: Isolation and quantification of ferulic acid from MUSE was carried out by HPTLC and HPLC. In vitro antioxidant studies were performed on MUSE. Cardiac abnormalities were induced in rats by administering them fructose (25 % w/v) in drinking water for 45 days. MUSE (200 mg/kg and 400 mg/kg) and ferulic acid (80 mg/kg) were administered to rats along with fructose. Results: MUSE showed significant DPPH free radical scavenging activity and reductive ability when compared with Quercetin. MUSE and ferulic acid treatments elicited significant cardioprotective activity by attenuating the fructose-elevated activities of the serum marker enzymes AST, LDH and CK-MB and MDA, and by restoring the fructose depleted activities of the marker and antioxidant enzymes in heart. A notable decrease in cardiac hypertrophy, left ventricular hypertrophy and heart collagen was observed with MUSE treatment when compared with the fructose fed animals. Conclusion: The present findings suggest that MUSE may be useful as an adjuvant for the management of cardiac abnormalities associated with the metabolic syndrome. The potent antioxidant activity of its phenolic phytoconstituents, particularly ferulic acid, may be a major factor towards this activity.
CVS-18
A comparative Study of Efficacy of Atorvastatin Alone and Atorvastatin with Omega-3 Fatty Acids Combination in Patients with Dyslipidaemia Attending Tertiary Care Hospital
Krishna PN, Rao PM
Department of Pharmacology, Kakatiya Medical College, Warangal, Telangana, India
Objectives: ( 1) To compare the efficacy of Atorvastatin alone with Atorvastatin plus Omega-3 fatty acids combination in management of dyslipidaemia. (2) To note down any untoward effects with these drugs. Materials and Methods: The study was a comparative, randomized, prospective, open labelled study. A total of 100 patients were selected by inclusion and exclusion criteria and divided randomly into two Groups (Group-A, Group-B). Group-A received Tab. Atorvastatin 10 mg/day. Group-B received Tab. Atorvastatin 10 mg/day plus Cap. Omega-3 fatty acids 600 mg/day. Study duration was 6 months with monthly follow up. Written informed consent and institutional ethical committee approval taken. Efficacy was measured by assessing change in parameters like TC, HDL-C, LDL-C, VLDL-C, TG's. Results: Results were compared by applying appropriate statistical tests. By paired t-test both groups showed statistically significant Results (p value < 0.001). By unpaired t-test the mean increase of HDL-C in GROUP-A was 2.16 ± 1.01 and mean increase of HDL-C in Group B was 3.57 ± 1.26 (P < 0.01). Percentage increase in HDL cholesterol levels in Group-A was 5.54% and in Group-B was 9.2%, the difference in increase being 3.7%. Other parameters TC, LDL-C, TG's and VLDL showed statistically no significant Results (p > 0.05). Conclusion: The study Results showed that combination was more effective than Atorvastatin alone in improving HDL-C from base line. Other parameters TC, LDL-C, TG's and VLDL-C showed less significant changes.
CVS-19
Cost Variation Analysis of Antihypertensive Agents Available in Indian Market: An Economic Perspective
Satish GR, Kamath L
Department of Pharmacology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India
Objectives: To analyse the percentage cost variations among different brands of the commonly prescribed anti-hypertensive drugs. Materials and Methods: The cost of different brands of commonly used antihypertensive drugs was sorted out by referring latest CIMS, MIMS, Drugs Monitor and IDR. The cost of 10 dosage forms (Tablets/capsules) in INR of each brand, Cost Ratio and Percentage Cost Variation were calculated. Results: The percentage variation in the cost was above 100% with most of the commonly used antihypertensive drugs like Amlodipine (2.5 mg) 1040.58%, Atenolol (50 mg) 564.10%, Telmisartan (40 mg) 542.22% and Ramipril (10 mg) 478.39%. Among the combination therapy Atenolol + Hydrochlorothiazide (50 + 12.5 mg) 504.82%, Amlodipine + Atenolol (5 + 50 mg) 437.86% and Lisinopril + Hydrochlorothiazide (5 + 12.5 mg) 403.33% variation. Conclusion: Hypertension is the most common cardiovascular disease and drugs are to be prescribed for prolonged period. If a costly brand is prescribed, the patients have to pay more money unnecessarily for their treatment. The costly brand of same generic drug is proved to be in no way superior to its economically cheaper counterpart. Ideally, therefore, the drugs should be prescribed in generic to save the patient's money and to enhance the compliance.
CVS-20
In-vivo Evaluation of Anti-atherosclerotic Activity of the Drug Alpha Lipoic Acid
Pitroda KA 1 , Tirgar P 1 , Gohel SH 2
1 Department of Pharmacology, R. K. University, Tramba, Rajkot, Gujarat, India, 2 Department of Pharmacology, R. D. Gardi Pharmacy College, Rajkot, Gujarat, India
Aim: Investigation of in-vivo Anti-Atherosclerosis potential of Antioxidant Alpha lipoic acid and also beneficial effect in Atherosclerotic associated complications such as in cardiovascular disease and hyperlipidemia. Materials and Methods: Anti-atherosclerotic and Anti-oxidant activity drug alpha lipoic acid along with standard drug Atorvastatin were assessed against high fat diet induced Hyperlipidemic model in Wistar rats which results in condition of weight gain along with Atherosclerosis associated complication such as cardiovascular disease and hyperlipidemia. At the end of 30 days of in-vivo trial, body weight and food intake were estimated. All biochemical parameters total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, CK-MB, levels including complications on vital organ (SGPT, SGOT, Serum creatinine) were estimated. Results: There were significant increased in HDL cholesterol and decreased in body weight, food intake, total cholesterol, LDL cholesterol, triglyceride Level in Disease animal treated with Drug Alpha lipoic acid and Atorvastatin were observed compared to high fat diet diseases control group. These beneficial effects were observed because of Alpha lipoic acid have mechanism such as, antioxidant effect, decrease the total cholesterol level and Atherogenic index in high fat diet rats were confirmed by pharmacological study and reduction in various markers like SGPT, SGOT, creatinine. Conclusions: Data of our study confirmed that the drug Alpha lipoic acid have significant Antiatherosclerotic activity, beneficial effects on biochemical parameters and Atherogenic index. Thus the Drug Alpha lipoic acid is very beneficial in management of Atherosclerosis and associated complication cardio-vascular disease and hyperlipidemia.
CVS-21
Comparative Analysis on Incidence of Pedal Oedema Between Amlodipine, Cilindipine and S Amlodipine in Mild to Moderate Hypertensive Individuals
Sougata Sarkar
Department of Pharmacology, Kalinga Institute of Medical Sciences, Patia, Bhubaneswar, Odisha, India
Objectives: According to JNC VIII guideline calcium channel blockers are first line of treatment in both general black or non black population (including those with diabetes). It controls hypertension adequately, but very often produces ankle oedema. Our object of study was to compare the incidence of ankle oedema and its variation on the basis of gender, amongst commonly used Dihydropyridine Calcium Channel Blockers like racemic Amlodipine, s Amlodipine, L/N type CCB Cilndipine in mild to moderate hypertensive patients. Materials and Methods: This was a prospective OPD based study performed on 180 patients between 40 to 60 years, divided into two groups of either sex with 90 each, amongst which, 30 patients were on amlodipine, 30 on s amlodipine and 30 on cilnidipine. Congestive cardiac failure, cirrhosis of the liver, concomitant Nephropathy and secondary hypertension were excluded by clinical examination and appropriate laboratory tests.. Clinical assessment of blood pressure, pulse rate, ankle oedema were recorded at the beginning of the study and after one month and three months of therapy. Results: Twelve weeks follow up of patients revelled adequate blood pressure control with higher incidence of oedema for Amlodipine and lowest incidence for Cilndipine and much lower incidence for s Amlodipine when compared to Amlodipine. Incidence of oedema is higher in females than males for each drug. Conclusion: Cilnidipine being N-type and L-type CCB, associated with much lower incidence of pedal oedema compared to only L-type channel blocked by amlodipine. The less incidence of ankle oedema by s-amlodipine as showed in this study coincides with the fact that the R-enantiomer component could be the reason for the appearance of oedema with racemic amlodipine.
CVS-22
MCR-788 a novel ACAT inhibitor prevent hypercholestrolemia in rats
Sagar Patel, Hardik Gandhi, Palash Pal, Kirti Patel, MR Yadav
Department of Pharmacy, Faculty of Technology and Engineering, The M.S. University of Baroda, Vadodara, Gujarat, India
Objectives: To develop sensitive and specific method for screening novel ACAT inhibition and evalauion of novel potent compound in diet induced hypercholesterolemia in rats. Materials and Methods: compounds were screened by high performance thin layer choromatogrpahy using liver microsome as source for ACAT enzyme. Acute toxicity was carried for establishment for safety of MCR-788. Finally compounds was evaluated in diet induce atherogenesis in rats for one month. Various metabolic parameters were studied using commercially available kits. Results: From literature review it can be understood that Acetyl CoA acetyltransferase (ACAT) is potential target for hypercholesterolemia. This compound are evaluated by radioligand binding assay so we have developed sensitive, specific robust a planar-chromatography based method for the quantitative determination of cholesteryl esters, which could be used for the screening of compounds having their effect on ACAT catalytic activity.Based on the screening results, one compound MCR-788 (IC 50 = 2.43 ± 0.38) was chosen for further evaluation. Toxicity studies with this compound revealed that the compound did not show any signs of distress/morbidity. An acute model of triglyceride turnover, poloxamer-407 mediated LPL inhibition, it was found that MCR-788 prevented elevation in triglycerides comparable with standard ACAT inhibitor, avasimibe. A model of diet-induced atherogenesis in rats over a period of 8-weeks was utilized for evaluation of compound in chronic condition. Both the treatment groups (10 and 30 mg/kg) exhibited dose dependent beneficial effect on total cholesterol and lipoprotein level in serum. Conclusion: These studies represent development of simple screening method for novel ACAT inhibitors and use of such potential novel compounds for further drug development.
RSP
RSP-1
Errors in Use of Inhalational Devices in Patients with Mild to Moderate Bronchial Asthma
Akhoon N, Dick LCB, Sharma AK
Department of Pharmacology, Armed Forces Medical College, Pune, Maharashtra, India
Objectives: To assess the prevalence and type of errors in the use of inhalational devices in patients with mild to moderate bronchial asthma. Materials and Methods : Adult patients, diagnosed with mild to moderate bronchial asthma of either sex were recruited from respiratory OPD of a tertiary care hospital after taking informed consent. The demographic profile of patients and errors made while using the devices were observed. Results : A total of 124 patients were recruited in the study and were found to be classifiable into two major groups: Group I - Those using metered dose inhaler (MDI) without spacer and Group II - Those using MDI with spacer. The demographic profile of study subjects were found to be similar. Among the recruited patients, 82 (66.12%) formed group I and 42 (33.87%) formed group II. In group I, the most common error observed was failure to inhale to total lung capacity after actuating the MDI (21.95%; n = 18) followed by failure to hold the breath for 4 seconds after inhaling aerosol (8.53%; n = 7) and combination of both of the above errors (6.09%; n = 5). In group II most common error observed was failure of forceful expiration (16.66%; n = 7) before inhaling the aerosol followed by failure to hold the breath for 4 seconds after inhaling aerosol (7.14%; n = 3) and combination of these errors (4.76%; n = 2). Overall, 36.58% patients in group I and 28.57% patients in group II were committing errors in use of inhalers. Conclusion: It is hence observed that use of spacer helps in minimizing the number of errors.
RSP-2
The Legionnaires' Disease: Intricacies and Current Management Options
Gehlot A 1 , Gehlot SS 2 , Sharma M 1 , Singh A 1 , Dua M 1 , Singh J 1
1 Department of Pharmacology, Dr. S.N.M.C, Jodhpur, Rajasthan, India, 2 Department of Structural Engineering, Dr. S.N.M.C, Jodhpur, Rajasthan, India
Objectives: Legionnaries' disease, also known as Legionellosis or Legion fever, is a form of atypical pneumonia, caused by any type of legionella bacteria. Over 90% of cases of Legionnaires' disease are caused by Legionella pneumophila. It has only been found on aquatic systems, where it is symbiotically present in aquatic borne amoebae. It thrives in temperatures between 25 and 45°C. During infection, the bacterium invades macrophages and lung epithelial cells and replicates intracellularly. Materials and Methods: Almost all patients with Legionnaires' disease experience fever, while approximately half have cough with sputum and one third cough up blood or bloody sputum. Laboratory tests may show abnormal kidney, liver function and low sodium in the blood. Chest X-rays often show pneumonia with bi-basilar consolidation. Results: A significant under reporting problem occurs with Legionellosis. This is partly due to being a relatively rare form of pneumonia. The fatality rate of Legionaries' disease has ranged from 5% to 30% during various outbreaks and approaches 50% of nosocomial infections especially when treatment with antibiotics is delayed. Conclusion: Current management options include use of antibiotics having excellent intracellular penetration. Most frequently used are levofloxacin, doxycycline and azithromycin. More recently among non-pharmacological measures, an internet delivered hand washing intervention to modify influenza like illness and respiratory infection transmission (PRIMIT) has been tried.
RSP-3
Trends and Outcome of Snake Bite in a Tertiary Care Hospital of West Bengal: A Prospective Observational Study
Verma V, Chatterjee S, Hazra A, Choudhury S, Lahiry S, Bhunya PK
Department of Pharmacology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India
Objectives: Poisonous snake bites associated with high morbidity and mortality and imposes a substantial burden on our healthcare system. However, prospective data on the epidemiology and outcome from Eastern India are limited. This prospective observational study aimed to evaluate the frequency, treatment and mortality profile of snake bite cases admitted to a tertiary care hospital of West Bengal over 18 months. Materials and Methods: All diagnosed cases of snake bites were prospectively evaluated till death or discharge. Data related to socio-demographic background, nature of bite, lag period for medical attention, treatment received, clinical parameters and outcome were recorded. Descriptive analysis and a logistic regression model was constructed to identify predictors of mortality. Results: Snake bites (264 cases) constituted 44.59% of total admissions due to acute poisoning during the study period. The median age was 25 (IQR 11 to 0.40) years with preponderance of male (67.8%) and rural background (79.5%). Majority were referral from primary centers; 84.5% cases received anti-snake venom serum (ASV); 34.1% needed dialysis due to acute kidney injury. Despite all death cases having received ASV, 46 deaths contributed to a mortality rate of 17.4% (95% CI 12.85-22.0%). Logistic regression modeling for death predictors, identified long time interval from bite to primary hospitalization as the strongest predictor (adjusted odds ratio 15.49; 95% CI 5.78-41.52). Conclusion: Snake bite poses a significant burden due to high mortality. Despite usage of ASV over 17% succumbed at tertiary care. Appropriate primary care, protocol compliance and public awareness are important to reduce this burden.
RSP-4
Comparative Study of Efficacy and Safety of Garenoxacin and Moxifloxacin in Lower Respiratory Tract Infection
Basumatary B 1 , Srivastava B 1 , Nautiyal RG 2 , Bhardwaj R 1 , Ahuja S 1 , Bharat S 1
1 Department of Pharmacology, Government Medical College, Haldwani, Nainital, Uttarakhand, India, 2 Department of T.B. and Respiratory Disease, Government Medical College, Haldwani, Nainital, Uttarakhand, India
Objectives: Lower respiratory tract infection are difficult to treat owing to resistant gram negative bacteria. New quinolone - Garenoxacin showed excellent antimicrobial activity against the common bacterial pathogens causing community-acquired RTIs. This study was planned to evaluate the efficacy and safety of Garenoxacin and Moxifloxacin in the treatment of lower respiratory tract infections. Materials and Methods: This prospective, open-label, comparative study was done in the department of Pharmacology & TB and Chest of Government Medical College Haldwani. 100 patients were selected and randomly allocated to two groups. Group 1: Moxifloxacin 400 mg once daily for 7 days. Group 2: Garenoxacin 400 mg once daily for 7 days. Evaluation of efficacy and safety employing clinic-radiological and haematological parameters. Results: The mean age of patient was 60.97 + 11.48 year in Garenoxacin group and 57.87 + 10.57 year in Moxifloxacin group. The Clinical responses classified as cure were comparable with 21.1% in Garenoxacin group and 18.3% in Moxifloxacin group, improvement in 59.5% subjects in group 1 and 60.1% in group 2 with relapse in 14.1% and 16.1% and unable to determine 5.3% and 4.9% in group 1 and 2 respectively. All adverse effects were mild, self-limiting and few (two in Garenoxacin and three in Moxifloxacin). Conclusion: The Results showed that 7 day course of Garenoxacin and Moxifloxacin is therapeutically comparable in efficacy and safety.
RSP-5
Add on Therapy of Virechana with Kantakaryavaleha in the Management of Bronchial Asthma in Children
Arun RGR, Shailaja U, Rao PN, Patil R
Department of Kaumarabhritya, SDM College of Ayurveda and Hospital, Hassan, Karnataka, India
Objectives: Bronchial asthma in children is a worldwide problem having an incidence rate of 10-15% in boys and 7-10% in girls. To assess the Role of Virechana and Kantakaryavaleha in the Management of Bronchial asthma in children. Materials and Methods: 30 patients of Bronchial asthma satisfying diagnostic criteria and age 5-16 years were selected from outpatient & inpatient Department of Kaumarbhritya, SDM College of Ayurveda and Hospital, Hassan, Karnataka, India. In Group A, after Virechana with Trivrit leha, Kantakaryavaleha was administered orally twice a day for 1 month. In Group B, patients were treated with Kantakaryavaleha as a Shamana Chikitsa for 1 month. Results: Group A & B shown improvements in dyspnoea (93%, 60%), wheezing (92%, 79%), cough (66%, 55%), sputum (70%, 57%), sneezing (93%, 33%), common cold (92%, 54%), daytime onset of asthma (90%), night time onset of asthma (75%, 50%), discomfort (60%), tightness of chest (66%, 60%), chest pain (81%, 50%), loss of sleep (75%, 62), PEFR (41%, 29%), impact on activity (58%, 48%), palpitation (70%, 50%), mean respiratory rate (10%, 6%), frequency of attack (62%, 53%), duration of symptoms (68%, 66%). Conclusion: In comparison study, group a patients administered with Virechana followed by Kantakaryavaleha showed maximum improvement in all the parameters of assessment criteria.
RSP-6
Profiling of Moderate Persistent Asthma Patients in Dr. RPGMC Tanda in Himachal Pradesh
Sood V, Sharma P, Bansal R, Kansal D, Dahiwele A
Department of Pharmacology, Dr. RPGMC, Kangra, Tanda, Himachal Pradesh, India
Objectives: To find age, gender, occupational distribution and other comorbidities in cases of moderate persistent asthma. Materials and Methods: Patients attending OPD of Dr. RPGMC Kangra were diagnosed as moderate persistent asthma as per GINA guidelines and profiling was done for duration May 2014 to December 2014 on the basis of detailed history. Results: Total 64 cases of moderate persistent asthma were enrolled in above duration. 54% cases were housewives and 67% cases were females in the study. Family history (40%) and smoking (33%) were important comorbidities in the study. 46% cases in the study were in middle age group. Conclusion: Attempt has been made in this study to collect data for various subtypes of asthma, especially in rural areas, which is not yet available. This study's Results of gender distribution (females), occupational distribution (housewives), age distribution (middle age group) are different from other studies on asthma. This underlines the need for more data collection and research in the field of moderate persistent asthma with emphasis on rural areas where Results may differ.
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An Evaluation of the Impact of Interventions on the Technique of Use of Metered-dose Inhaler in Patients of Bronchial Asthma and Chronic Obstructive Pulmonary Disease
Purohit AN, Patel PP, Gandhi AM, Desai MK
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India
Objectives: To evaluate the impact of two interventional techniques i.e., Demonstration Vs Leaflet in patients using Metered Dose Inhaler (MDI). Materials and Methods: This interventional study was done in patients who were prescribed drugs through MDI at TBCD department. The patients were enrolled in Group A or Group B as per random table Methods. The Methods to use MDI was assessed by using checklist by WHO Guide to Good Prescribing at baseline. In group A, the use of MDI was taught by demonstration while in group B, it was taught by a leaflet with photographs. Patients were then followed up after 15 days and were assessed for use of MDI. Results: A total 100 patients (65 COPD, 35 asthma) were included in the study and were divided into group (47) and group B (53). Majority of the patients were taught by the treating physician about the Methods to use MDI. Majority of patients followed the step to place the lips tightly around the mouthpiece and to hold the aerosol as indicated in the manufacturer's instructions at baseline in both the groups while the step least followed was coughing up sputum before inhalation. The average steps followed by the patients in group A and B at baseline were 5.17 ± 2.07 and 5.11 ± 2.04 and after intervention were 9.19 ± 0.67 and 6.67 ± 0.63 respectively which showed significant improvement. In group A and Ball the 5 important steps were followed by 25.53% and 26.41% patients at the baseline and after intervention by 85.11% and 49.06% patients (p = 0.003). All the 10 steps were followed by 34.04% patients from group A and 0 patient from group B post intervention (p = 0.0001). Conclusion: The inhalation technique of the use of MDI is inappropriate and hence repeated demonstration by the physician/nurses can help in better drug efficacy.
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Efficacy and Safety of Bromocriptine as an Antidiabetic Drug: Meta Analysis
Rodrigues A, Kamath L
Department of Pharmacology, BMC&RI, Bengaluru, Karnataka, India
Objectives: In May 2009 FDA approved Bromocriptine QR, a cental sympatholytic, as an antidiabetic drug either as monotherapy or as an add on therapy for type 2 diabetes. To assess the efficacy and safety of bromocriptine-QR in adults with type 2 diabetes mellitus based on randomized controlled trials published in peer-reviewed journals. Materials and Methods: We performed a comprehensive literature search of Google, PubMed/Medline, Embase, Scopus and the Cochrane Library up to September 2015. Randomized controlled trials of bromocriptine-QR therapy in type 2 diabetes mellitus were eligible. Information was collected concerning basic study data, patient characteristics, efficacy and safety outcomes and Methodsological quality. Results: There were seven randomized controlled trials on bromociptine QR as add on therapy. All seven trails revealed a statistically significant (P < 0.05) reduction in glycemic markers in bromocriptine group. Compared to placebo group Bromocriptine-QR as add-on therapy lowered hemoglobin A1c with weighted mean difference −0.67, 95% CI −0.76 to −0.45. Similarly FBS was reduced with weighted mean difference 18 mg/dl, 95% CI 14 mg/dl to 23 mg/dl and PPBS was reduced with weighted mean difference 28 mg/dl, 95% CI 24 mg/dl to 33 mg/dl. Safety data show that nausea, headache, vomiting, somnolence, and hypoesthesia commonly reported (7-11%). But they are mild and transient. Moreover Bromocriptine-QR group had no increased risk of hypoglycaemia, hypotension and positive cardiovascular effects. Conclusion : Bromocriptine-QR therapy offers an attractive alternative option to currently available oral antidiabetic agents for type 2 diabetes mellitus because of novel mechanism of action, good side effect profile and its effects to reduce cardiovascular event rates. Key words: Bromocriptine, diabetes mellitus, FDA, glycemic markers, novel.
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Geraniol a Major Component of Essential Oil Ameliorates Endothelial Dysfunction in Streptozotocin-induced Diabetic Rats
Kshirsagar R 1 , Majmudar HF 1 , Deshmukh VK 2 , Kumar BD 3 , Reddy GB 3 , Diwan P 4
1 Department of Pharmacology, Yash Institute of Pharmacy, Aurangabad, Maharashtra, India, 2 MES's College of Pharmacy, Sonai, Maharashtra, India, 3 National Institute of Nutrition (ICMR), Hyderabad, Telangana, India, 4 Basic Science Research Center, KLE University, Belgaum, Karnataka, India
Objectives: Geraniol a major component of geranium oil and also found in essential oils of various spices and aromatic herbs. Geraniol a monoterpene is known for potent anti-inflammatory, antihypertensive, hypoglycemic and antioxidant activity. The present study was aimed to explore the vasorelaxant and cardioprotective property of geraniol in Streptozotocin induced diabetes associated vascular complications in rats. Methods: Diabetes complications were induced by Streptozotocin (45 mg/kg i.p.) in male Wistar rats. Animals were divided in five groups as normal control group, diabetic group and three treatment groups administered with geraniol (100, 200, 400 mg/kg p.o) for 6 weeks. Plasma glucose, insulin, lipid profile, HOMA-IR, glucose tolerance, antioxidants levels, lipid peroxidation, serum NO level, ECG changes, mean arterial pressure (MAP) and endothelial dependent and independent vascular function in aorta were assessed. Results: Administration of geraniol in diabetic rats exhibited a significant decline in glucose, insulin, insulin resistance, triglyceride, total cholesterol, LDL levels and increase in HDL levels. Decreased serum NO level, increased oxidative stress (as estimated by the attenuated levels of anti-oxidant enzymes and increased MDA levels) and impaired glucose tolerance were attenuated by geraniol in dose dependent manner. Also increased MAP and ECG changes were normalized and reduced acetylcholine-induced, endothelium-dependent relaxation was improved significantly in geraniol treated rats (92.34 ± 0.38%). Conclusion: Geraniol ameliorates endothelial dysfunction and metabolic complications in diabetic rats by repressing insulin resistance, oxidative stress, lipid lowering effect with normalizing MAP, ECG changes & NO bioavailability.
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Evaluation of Anti-oxidant Activity of Anti-diabetic Drug Teneligliptin by In-vitro Study
Sharanya S, Elang P, Darling C
Department of Pharmacology, Sri Ramachandra Medical College & Research Institute, Porur, Chennai, India
Objectives: To assess the antioxidant potentials of the new anti-diabetic drug Teneligliptin using DPPH assay. Materials and Methods: DPPH radical scavenging activity was done using the method of Naznin Araand Hasan Nur (2009)-3.7 ml of absolute methanol was taken in all test tubes along with blank. Then 100 μl of absolute methanol was added to blank. Then 100 μl of BHT was added to the tube marked as standard and 100 μl of respective samples were added to all other tubes marked as tests. Then, finally 200 μl of DPPH reagent was added to all the test tubes at room temperature and it was conditioned for minimum of 30 minutes then, absorbance of all samples was checked at 517 nm. Here BHT was used as standard drug in the study. Results: The Scavenging property of Teneligliptin was found to be 71.87 ± 0.12%, 65.62 ± 0.25%, 60.10 ± 0.33%, %inhibition while that of BHT was found to be 99.7 ± 0.76%, 96.4 ± 0.34%, 94.8 ± 0.16, %inhibition at the following concentrations 1000, 750, 500 μg/0.1 ml respectively. Conclusion: From the study we found that the drug teneligliptin has significant Antioxidant property which could probably play a role as cytoprotective agent conditions associated with oxidative stress along with its anti-diabetic action.
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Study of Anti-hyperglycemic Activity of Teneligliptin in Patients of T2DM
Prakash KP, Dange SV
Department of Pharmacology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune, Maharashtra, India
Objectives: (1) To study the anti-hyperglycemic activity of Teneligliptin in patients of T2DM. (2) To study the efficacy of Teneligliptin as an add-on therapy to metformin in patients of T2DM. Materials and Methods: An uncontrolled, open label, observational study was conducted to assess the antihyperglycemic activity of Teneligliptin. Patients of T2DM attending OPD of Dhanashree Hospital, Pune were included in the study after obtaining informed written consent. Patients who were uncontrolled on metformin were selected. Teneligliptin 20 mg/day was added to current treatment. Duration of study was three months. BSL-F and BSL-PP were estimated monthly. HbA1c was estimated initially and at the end of 12 weeks. Results were analysed by Student's paired "t" test. P value < 0.05 was considered as statistically significant. Results: Baseline Results were BSL-F: 172.4 +/- 32.5 mgdl, BSL-PP: 225.5 +/- 42.2 mg/dl and HbA1c: 9.5 +/- 1.40%. At the end of three months, the Results were BSL-F: 124.5 +/- 26.4, BSL-PP: 176.4 +/- 38.6 mg/dl, HbA1c: 8.6 +/- 0.9%. Teneligliptin was well tolerated and Resulted in significant (P < 0.05) reduction in BSL-F, BSL-PP and HbA1c levels. Conclusion: Teneligliptin can be considered as an effective alternative for add-on treatment in patients of T2DM uncontrolled on metformin monotherapy.
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Vijaysar: A Boon for Diabetes
Shukla R, Patel R, Buch P, Bhalodia P, Sheth N
Department of Pharmaceutics Sciences, Saurashtra University, Rajkot, Gujarat, India
Diabetes is a chronic metabolic disease reaching an outbreak ratio in the world. By the year 2025 it may cross 5.4% of the total mankind. Presently, India achieves the position of the diabetic capital of the world due to the highest percentage of patients of its population suffering from diabetes. India is a country of treasure of acquaintance of traditional herbal medicine for the treatment of chronic disease like diabetes. Currently available oral hypoglycemic agents are still the pioneers of the market but eventually people grow interest in herbal treatments due to the side effects associated with the oral hypoglycemic agents. Traditional drugs are gaining prominence globally due to their distinct advantages. There is an emergent demand for the molecule with potential ant hyperglycemic activity and Vijaysar has ancient reputation to manage diabetes in Ayurveda. Many of the constituents that contribute toward the antidiabetic activity are still mystery and necessitate further attention. Several potential have been explored from the plant and still the several is obscurity.
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Methylcobalamin Prevents STZ Induced Diabetic Neuropathy in Rats
Singh J 1 , Nishikant, Sood S 2
1 Department of Pharmacology, Postgraduate Institute of Medical Science, Rohtak, Haryana, India, 2 Department of Pharmacology and Physiology, Postgraduate Institute of Medical Science, Rohtak, Haryana, India
Objectives: To study the role of methylcobalamin in prevention of STZ induced diabetic neuropathy in rats. Materials and Methods: In Albino rats of either sex, weighing 220-250 g, diabetic neuropathy (DN) was induced by streptozotocin (STZ) 50 mg/kg, ip, single injection. Motor nerve conduction velocity (MNCV) was determined in sciatic posterior-tibial conducting system of ether anesthetized rats by EMG. Body weight, blood and urine sugar levels were estimated initially (0 hr) and at weeks 4, 8 & 12. Rats were divided into 4 groups of 10 each. Group I - Control, Group II - STZ (50 mg/kg, ip) diabetic control. Group III - methylcobolamin (500 mcg/kg, im,) every alternate day, 5 days prior to STZ and continued for 12 weeks. Group IV - STZ + insulin (4 unit/kg, SC, twice daily) for 12 weeks. Results: In STZ diabetic rat, MNCV was significantly (p < 0.01) reduced after 8 weeks of STZ. Marked improvement in MNCV was observed in methylcobolamin pre-treated group. Insulin pre-treatment also prevented the reduction in MNCV in diabetic rats. Methylcobalamin pre-treatment failed to alter blood, urine sugar levels and body weight in diabetic rats. A significant increase in body weight was observed in insulin + STZ group as compared to animals received STZ only. Conclusion : Methylcobalamin prevents reduction in MNCV in STZ diabetic rats.
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Study of Knowledge, Attitude and Practice About Diabetes Among Urban Adult Population of Bengaluru
Kumar A, Girish K, Pundarikaksha HP
Department of Pharmacology, KIMS, Bengaluru, Karnataka, India
Objectives: To assess the Knowledge, Attitudes and Practice regarding type 2 Diabetes Mellitus amongst urban population of Bangalore. Materials and Methods: Data was collected using purposive sampling from 200 adults residing in an urban district of Bangalore. A structured validated KAP questionnaire was used to obtain information related to socio-demography, knowledge, attitude and practice about diabetes. Descriptive and Chi-square analysis were performed. Results: Out of 200 individuals, 76.5% were male participants and 66% belonged to 35 to 49 years age group. Most of them were either graduates 28.5% or had passed high school 26% and 98% population had heard about diabetes and 61% knew the incidence of diabetes is increasing in India. 52% knew it is related to insulin and 55.5% knew that it can be prevented. There was a significant relation (p < 0.05) between education status and regular health check-up. Exercising behaviour was significantly related (p < 0.05) to participants with age more than 50 years. Conclusion: This study indicates that the awareness and level of knowledge of diabetes is limited amongst urban population and also reflects poor practices towards general health requiring the development of comprehensive public health programmes regarding diabetes to check the growing diabetic problem in India.
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An Internet Based Study to Find out Evidences in Support and Against of Berberin for the Treatment of Diabetes Mellitus
Lakhani P, Tutu S, Saxena U, Kumar R, Singh D, Dixit RK
Department of Pharmacology and Therapeutics, King George Medical University, Lucknow, Uttar Pradesh, India
Objectives: The study was done to find out supportive evidences as well as the evidences against use of berberin for the treatment of diabetes mellitus using web based literature. Materials and Methods: The study was performed by extensive web based survey of literature related to berberin. The studies related to diabetes and berberin were segregated from the others and the data were collected separately for animal and for human studies. The data were also separated for support as well as for against the use of berberin for the treatment of diabetes mellitus. Results: Berberine (an alkaloid) is a plant extract found to be of therapeutic use as antimicrobial, antioxidant etc. Recently number of studies have claimed its effects in lowering of blood sugar and blood lipid levels in animals as well as human. The present study was planned to collect the data from the published articles and critically analyzing them regarding the effect on blood sugar and blood lipid level. The in vitro studies show that berberine increases number of insulin receptors on cells in pancreatic, immune, and connective tissue cells. It has been found that cells become more responsive to insulin after being treated with berberine. Studies on rats have also shown its effect as renal protective agent. Berberine was found to lower fasting, post-prandial blood sugar levels, triglycerides levels and blood pressure. The reductions shown by different studies ranges from 20-32% for blood sugar levels, 14-21% reduction in HbA1c levels, 15-24% for triglycerides levels, and 12-19% reduction in blood pressure reading. The studies have also shown in dropping of insulin resistance by 34-46%. Hypothesis regarding berberine's effects were due to activation of a primal metabolism-regulating enzyme in the body called AMPK. AMPK stimulates cells to take in more blood sugar, thus improving insulin sensitivity. But it also slows liver's own production of extra blood sugar. The Results were comparable significantly when compared to metformin (P < 0.05). Conclusion: The internet based literature survey of animal as well as human studies are in favour of effect of berberin on reduction of blood sugar levels, lipid levels, blood pressure and body weight. The berberin may be a promising agent for treatment of metabolic disorder.
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Comparative Study of Voglibose Versus Linagliptin on Glycaemic Control NAD Lipid Profile in Patient of Type 2 Diabetes Mellitus
Kumar P, Zaman Z, Sinha HK
Department of Pharmacology, Jawahar Lal Nehru Medical College, Bhagalpur, Bihar, India
Objectives: Diabetes mellitus is one of the most common non-communicable diseases globally associated with microvascular complication. Due to progressive nature of type 2 diabetes mellitus dual & triple drug combination with submaximal doses are uses. Present study is designed to study the effect of voglibose to linagliptin on glycaemic control and lipid profile as an add on drug in patients with diabetes mellitus. Materials and Methods: The present 5 study was open, randomized parallel group comparison of two active treatment groups over six months periods Hundreds patients of either sex between the age group 30-70 years suffering from type 2 diabetes mellitus, with FBG >126 mg/dl and HbA1c between 7-10% were selected at random. The effect of voglibose and linagliptin were observed on various parameter i.e. FBG, PPBG, HbA1c and lipid profile. Results: At the end of 6 months it was observed that both linagliptin and voglibose reduced FBG, PPBG and HbA1c significantly but linagliptin caused a significantly greater percentage changes FBG as well as PPBG. Also, fall in total cholesterol, TG, LDL, & VLDL was significant. Conclusion: Though both linagliptin and voglibose were equally effective in lowering HbA1c level but linagliptin shows better Results in improving & lipid profile as compare to voglibose.
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Beneficial Effect of L-methyl Folate Against Adverse Biochemical Changes in Streptozotocin Induced Peripheral Neuropathy in Diabetic Rats
Chhetri S, Bhadri N, Razdan R
Al Ameen College of Pharmacy, Bengaluru, Karnataka, India
Objectives: To investigate the potential ameliorative effect of l-methylfolate (LMF) against biochemical deficit in STZ induced peripheral neuropathy in diabetic rats. Materials and Methods: Diabetes was induced via a single intraperitoneal injection of STZ (55 mg/kg) in male Wistar Albino rats. Treatment with LMF (5, 10, 15 mg/kg; per oral) began on the confirmation of diabetes after 72 hours and was continued for 8 weeks. At the end of the study serum levels of glucose, triglycerides (TG), total cholesterol (TC), high density lipoproteins (HDL) and low density lipoproteins (LDL) were determined. Furthermore the sciatic tissue levels of nitric oxide (NO) malondialdehyde (MDA) and reduced glutathione (GSH) were determined as well as the activity levels of superoxide dismutase (SOD) and catalase (CAT). Results: STZ treated rat showed high serum glucose, TG, TC and LDL levels while marked reduction in HDL (p < 0.001). In sciatic nerve there was a significant increase in MDA level and poor antioxidant levels were observed. Oral administration LMF Resulted in significant reduction of TG, TC and LDL. A marked increase in HDL was observed while in LMF treated group no significant difference in serum glucose levels were observed when compare to STZ treated group. Reduction in MDA level (p < 0.001) and NO was determined nevertheless increase in the antioxidant level was perceived in LMF treated group. Conclusion: Supplementation of LMF ameliorated the adverse biochemical changes which are associated with diabetic neuropathy.
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Supplementation of L-methyl Folate Ameliorates the Behavioural and Electrophysiological Deficits in Streptozotocin Induced Peripheral Neuropathy in Diabetic Rats
Aqib M, Bhadri N, Razdan R
Al Ameen College of Pharmacy, Bengaluru, Karnataka, India
Objectives: To evaluate the neuroprotective potential of l-methylfolate (LMF) against behavioural and electrophysiological deficits in STZ induced peripheral neuropathy in diabetic rats. Materials and Methods: Diabetes was induced via a single intraperitoneal injection of STZ (55 mg/kg) in male Wistar Albino rats. Treatment with LMF (5, 10, 15 mg/kg; per oral) began on the confirmation of diabetes after 72 hours and was continued for 8 weeks. Body weight and behavioural tests were performed subsequently in every two week during LMF treatment period. In addition sciatic nerve conduction velocity studies were performed. In vitro antioxidant activity and AGE inhibitory assay of LMF were also performed. Results: The diabetic control exhibited reduction in muscle coordination, grip strength and thermal hyperalgesia. Furthermore diabetic rats showed decrease in sciatic nerve conduction velocity (NCV) (p < 0.001). Treatment with LMF attenuated diabetes induced modification with regard to the improvement in behavioural parameters and NCV (p < 0.001). In vitro studies have shown good antioxidant activity of LMF. Conclusion: LMF treatment shows efficacy for preventing diabetic deterioration by reducing the oxidative stress and improving the behavioural and electrophysiological deficit in experimental diabetic neuropathy in rats, as compared with diabetic control group.
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Voglibose: Promising Drug for Postprandial Hyperglycemia in Type 2 Diabetes Mellitus
Dharao PG, Sameer B
Vasantrao Pawar Medical College, Nashik, Maharashtra, India
Voglibose belongs to an alpha glucosidase inhibitor (-Gls) discovered in Japan in 1981 which play vital role in reduction of postprandial plasma glucose (PPG) level & thus reduces cardiovascular complications in type 2 diabetes patients. It causes reversible inhibition of α glucosidase enzyme in intestinal brush border & reduce intestinal absorption of starch, dextrin & disaccharides. Its action is insulin independent. Several trials support use of voglibose in control of PPHG & indicated as adjuncts to diet, exercise & also in combination with oral antidiabetic agents and/or insulin in diabetic patients not reaching glycemic control. It also reduces risk of development of frank type 2 diabetes mellitus in high risk individuals with impaired glucose tolerance. In clinical studies it reduce A1c by 0.5 to 0.8%. Its added advantage over sulfonylureas or insulin is, its overdose will not lead to hypoglycemia. It does not cause weight gain. GIT side effects like malabsorption, flatulence, abdominal bloating observed in some individuals, but significantly less with voglibase as compared to other glucosidase inhibitors e.g. Acarbose, Miglitol. Now a day's voglibose appears the most promising drug in treatment of type 2 DM.
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A Comparison of Control of Type 2 Diabetes by Oral Anti-diabetic Agents, Between Tribal and Non-tribal Population of Paschim Medinipur, West Bengal
Modak B 1 , Purkait B 2 , Maity RN 1
1 Department of Pharmacology, Midnapore Medical College, Medinipur, West Bengal, India, 2 Department of Biochemistry, Midnapore Medical College, Medinipur, West Bengal, India
Objectives: This study was conducted to compare the disease control in the tribal and non-tribal population of the district of Paschim Medinipur, West Bengal, diagnosed as type 2 diabetes mellitus and receiving oral anti-diabetic agents of similar groups for the last one year. Materials and Methods: A total 258 subjects of type 2 adult diabetics were chosen in a systematic stratified random manner into groups based on ethnicity and sex, from the OPD of Midnapore Medical College. There were 129 subjects each in non-tribal and tribal group, comprising of 73 males and 56 females. Control of type 2 diabetes was assessed by the analysis of serum glucose level (fasting and post prandial), HbA1c and the lipid profile. Estimated glucose disposal rate was calculated. Statistical analysis was done by SPSS-15. Results: Tribal diabetics were significantly older and their BMI lower on average, than the non-tribal in both sexes. Average fasting and post prandial serum glucose and HbA1c were significantly lower in the tribal than the non-tribal in both sexes. Estimated glucose disposal rate was higher in the tribal than in the non-tribal. Conclusion: There is significant difference in disease control after 1 year of regular treatment with oral anti-diabetic drugs, between tribal and non-tribal type 2 diabetics. However, the significance in the difference in insulin resistance was not high. A longer duration of study and a greater sample size is essential to explain the difference in disease control.
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Protective Effect of Resveratrol in Experimental Models of Insulin Resistance
Mourya AK, Choudhary S, Sah SP, Kumar A
Division of Pharmacology, UGC-Center for Advance Studies, Indian Pharmacological Society, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India
Objectives: The aim of present study is to determine the role ofresveratrol and its possible underlying mechanism in reducing complications of insulin resistancein experimental model of chronic restrained stress. Materials and Methods: Restraint stress or immobilization stress (IS) is an easy and convenient Methods to induce both psychological (escape reaction) and physical stress (muscle work), Resultsing in restricted motility and aggression causing stress and inflammation contributing to development of insulin resistance. Animals were restrained in a modified restrainer individually for 2-hr daily at variable time periods between 9.00-17.00 hrs for 30 days. Resveratrol (5, 10 mg/kg) was dissolved in distilled water and administered intraperitoneally (i.p) 45 minutes prior to CRS for 30 days. Behavioral activities like locomotor activity was evaluated weekly intervals using actophotometer. Biochemical estimation (lipid peroxidation, GSH, nitrite, catalase) of liver and pancreas homogenate was done at the end of the protocol. Results: Resveratrol treatment restored the loss in body weight, attenuated rise in fasting blood glucose, blood pressure, glycosylated hemoglobin, serum insulin levels. Its treatment also attenuated the corticosterone levels, TNF-α, IL-1α, cholesterol and triglycerides as compared to control. Resveratrol produced antioxidant like effect causing decrease in lipid peroxidation, nitrite level and restored GSH and catalase activity in liver and pancreas. Conclusion: The present study suggest the protective effect of resveratrol against c hronic restrained stress induced insulin resistance. The protective effect of resveratrol could be due to its anti-inflammatory and antioxidant like effect.
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Effects of Aqueous Extract of Phyllanthus Niruri on the Relative Weights of Kidney, Liver and Pancreas in STZ-induced Diabetes in Wistar Rats
Bharati D 1 , Tauro S 1 , Dhokchawle B 1 , Sharma P 2 , Shrivastava B 2
1 Department of Pharmacology, St John Institute of Pharmacy and Research, Palghar, Maharashtra, India, 2 School of Pharmaceutical Sciences, Jaipur National University, Jaipur, Rajasthan, India
Objectives: The aim of the study was to find an association between the body weights of diabetic animals and the relative weights of kidney, liver and pancreas in proportion to the body weight of animals and effects of aqueous extract of Phyllanthus niruri (AEPN) at dose of 600 mg/kg/day p.o., on streptozotocin (STZ)-induced diabetes Wistar rats. Materials and Methods: Diabetes was induced by a single intraperitoneal injection (i.p.) of 55 mg/kg, (in 0.1 M citrate buffer, pH 4.5). Wistar rats were divided into four groups: Control (NC), Control treaded with AEPN (NC + AEPN), STZ treated (DC), STZ treated with AEPN (DC + AEPN) which were sacrificed 4 week post treatment. All the animals were weighed prior to the administration of streptozotocin and at sacrificial time. Kidney, liver and pancreas were removed, dried and weighed on Citizen CTG10 balance. Results: A decrease in body weight was observed in the case of STZ diabetic control group whereas no loss in the weight of animal is observed in the group treated with the aqueous extract of P. niruri. The Kidney and liver weight was significantly (p < 0.05) increased, while pancreas weight was slightly increased in diabetic animals. The Kidney, liver and pancreas weight were unaffected due to the 28 days treatment of aqueous extract of P. niruri. Conclusion: It seems that the STZ-induced diabetes causes a significant reduction (p < 0.05) in the body weight of diabetic animals while the relative weights of kidney, liver, pancreas were increased (p < 0.05) while in the group treated with the aqueous extract of P. niruri (600 mg/kg), weight loss was reversed and the relative weights of kidney, liver, pancreas were unaffected.
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Delayed Onset Carbimazole Induced Agranulocytosis
Chandran A, Raghavan V, Pradeep S
Objectives: Thyrotoxicosis is an endocrine disorder Resultsing in excess T3 and T4 usually effecting women. It is treated by antithyroid drugs or by radioactive drugs or by surgical ablation. Antithyroid drug is associated with fatal complication namely agranulocytosis (1 in 500). Associated with a mortality rate of 21.5%. 40 year old female with thyrotoxicosis who was on carbimazole since one year presented to the outpatient department with fever of 4 days duration which was high grade. It was also associated with nausea, vomiting, sore throat and cough. No bleeding manifestations. One year back she had history of loss of weight, heat intolerance and increased sweating and was diagnosed to have thyrotoxicosis for which she was put on carbimazole 20 mg. On examination, alert and conscious. She had few rashes on her forehead and nose. Systems within normal limits. Lab investigations-Hb - 11.3 g%, total count - 1000/μl with a differential count L87, platelet - 1 lakh, TSH - 0.4 mlU/dl, T3 - 103 pg/dl (normal - 84-201 pg/dl). Treatment given - broad spectrum antibiotics, Granulocyte colony stimulating factor (GCSF). Results: WHO SCALE - Certain. Naranjo scale - Definite. Conclusion: Antithyroid drugs bind to thyroid peroxidase and prevent oxidation of iodine and thereby inhibit iodination of tyrosine residues in thyroglobulin and inhibit coupling of iodo tyrosine residues to form T3 and T4. Thyroid colloids is depleted over time and levels of T3 and T4 are progressively lowered. Agranulocytosis an absolute granulocyte count of less than 500/millimetre cube is a rare complication associated with carbimazole. Most cases of agranulocytosis occur within the first 90 days of treatment. This complication can occur even a year or more after starting a therapy. Risk of agranulocytosis is greater in elderly patients and they have higher risk of death. Fever and sore throat are the most common complaints. If High grade fever chills and prostration sepsis should be suspected. The administration of G-CSF therapy may shorten the time of recovery and length of hospitalization in patients with agranulocytosis due to antithyroid drugs.
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To Assess Safety of Saxagliptin in Patients of Type 2 Diabetes Mellitus
Dahiwele A 1 , Kansal D 1 , Sharma P 1 , Kapoor D 2 , Sood V 1
1 Department of Pharmacology, Dr. R.P.G.M.C., Kangra, Tanda, Himachal Pradesh, India, 2 Department of Medicine, Dr. R.P.G.M.C., Kangra, Tanda, Himachal Pradesh, India
Objective: Recently warning was issued by FDA in august 2015 regarding joint pain and dose limitation based on renal function. In the background of this warning, safety of saxagliptin needs to be assessed. Materials and Methods: A cross sectional study was conducted in patients of Type 2 diabetes mellitus attending diabetes OPD in Dr RPGMC kangra and taking metformin and saxagliptin combination in the doses of 1500 mg and 2.5-5 mg respectively. Safety was assessed using laboratory parameters of renal function tests, Liver function tests and history based enquiries of any adverse reaction since drug intake. Results: 10 patients were enrolled in the study after informed consent. After applying t test the p values in paired sample groups of SGOT, SGPT, Total Bilirubin, BUN and Serum Creatinine are 0.83, 0.182, 0.28, 0.322 and 0.121 respectively. Conclusion: Since none of above probability values are significant, it can be said that saxagliptin intake in combination with metformin is found to be safe in mentioned dosages for consumption in type 2 diabetes patients for 2 month duration on above parameters.
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Cancer Risk in Diabetic Patients Treated with Insulin Glargine: A Review
Singh S, Mehrotra A, Kumar R, Kumar N
Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, Uttar Pradesh, India
Insulin glargine is a long acting insulin analogues used to provide basal insulin secretion injected once-daily. It is absorbed more slowly after injection than normal human insulin with no pronounced peak. It differs from human insulin by replacing asparagine with glycine in position 21 of the A-chain and by carboxy-terminal extension of B-chain by 2 arginine residues. The role of insulin glargine as a risk factor for cancers (breast cancer, gastrointestinal cancer, colorectal cancer, hepatobiliary cancer and bladder cancer) is controversial in human studies. Initially in 2009, four observational studies published in Diabetologia showed a possible association between insulin glargine and cancer, particularly breast cancer. Carol Wilson also suggested that use of insulin glargine for >5 years might increase the risk of breast cancer in women with type 2 diabetes mellitus (T2DM), especially if they have previously been treated with other insulins before starting to take insulin glargine. FDA has completed its review of the studies and has determined that the evidence presented in these studies is inconclusive due to Methodsological limitations such as significant heterogeneity in terms of population demographics, follow-up time, study design, sample size and insulin dose. Several meta-analysis studies showed no evidence that use of insulin glargine increases any type of cancer risk in patients as compared with non-glargine. The data for breast cancer also suggests that insulin treatment is not involved in tumour initiation, but might induce tumour progression by up regulating mitogenic signalling pathways. So further investigations are required to observe the association between insulin glargine and breast cancer.
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To Evaluate Effect of Brewer's Yeast Containing Glucose Tolerance Factor on Glycemia and Lipid Profile in Streptozotocin Induced Diabetic Rats
Patil JS, Naikawadi AA, Wali RS, Vanajanarsapur, Bharathaambadasu
Department of Pharmacology, BLDEU's Sri B.M. Patil Medical College, Vijayapur, Karnataka, India
Objectives: Brewer's yeast may have beneficial effects on insulin receptors in diabetic rats because of its glucose tolerance factor. This study was conducted to investigate the effects of Brewer's yeast onglycemia and lipid profile in Streptozotocin (STZ) induced diabetic rats. Materials and Methods: Twenty four Wistar Albino rats of either sex weighing 170-220 gbw were divided into four groups, (i) Control (ii) Control treated with Brewer's yeast (iii) STZ induced diabetic rats (iv) STZ induced diabetic rats treated with Brewer'syeast. Effect of a four-week oral administration of Brewers yeast (160 mg/kg/day) on the glucose homeostasis & lipid profile was assessed in Control & STZ-induced diabetic rats. Body weight, food consumption, blood glucose, lipid profile were measured. Results: Administration of STZ produced a significant increase in blood glucose levels (p < 0.05) as compared to control group. Treatment with Brewer's yeast significantly reduced blood glucose levels (p < 0.05) in STZ induced diabetic rats. Significant decrease in blood glucose levels were also observed in control rats treated with Brewer's yeast. Alterations in lipid profile produced in STZ group of rats were reversed with Brewer's yeast. Conclusion: Based on this study, it can be concluded that Brewer's yeast supplementation has a modest beneficial effect on glycemia and lipid profile in STZ induced type 2 diabetic rats. Further studies are required to confirm the more beneficial effects of Brewer's yeast in diabetes mellitus.
END-20
To Evaluate the Interaction of Piperine with Repaglinide Using Oral and Intraperitoneal Routes of Administration, in Lowering Blood Glucose Level in Diabetic Mice
Atal S, Vyas S, Gudsurkar G
Department of Pharmacology, MGM Medical College, Indore, Madhya Pradesh, India
Objectives: Aim of the study was to evaluate the blood glucose lowering property of piperine given in combination with Repaglinide. Materials and Methods: Diabetes was induced using alloxan in swiss Albino mice. A single dose study employing serial blood sampling was performed. Diabetic mice were grouped as: Group I 2% gum acacia (10 ml/kg, p.o), Group II 2% gum acacia (10 ml/kg, i.p), Group III repaglinide (1 mg/kg, p.o), Group IV repaglinide (1 mg/kg, i.p), Group V repaglinide and piperine (1 mg/kg + 10 mg/kg, p.o), Group VI repaglinide and piperine (1 mg/kg + 10 mg/kg, i.p.) and dosing given accordingly. Blood glucose level was measured at 0 hr, 1, hr, 2 hr, 3 hr, and 4 hr. One way ANOVA followed by multiple tukey's comparison test was employed for statistical analysis. Results: Both standard and combination groups in which the drug was given by oral & intraperitoneal route showed significant lowering of blood glucose as compared to respective control groups where vehicle was given by oral & intraperitoneal routes at all-time points (P < 0.05). Repaglinide given in combination with piperine by oral route showed significantly greater lowering of blood glucose as compared to repaglinide given alone by oral route, at 4 hrs after drug administration (p < 0.05). Repaglinide given in combination with piperine by intraperitoneal route improved blood glucose lowering, but not significantly as compared to repaglinide given alone by intraperitoneal route at 4 hrs after drug administration (p > 0.05). Conclusion: Prolongation of duration of action of the short acting drug repaglinide reflects bio enhancing activity of piperine probably due to increased bioavailability of the drug.
END-21
Evaluation of Antioxidant Property of Saroglitazzar by Nitric Oxide Radical Scavenging Assay
Elango P, Sharanya S, Darling C
Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra University, Porur, Chennai, Tamil Nadu, India
Objectives: Management of Diabetes Mellitus needs constant supervision to maintain normal glycemic level and to prevent its complications. The complications are not only due to high blood sugar levels but also dyslipidemia. Saroglitazar has got dual action as an insulin sensitizer and also a hypolipidemic agent as well. In this research work we have explored its antioxidant activity using nitric oxide radical scavenging assay. Materials and Methods: Nitric Oxide scavenging ability: Nitric oxide scavenging activity was determined according to Griess Illosvoy reaction. Ascorbic acid was used a positive control. Nitric oxide scavenging ability (%) was calculated by using the formula: ([A 540 nm of Control − A 540 nm of Sample]/[A 540 nm of Control]) × 100. Results: Saroglitazar showed 42.85% of free radical scavenging activity in lower concentration and 65.30% in higher concentration and when it is compared ascorbic acid as standard which showed 78.57% of free radical scavenging activity in lower concentration and 97.95% in higher concentration. This shows that Saroglitazar showed antioxidant activity in parallel with ascorbic acid in the Methods of nitric oxide radical scavenging assay. Conclusion: In addition the beneficial effects of Saroglitazar as an insulin sensitizer and hypolipidemic agent, its free radical scavenging activity can be further investigated and be added as an adjuvant drug in the management of diabetes mellitus
END-22
Synergistic Neuroprotective Activity of Benfotiamine Co-administered with Erythropoietin in Diabetes Induced Peripheral Neuropathy
in Rats
Arpitha K 1 , Hariprasad MG 1 , Razdan R 1 , Yasha TC 2
1 Department of Pharmacology, Al-Ameen College of Pharmacy, Bengaluru, Karnataka, India, 2 Department of Neuropathology, NIMHANS, Bengaluru, Karnataka, India
Objectives: The present study was undertaken to evaluate the individual and combination effects of benfotiamine (BT) and erythropoietin (EPO) in diabetes induced peripheral neuropathy (DPN) in rats. Materials and Methods: Diabetes was induced in Wistar rats by single intraperitoneal injection of 50 mg/kg, Streptozotocin (STZ). After confirmation of diabetes the diabetic rat were administered BT (100 mg/kg p.o daily), EPO (500 U/kg, i.p.) twice a week and their combination for 5 weeks. The degree of protection was determined by measuring behavioural parameters like motor in-coordination, thermal & cold hyperalgesia, grip strength, electrophysiological properties of sciatic nerve like nerve conduction velocity, and histopathology of sciatic nerve. Results: Diabetic control rats developed neuropathy which was seen in the form of reduction in motor in-coordination, thermal & cold hyperalgesia, grip strength and sciatic nerve conduction velocity. Treatment with BT, EPO and their combination ameliorated the above deficits. Histopathology of sciatic nerve showed improvement in the neuronal architecture. Conclusions: Combination of BT and EPO exhibited synergistic neuroprotective effect in diabetic neuropathic rats.
END-23
Effect of Monosodium Urate on Oxidative Stress Markers in High-fat Diet and Lipopolysaccharide Induced Diabetic Nephropathy
Ahir S, Chorawala M
Department of Pharmacology, KB Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India
Objectives: Development of the rat model which simulate pathological characteristics of chronic diabetic nephropathy & validation of this model. Materials and Methods: The concept of this model was involvement of innate immune response and low grade inflammation that leads to insulin resistance and subsequently diabetic nephropathy. During 63 days of study period, rats were given HFD, Lipopolysaccharide (LPS) and Monosodium urate (MSU). Different parameters related to glucose tolerance, renal function and oxidative stress were measured. Hematological and histopathological parameters measurements were also done to accomplish desire Results. Results: Lipopolysaccharide given once weekly for 63 days produced typical symptoms of diabetic nephropathy with increased AUC of glucose, serum creatinine, urine albumin, urine creatinine. Glomerular filtration rate (GFR) was reduced as indicated by the 24 hrs urine creatinine clearance. Reduction of hematological parameters, change in oxidative stress parameters & change in renal morphology also indicates diabetic nephropathy in HFD + LPS treated group and HFD + LPS with MSU treated groups. Conclusion: HFD-fed & LPS treated animals additionally injected with different doses of MSU does not have any direct effect but it can accelerate oxidative stress involved in DN.
END-24
Antihyperlipidemic and Hepatoprotective Effects of Macrotyloma Uniflorum Seeds in Fructose Induced Metabolic Syndrome in Rats
Mistry K, Panda V, Desai Y
Principal K. M. Kundnani College of Pharmacy, Mumbai, Maharashtra, India
Objectives: The present study evaluates the protective effects of a hydro alcoholic extract of the seeds of Macrotyloma uniflorum (MUSE) and ferulic acid in hyperlipidemia and liver abnormalities associated with the metabolic syndrome in rats. Materials and Methods: Liver and lipid abnormalities were induced in rats by administering them fructose (25% w/v) in drinking water for 45 days. MUSE (200 mg/kg and 400 mg/kg), ferulic acid (80 mg/kg) and the reference drug gemfibrozil (60 mg/kg) were administered to rats along with fructose. Results: MUSE and ferulic acid treatments significantly attenuated the fructose-elevated activities of the serum marker enzymes AST and ALT, and malondialdehyde. Weight of liver as well as liver to body weight ratios were found to be significantly lower in MUSE and ferulic acid treated rats when compared with the fructose control rats. Treatment with MUSE and ferulic acid restored the fructose depleted activities of the antioxidant enzymes superoxide dismutase, catalase, and glutathione peroxidase and glutathione reductase in liver. A significant alteration in lipid profile was observed in the treatment groups when compared with the fructose fed animals. Both treatments showed a dose dependent decrease in levels of congestion, degeneration and necrosis of hepatocytes when compared with the fructose control group. Conclusion: The present findings suggest that MUSE may be useful as an adjuvant for the management of hyperlipidemia and liver abnormalities associated with the metabolic syndrome. The potent antioxidant activity of its phenolic phytoconstituents, particularly ferulic acid, may be a major factor towards this activity.
END-25
Effect of Stevioside on Advanced Glycation Endproduct Formation
Gogawale V, Aswar U, Maniyar P, Aswar M
Department of Pharmacology, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India
Objectives: The effects of stevioside (Stv) treatment on advanced glycation product (AGE) formation were evaluated. Materials and Methods: The antiglycation property of Stv was evaluated using in vitro model, SDS-PAGE followed by in vivo study. Streptozotocine (Stz; 30 mg/kg i.p.) induced diabetic rats, which showed a glucose level above 250 mg/dl were divided into five groups (n = 8). The animals which showed more than 7 HbA1c were treated with either metformin (Met; 500 mg/kg, p.o.), Stv (50 mg/kg, p.o) and Stv (100 mg/kg, p.o) for 28 days. Body weight, blood and urine analysis were done for various biochemical parameters every week. On the last day of treatment, the animals were sacrificed; the kidney was isolated and studied for renal AGE as well as histology. Results: An in vitro insulin glycation assay showed Stv as glycation inhibitor. The persistent hyperglycaemia for 3 weeks led to a significantly increased blood glucose as well as HbA1c (p < 0.0001). Treatment with Met as well as Stv significantly reduced serum blood glucose as well as HbA1c (p < 0.001). It also had a favourable effect on blood lipid profile. Urine analysis indicated reduced level of glucose, proteins, albumin and creatinine (p < 0.001) as compared to Stz control. Stz control group showed a significant increase in renal AGE while Stv treatment significantly reduced renal AGE (p < 0.001). Conclusion: Stevioside demonstrates potent anti glycation activity.
END-26
Comparative Study of Vitamin E and Omega 3 Fatty Acids in Type 2 Diabetes Mellitus
Dass AS 1 , Sarala N 1 , Venkatarathnamma PN 2
1 Departments of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India, 2 Department of Medicine, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India
Objectives: To assess the effect of vitamin E (Vit-E) and omega 3 fatty acids (OFA) on fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated haemoglobin (HbA1c), anthropometric measurements (BMI, waist-hip ratio[WHR]), lipid profile (TC, TG, LDL, HDL) and cognitive function using mini mental state examination scale (MMSE). Materials and Methods: Randomized, parallel, open label study was conducted on patients attending Medicine Department of R.L. Jalappa Hospital and Research Centre from February 2014 to June 2015. Hundred patients diagnosed with type 2 diabetes mellitus (T2DM) receiving combination of metformin (500 mg) and glimepiride (1 mg) were recruited. They were randomly assigned to receive add on therapy of Vit-E 400 mg (G1) or OFA (eicosapentaenoic acid-180 mg, docosahexaenoic acid-120 mg) (G2), once daily for 12 weeks and Group 3 (G3) served as control. FBS, PPBS, HbA1c, BMI, WHR, lipid profile, MMSE were done at the baseline and 12 weeks. Results: Eighty seven patients (G1 = 31, G2 = 29, G3 = 27) completed the study. Significant reduction in FBS, PPBS, HbA1c and TG was observed in all three groups at 12 weeks. TC and LDL was significantly reduced in patients receiving add on therapy and control respectively at 12 weeks. BMI and WHR were significantly increased in control group. In patients receiving Vit E and OFA the reduction of FBS, PPBS, and HbA1c and lipid levels were similar. TC was significantly reduced by Vit-E compared to control. There was no significant effect on cognitive function. Conclusion: Vit-E or OFA supplementation in type 2 diabetes mellitus patients on oral anti-diabetic therapy had similar effect on glycemic control and lipid profile.
TOX
TOX-1
Amelioration of Cyclophosphamide Induced-hemorrhagic Cystitis, DNA Damage and Oxidative Stress by Thymoquinone: Role of Nrf2
Chandrayan G, Gore PR, Mahajan UB, Prajapati C, Goyal SN, Patil CR
Department of Pharmacology, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra, India
Objectives: To evaluate the protective effect of Thymoquinone (TQ) against the cyclophosphamide (CP)-induced hemorrhagic cystitis in Balb/c mice. Materials and Methods: TQ was administered intraperitoneally at 10, 20 and 30 mg/kg/day doses, twice a day, for three days after the intraperitoneal injection of 200 mg/kg CP. The protective efficacy of TQ was determined in terms of the protection against histological perturbations in the bladder tissue, reduction in the oxidative stress in bladder homogenates and inhibition of the DNA damage estimated through comet assay and DNA fragmentation assay. Immunohistochemistry of the bladder sections was carried out to examine the Nrf2 expression. Results: TQ dose dependently reduced the CP-induced oxidative stress and DNA damage. Significant decrease in the cellular infiltration, edema, epithelial denudation and hemorrhage were observed in the histological studies in the group treated with 30 mg/kg TQ. A dose dependent rise in the Nrf2 expression was observed in TQ treated mice. Conclusion : These Results confirm that TQ ameliorates the CP-induced hemorrhagic cystitis in mice through reduction in the CP-induced oxidative stress, reduction in the DNA damage and through increased expression of the Nrf2 in the bladder tissue.
TOX-2
A Simple RP-HPLC Methods for Determining Imidacloprid Residues in Goat Tissues
Dewangan G 1 , Mishra A 2 , Mandal T 2
1 Department of Pharmacology and Toxicology, College of Veterinary Science and Animal Husbandry, NDVSU, Mhow, Madhya Pradesh, India, 2 Department of Pharmacology and Toxicology, West Bengal University of Animal and Fishery Sciences, Mohanpur Campus, Nadia, West Bengal, India
Objectives: The present work is aimed to develop a rapid, simple, sensitive and reliable reverse phase high performance liquid chromatography (RP-HPLC) Methods for determining imidacloprid and its residues in different substrates of goat. Materials and Methods: The Methods consists of extracting with acetonitrile from different tissues and cleans up with acetonitrile and hexane (50%) mixture. Quantification was performed by reverse phase (RP) HPLC with PDA detector. Separation was achieved using C-18 column with mobile phase consisting of acetonitrile and purified HPLC grade water. Results: The chromatogram showed a well-resolved peak of imidacloprid, and the retention time was 3.30 minutes. The limit of detection and limit of quantification were 0.01 μg ml -1 and 0.04 μg ml -1 respectively and recovery from different substrates was 92-98%. Conclusion: The Methods is satisfactory and proved to be very precise and most suitable for rapid precise analysis of imidacloprid in animal tissues.
TOX-3
Amelioration of Cisplatin Induced Renal Injury by Terminalia Chebula in Wistar Rats
Kalra P, Karwasra R, Singh S, Gupta YK
Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India
Objectives : The aim of the present study was to evaluate the renoprotective effect of hydro alcoholic extract Terminalia chebula in cisplatin induced nephrotoxicity model in Wistar rats. Materials and Methods : 50 mg, 100 mg and 200 mg/kg body weight of Terminalia chebula hydro alcoholic extract was orally administered to Wistar rats (n = 6) for 10 days. On day 7, 8 mg/kg of cisplatin was administered intra-peritoneally to rats in all groups. Serum creatinine and blood urea nitrogen levels were measured on day 1 and 10. The toxicity was evaluated by biochemical, histopathological and immuno histochemical analysis. Results: Our study demonstrated that 200 mg/kg dose of hydro alcoholic extract of Terminalia chebula significantly inhibited the elevation of biochemical parameters viz a viz serum creatinine and blood urea. The immuno histochemical analysis of caspase 3, an apoptotic marker revealed that the increased levels of caspase 3 in cisplatin group were significantly lowered by Terminalia chebula hydro alcoholic extract. The kidneys of cisplatin treated rats showed diffuse acute tubular necrosis and infiltration of inflammatory cells which was reversed by our treatment group. Conclusion: This study successfully reports that terminalia chebula hydro-alcoholic extract is effective in improving cisplatin induced nephrotoxicity by exerting its anti-oxidative, anti-inflammatory and anti-apoptotic effects.
TOX-4
Carbamazepine Induced Toxic Epidermal Necrolysis in a Patient of Seizure Disorder
Gurung A, Jaju JB, Solunke R, Dharmadhikari SC, Deshmukh VS, Pawar G
Department of Pharmacology, Government Medical College, Latur, Maharashtra, India
Objectives: Toxic epidermal necrolysis (TEN), also known as Lyell's syndrome, is a widespread life-threatening mucocutaneous disease where there is extensive detachment of the skin and mucous membrane. Many factors are involved in the aetiology of TEN, the most common being the adverse drug reactions. Case Report: Patient is a known case of generalised tonic-clonic seizure receiving prophylactic Sodium Valproate since two years. When patient's seizure were not controlled by Sodium Valproate, she was taken to a private neurologist where she was prescribed tablet Tegritol CR 200 mg (tab. Carbamazepine Extended release Tablets). On the 8 th day of Carbamazepine, patient developed fever and blisters all over the body followed by epidermal detachment of >30% body surface area. The clinical impression was TEN induced by Carbamazepine. On applying World Health Organization causality assessment scale and Naranjo adverse drug reaction probability scale the association between TEN and Carbamazepine was "probable". Carbamazepine was stopped immediately. She was treated with high dose intravenous Hydrocortisone and systemic and topical antibiotics. After 10 days, the progression of the skin lesions halted and she was discharged. Conclusion: In the view of "probable" association between Carbamazepine and TEN in this case report and the increase in the number of prescriptions for Carbamazepine in recent years, this case has been reported to highlight the importance of using Carbamazepine judiciously as it is associated with this life threatening adverse reaction.
TOX-5
Assessment of Lipid Peroxidation Biomarker Malon-di-aldehyde Among Adolescent Inhalant Users
Verma A 1 , Jain R 1 , Dhawan A 1 , Lakshmy R 2
1 National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, India, 2 Department of Cardiac Biochemistry, All India Institute of Medical Sciences, New Delhi, India
Objectives: Inhalant use is on rise among children and adolescents in recent years. Literature suggests that toluene inhalation affects antioxidant protective systems of various tissue with numerous adverse health effects. The present study evaluated the association between excretions of Malon-Di-Aldehyde (MDA), and lipid peroxidation biomarker among adolescent Inhalant users seeking treatment at a tertiary care Centre of India. Materials and Methods: The study included individuals exposed to toluene (Group I) and healthy individuals with no history of drug use (Group II). Five ml of blood and thirty ml of urine was collected from each patient, meeting the inclusion criteria. Urinary Hippuric acid and serum concentration of MDA were determined by using Gas Chromatography and spectrophotometric assay respectively. Results: A total of 60 male subjects (toluene exposed, n = 30 and unexposed, n = 30) were included. Mean Age for Group I and Group II were 15.05 ± 1.99 and 15.2 ± 2.36 years respectively. Mean Urinary Hippuric Acid and creatinine concentration ratio in Group I and Group II was found to be 1.6 ± 2.1 and 0.26 ± 0.32 respectively. Toluene exposed subjects showed significant increase in MDA levels (nmol/ml) when compared with healthy controls (29.25 ± 14.42 vs 5.27 ± 2.81, p < 0.001). Conclusion: The findings suggest that exposure to toluene induces oxidative stress, particularly Lipid Peroxidation. Further studies with larger sample size are needed to clarify the biological significance of MDA among inhalant users. Supported by National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi and University Grants Commission, Government of India.
TOX-6
Antioxidant Effect of Metformin in Alcoholic Liver Disease in Rats
Borole K 1 , Bodhankar SL 1 , Padalkar P 2
1 Department of Pharmacology, Bharati Vidyapeeth Deemed University Medical College, Pune, Maharashtra, India, 2 Department of Biochemistry, Bharati Vidyapeeth Deemed University Medical College, Pune, Maharashtra, India
Objectives: Excessive alcohol consumption causes toxic effects in which liver damage is very common. There are no promising drugs available to prevent or cure ALD. ALD is related to increased oxidative stress by acetaldehyde; the metabolite of alcohol. Metformin has shown beneficial effects in non-alcoholic fatty liver disease by virtue of its anti-oxidant action. So this study was undertaken to evaluate anti-oxidant effect of Metformin in alcohol induced hepatic damage in rats. Materials and Methods: 30 S.D. Rats of either sex weighing 200-250 g were divided into 5 groups. Ethanol (E) 40% v/v in dose 1 ml/100 g/d was given orally. Drug treatments given were as: Group-I: Control (E), Group-II-vehicle control (E + DW): Distilled water, Group-III: (E + Metformin 125 mg/kg) low dose metformin, Group-IV: (E + Metformin 250 mg/kg) moderate dose metformin, Group-V: (E + Metformin 500 mg/kg) high dose metformin. On day-22 animals sacrificed, livers removed and MDA, SOD, CAT levels were estimated spectrophotometrically. Results: Pro-oxidant MDA levels were significantly lower and Anti-oxidant SOD and CAT levels were significantly high in metformin treated groups than ethanol and vehicle treated groups. Conclusion: Metformin offers beneficial anti-oxidant effects against ethanol induced oxidative stress leading to liver damage.
TOX-7
Warfarin Toxicity Presenting as a Massive Hemoptysis, Hemeturia and Malina: A Case Report
Rajpara A, Kanani N
Department of Pharmacology, Government Medical College, Vadodara, Gujarat, India
Objectives: Warfarin is a coumarin derivative anti-coagulant drug, very widely used for prevention and treatment of many thromboembolic event in some clinical situations. Generally, it is considered as a safe drug, but its toxicity, may Results in massive coagulopathy i.e., bleeding from various sites of body, internal or external. Here, we report a case, who presented with bleeding in sputum, urine and stool. On elaboration, he had past history of LV Apical clot and was on tablet warfarin 5 mg since last three and half month. His coagulation profile laboratory shown PT >180 seconds with INR >17.79 on admission. Warfarin was stopped immediately and patient was given injection Vit.K 1 ampule intravenously once for next day. Patient was transfused with 8 units of Fresh Frozen Plasma over 4 days. The recovery was good clinically as well as in terms of coagulation profile. Patient was discharged and started low dose (2 mg) warfarin for prophylaxis of LV Apical clot and asked for follow up after 15 days. Conclusion: Patient on long term warfarin therapy should be screened at regular interval for any abnormality in coagulation profile or any clinical sign of internal bleeding. Warfarin toxicity can be treated by withholding the drug and giving Vit.K with Fresh Frozen Plasma.
TOX-8
Prenatal Developmental Toxicity Study of Oligosaccharide Based Standardized Extract from Trigonella Foenum-Graecum in Rats
Deshpande P, Mohan V, Thakurdesai P
Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, India
Objectives: The prenatal developmental toxicity of oligosaccharides based standardized extract of Fenugreek (Trigonella foenum-graecum) seeds (SFSE-OS) in pregnant female rats and their developing fetuses was evaluated in Wistar rats. Materials and Methods: SFSE-OS (250, 500 and 1000 mg/kg body weight/day) was orally administered to each group of 30 mated females on gestation days (GD) 5 to GD 19. Food consumption, body weight, and clinical signs were monitored throughout gestation period. Cesarean sections were performed on GD 20 and maternal parameters like number of corpora lutea, gravid uterus weight along with cervix, number of implantations, number of early and late resorptions, and number of live and dead fetuses were recorded. Live fetuses were weighed and examined for external, visceral and skeletal variations and malformations. Results: No signs of gross pathological abnormalities were recorded in any dam from any dose group. The parameters such as number of corpora lutea, implantation sites, live foetuses, dead foetuses, and resorptions, pre-implantation and post-implantation loss did not vary between the control and the treated groups. There was no significant difference in the mean litter size, mean number of males and females per litter, overall incidence of external, visceral and skeletal anomalies of the control group and treated groups. Conclusion: The "No-Observed-Adverse-Effect-Level (NOAEL)" of SFSE-OS for maternal toxicity, fetotoxicity and teratogenicity in Wistar rat was 1000 mg/kg body weight.
TOX-9
Pattern of Adverse Drug Reactions During Use of Steroids in Patients of a Tertiary Care Hospital in India
Paradkar SG 1,2 , Sinha SR 1,2 , Patil P 1,2 , Patel SB 1,2
1 Department of Pharmacology, Grant Government Medical College and Sir JJ Group of Hospitals, Byculla, Mumbai, Maharashtra, India, 2 Department of Medicine, Grant Government Medical College and Sir JJ Group of Hospitals, Byculla, Mumbai, Maharashtra, India
Objectives: Corticosteroids have been used as an anti-inflammatory and immunosuppressant agent in a variety of pathologies. However, steroids have short term side effects such as cutaneous, neurophysiological, hematologic effects and long term ones like osteoporosis, adrenal insufficiency, hyperlipidemia etc. Steroid use needs to be monitored for adverse drug reactions and the drug use may be tapered or an alternative may be prescribed when the risks outweigh the benefits. Hence we planned this study with the Objectives of observing the pattern of such adverse drug reactions, conducting a causality assessment of the same and assessing the steps taken to attenuate the reaction. Materials and Methods : Approval from the Institutional Ethics Committee has been taken for the study. The details of all adverse drug reactions due to steroids reported by patients from the medicine ward of Sir JJ group of hospitals to The Department of Pharmacology which is adverse drug monitoring centre for the Pharmacovigilance programme of India within a time period of two months are being entered in suspected adverse drug reaction forms after causality assessment by the WHO-UMC system. Waiver of consent has been approved for the study. The outcomes of interest are the disorder for which steroids have been prescribed, dose, duration, relevant lab investigations and treatment of the adverse drug reaction. All the data will be entered in a pre-determined excel sheet and the individual percentages of the outcomes of interest will be calculated. Results and Conclusion: The study is currently ongoing, hence will be displayed at the time of conference.
TOX-10
Chronic Exposure to 900 MHz and 1800 MHz Radiofrequency Radiation Alters Cognitive Function in Male Rats
Das PP, Devasani K, Chaithanya K, Razdan R
Al Ameen College of Pharmacy, Bengaluru, Karnataka, India
Objectives: The current study was designed to evaluate the possible implications on cognitive function and alteration in neurotransmitter level on exposure to radio frequency - electromagnetic radiation (RF-EMR) in male rats at 900 MHz and 1800 MHz frequency. Materials and Methods: Male Wistar rats (180-250) were divided into 3 groups (6 in each), sham exposure, exposure to 1800 MHz and exposure to 900 MHz for 2 hours per day for 3 months. At the end of the study effect on cognitive function and behavioural pattern was carried out on elevated plus maze, T maze, step down passive avoidance and locomotor activity. Brain was removed to estimate dopamine, nor-adrenaline, and GABA level and acetylcholinesterase enzyme activity. Histopathological study of brain by H&E staining was performed. Results: Rats exposed to 1800 MHz and 900 MHz radio frequency radiation showed an increase in transfer latency when studied in elevated plus maze and in Tmaze indicating reduction in learning and memory. Locomotor activity was reduced when compared to sham control. Time spent in shock free zone was reduced in rat exposed to 900 MHz in step down passive avoidance test. The brain levels of dopamine, noradrenaline, GABA and cholinesterase activity was significantly reduced when compared to sham control. Histopathological findings of brain showed marked congestion of the cerebral blood vessels and few of the pyramidal cells and neuroglial cells showed degenerative changes with mild inflammatory infiltration in male rats exposed to 1800 MHz and 900 MHz. Conclusion: Exposure of RF-EMR to male rats causes reduction in cognition functions like memory, learning and locomotory activity and an increase in anxiety - related behavior.
TOX-11
A Case Report of Exfoliative Dermatitis due to Phenytoin in Epileptic Patient as ADR
Nandini BN 1 , Rao RS 1 , Kiran PU 1 , Rao MVVT 2
1 Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India, 2 Department of General Medicine, Rangaraya Medical College, Kakinada, Andhra Pradesh, India
Objectives: To report the exfoliative dermatitis induced by phenytoin in epileptic patient and to emphasize its early recognition. Materials and Methods: A case report of a patient who had hypersensitive exfoliative dermatitis of skin due to phenytoin. Phenytoin (Diphenylhydantoin/Dilantin) is highly effective and widely prescribed anticonvulsant agent used in treatment of grandmal and psychomotor epilepsy. Phenytoin is linked with anticonvulsant hypersensitivity syndrome manifested by fever, lymphadenopathy, and exfoliative dermatitis (2.4%) which starts 2-8 weeks after initiation of therapy. Dechallenge and rechallenge was done. Results: A 45 years old man with fever, exfoliative dermatitis was admitted in General Medicine ward Government General Hospital, Kakinada. Exfoliative dermatitis - scaling and crusting involving face, neck, trunk and extremities. A careful history revealed that phenytoin therapy started 6 weeks prior to admission by local physician for seizures. Steroids, supportive therapy and alternative antiepileptic (Tab Carbamazepine) were started. He was kept under observation and symptoms subsided on 6 th day of admission. Dechallenge was done but no reaction observed. Rechallenge was done on 7 th day after taking proper consent and risk explained, same symptoms reappeared and he was treated in the same way. ADR reported. Blood reports: Haemoglobin - 10.1 gm%, Total leucocyte count - 14,400 cells/m 3 , Absolute eosinophil count - 340 cells/μl, Bilirubin - 12.0 mg/dl. Conclusion: As patient showed positive response towards rechallenge and dechallenge this implies the contribution of Phenytoin to the skin reaction . Screening for sensitivity of the drug like phenytoin is to be considered before continuation of the treatment.
TOX-12
Trends and Outcome of Snake Bite in a Tertiary Care Hospital of West Bengal: A Prospective Observational Study
Verma IK, Chatterjee S, Hazra A, Choudhury S, Lahiry S, Bhunya PK
Department of Pharmacology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India
Objectives: Poisonous snake bites associated with high morbidity and mortality and imposes a substantial burden on our healthcare system. However, prospective data on the epidemiology and outcome from Eastern India are limited. This prospective observational study aimed to evaluate the frequency, treatment and mortality profile of snake bite cases admitted to a tertiary care hospital of West Bengal over 18 months. Materials and Methods: All diagnosed cases of snake bites were prospectively evaluated till death or discharge. Data related to socio-demographic background, nature of bite, lag period for medical attention, treatment received, clinical parameters and outcome were recorded. Descriptive analysis and a logistic regression model was constructed to identify predictors of mortality. Results: Snake bites (264 cases) constituted 44.59% of total admissions due to acute poisoning during the study period. The median age was 25 (IQR 11 to 40) years with preponderance of male (67.8%) and rural background (79.5%). Majority were referral from primary centers; 84.5% cases received anti-snake venom serum (ASV); 34.1% needed dialysis due to acute kidney injury. Despite all death cases having received ASV, 46 deaths contributed to a mortality rate of 17.4% (95% CI 12.85-22.0%). Logistic regression modelling for death predictors, identified long time interval from bite to primary hospitalization as the strongest predictor (adjusted odds ratio 15.49; 95% CI 5.78-41.52). Conclusion: Snake bite poses a significant burden due to high mortality. Despite usage of ASV over 17% succumbed at tertiary care. Appropriate primary care, protocol compliance and public awareness are important to reduce this burden.
TOX-13
A Prospective Study of Exploring Use of Polyvalent Anti-snake venom ASV and Clinical Outcomes in Snake Bite Patients
Pore SM, Shah RD, Kumbhar AV, Salunke AT, Ramanand SJ
Department of Pharmacology, Government Medical College, Miraj, Maharashtra, India
Objectives: The Objectives of the study was to evaluate use of anti-snake venom (ASV) in terms of indication for ASV, total dose of ASV administered and occurrence of adverse reactions to ASV. The recovery time and clinical outcomes in terms of cure, complications and death were also assessed. Materials and Methods: This prospective study was conducted at two tertiary care teaching hospitals during the period of February 2015-August 2015. All indoor patients receiving ASV were included. Results: Thirty-two patients receiving ASV were enrolled in the study. The indication for ASV was neurotoxic snake bite in 37.5% patients and vasculotoxic snake bite in 37.5% patients while ASV was administered without signs and symptoms of systemic envenomation in 25% patients. The mean dose of ASV in neurotoxic snake bite was 22.91 ± 19 vials while 13.75 ± 6.78 vials in vasculotoxic snake bite. The mean recovery time in vasculotoxic snake bite was 84 ± 2.78 hours and 96 ± 3.13 hours in neurotoxic snake bite. Among patients with systemic envenomation with vasculotoxic or neurotoxic snake (n = 24), 83.33% cured, 12.5% were discharged with cellulitis and one patient of neurotoxic snake bite died. Two patients showed anaphylactic reaction to ASV. Conclusion: Inappropriate use of ASV in absence of systemic envenomation was seen in substantial number of suspected snake bite patients. Neurotoxic snake bite required higher dose of ASV as compared to vasculotoxic snake bite.
GIT
GIT-1
Antiulcer Activity of the Most Active Sub-fraction of Methanolic Leaf Extract of Buchanania Lanzan Spreng
Rai U 1,2 , Singh S 2 , Ramoji K 2 , Pattnaik AK 1
1 Department of Pharmaceutical Sciences, Birla Institute of Technology, Mesra, Ranchi, Jharkhand, India, 2 Department of Pharmaceutics, Indian Institute of Technology (BHU), Varanasi, Uttar Pradesh, India
Objectives: The study was aimed at evaluating the antiulcer activity of the most active sub-fraction (F 4 ) of Buchanania lanzan Spreng. Leaves methanolic extract (BLE). Materials and Methods: The antioxidant activity of BLE fractions and sub-fractions has been assayed to determine the F 4 by applying chromatographic analysis and in vitro antioxidant Methods like hydrogen peroxide free radical scavenging assay, hydroxyl radical scavenging assay, DPPH (1,1-diphenyl-2-picryl hydrazyl) radical scavenging activity, total flavonoid and total phenolic content estimation. The antiulcerogenic activity of F 4 (50 and 100 mg/kg, b.w., orally) was evaluated employing aspirin + pylorus ligation (APL), HCl/ethanol (HE) induced gastric ulcer models in rats and histopathological examination of stomach tissues of rats. Results: F 4 exerted a significant (P < 0.01) dose-dependent decrease in the ulcerative lesion index produced by APL and HE as compared to the standard drugs omeprazole (30 mg/kg, b.w. orally) and ranitidine (32 mg/kg, b.w. orally) respectively. The reduction in gastric fluid volume, total acidity and an increase in the pH of the gastric fluid in APL treated rats proved the antisecretory activity of F 4 . From histopathological examination it was found that, in tissues of both the models that received pre-treatment with F 4 showed better protection of the gastric mucosa in a dose dependent manner as indicated by reduction or absence of mucosal erosion and infiltration of leucocytes. Conclusion: These Results suggest that leaves of Buchanania lanzan Spreng. Possess potential antiulcer activity, which may be attributed to its antioxidant mechanism of action.
GIT-2
Study of Antiulcer Activity of Hydro Alcoholic Extract of Triticum Aestivum Shoot in Aspirin Induced Ulcer in Rats
Singh PK, Rapelliwar AP, Varma SK
Department of Pharmacology, MGIMS, Sewagram, Wardha, Maharashtra, India
Objectives: To study the antiulcer activity of triticumaestivum shoot extract in aspirin induced ulcer in rats. Materials and Methods: Plant was collected, identity of plant was confirmed and authenticated by botanist. The present study was conducted in Wistar rats. Aspirin Induced Gastric Ulcers: Gastric ulcers were induced by oral administration of a single dose of aspirin (200 mg/kg) by the Methods of Hemmati et al (1973). Results: Aspirin (200 mg/kg, PO) produced various grades of ulcers in 100% animal in the distilled water (10 ml/kg, orally) treated control group. Triticum aestivum extract was administered orally in doses of 100 mg/kg and 200 mg/kg. In the dose of 100 mg/kg, it showed protection against ulcers in 30.87% animals as well as significant (p < 0.05) decrease in the number of ulcers and ulcer index. In the dose of 200 mg/kg, it showed protection against ulcers in 47.73% animals and reduced the number of ulcers and ulcer index significantly (p < 0.05). Ranitidine (10 mg/kg, PO), as standard drug for comparison showed protection against ulcers in 82.11% animals. It also significantly (p < 0.05) decreased the number of ulcers and the ulcer index in comparison to the control group. Conclusion: Peptic ulcer disease (PUD) refers to ulceration of the stomach, duodenum, or both. The antiulcer activity of Triticum aestivum was evaluated in aspirin induced ulcer model. Triticum aestivum showed significant antiulcer activity in aspirin induced gastric ulcers in Wistar rats. This was evident by a decrease in the percent incidence of ulcers, number and severity of ulcers. We compared the antiulcer effect of Triticum aestivum with ranitidine and found it equieffective in both experimental model and showed protection significantly.
GIT-3
Pharmacological Effect of Acetoacetate in Diclofenac Induced Peptic Ulcer
Shah A, Nivasarkar M, Panchal S
Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India
Objectives: To study the effect of ketone bodies in peptic ulcer by using diclofenac as inducing agent. Objectives: Peptic ulcer disease is the most common disease worldwide. Diclofenac sodium is the highest prescribed drug amongst the analgesics, antipyretics and anti-inflammatory agents. Diclofenac sodium induces peptic ulcer in rats because of its prostaglandin inhibitory properties. Acetoacetate, a ketone body is the chemical produced by our body and it breaks down the fat for energy consumption. Materials and Methods : Wistar rats were taken for the study. They were divided in 4 groups: normal control, disease control, positive control and test (each of 6 animals). Peptic ulcer was induced with diclofenac sodium. Diclofenac sodium (20 mg/kg), acetoacetate (5.26 mg/kg) and ranitidine (13.5 mg/kg) were given for 4 days consecutively. Animals were sacrificed on fifth day. The stomach was isolated for ulcer index tissue measurement, estimation of oxidative stress parameter and histopathological studies. Results: There was significantly decreased in the ulcer index and catalase in all the groups compared to disease control group. In SOD and lipid peroxidation the significant increase was noted between the normal control and disease control groups. Histopathological study was found that decrease inflammation in test and positive control group compare to disease control group. Conclusion: Acetoacetate showed protective action against diclofenac sodium induced peptic ulcer.
GIT-4
Evaluation of Hepatoprotective Activity of Aqueous Extract of Abutilon Indicum in Wistar Rats
Naveen A, John P
Department of Pharmacology, Mamata Medical College, Khammam, Telangana, India
Objectives: Evaluation of Hepatoprotective Activity of Aqueous Extract of Abutilon indicum in Wistar Rats It belongs to family Malvaceae. It has anti-diabetic, antihepatotoxin, antioxidant, wound healing activity. Anti-microbial, anti convulsant, anti-HIV, anti-malarial, and anti-Inflammatory activity. Materials and Methods: The animals were divided into five groups, each group contain six animals. Group I - Normal saline (10 ml/kg, p.o.) daily for 20 days, Group II - Normal saline (10 ml/kg, p.o.) daily for 20 days. CCl 4 : olive oil (1:1, 2 ml/kg, i.p.) 2 nd , 5 th and 8 th day, 30 min after administering normal saline. Group III - Liv 52 (100 mg/kg, p.o.) daily for 20 days. CCl 4 : olive oil (1:1, 2 ml/kg, i.p.) 2 nd , 5 th and 8 th day, 30 min after administering of standard drug. Group IV & V - Abutilon indicum extract (250 & 500 mg/kg, p.o.) daily for 20 days. CCl 4 : olive oil (1:1, 2 ml/kg, i.p.) 2 nd , 5 th and 8 th day, 30 min after administering of plant extract. On the 21 st day, all animals were anesthetized with mild ether and blood samples were collected. Serum levels of SGOT, SGPT, ALP and Bilirubin were estimated. Results and Conclusion: The Results were statistically analysed and the data shows a dose dependent hepatoprotective activity.
MIS
MIS-1
Toxic Epidermal Necrolysis Induced by Carbamazepine: A Case Study
Laskar IJ, Chakravarty P
Department of Pharmacology, Silchar Medical College and Hospital, Silchar, Assam, India
Objectives: The Objectives of this case study is to evaluate the importance of detection, assessment and reporting of an adverse drug reaction and to improve the medication perseverance. Materials and Methods: This is an observational type of case report which we observed and analysed in Silchar Medical College & Hospital on regular ward rounds after approval from Institutional ethical committee. Results: A case report of Toxic epidermal necrolysis (TEN) due to a Carbamazepine administration by a 47 years old male patient who presented as a follow up case of Ischaemic stroke. Causality assessment of the event done with Naranjo' Causality assessment scale suggests to be "Probable". Conclusion: Carbamazepine is being increasingly prescribed for control of pain in neuralgias and diabetic neuropathy, apart from control of seizures. Awareness about the drugs implicated in life threatening drug reactions will help physicians in preventing them by cautious use of the drugs. Moreover, proper counseling to the patient regarding the use of medications is of utmost importance, in such life threatening conditions where treatment guidelines remain indistinct.
MIS-2
A Descriptive Study on the Pattern of Use of Antimicrobial Agents in Post-operative Period in a Tertiary Care Hospital
Jeevitha N, Kokila BN, Rajasekhar C
Department of Pharmacology, KVG Medical College and Hospital, Sullia, Dakshina Kannada, Karnataka, India
Objectives: To record the trend and pattern of drugs utilized in the management of surgeries performed in OBG department. Materials and Methods: This is a prospective observational study. The data was obtained from the medical case records of the post-operative patients from the in-patient unit of Department of OBG at K.V.G. Medical College and Hospital, Sullia (D.K). All the relevant data was recorded in a specially designed case reporting form and analysed. Results: Out of 206 cases included in the study, LSCS (52.60%) was the most common surgery performed followed by hysterectomy (41%). Cephalosporins (71.8%) were the most commonly used antimicrobial agents. The first generation cephalosporin drug, cefazolin (42%) was the preferred antimicrobial agent of choice. In addition 44% patients received metronidazole, 1.1% patients received macrolides and 0.8% patients received aminoglycosides. Monotherapy (55.3%) was preferred over polytherapy (44.7%). Analgesics (35.8%) were the frequently used drugs among the adjuvants. Dicolofenac was the preferred analgesic agent. Gastro-protective agents (23%) were used among which pantoprazole most commonly was used. Anti-emetics were used in 13.2% cases. Promethazine was the preferred anti-emetic drug. Conclusion : The antimicrobial prophylaxis used in the post-operative period was in accordance to standard guidelines.
MIS-3
Quantity and Cost of Commonly Used Ophthalmic Solutions in Ophthalmic Department in Tertiary Care Teaching Hospital, Rajkot
Barla C, Vachhani PK, Mehta DR, Patel PA, Singh AP
Department of Pharmacology, PDU Government Medical College, Rajkot, Gujarat, India
Objectives: To quantitate the number of drops per milliliter of the most commonly prescribed. Ophthalmic agents and to compare it with the current standard of 20 drops per milliliter. To calculate the cost of a 30-day supply for the most commonly used agents. To evaluate the cost difference when bore size is not fixed. Materials and Methods: Ophthalmic solutions like Timolol, Pilocarpine, Ciprofloxacin, Sulphacetamide and Gentamicin were used for the study. Number of drops per milliliter and total volume of drug in one container was measured. Cost was calculated on the basis of average number of drops per container and acquisition cost for standard dosage of each drug for one month treatment. Results : Four agents had greater than 20 drops per milliliter, while one had 20 drops or less. All five agents (100%) were under-filled (volume less than reported on the label). The average cost difference evaluated was 19.12%. Conclusion : The actual volume and number of drops per milliliter of 5 commonly prescribed ophthalmic solutions were variable. Cost of treatment increases when bore size of dropper tip is not fixed.
MIS-4
Formulation and Characterization of Fluconazole Loaded MCM-41 Powder for Topical Drug Delivery
Goswami A, Raval MK, Bagada A, Sheth N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: To enhance drug dissolution and improve moisture adsorption for better therapy of topical fungal infections. Materials and Methods: Fluconazole complex was prepared using MCM-41 and ß-CD as carriers in different proportions by melt, solvent evaporation and kneading Methods. The complex was converted into powder formulation by adding Talc, SiO 2 , ZnO and MCM-41 as excipients. Results: The inclusion compound was characterized by X-ray powder diffraction (XRPD), FTIR and differential scanning calorimetry (DSC). The optimized Methods of preparation determined by in-vitro dissolution was melt Methods. This complex was then tested for in-vitro dissolution and antifungal activity. Out of all, formulation B containing the inclusion complex as well as MCM-41 as the bulk excipient had better performance; it showed 92.95 ± 0.33% CDR at the end of 60 minutes and higher moisture adsorption. Conclusion: Thus, a Fluconazole topical formulation with improved drug dissolution and moisture adsorption was designed. From in-vitro tests, formulation B had better performances than the commercial formulation toward skin mycotic infections.
MIS-5
Use of Bacteriophage Against Antibiotic Resistant Bacteria Isolated from Bovine Mastitis
Joshi BR, Bhatt VD
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: The aim of the present study was, use of bacteriophages as a tool for the control of pathogens is an alternative treatment to antibiotic therapy. Materials and Methods: Milk samples collected from indigenous and crossbred cattle were subjected for somatic cell count and for bacterial and fungus isolation. The isolated bacteria were identified on the basis of their cultural and morphological characteristics. DNA was isolated from 14 bacterial isolates from infected milk samples. Antibiotic resistance genes were screened by PCR technology and Results were validated with traditional antibiotic assay. Bacteriophages were isolated from Sewage samples, collected from sewage treatment plant, Rajkot, Gujarat, against isolated bacteria from infected milk. The efficiency of phages were checked against isolated bacteria. Animal study was also carried out for phage therapy in mammary glands of female rats "Wister Albino" and blood samples were also collected for CRP test. Results: 10 indigenous and 13 crossbred milk samples were found to be infected . Total 14 different isolates (includes both Gram's positive and Negative) were selected as presumptive pathogens for mastitis. The Results of PCR assay was somehow not matching with traditional antibiotic assay. Total 3 bacteriophages were isolated, one against isolate 2 (Gram's Positive) and two against isolate 7 and 8 (Gram's Negative). In animal study, visible signs (swelling, heat, redness) of infection were observed and CRP level was significantly increases after infection. After infusion of sterile phage suspension, recovery was observed in infected rats. Conclusion: Bacteriophage have significant potential as antibacterial agents and their ability to replicate exponentially within their hosts and their specificity, make them ideal candidates for more sustainable mastitis control.
MIS-6
Standardization of Homeopathic Mother Tincture of Toxicodendron Pubescens and Correlation of its Flavonoid Markers with the Biological Activity
Patil CR, Jadhav HP, Chaudhari GG, Goyal SN
Department of Pharmacology, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra, India
Objectives: To validate the HPTLC Methods for homeopathic mother tinctures of Toxicodendron pubescens and to correlations of content of these markers with its anti-inflammatory effects. Materials and Methods: In present study, High-Performance Thin-Layer Chromatography (HPTLC) standardization Methods of homeopathic mother tinctures of Toxicodendron pubescens using quercitrin and rutin as chemical markers is validated and correlations of content of these markers with its anti-inflammatory effects are established. Results: It was observed that quercitrin (RF value 0.63) and Rutin (RF value 0.41) are well resolved. The minimum detectable concentrations for quercitrin and rutin were 5 ng/spot. The linearity range was between 100 and 2000 ng/spot for both the markers. Subsequently, anti-inflammatory activity of these formulations was determined against carrageenan-induced paw edema in rats, pain threshold determined by electronic Von-Frey apparatus and paw withdrawal latency (PWL) on hot-plate. All the tested formulations of Rhus Tox showed anti-inflammatory and analgesic activity against carrageenan induced paw edema in rats. Quantitative correlation between the content of markers and anti-inflammatory activity of mother tinctures was established. Conclusion: This study validates a quantitative HPTLC Methods for standardization of homeopathic mother tincture of RhusTox. Contents of quercitrin and rutin in T. pubescens mother tincture correlate with its anti-inflammatory and analgesic actions and the validated HPTLC Methods can be used in standardization of homeopathic mother tincture of T. pubescens.
MIS-7
Formulation and Characterization of Metoprolol Succinate Sublingual Tablet
Patel P, Jani N, Bagada H, Raval M, Sheth N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: The purpose of present research work was to prepare Metoprolol succinate sublingual tablet for emergency disease like hypertension, CHF and Angina along with improve the bioavailability and study the effect of processing parameters on disintegration time and friability. Materials and Methods: Metoprolol succinate is the promising drug used as β1 Selective blocker in hypertension, CHF & Angina. Bioavailability of the drug is 45-50% of orally administered dose. An attempt was made to provide safe medicine meeting pharmacokinetics requirement of plasma concentration by formulating a sublingual tablet of Metoprolol succinate by using sublimation tech. by using different polymers Cros povidone along with menthol. 3 2 full factorial design was applied and 9 runs were conducted. Multiple regression analysis and response surface Methodsology were evaluated. The tablets were evaluated for general appearance, size, shape, thickness, hardness, friability, disintegration test, content uniformity, wetting time, in vitro dispersion time and in vivo dissolution using USP dissolution apparatus type 2 along with characterization of DSC and FTIR Study. In vivo bioavailability study was done by using rabbits by approved by CPCSEA as per protocol no: (SU/DPS/IAEC/1315) the in vivo bioavailability of oral solution available and optimized sublingual tablet of Metoprolol succinate was compared. The in vivo analysis of Metoprolol succinate of rabbit plasma was done using HPLC Methods. Results: Conc. of menthol and cross povidone shows impact on %D.T and conc. of cross povidone shows influence on % friability. D.T range of 9-30 sec. and 0.325-0.609% friability were obtained by sublimation technique. Tablets were pass out all precompressional parameters along with post compressional parameters like wetting time 18 sec. drug content 101.06%. Dissolution study revealed that 95% drug release. Within 5 minutes. % relative bioavaibility was found to be 135.5% which was 1.2 times higher than oral dose. Conclusion: By sublimation technique prepared tablets pass all the physic chemical parameters along with improve the bioavailability. This formulation gives a wide range for the treatment of emergency disease like hypertension, angina and CHF.
MIS-8
Recent Trends and Global Prospectives of Nutraceuticals
Desai B, Vadia N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Nutraceuticals a portmanteau of the words "nutrition" and "pharmaceutical," is a food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease. In recently years, the increases of so-called lifestyle related diseases, such as diabetes mellitus and obesity have been referred as social issues which lead to the loss of Quality of Life. As a solution to the issue, there has been an attempt to create a society for healthy aging, by shifting the way of thinking away from lifestyle related diseases and "treatment by drugs" to "positive prevention of disease by food". Nutraceuticals are products that provide health and medicinal benefits, including the prevention and treatment of diseases in addition to the basic nutritional value found in foodstuff. Nutraceuticals are particularly of interest to the present generation because they have the potential to substantially reduce the expensive, high-tech, disease treatment approaches presently being employed in Western healthcare. Primarily used in functional foods and dietary supplements, nutraceuticals ingredients are natural bioactive, chemical compounds that have health promoting, disease preventing or medicinal properties. The market for these products is anticipated to increase even further in the years to come. However, there still exists ambiguity about the regulatory requirements related to nutraceuticals worldwide. Stringent regulations related to the safety and efficacy of these products is imperative to create a conductive environment for the sustainable growth of the nutraceutical industry.
MIS-9
Polypharmacology or Network Pharmacology: An Emerging and Novel Technique for Drug Discovery and Scientific Research
Vadia N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Polypharmacology, which focuses on designing therapeutics to target multiple receptors, has emerged as a new paradigm in drug discovery. Polypharmacological effects are an attribute of most, if not all, drug molecules. With the growing understanding of complex diseases, the focus of drug discovery has shifted away from the well accepted "one target, one drug" model, to a new "multi-target, multi-drug" model, aimed at systemically modulating multiple targets. Materials and Methods: Drug molecules often interact with multiple targets and the unintended drug-target interactions could cause side effects. There have been a number of studies relating the oral bioavailability screening, drug-likeness evaluation, blood-brain barrier permeation; target identification etc. has been investigated with the concept of polypharmacology. In presented work we outline the latest progress and challenges in polypharmacology studies. Results: In recent years even with remarkable scientific advancements and significant increase of global R&D spending, drugs are frequently withdrawn from markets. This is primarily due to their side effects or toxicities. Polypharmacology implies action of drugs against multiple targets and able to address the limitations with current drug discovery challenges. Polypharmacology remains to be one of the major challenges in drug development, and it opens novel avenues to rationally design next generation of more effective but less toxic therapeutic agents. Conclusion: Gaining a deeper knowledge on the origins of drug polypharmacology is the first step towards understanding of therapeutically relevant target space and anticipating toxicity risks. Network pharmacology or poly-pharmacology identifying repurpose opportunities of existing drug molecules for different therapeutic conditions.
MIS-10
Numerical Skills for Chemistry Diagnostic Visually-displayed Test for Assessing Pharmacy Level
Ramana PV
Department of Civil Engineering, MNIT, Jaipur, Rajasthan, India
The chemistry diagnostic test is a simple-to-use tool for understanding and evaluating student learning in chemistry. Its format allows for a variety of chemistry question styles and provides timely feedback even when used with large cohorts of students. The test highlights specific areas of fundamental chemistry which may be poorly understood, or lacking, in a cohort of students and therefore can be targeted directly in teaching activities and feedback and also diagnostic tests for all level pharmacy degree programmes are usually written tests; however, these may not always give an accurate reflection of students' ability to deal with simple problems that test basic numerical skills in a defined period of time. An MS PowerPoint-based test comprising 30 questions presented in a timed sequence was developed. The questions ranged from simple multiplication to more complex problems involving calculations of concentration and were presented to pharmacy of post-graduate & under-graduate levels. The results showed that although the majority of the students from several institutions were able to answer simple arithmetic questions correctly, they performed less well on questions involving fractions, powers of ten, multistep calculations and calculations of concentration from text-based problems. This test highlights the types of problems students find difficult to solve and, serves as a useful diagnostic tool enabling a more targeted approach to teaching.
MIS-11
Determinants of Full Immunization of Children Aged 12-59 Months in Northern Uganda
Hedmon O 1 , Lubaale YM 2 , Wamala R 2 , Mohaddesi B 3
1 Institute of Biotechnology, Saurashtra University, Rajkot, Gujarat, India, 2 School of Statistics and Planning, Makerere University, 7062 Kampala, Uganda, 3 Department of Pharmaceutical Science, Saurashtra University, Rajkot, Gujarat, India
Objectives: Immunization is one of the successful and cost effective public health intervention but in spite of global effort to increase childhood immunization coverage, still the proportions of children who are fully immunized in most developing countries is low. In 2011, more than half of the children in northern Uganda did not receive full immunization against the eight vaccine preventable diseases. This poses a great health burden and to address this issue the study of child and caretakers characteristics was done. Materials and Methods: In the study the analysis was made using frequency distributions, Chi square statistic and logistic regression as per binary logistic regression of the 2011 Uganda Demographic and Health survey data of 695 children aged 12-59 months born to mothers aged 15-59 years was done. Results: Based on this study about six in every ten children (62.6%) were not fully immunized, rural children just like those born to separated/widowed mothers were greatly disadvantaged as far as full immunization is concerned (OR = 0.335, OR = 0.557 respectively). The same applies to those born to parents in middle wealth quintile (OR = 0.355). Religions, birth order, age of the mother, ANC attendance were among factors with no effect on full immunization in northern Uganda. Conclusion: Full immunization remains low in Northern Uganda (37.4%). This study emphasizes the need to; increase accessibility of immunization services to rural areas, follow up parents/caretakers to ensure completion of the recommended vaccines and advocate for immunization services.
MIS-12
In vitro Antioxidant Activity of Ethanolic Extract of Leaves of Adhatoda Vasica Nees
Kanani S, Marsoniya Y, Patel J
B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India
Objectives: The present study was aimed to evaluate in vitro anti-oxidant activity of the ethanolic extract of leaves of Adhatoda vasica Nees (Acanthaceae). Materials and Methods: Phytochemical screening was performed for the ethanolic extract of leaves of Adhatoda vasica Nees (EEAV). In vitro antioxidant activity of EEAV was evaluated by Ferric reducing antioxidant power (FRAP), a - diphenyl-ß picrylhydrazyl (DPPH) scavenging, Hydrogen peroxide (H 2 O 2 ) radical scavenging Methods. Results: Phytochemical analysis of ethanolic extract of leaves of Adhatoda vasica shows presence of alkaloids, saponin, and phenols. The EEAV showed Ferric reducing power ability (IC-250.717 μg/ml), H 2 O 2 radical scavenging activities (IC5050-286.038 μg/ml) and DPPH scavenging activity (IC50 433.246 μg/ml). Conclusion: Phytochemical analysis of ethanolic extract of Adhatoda vasica Nees shows significant antioxidant activity. Further studies are suggested to isolate the active principle responsible for the activity.
MIS-13
Paradigm of Pharmaceutical Co-crystals: Effects on Drug Functionality and Pharmacokinetics
Patel RD, Shukla RH, Buch PR, Bagada HL, Sharma T, Raval MK
Department of Pharmaceutics Sciences, Saurashtra University, Rajkot, Gujarat, India
Pharmaceutical cocrystal has generated enormous interest in the past decade as a new strategy to enhance the clinical performance of orally administered drugs. Poor aqueous solubility can compromise drug performance and cocrystallizationis attractive to pharmaceutical scientists because they can significantly diversify the number of crystal forms that exist for a particular active pharmaceutical ingredient (API), and they can lead to improve the physical properties including their solubility, bioavailability, stability toward thermal and humidity stress, Materials flow and compressibility during tablet formulation and pharmacokinetics properties without changing the efficacy of the drug. Cocrystals not only provide a technique for advancement of functionality and pharmacokinetic properties but also provide opportunity to the researchers of pharmaceutical companies regarding intellectual property. With the increasing recognition of pharmaceutical cocrystals from clinical, regulatory and legal perspectives, the systematic commercialization of cocrystal containing drug products is just a need of time. In this review we focus on cocrystal design strategies, formulation Methods, studies of physicochemical and mechanical property, characterization techniques, and recent theoretical developments in cocrystal screening and mechanisms of cocrystal formulations with the help of suitable examples.
MIS-14
Nanoparticles: New Era for Cancer Treatment
Manvar A, Patel P, Raval M
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Cancer remain one of the world's most deadly disease still today. Chemotherapy, radiation and surgery are effective treatment available for treatment of cancer but have serious side effect. Nanotechnology has the potential to impact many long standing challenges in cancer therapy. In recent years, nano-sized, non-invensive and biocompatible nanoparticle have attracted great attention as cancer cell-specific drug carrier system capable of drug delivering cancer drug candidate. Targeted delivery of anticancer agent is achieved by exploting a unique characteristics of the tumor cells called the enhanced permeation and retention effect (EPR effect). In addition to this passive targeting based mainly on size, the nanoparticle surface may be modified with a variety of ligands that would interact with specific receptors over-expressed on the surface of the tumor cells, thus imparting specificity for active targeting. Cancer nanotechnology is an interdisciplinary area of research in science, engineering, and medicine with broad applications for molecular imaging, molecular diagnosis, and targeted therapy.
MIS-15
Characterization of Cyclodextrin Complexes in the Solid State by Various Analytical Techniques: A Review
Bagada H, Patel P, Patel R, Raval M, Sheth N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Cyclodextrins are cyclic oligosaccharides able to form inclusion complexes with a variety of hydrophobic guest molecules and positively modifying their physicochemical properties. There are various analytical characterization techniques available for the characterization of cyclodextrin complexes having fundamental importance to provide an adequate support in selection of the most suitable cyclodextrin for each guest molecule. An extended review of the literature was carried out to characterize the formation of inclusion complexes by different techniques in the solid and in the solution state. The characterization of inclusion complexes was done with a purpose to determine the interaction of drug molecules with cyclodextrins. This technique give the confirmation of the formation of inclusion complexes. Formulation technique used of solid complex can strongly influence the properties of the final product. Various instrument such as FI-IR, DSC, XRD and NMR used to characterization of complex. This techniques have been investigated to explain the Methods for preparation of inclusion complexes. In the present review, an attempt was made to discuss various complexation techniques and tried to briefly highlight the potential applications, technical and economical limitations associated with these approaches.
MIS-16
An Overall Review on Adulterants and Substitutes Used in the Formulation of Talicatic Curanam and their Identification
Joshi A
Pharmacopoeial Laboratory for Indian Medicine, Ghaziabad, Uttar Pradesh, India
Objectives: Tracing and eliminating adulteration is a very difficult and tedious task, even for the most commonly used ingredients of traditional medicines. The present review is a detailed study of the current market status, botanical (morphological and microscopic characters) and chemical nature of the ingredients used in the formulation of Talicatic Curanam, a classical Siddha formulations that focuses on their proper identification. Materials and Methods: Research journals and databases were studied to find relevant data regarding the marketing of herbal drugs, botanical names, synonyms, local names, trade names, medicinal uses, market price, botanical identification, chemical constituents, content of active constituent(s), marker compound(s), adverse effects and threat status (IUCN) of the ingredients of Talicatic Curanam (Classical Siddha Formulation) and their adulterants/substitutes. Results: This study Resultsed in the compilation of the data available for the identification of these ingredients and their adulterants/substitutes. The obtained data may be used as a source of information for future studies on adulteration/substitution of these ingredients. Conclusion: The study undertaken suggested that no scientific approach is undertaken in trade of medicinal plants for their authentication. Most of the authentic ingredients to be used in the formulation of Talicatic Curanam can be authenticated only after detailed study of the botanical and chemical nature of the ingredients.
MIS-17
Cytotoxicity Screening of the Commonly Used Indigenous Medicinal Plants using Brine-shrimp Lethality Bioassay
Bhatt D, Jethva K, Patel S, Zaveri M
K.B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India
Objectives: In the present work commonly used Indian medicinal plants weretested for brine shrimp lethality in order to detect potential sources of novel cytotoxic, antitumor and pesticidal compounds and also to correlate cytotoxicity Results with known pharmacological activities of the plants. Novel cytotoxic, antitumor, and pesticidal compounds can be isolated from potential plant sources through the assessment of cytotoxic activity against brine shrimps. Materials and Methods : The alcoholic and aqueous extracts of the selected plants were tested for their cytotoxicity. Ten nauplii were added into three replicates of each concentration of the plant extract. After 24 hours the surviving brine shrimp larvae were counted and percentage viability was reported. Results: Amongst tested extracts, alcoholic extracts of Piper longum, Curcuma Longa, Ocimum sanctum, Adhatoda vasica and Azadiracta indica showed most potent cytotoxic activity. Conclusion: Thus, the Results support the uses of these plant species in traditional medicine and can be further evaluated for their cytotoxic effects on the cell lines.
MIS-18
Evaluation of the Interaction of Nimodipine with Pantoprazole in Wistar Rats
Raut A, Arulmozhi S, Sutar DH, Sirvi D, Sonawale SB, Pawar AP
Department of Clinical Pharmacy, Bharati Vidyapeeth Deemed University, Poona College of Pharmacy, Pune, Maharashtra, India
Objectives: The aim of the present study was to evaluate the effect of pantoprazole in pharmacokinetics of Nimodipine in Wistar Rats. Materials and Methods : Pharmacokinetic study was performed to evaluate the effect of pantoprazole on nimodipine. The proposal was approved by the institutional animal ethics committee. Animals were divided in to two groups of 18 animals each. Group I was administered with nimodipine while group II was co-administered with nimodipine and pantoprazole. Blood was withdrawn at 0, 0.05, 0.25, 0.50, 0.75, 1, 2, 4, 6, 8, 12, 24, 36 h after administration of nimodipine and plasma was separated. The concentration of nimodipine in plasma was evaluated by HPLC using methanol water (80:20, v/v) as mobile phase and using UV detector at 226 nm. Felodipine was used as internal standard. Results: In the present study, co-administration of Pantoprazole Resultsed in significant increase (p < 0.05) in maximum serum concentration (Cmax) of nimodipine in group II compared to group I. Further, there was a significant increase in volume of distribution, while there was a non-significant increase in half life. There was a significant decrease in clearance of nimodipine in group II compared to group I. However, Tmax i.e. the time at which the Cmax remained to be same in both the groups. Conclusion : PPIs are widely prescribed for prevention and treatment of peptic ulcer. The interaction of pantoprazole with nimodipine was found to increase the concentration on nimodipine and non-significantly increase t 1/2 . The observed interaction may be due to ability of pantoprazole to inhibit CYP2C19, the CYP enzyme responsible for metabolism of nimodipine.
MIS-19
Optimization of Process and Formulation Parameters for Preparation of Lercanidipine Hydrochloride Nanocrystals
Gadhiya D 1 , Kher M 1 , Patel J 2
1 Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India, 2 Nootan Pharmacy College, Visnagar, Gujarat, India
Objectives: The present study was undertaken to optimize the process and formulation parameters of media milling technique for preparation of Lercanidipine HCl nanocrystals to enhance solubility and dissolution. Materials and Methods: Media milling technique was used to prepare nanocrystals. For the optimization, parameters like time of stirring, speed of stirring, amount of milling agent and size of milling beads were selected as process parameters and polymers, concentration of polymer, and ratio of drug to polymers were selected as formulation parameters. Optimization of parameters done on the basis of size of nanoparticles, PDI and Zeta potential. Optimization of parameters analysed using appropriate statistical Methods. Results: Among the different optimized parameters, concentration of polymer and speed of stirring has significant effect on particle size reduction, PDI and Zeta potential.
MIS-20
In-vitro Cytotoxicity Study of Some Plants Used in Tuberculosis
Jethva K, Bhatt D, Zaveri M, Patel S
KB Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India
Objectives : The challenge of discovering a new, urgently needed anti-TB drug from natural sources requires a truly interdisciplinary research. Cutting-edge mycobacteriology and innovative natural products tools have to be developed and employed in tandem. Materials and Methods: The present research was carried out to evaluate the In-vitro cytotoxicity study to Vero cell lines (normal kidney cells of African green monkey) by using the (4,5-dimethylthiazol-2-yl)-2, 5-diphenyl tetrazolium bromide (MTT) reduction assay and Trypan blue cell viability assay of eleven popular medicinal plants. The toxicity of a plants has to be studied for further exploration of various biological activities especially anti-TB. Two different alcoholic and aqueous extracts of all plants were used to evaluate the cytotoxicity assay. Results : All the aqueous and alcoholic extracts of plants showed very very less cytotoxicity but aqueous extracts of plants are less cytotoxic than alcoholic extracts. Conclusion : It conclude that all the plants are less cytotoxic to normal cells so it proves the safety of these plant extracts for future scientific anti-tubercular studies in its medical properties.
MIS-21
Role of In vitro-In vivo Correlation in Formulation Development
Koradia K 1 , Koradia H 2 , Vadalia J 1 , Raval M 1 , Sheth N 1
1 Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India, 2 Department of Pharmaceutics, L. M. College of Pharmacy, Ahmedabad, Gujarat, India
In vitro-In vivo Correlation (IVIVC) plays a key role in pharmaceutical development of dosage forms. Development and optimization of formulation is an integral part of manufacturing and marketing of any therapeutic agent which is indeed a time consuming and costly process. A good correlation is a tool for predicting in vivo Results based on in vitro data. This tool speeds up the drug development process and leads to improve the product quality. It is an integral part of the immediate release as well as modified release dosage forms development process. It is also recommended by regulatory authorities. IVIVC is a tool used in quality control for scale up and post-approval changes e.g. to improve formulations or to change production processes & ultimately to reduce the number of human studies during development of new pharmaceuticals and also to support the bio waivers. This review article represents the FDA guidance, development, evaluation, and validation of an IVIVC, and to set dissolution specifications for oral dosage forms, bio pharmaceutics classification systems (BCS), application of BCS in IVIVC development and levels of IVIVC, and prediction of IVIVC from the dissolution profile characteristics of product.
MIS-22
An Investigation to Determine Effect of Tephrosia Purpurea on Bleeding Induced by Blood Thinners
Rajput H, Desai D, Bhatt P
L. M. College of pharmacy, Ahmedabad, Gujarat, India
Objectives: To access effect of Tephrosea Purpurea on bleeding induced by blood thinners in rats, speculate mechanism of action of Tephrosea Purpurea. Materials and Methods : Wistar rats of either sex weighing 150-270 gms were divided into 6 groups: normal control, Tephrosea purpurea aqueous root extract control (300 mg/kg) (T.P.R.E.), disease control treated with Aspirin (27 mg/kg) + Clopidogrel (13 mg/kg), disease control treated with Dabigatran (30 mg/kg), treatment control treated with Aspirin (27 mg/kg) + Clopidogrel (13 mg/kg) + T.P.R.E. (300 mg/kg), treatment control treated with Dabigatran (30 mg/kg) +T.P.R.E. (300 mg/kg). Beside to it, for one day model of gastric bleeding another two group included positive control (aspirin + Clopidogrel treated) and herb control (T.P.R.E. 300 mg/kg). The evaluation of various haematological, blood coagulation parameters, platelet aggregation assay, gastric bleeding model were done after completion of ten days treatment. Results: Dabigatran Resultsed in an approximately 3 fold rise in activated partial thromboplastin time and 2.5 times increase in thrombine time (TT). However; in presence of T.P.R.E. (300 mg/kg) activated partial thromboplastin time was reduced to normal range (27.8 ± 1.80) but TT rested at (33.3 ± 1.34) slightly above normal. Dabigatran did not show any action on prothrombine time (PT). Moreover Aspirin plus Clopidogrel combination indicated 2 fold rise in activated partial thromboplastin time but neither (PT) nor (TT) got affected by it. In platelet aggregation assay by ELISA READER Aspirin plus Clopidogrel treated group depicted platelet deaggregation. However Dabigatran did not influence platelet aggregation. When T.P.R.E. was given with Aspirin plus Clopidogrel it showed approximately 700% increase in platelet aggregation. Moreover one day gastric bleeding model also showed positive Results with T.P.R.E. (300 mg/kg for 10 days) as decreased observed by haemoglobin concentration (μ/ml) in perfusate. Conclusion: T.P.R.E. (300 mg/kg) possess antithrombolytic effect against Aspirin plus Clopidogrel induced bleeding but is not as effective against Dabigatran induced bleeding. Tephrosia Purpurea possibly acts as antithrombolytic agent via intrinsic pathway due to an active constituent possibly rutin in the aqueous extract which exhibits platelet accelerating action.
MIS-23
Knowledge, Attitude and Practice of Resident Doctors for use of Generic Medicines at a Tertiary Care Hospital
Kamejaliya DZ, Desai CK, Kapadia J, Desai MK
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India
Objectives: To assess knowledge, attitude and practice of resident doctors regarding generic medicines at a tertiary care teaching hospital. Materials and Methods: This cross sectional study was conducted in 296 resident doctors of a tertiary care teaching hospital using a prevalidated questionnaire, consisting questions of knowledge (17), attitude (8) and practice (10). Data were analysed in Microsoft Excel. Results: A total 242 (81.76%) resident doctors responded. Respondents were aware of the term generic medicines (100%), branded generic (173, 71.49%) and brand drugs (216, 89.26%). Majority of participants responded equivocally to: whether generic medicines are cheaper (154, 63.63%) and equally efficacious (166, 68.59%) as brand drugs; are easily available (125, 51.65%) and switching from brand to generic medicines affects the outcome (192, 79.33%). Respondents believed that generic medicines cost less because of inferior quality (174, 71.90%) and have doubtful efficacy in serious diseases (108, 44.63%). Fifty percent respondents disagreed on substitution of a brand with a generic medicine by pharmacists. Nearly 37% respondent's favoured making generic prescribing compulsory. All the respondents prescribed generic medicines, these consisted 68.9% of total prescription medicines. Concerns about efficacy (242, 100%), safety (149, 61.57%) and poor availability (140, 57.85%) were the major reasons cited for preferring brand versions. Most respondents (178, 73.55%) were aware of regulations regarding prescription of generic medicines. Regulations by government (186, 76.86%), education of medical students about generic medicines (187, 77.27%) and incentives to doctors (149, 61.57%) were suggested to improve generic prescribing. Conclusion: Generic medicines are commonly prescribed by resident doctors in tertiary care hospital. Concerns about efficacy safety and availability of generic medicines are major reasons for preferring brand versions.
MIS-24
Enzymatic Potential and Antibiotic Sensitivity of Bacterial Species Isolated from Industrial Wastes
Ghori VL 1 , Khunt CV 2 , Shah PI 1 , Upadhay MG 1 , Kothari R 3
1 Shantilal Shah Pharmacy College, M.K. Bhavnagar University, Bhavnagar, Gujarat, India, 2 Department of Pharmaceutical Sciences, Rajkot, Gujarat, India, 3 Department of Biosciences, Saurahstra University, Rajkot, Gujarat, India
Objectives: Bacterial strains have been isolated and identified that they can survive in the presence of the pollutant and have the ability to break down or alter environmental pollutants. The Objectives of present research work was to verify the diversity of bacteria and its enzymatic profile, isolated from industrial effluent. Materials and Methods: Thirty different bacterial isolates were isolated from Industrial effluent samples collected from three different sites of kheda region in Gujarat, India. Bacterial isolates were evaluated for colony characterization, Gram's reaction, enzymatic potential and resistance to six different antibiotics. Results: Some isolates found positive for amylase and protease activity. Bacteria resistant to Erythromycin, Roxihromycin, Cefalexin, Cloxacillin, Ciprofloxacin, and Cefixime were detected in all isolates. It was found that some isolates having multiple antibiotic resistances and one isolate resistance to all antibiotics. Conclusion: Bacteria isolated from samples, can degrade sugars and proteins and therefore can be used to treat wastes on industrial scale. Almost all isolates were found to be resistant against various antibiotics tested. The future plan of work will be focused on identification of useful isolated by 16S RNA to understand the enzymology, antibiotic resistance properties and their survival mechanism in harsh environment and thus to understand the role of molecular biology for environmental protection.
MIS-25
Change in QTc Interval with Use of Olanzapine and Risperidone: A 16 Weeks Follow-up Study
Khan ZP, Uike P, Bachewar NP, Mehta MC, Dudhgaonkar S
Department of Pharmacology, Shri Vasantrao Naik Government Medical College, Yavatmal, Maharashtra, India
Objectives: To observe the effect of Olanzapine and Risperidone on QTc interval. Materials and Methods: This was a 16 weeks two group, observational, follow up study carried out in newly diagnosed 60 schizophrenic patients in the age group 18-65 years of either sex in outpatient department who received either Olanzapine (10 mg/day) orRisperidone (3 mg/day). ECG were taken at baseline and repeated during follow-up visits at 4 weeks (visit I), 8 weeks (Visit II), 12 weeks (Visit III), and 16 weeks (Visit IV) to note any change in QTc interval. Results: In patients taking Olanzapine QTc interval were 0.3828 ± 0.02968 at baseline and 0.4047 ± 0.02559 at 16 weeks with 'p' value 0.0099 (< 0.05) by one way ANOVA (Kruskal Wallis Test). In patients taking Risperidone QTc interval were 0.3818 ± 0.03059 at baseline and 0.3979 ± 0.02281 at 16 weeks with 'p' value of 0.0575 (>0.05). Conclusion: We found statistically significant increase in QTc interval at the end of 16 weeks in patients using Olanzapine, however the same was not increased significantly in Risperidone group.
MIS-26
An Improvement of Physicochemical and Pharmacotechnical Parameters of Ketoprofen Crystals
Vaghela P 1 , Tank HM 2 , Chavda JR 2 , Parikh HD 2 , Tank PH 2
1 School of Pharmacy, R.K. University, Rajkot, Gujarat, India, 2 Shantilal Shah Pharmacy College, M.K. Bhavnagar University, Bhavnagar, Gujarat, India
Objectives : Objectives of the present research work is to improve the physicochemical and pharmacotechnical parameters of Ketoprofen, BCS Class-II drug of NSAID category with poor flowability, using crystal engineering approach for the greater improvement in its aqueous solubility, dissolution rate and processing parameters. Materials and Methods : Among all the Methods applied for the preparation of crystals, the Methods which found to produce encouraging Results will be selected for further study. Ketoprofen is treated with different excipient/s for preparing the crystals of better aqueous solubility with improvement in manufacturing parameters. The treated crystals which showed greater improvement in In-vitro dissolution rate are further evaluated by particle size and shape by Optical microscopy. Results : The improvement in aqueous solubility of treated crystals of molar ratio 1:1 of drug: excipient was found about 16 fold compared to pure drug. In-vitro drug release study depicted that Ketoprofen crystals with 1:1 molar proportion showed greater drug release (57.88%) while 1:2 molar ratio showed drug release (52.54%) within one hour. Results also revealed that the treated crystals of 1:1 molar proportion showed drastic increase in drug release compared to pure drug (28.27%) and control batch (48.77%) within one hour. Micromeritic properties of treated crystals also showed improvement in flow parameters compared to pure drug and its control batch. Conclusion : Present work revealed that crystal engineering approach will be a potential option to enhance the physicomechanical and processing parameters of selected BCS Class-II drug having poor flowability.
MIS-27
Deficiency of "Sunshine Vitamin" in "Sunny Country-India": Review of Literature
Datta M, Ghosh R, Das L
Department of Pharmacolgy, Tripura Medical College and Dr. BRAM Teaching Hospital, Agatala, Tripura, India
Objectives: Vitamin D has emerged as a topic of great interest among researcher in present days. Recent evidence indicates that the world facing vitamin D deficiency pandemic and sunny country India is no exceptional. To find out the prevalance of Vitamin D Deficiency (VDD) in our country? Why VDD is common in IndiaTo find out relation between VDD with chronic illness. Evidence Acquisition: We performed literature search using PUBMED/Medline, Cochrane under Medical Subject Heading (MeSH) terms Vitamin D or Vitamin D deficiency combined with term India or Asian Indians, written in English of last 5 yrs. Observations: Vitamin D deficiency is highly prevalent in India - widespread prevalence of varying degree 50-90% of Indian population who have low calcium intake. Sunshine exposure alone as a healthy lifestyle measure would not Results in vitamin D sufficieny among Indians Debate is still on in regard to link between VDD with non skeletal health such as DM, CVD, Malignancy. Conclusion: New look into RDA of Calcium & Vitamin D for Indians is need of the hour Widely prevalent VDD has functional relevance to skeletal health, there is need of exploration to search for linkage with nonskeletal health.
MIS-28
Rationality and Ethics of Promotional Drug Literature in Medical Journals
Sharma R, Dhasmana DC, Sharma T, Kalra J, Bala S
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India
Objectives: Rational use of medicines is a major concern to community physicians. Most of the physicians depend on the promotional literature of pharmaceutical companies in medical journals to keep themselves well informed about new drug entering into the market every year. This is why it is important that the quality of advertisement of pharmaceuticals in journals should be of high standards. Maintaining such standards will help physician prescribe drugs in a rational manner. To evaluate and compare the quality of promotional advertisement published in a national and international medical journal and exploring the scope for improvement in it. Materials and Methods: It was an observational cross sectional study of all advertisement on medicinal drugs in two medical journal i.e. one national and one international journal published over a period of one year (June-2014 to June-2015). Advertisements for parenteral fluids, milk foods, medical devices, laboratory equipment and the educational advertisements were excluded. An assessment was made of whether the advertisement adhered to the guidelines of the WHO or the OPPI. Results: A total of 76 and 35 medicinal drug advertisements were published in a national and an international medical journal respectively. There was a significant difference in compliance to WHO criteria among national (43.5 +/- 35.2) and international (70.6 +/- 23.8) journal (p < 0.05). Only brand name and manufacturer details were provided in all the promotional drug literature i.e. 100% compliance. There was significant difference in the compliance to WHO criteria for active ingredient causing adverse reaction, pregnancy category, precaution and contraindication, drug interaction, dosage regimen and date of production in the two journals. Conclusion: The compliance criteria are frequently overlooked by the medical journal publishers. It is expected that the promotional drug literature may be thoroughly checked for compliance more so by the reputed national than an international medical journal.
MIS-29
Lipid Lowering Effect of Cilnidipine Microemulsion Using Tocotrienol as Oil Component
Upadhyay M 1 , Tandel H 2 , Parikh HD 1 , Ghori VL 1 , Vaghela PD 1
1 Shantilal Shah Pharmacy College, M.K. Bhavnagar University, Bhavnagar, Gujarat, India, 2 Department of Pharmacy, Faculty of Technology and Engineering, M.S. University of Baroda, Vadodara, Gujarat, India
Objectives: Objectives of Present study was to analyse the efficacy of Cilnidipine microemulsion in tocotrienol (oil), for anti hyperlipidemic activity in metabolic syndrome. From literature Cilnidipine and tocotrienol both were found to be effective in treating metabolic syndrome. Materials and Methods: A microemulsion based drug delivery system was formulated and optimized, stable formulation was subjected to pharmacodynamic study using Wistar Albino rats. The Albino rats were feed with high fat diet for a period of 10 weeks, to induce metabolic syndrome. The body weight and serum lipid were carefully estimated, both at the initiation and at the end of 10 weeks. The animals were divided into two groups the control group (I) and the test group (II & III). The control group received no drug but kept on similar condition as of treated group, while the treated group II received Cilnidipine microemulsion (CME) and treated group III received plain tocotrienol microemulsion (TME) daily. At the end of treatment period the animals were weighed and were used for further evaluation and collection of blood sample. Results: Study of CME and TME in various parameters of metabolic syndrome Results in significant reduction of Body weight, blood pressure, serum total cholesterol, triglycerides and LDL of treated rats. Increase in HDL and decrease in LDL is highly significant observation for treatment of metabolic syndrome. Conclusion: The Results revealed that Cilnidipine formulated with tocotrienol oil in microemulsion formulation gives synergistic effect to control different parameters of metabolic syndrome.
MIS-30
Evaluation of Knowledge, Attitude and Practices of Prescription Writing Among Medical Interns in a Tertiary Care Hospital, Mumbai
Purnaye AP, Joshi AD, Gambre RS, Patel SB
Department of Pharmacology, GGMC and Sir JJ Group of Hospitals, Mumbai, Maharashtra, India
Objectives: Prescribing habits are formed during internship. It's a legal document but highly prone to errors. Seeking the level of awareness amongst interns will be useful to determine further attempts that can be undertaken at reducing errors. Objectives of the study was to 'assess knowledge, attitude and practices of prescription writing among medical interns in a tertiary care hospital, Mumbai. Materials and Methods: After obtaining approval from the Institutional Ethics Committee, study was conducted among the interns who were willing to participate. A questionnaire was formulated to evaluate knowledge, attitude and practice of prescription writing. Results: Out of 130 most of the respondents were aware of what a prescription is (86%), legal status (90%) and mandatory details pertaining to prescription (80.7%). Inadequate knowledge about laws regulating prescription (50%) and availability of Model prescription (68.4%) was evident. Mixed opinions were cited for writing diagnosis on prescription. Very few interns (46.9%) knew about National list of Essential Medicines. E-prescribing was preferred over conventional by 72.3% interns seeking ease and time-saving benefits. Conclusion : In summary, this KAP study showed overall awareness among medical interns regarding writing prescription needs to be further improved. This suggests the need for suitable changes in the undergraduate teaching curriculum which includes a comprehensive training regarding writing prescriptions before the outset of internship.
MIS-31
A Survey of Knowledge and Awareness of Interns About the Instructions Given to the Patients While Prescribing Various Dosage Forms
Gaikwad MM, Dabhade SS, Jagtap RP, Ghongane BB
Department of Pharmacology, B.J. Government Medical College and SGH, Pune, Maharashtra, India
Objectives : To assess the knowledge of interns regarding the dosage forms of drugs and their administration techniques. Materials and Methods : An Observational questionnaire based study was conducted in 153 interns of Government medical College to evaluate the awareness about prescribing common dosage forms. Score 1 for correct response and score 0 for incorrect response was give. Interns were also asked to demonstrate Methods of administration of metered dose inhaler, insulin injection, eye and nasal drops and their steps were evaluated by the investigators. Results : Regarding question naire only 7% (11/153) interns answered >85% MCQs correctly, 43.42% (66/153) answered 71-85% MCQs correctly, 40.13% (61/153) answered 51-70% MCQs correctlyand 9% (14/153) answered <51% MCQ correctly <50% interns answered correctly to the MCQ framed on suspension and GTN transdermal patch of dosage forms. While assessing for demonstration for administration of metered dose inhaler, nasal drops, eye drops, preparation of 40 units of 10 U humulin-R and 30 U humulin-N in one syringe and subcutaneous administration of premixed insulin only 14%, 11%, 2%, 1% and 28% interns demonstrated all steps in proper sequence respectively 37% interns were not even knowing a single step for subcutaneous administration of premixed insulin. Conclusion : This study explains the need for more emphasis in curriculum on the commonly prescribed dosage forms. Demonstration techniques should be included in undergraduate practical training, which will also increase the psychomotor skill in them as well as prepare effective doctors aiming at better therapeutic outcomes in patients.
MIS-32
Development and Evalution of Terbinafine Hydrochloride Loaded Solid Lipid Nanoparticles for Topical Drug Delivery
Jaydeep Savaliya, Mittal Patel, Jaydeep Patel, Arti Bagada, Mihir Raval
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: The objective of this research was mainly for Formulation & development of Solid lipid nanoparticle (SLN) of Terbinafine Hydrochloride (TH), Conversion of TH loaded SLN to a gel system, Evalution of TH loaded SLN based gel, Stability. studies of SLNs dispersion as well as SLN based gel. The primary objective of topical SLN based formulation for treatment of cutaneous fungal disease was to deliver the drug at the target site with required concentration & to achieve its therapeutic action because fungal infection of skin is present in upper layer of skin. Thus by formulating TH as SLNs based sustained release system may enhance the efficacy of drug by targeting drug to disease site accomplished by all important patient compliance by reducing dosing frequency. Materials and Methods: SLN prepared by solvent diffusion evaporation method. A lipid & TH were dispersed in organic solvent. An aqueous phase was separately prepared by dissolving Tween-80 with water. The oil phase was added in surfactant containing hot aqueous phase. The suspension was evaporated. The resultant suspension was finally poured into cold water (2-3°C) which kept under stirring at 1000 rpm for 5 min. The dispersion was then centrifuged at 10,000 rpm for 15 min. Results: The optimized batch SLN 19 was observed mean particle size 11.73 ± 0.49 nm, zeta potential + 32.82 mV, %DL as well as %EE 99.62%. DSC, FT-IR, XRD & TEM studies. In-vitro release profile of TH from SLN & its gel showed sustained drug release up to 24 hrs. Gel showed pH 6.05 ± 0.24, Spreadability 5.8 cm, drug content 98.19%, occlusion factor 33.3 in 48 hours & viscosity of gel was 6299 cp at 100 rpm. Occlusionstudy of gel revealed with improved skin hydration. Conclusion: An attempt was made to enhance the topical availability of TH in treatment of fungal infection by preparing TH loaded SLN based gel. SLNs represents a highly effective for topical preparations, where improve skin hydration & drug penetration is desired. SLNs also have the potential to localize the drug at the site & could be useful for site-specific delivery of drugs to the skin.
MIS-33
Developement and Screening of In situ Gel of Nyctanthes Arbor Tristis Linn for Glaucoma
Jarag R, Gosavi R, Swami S, Jarag R, More H
Department of Pharmacology, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra, India
Objectives: Glaucoma remains a leading cause of blindness above age 60. Conventional ophthalmic solutions eliminate rapidly after administration. The Objectives is To Formulate in situ gel of Nyctanthes arbor-tristis Linn and to reduce intraocular pressure. Materials and Methods: In situ gel system contains of Nyctanthes arbor-tristis Linn. Along with pluronic F 127 as gelling agent, HPMC-E50 as viscosity enhancer and benzalkonium chloride as preservative. Eye irritation was tested on Albino rabbitaccording to the OECD guideline. In vivo Experimental protocol was approved by the IAEC under CPCSEA. Glaucoma was induced by Dexamethasone and IOP was observed at 3, 6, 9 and 12 hrs. Post treatment by using Tonometer. Results: Isotonicity and eye irritation test indicates formulation was free from tissue damage and eye irritation. The rheology study was found pseudoplastic behavior. In-vitro drug release study indicates formulation was achieved a sustain drug release. In-vivo study indicates formulation shows 18.51% reduction of intraocular pressure on Dexamethasone induced glaucomatous rabbit's model. Conclusion : In situ gel system based on pluronic F127 and extract of Nyctanthes arbor-tristis Linn was developed for ophthalmic drug delivery. Formulation is stable, non-irritant, and isotonic in nature and found 18.51% reduction of IOP in glaucomatous rabbits.
MIS-34
A Study of Awareness Regarding Safe Disposal of Expired Medications Among First Year Medical Students
Shivanna A, Pundarikaksha HP
Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India
Objectives: Expiry date is until which the drug manufacturer can guarantee that the medicine is fully potent and safe to take based on scientific testing. Awareness of safe disposal methods for various categories of expired medication is necessary to prevent contamination of the ecosystem. To assess the awareness of first year medical students regarding safe disposal of expired medication. Material and Methods: A cross sectional questionnaire based study was conducted on a total of 120 first year medical students of which 113 were available and consented to participate in the study. The data was analysed using proportions. Results : 23.8% felt that safe disposal of expired medication was important. 30.9% knew that the first step towards safe disposal of expired medication is segregation. 11.5% knew that expired medication has to be disposed by mixing with coffee ground at the household level. 16.8% knew that expired medication is disposed by returning to manufacturer, waste immobilization, landfill and incineration at the health care facility. 28.3% knew that medications disposed by humans appear in sewage system and are detectable in the ecosystem. 12.3% knew that the Indian Law that deals with safe disposal of expired medications is The Biomedical Waste (Management & Handling) Rules, 1998. Conclusion : Awareness regarding safe disposal of expired medication among first year medical students was found to be inadequate. Health care professionals must be educated and trained to practice safe disposal methods at the health care facility and give information to the general population for safe disposal at households.
MIS-35
Quantification and In vitro Screening of Extracts of Portulaca Oleracea
Sanaye MM 1 , Venna MV 2
1 K. M. Kundnani College of Pharmacy, Mumbai, Maharashtra, India, 2 Principal K. M. Kundnani College of Pharmacy, Mumbai, Maharashtra, India
Objectives: (1) Extraction of plant. (2) Quantification of linoleic acid (Polyunsaturated fatty acids PUFA) from extracts. (3) In vitro antioxidant assay of the extract. Materials and Methods: Shade dried leaves and stems of plant were extracted with different solvents (ethanol, petroleum ether, hexane) using soxhlet extraction technique. Qualitative phytochemical screening was performed. In vitro antioxidant assay and quantification of linoleic acid using HPTLC will be done. Results: Preliminary phytochemical testing has shown the presence of organic acids. In vitro antioxidant assays have shown significant antioxidant effect of the extracts of Portulaca oleracea (PO) Quantification studies of PO extract for linoleic acid may provide guideline for further in vivo evaluation of plant extracts. Conclusion: Literature reports presence of PUFA in PO which can be quantified using HPTLC. PUFA are known to be potential antioxidants and afford cardioprotection from oxidative stress. Although other pharmacological effects of PO have been studied by in vivo and in vitro Methods, its cardioprotective potential has not been explored. Hence quantification and in vitro assays will provide guidelines for its in vivo evaluation for cardioprotective effect in future.
MIS-36
Evaluation of Antioxidant Activity and Quantification Studies of Portulaca oleracea
Sanaye MM, Shetty RS
K. M. Kundnani College of Pharmacy, Mumbai, Maharashtra, India
Objectives: Extraction, in vitro antioxidant assay, Quantification of methanolicextract of Portulaca oleracea (MEP). Materials and Methods: Shade dried leaves of Portulacaoleracea were extracted with mixture of methanol: water (50:50) using soxhlet extraction technique. In vitro antioxidant assays and quantification of dopamine and L-DOPA content of MEP will be carried out by using HPTLC and HPLC. Results: In vitro assay of MEP showed potential antioxidant effect. The Results of antioxidant studies and quantification studies may provide guidelines for in vivo evaluation MEP for antiparkinson effect in future. Conclusion: It has been reported that Portulaca oleracea consists of dopamine and L-DOPA which can be quantified by using sophisticated techniques. Although other pharmacological activities of the plant extracts are reported by using in vitro and in vivo studies but antiparkinsons screening has not been addressed. Hence quantification of Dopamine and L-DOPA are required before Portulaca oleracea can be considered for preclinical and clinical use as antiparkinsondrug. Moreover it is seen that reactive oxygen species (ROS) generation leads to neurodegeneration of dopaminergic neurons, so antioxidant effect of the MEP may inhibit the ROS generation. In vitro antioxidant and quantification studies will lead to systemic and scientific exploration of a new medicinal plant for its antiparkinsons effect.
MIS-37
Silibin in Ameliorates the Hepatic Blood Flow in T2dm Animals
Garabadu D, Easwaran S, Bhaseen S, Paliwal P, Rajat V, Krishnamurthy S
Department of Pharmaceutics, Pharmacology Laboratory, Indian Institute of Technology (Banaras Hindu University), Varanasi, Uttar Pradesh, India
Objectives: To assess the effect of silibinin (SIL) on type-2 diabetes mellitus (T2DM)-induced attenuation in hepatic blood flow. Materials and Methods: On day-1 (D-1) of experimental schedule streptozotocin (45 mg/kg, i.p.) was administered, after time lag of 15 minutes, nicotinamide (110 mg/kg, i.p.) was injected. Thereafter, SIL (100 mg/kg, p.o.) and metformin (MET) (25 mg/kg, i.p.) were administered to animals from D-7 to D-13 after the intraperitoneal administration of streptozotocin. On D-13, hepatic blood flow was estimated via laser Doppler imager (OMEGAZONE OZ-2) followed by oral glucose tolerance test (OGTT) and insulin tolerance test (ITT) to evaluate the functioning of βcell and insulin sensitivity respectively in T2DM subjected rodents. Results: SIL significantly ameliorated the T2DM-induced changes in terms of increase in hepatic blood flow. Further, this was comparable to MET. Moreover, SIL and MET reversed the T2DM-induced modulations in glucose tolerance and insulin sensitivity in rats. Conclusion: We for the first time have reported that SIL may mitigate T2DM-induced decrease in hepatic blood flow.
MIS-38
The Clinical Use of Antisense Oligonucleotides for RNA-targeting Therapies: An Overview
Kumar R, Zilate S, Varma S, Kirde S
Department of Pharmacology, MGIMS, Sevagram, Wardha, Maharashtra, India
Antisense oligonucleotides (ASO) target RNA molecules on the basis of Watson-Crick base pairing in sequence-specific manner. ASOs generally Results in destruction of the target RNA by RNase-H mediated mechanisms, although they may also sterically block translation, also Resultsing in loss of protein production. Antisense-induced degradation or inhibition of translation of a target mRNA is potentially capable of inhibiting the expression of any target protein. ASOsis discovered twenty years ago that antisense oligonucleotides (ASOs) could be used to modulate the expression of protein. But there are only two approved antisense drugs for clinical use till date. Even with this low achievement rate, the antisense field is experiencing reappearance. A considerable number of ASOs have progressed into clinical trials, although most have relatively long histories in Phase I/II settings. Clinical trial Results are surprisingly difficult to find, although few ASOs appear to have yet established efficacy in Phase III levels. Various liposomal vehicles have been used for systemic delivery with some success, and recent modifications appear to enhance systemic delivery, at least to liver. Various nanoparticle formulations are now being developed which may also enhance delivery. In this review, we introduce the major therapeutic strategies in the antisense field, highlighting new clinical findings that exhibit the noteworthy potential of these approaches for development of novel therapies in many diseases.
MIS-39
Nanotechnology in Cancer Chemotherapy
Krishnaprasad C, Sankar K, Ramana VV, Chandrakala K
Department of Pharmacology, Siddhartha Medical College, Vijayawada, Andhra Pradesh, India
Nanotechnology is defined as intentional design, characterisation, production of Materials, structures, devices & systems by controlling their size & shape in nanoscale range (1-100 nm). This can be applied in various areas of medicine, especially in cancer for improving cancer chemotherapy in the form of site specific targeted drug delivery against cancer cells & this has great importance in the near future. The main advantage of this application is-preservation of intactness of surrounding healthy cellular architecture, as the nanomedicines are close to biological molecules in size & have very high surface/volume ratio & their outer surface or their core can be loaded with chemicals/drugs which can be administered in cancer patients which will have high cancer cell selectivity. Poster depicts various nanotechnology based drug delivery systems in cancer chemotherapy like-Nanoshells, Nanoparticle-albumin bound (Nab) platform technology, carbon nanotubes (nanoneedles) for delivery of anticancer drugs into cancer cells selectively.
MIS-40
A Comparative Study on Awareness About Substance Abuse Among Undergraduate Medical, Physiotherapy and Pharmacy Students
Apoorva R, Vasundara K, Pundarikaksha HP
Department of Pharmacology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India
Objectives: India has an estimated number of 13.4 million substance abuse victims mostly youths. As Undergraduate medical and paramedical students are the future healthcare professionals involved in management of problems related to substance abuse and hence the present study was taken up. To evaluate the knowledge about substance abuse among undergraduate medical, physiotherapy and pharmacy students. Materials and Methods: A cross sectional, pre-validated questionnaire on knowledge about substance abuse was administered to second year medial (100), physiotherapy (35) and pharmacy (50) students in the month of August 2015 after obtaining informed consent. Results obtained were compared using One-way ANOVA and Post-Hoc Tukey test. P-value < 0.05 was considered statistically significant. Results: All groups showed statistically significant difference in their knowledge scores (P < 0.001). On intergroup comparison, medical students had better knowledge than physiotherapy (p < 0.001) and pharmacy (p < 0.001) students while physiotherapy students had better knowledge than pharmacy (p < 0.001). Conclusion: Pharmacy students had poor knowledge compared to physiotherapy and medical students about substance abuse. Thus implementation of CME's and workshops are needed to educate undergraduate medical and paramedical students to identify and manage widely rampantproblems of substance abuse.
MIS-41
Paracetamol Induced Bullous Erythema Multiforme: A Case Report
Kumar M, Keshri USP, Kumar H, Chakroborty K, Mondal S, Modi SK
Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India
Erythema multiforme is a mucocutaneous hypersensitivity reaction triggered by variety of viral, bacterial or chemical antigens including drugs. Commonly implicated drugs are: sulphonamides, penicillin, phenytoin, aspirin, antituberculosis drugs, barbiturates, allopurinol etc. Lesions presented with central bullae surrounded by rim of edema which in turn were surrounded by erythema showing typical "target lesion". Few lesions presented with central pigmented depression and few with central necrosis. There was detachment of dermis from epidermis involving less than 10% of body surface area and also involved mucous membrane of more than one site. Paracetamol is a potent antipyretic agent and most commonly used drug for fever. We herein report a case of drug induced erythema multiforme with bullous target lesions in a 64 yrs old female, who had taken 5 tablets of paracetamol 500 mg sos for fever with chills and rigor. Within 4 days of onset of fever, she suddenly developed multiple raised erythematous bullae with itching and burning sensation, initially on right forelimb gradually involving other limbs, forehead and tongue. The left margin of the tongue later on showed multiple white plaques due to superimposed candidal infection. These lesions gradually healed with crusting over 3 weeks after proper treatment. With Naranjo causality score +4, paracetamol was suspected as a "possible" offender. Our report mainly emphasize on key role of paracetamol in causation of bullous erythema multiforme. Clinicians should be aware of occurrence of such phenomenon so that they can take prompt action to escape any toll.
MIS-42
Study of Pharmacodynamic Interaction of Zingiber Officinale and Sitagliptin on Experimental Rat Model
Jadhav V
College of Pharmacy, Bharati Vidyapeeth, CBD Belapur, Navi Mumbai, Maharashtra, India
Objectives: Diabetes Mellitus (DM) a metabolic endocrine disorder; is one of the most rapidly growing diseases worldwide. The simultaneous use of regenerational therapies like nutraceuticals and antioxidants with conventional therapies has gained importance in DM management. Though this approach has been found to be promising, the risk of pharmacological interactions cannot be overlooked. Hence, the present study was conducted to evaluate the pharmacodynamic interaction between dipeptidyl peptidase-4 inhibitor sitagliptin (20 mg/kg) and nutraceutical Zingiber officinale (4 ml/kg). Materials and Methods : Streptozotocin and high fat diet induced Type II DM rat model was used to determine possible interactions. The effect of combination of Zingiber officinale with sitagliptin on serum glucose and lipid levels was evaluated. Rats were randomly divided in Vehicle control, Disease control, Sitagliptin treatment, Zingiber officinale treatment and combination treatment group (n = 6). Except for Group I all other groups were fed high fat diet throughout the study. STZ challenge was given to overnight fasted rats at the dose of 40 mg/kg, on fifteenth day of initiation of study. Results : The pharmacodynamic evaluations showed equivalent decrease in blood glucose while, the lipid levels in combination treated group showed significantly better Results (p < 0.05) than individually treated groups. The histopathological findings also found to improve the cellular and functional capabilities of affected organs viz. pancreas and liver. These observations showed that combination group did not prove to be significantly better than conventional therapy in regulating glucose levels, but showed better Results in curing altered lipid levels which are secondary complications to chronic diabetes.
MIS-43
A Comparative Study of Knowledge, Attitude and Practice of Self-medication Among Medical and Non-medical Students
Indhumathi M, Vijai SE, Ramya EJ
Department of Pharmacology, Tirunelveli Medical College, Tirunelveli, Tamil Nadu, India
Objectives: To assess and compare the Knowledge, Attitude & Practice of Self-medication among Medical & non-medical students. Materials and Methods: The study was commenced with Institutional Ethical Committee's approval and the students were enrolled according to the study protocol after obtaining informed written consent. This was a cross-sectional and pre designed questionnaire based study among 100 medical students of Tirunelveli Medical College & 100 non-medical students of Sarah Tucker College of Arts & Sciences. The questionnaire contains a total of 24 questions, among which 10 questions were assessing Knowledge, 11 questions for practice and 3 questions for attitude. For the students who participated in the study, the questionnaire were distributed and 20 min was given for them to answer the questionnaire. Answers were assessed on 5 point Likert scale. Data was analysed and presented as percentages. Results: It was found that medical students have better knowledge about the drugs, dose, duration & side effects of self-medication than the non-medical students. Family members were their main source of knowledge in both the streams. Both the groups had similar (positive) attitude towards Self-medication. 62% medical & 86% non-medical students had taken self-medication. The commonest indications for self-medication were fever and headache followed by cough. Anti-pyretics were the commonest drug used followed by analgesics. 83% of Medical students self-medicated as they had previous experience with the disease but 69% of non-medical students had taken self-medication due to the advice given by their family & friends. Both the groups were aware of checking the expiry date and package inserts. Conclusion: In the present study self-medication was found to be highly prevalent among non-medical students than medical student's inspite of their inadequate knowledge about drugs. Therefore health education & awareness is necessary to improve their knowledge and practice of self-medication. Responsible self-medication is a convenient alternative to treat minor illness and part of self-care, whereas inappropriate self-medication can have harmful effects.
MIS-44
Evaluation of Antioxidant Potential of Dapagliflozin by an In vitro Methods
Ramesh V, Vasanthi C, Darling CD
Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Porur, Chennai, Tamil Nadu, India
Objectives: To assess the antioxidant potential of Dapagliflozin, an SGLT2 inhibitor by DPPH radical scavenging assay. Materials and Methods: DPPH radical scavenging activity was done using the Methods of Yohozowa et al. The reaction mixture containing 1 ml of DPPH solution with different concentrations of Dapagliflozin (100, 200, 400, 800, 1000 μg/ml) was incubated in dark for 20 min at room temperature. The Resultant absorbance was recorded at 517 nm and the percentage inhibition was calculated. Similar concentrations of ascorbic acid was prepared and incubated in a similar manner which was taken as reference anti-oxidant in the study. Results: The Scavenging property of Dapagliflozin using DPPH assay was found to be 4.43%, 10.06%, 26.64%, 37.72%, 51.17% inhibition while that of Ascorbic acid was found to be 84.52%, 86.26%, 87.76%, 89.42% and 90.18% inhibition at 100, 200, 400, 800, 1000 μg/0.1 ml concentrations respectively. Conclusion: Oxidative stress plays a role in the pathogenesis of diabetes mellitus and its complications. Hyperglycemia increases oxidative stress, which contributes to the impairment of the main processes that fail during diabetes-insulin action and insulin secretion. From the study we found that the drug has significant Antioxidant property which could play a role as cytoprotective agent in such conditions associated with oxidative stress.
MIS-45
Early Interventions with Sepsis and their Effectiveness on Mortality in Patients with Sepsis
Priyanka K, Reddy GB, Arundathi M, Teja BS, Sadhana J, Sai KP
School of Pharmacy, AGI, Hyderabad, Telangana, India
Objectives: To examine the effectiveness of early interventions with sepsis bundles after their implementation in patients with sepsis presenting to the emergency department in a tertiary care. Materials and Methods: Quality improvement initiation analysis (1 st hour-3 rd hour and after 6 th hour) is done within a local tertiary care unit. (1) The parameters included for the analysis are: (a) serum lactate levels, (b) blood cultures, (c) administration of broad spectrum antibiotics, (d) fluid resuscitation, (e) administration of vasopressor, (f) central venous oxygen saturation. (2) System of 'scoring' is followed for assessing: (a) 0 = inappropriate for that bundle, (b) 1 = appropriate of the bundle. (3) Analysis of lactate levels, cultures and antibiotics administration will be done in 1-3 hours. (4) Analysis of fluid resuscitation, vasopressor administration and venous oxygen saturation will be done after 6 th hour. Results and Conclusion: The study is under process and requires some more quality time to provide the Results. The targeted outcome aims at improving the quality of sepsis management by use of bundles and to decrease the mortality rates.
MIS-46
Knowledge, Attitude, and Practice of Pharmacovigilance Among Health Care Professionals in a Tertiary Care Hospital: An Observational Study
Vinoth K, Meenakshi B, EzhilRamya J
Department of Pharmacology, Tirunelveli Medical College, Tirunelveli, Tamil Nadu, India
Objectives: The Present cross-sectional questionnaire survey was conducted with an aim of assessing the knowledge, attitude, and practice (KAP) related to pharmacovigilance among the health-care professionals in Tirunelveli Medical College and Hospital, Tirunelveli. (South India), a Tertiary care teaching Hospital. Materials and Methods: To assess KAPs of Health care professionals towards Pharmacovigilance and adverse drug reaction (ADR) reporting, a predesigned, structured, 20 item questionnaire was used. Results: A total of 200 questionnaires were distributed among the Health-care Professionals including Postgraduate, Interns and Staff nurses. 35.38% Health care Professionals gave correct response regarding the Definition of Pharmacovigilance. 59.87% of healthcare workers were aware of the Existence of a National Pharmacovigilance Program of India. Only 63.68% Healthcare professional felt that ADR reporting is a Professional obligation for them. Only 21.44% Healthcare professionals have been trained for reporting adverse reactions. But 96.33% healthcare professionals agreed that reporting of ADR is necessary and 92.97% were of the view that pharmacovigilance should be taught in detail to healthcare professional. Although around 76% experienced ADR in their practice, very few health-care professionals, that is, 26.53% have ever reported ADR to Pharmacovigilance center. Conclusion: The Deficiencies in knowledge and attitudes require urgent attention not only to improve the rate of spontaneous reporting, but also for enhanced safety of the patients and society at large. There was a huge gap between the ADR experienced, and ADR reported by the health-care professionals. It has been advised that the health-care professionals should be trained properly on ADR reporting to improve the current scenario in the pharmacovigilance program of the country.
MIS-47
Assessment of Knowledge Attitude Practice on Pharmacovigilance Among the Pharmacy Students and Experienced Pharmacists in a Silchar Medical College and Hospital
Chakravarty P 1 , Dewan B 2
1 Department of Pharmacology, Adverse Monitoring Centre, PvPI, Silchar Medical College and Hospital, Silchar, Assam, India, 2 Department of Pharmacology, ADR Monitoring Centre, Silchar Medical College and Hospital, Silchar, Assam, India
Objectives: Medicines (pharmaceuticals and vaccines) as a rule have known or unknown side effects. However many adverse drug reactions (ADRs) are preventable but it demands a good knowledge of pharmacology and good prescribing practice. An awareness about ADRs can decrease the irrational use of an inappropriate medicine. To assess the awareness, knowledge and the Methods of application of pharmacovigilance among Pharmacy Students and Experienced Pharmacists in Silchar Medical College& Hospital, Assam. Materials and Methods: A questionnaire was designed based on the preference which was set by previous studies and administered to 38 Pharmacy Students and 30 Experienced Pharmacists (Total 68) at Pharmacy Institute, where the seminar was conducted for pharmacist's knowledge update, Silchar Medical College & Hospital, Silchar. The questionnaire comprised of 20 questions (awareness-6, knowledge-6 and Methods of application-8) and each question had only one correct answer. The respondents were graded into 3 categories-poor, unsatisfactory and satisfactory, based on their individual scores. The data was then analyzed by using the descriptive statistics and one way ANOVA. Results: A total of 68 questionnaires were statistically analyzed. It was found that the awareness, knowledge and the Methods of application of pharmacovigilance was lesser in the pharmacy students, as compared to the experienced working Pharmacists. The Methods of application in the experienced Pharmacists were considerably higher, probably due to their clinical exposure and conducting continuous pharmacist knowledge update seminar. It was also observed that the awareness and knowledge were highly significant which is related to better Methods of application in experienced Pharmacists due to continuous clinical exposure. Conclusion: In overall, Pharmacy students have poor and unsatisfactory knowledge and Methods of application attitude as compared to working Pharmacists towards ADRs reporting and pharmacovigilance. Pharmacovigilance is being taught to some extent in theory, but the knowledge on the practical approach is lacking. This suggests the need of suitable changes in the Pharmacy teaching curriculum and additional training among the students regarding ADRs.
MIS-48
Formulation and Development of Nanoemulsion Loaded Transdermal Gel of Nebivolol HCL
Chotaliya M
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: The aim of present study was to develop Nanoemulsion based transdermal drug delivery systems of water insoluble drug Nebivolol Hydrochloride. To select various antihypertensive drugs which are suitable for poor solubility, and poor oral bioavailability enhancement. Formulation and development of novel drug delivery strategies for their dissolution and bioavailability enhancement. Optimization of process parameters and selection of optimized batches for each of formulations. In vitro evaluations and characterizations of optimized formulations. Conversions of optimized formulations into patient compliable formulation. Materials and Methods: Nanoemulsions were developed by the spontaneous emulsification Methods. A first 2nanoemulsion component of Oil was determined using various oils in which drug showed maximum solubility. The Selection of ideal nanoemulsion components of Surfactant and cosurfactant was determined on basis of emulsification ability as well as high percentage transmittance and ease of emulsification with selected Oil. Pseudo ternary phase diagram was constructed to find out optimum concentration range of Nanoemulsion components using titration Methods. Optimized nanoemulsion formulation was incorporated with carbopol 934 HPMC LV 50 get suitable viscous nanoemulsion loaded gel. The Nebivolol hydrochloride Nanoemulsion loaded gel was prepared by using the different combination of gelling agent like Carbopol-934 and HPMC LV 50 with employed 3 full factorial design. Transdermal ability of drug through skin was determined by Frans diffusion cell. Results: Highest solubility for drug was observed with Acrysol EL 135 (7.5 ± 0.36056 mg/g). 2 Transcutol P exhibited highest solubility (12.3733 ± 0.51472 mg/gm). Capryol 90 exhibited the highest emulsification efficiency with Acrysol EL 135 with highest transmittance (94.5 ± 0.143) and less no of inversions and cosurfactant Transcutol P showed (99.16 ± 0.4041) highest transmittance. In pseudo ternary phase diagram 4:1 ratio was selected due to highest nanoemulsion region. So based on phase diagram 10%, 30%, 50% for oil (X1) and 10%, 25%, 40% for S-Cos mix (X2) were selected in 3 full factorial design. Based on these analyses, Droplet size range from 9.87 ± 1.03-106.2 ± 3.81 were obtained from all batches. F3 batch posse's lowest p article siz e 9.87 ± 1.03 and highest transmittance 100 ± 0.61. Based overlay plot optimized formulation having globule size 10.25 ± 0.33 nm, zeta potential 34.17 ± 0.31 mv. Now this formulation was further studied with trandermal skin permeation study in gel. 32 full factorial design was employed to prepare Nanoemulsion based gel using Carbopol 934 (0.2% to 1%) and HPMC LV 50 (1% to 2%) as Gelling Agent at various concentration range. Optimized Nanoemulsion based gel showed 1097.08 μg/cm 2 hr at the end of 24 hrs as compare to its Nanoemulsion (1185.958 μg/cmhr). Conclusion: The present investigation revealed that both rate and extend of Nebivolol HCL transport across animal skin were highly dependent on the concentration of oil, surfactant, cosurfactant and water of developed formulations. The Nebivolol HCL loaded ME; composed with 8.2% w/w of capryol 90 as oil phase, 40% w/w of Acrysol el 135 and Transcutol p (s-cosurfactant mixture) and 51.8% water. The optimized batch of Nebivolol HCL loaded Nanoemulsion loaded gel delivered drug with a flux value of 59.17 μg/cm hr in the in vitro permeation study. Thus, it could be concluded from the present investigation that an O/W type Nanoemulsion could be an excellent approach for successful transdermal delivery of highly water insoluble drugs like Nebivolol HCl. However further, in vivo investigations are required to confirm improved antihypertensive efficacy of drug.
MIS-49
Effect of the Herbal Nutrition Attenuates Streptozotocin-induced Diabetic and Nephropathy in Rats
Thippeswamy AHM, Rafiq M, Azeemuddin M, Suryakanth DA, Thiyagarajan OS, Kavya KJ, Baig MR, Jagadeesh M, Prashanth JS, Puneeth V, Shyam R
R&D Center Himalaya Drug Company, Makkali, Bangluru, Karnataka, India
Objectives: Present study was aimed to evaluate the effect of balanced herbal nutrition supplement (HiOwna-DM) to protect against streptozotocin induced Diabetic (nephropathy) on rats. Materials and Methods: Diabetic was induced in rats by single intraperitoneal injection of streptozotocin (45 mg/kg). After 72 hrs, fasting blood glucose level ≤ 250 mg/dl and those rats were considered as diabetic rats. Further all the diabetic rats were grouped into following groups as normal control, diabetic control, Enalapril (10 mg/kg), HiOwna DM (2.5 g/kg) and HiOwna DM (5 g/kg). These rats were treated upto 120 days. All the rats were subjected to biochemical studies, the parameters such as serum glucose level, Urea, Creatinine were assessed, along with urine parameters, the changes in the kidney tissues were measured at the genomic level by focusing on gene expression like TNF-α & IL-6. Results: Treatment with HiOwna DM normalizes both blood and urine parameters like elevated glucose level, Urea and creatinine in dose dependent manner, along with supportive study of gene expression. Conclusion: HiOwna DM significantly restore the blood & urine parameters on STZ induced (diabetic) and diabetic nephropathy.
MIS-50
An Evaluation of Power Point Presentations and their Impact on Learning in Undergraduate Medical Students
Shah SD, Kapadia JD, Desai CK, Panchal JR, Desai MK
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India
Objectives: The present study aimed to evaluate the quality of PowerPoint presentations (PPT) and their impact on learning in undergraduate medical students. Materials and Methods: In this cross sectional study, a modified RUBRIC questionnaire was administered to undergraduate medical students at the end of the lecture to evaluate quality of PPT presentations, which contained questions regarding content (5), design (3) and presentation (4). Questions regarding difficulty level of the topic, attention level during lecture, knowledge of the topic before and after the lecture were also included. Impact of PPT on learning in students was assessed by a 10 question test at the end of the lecture. Results: A total of 471 responses were obtained from 12 lectures. Mean attention span of the students during lectures was reported at 6.29 ± 0.08. Students reported a significant improvement in level of knowledge topic after the lecture than before the lecture (P < 0.0001) and Mean score obtained by students in test was 6.91 ± 0.09. Mean scores of PPTs regarding quality of content were 14.46 ± 0.11 (maximum score of 20), while those for design (maximum score of 12) and presentation (maximum score of 16) were 7.86 ± 0.08 and 11.71 ± 0.12 respectively. Mean score obtained by students in test was 6.91 ± 0.09. A significant correlation of attention level was observed with quality of content (r = 0.311), design (r = 0.202), presentation (r = 0.317) and marks (0.219) obtained in test and also between overall quality of PowerPoint presentation (Mean score of 34.04 ± 0.27) and marks obtained (r = 0.359). Conclusion: Content, design and presentation of PPT positively correlates with the attention level of the students and their learning.
MIS-51
Evaluation of Learning Styles of Students and Concurrence with Current Teaching Methods in Pharmacology
Jani KK, Desai CK, Kapadia JD, Shah MH, Desai MK
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India
Objectives: Identification of learning styles of students can help teachers use the right teaching Methods. The study aimed to evaluate the learning styles and preference of students for various teaching-learning Methods and their concurrence with the currently practiced teaching Methods in Pharmacology. Materials and Methods: In this cross sectional study, following approval from the Ethics Committee, VARK questionnaire version 7.8 (2014) was administered to second year medical students for assessing their preferred learning style namely V (visual), A (aural), R (read/write) and K (kinaesthetic). Unimodal or multimodal learning preference was assessed using VARK assessment scoring breakdown. Students were assessed about their preference for teaching Methods. Faculty members in Department of Pharmacology were also assessed for their preferred teaching Methods using a prevalidated structured questionnaire. Results: A total of 264 students participated in the study. Mean scores obtained (out of a maximum score of 16) for different modalities preferred were maximum for aural learning (7.4 ± 2.7) followed by kinaesthetic learning (7.3 ± 2.5), visual learning (5.4 ± 2.7) and read/write learning (5.04 ± 2.4). Majority students exhibited unimodal learning preference (179, 67%) followed by quadmodal (102, 38.6%), bimodal (47, 17.8%) and trimodal (30, 11.36%) learning preference. Aural (44.7%) and kinaesthetic (43.5%) styles were most preferred among students showing unimodal preference (85). Students preferred PowerPoint presentation (197, 74.6%) followed by tutorials (107, 40.5%) and blackboard teaching (101, 38.2%). Faculty members (17) preferred Power Point presentation (15), tutorials (14) and blackboard teaching (9) for teaching. Conclusion: While most students prefer to learn using more than one sensory modality, aural and kinaesthetic styles of learning are preferred by majority of students. Currently practiced Methods of teaching by faculty concur with the preference of students.
MIS-52
A Prospective Observational Study to Monitor Adverse Drug Reactions of Psychiatric Medications in Tertiary Care Hospital
Ali MA, Kumar R, Devde R, Hareesh A, Rao AV, Kameshwari JS
Department of Pharmacology, Kakatiya Medical College, Warangal, Telangana, India
Objectives: The study is mainly aimed to analyse the causality and severity of Adverse Drug Reactions (ADR) with various medications in psychiatric outpatient unit. Materials and Methods: A cross-sectional observational study was performed in the psychiatric outpatient unit for monitoring ADRs with various medications over a period of six months. Hartwig and Siegel scale was used to assess severity and WHO scale to assess causality was used for causality assessment. ADRs were segregated using world health organization - adverse reaction terminology (WHO ART) into various system organ classes (SOC). Results: A total of 304 psychiatric patients were screened during the study and 184 patients developed 394 ADRs. ADRs were categorized under 14 different system organ classes. Antipsychotics (77.41%) were found to be with highest number of ADRs followed by almost equal contribution by antidepressants (11.16%) and anticonvulsants (10.65%). Most of the ADRs (91.11%) have a probable causal relationship. We observed an approximately equal proportion of mild (51.26%) and moderately (48.72%) severe reactions. Conclusion: This study presents indigenous data of adverse drug reactions in psychiatry outpatient unit in the tertiary care hospital. In this study number of patients and also number of ADRs identified were more among young age group, so an updated knowledge of ADR profile of drugs may help in managing undesirable effects and hence improve the quality of life of patients suffering from psychiatric illness.
MIS-53
Assessment for the Necessity to Change Undergraduate Pharmacology Curriculum in Medical Colleges: A Questionnaire Based Study
Mukherjee M, Begum SA, Mousumi D, Sengupta G, Das A
Department of Pharmacology, R.G. Kar Medical College, Kolkata, West Bengal, India
Objectives: Pharmacology being both a basic and applied science forms the backbone of rational therapeutics. The aim of the study was to assess whether an imperative need to change pharmacology curriculum to enable undergraduate medical students to prescribe the drug rationally. Hence, a survey was carried out at our teaching hospital to assess whether any change is needed in undergraduate pharmacology curriculum in medical colleges. Materials and Methods: This is a cross sectional study involving clinicians (including interns and house staffs) and faculty members of Pharmacology of R.G Kar Medical College in Kolkata, who were surveyed with 14 validated questionnaires which were designed based on internationally accepted "Likert Scale". Analysis was based on proportion and percentage wise distribution of various parameters used in the questionnaire. Results: In this study 15 pharmacologists and 15 clinicians were participated. Regarding bed side case study, teaching some topics in final year again and giving partial hand outs before lectures both the responded groups agreed. 71% clinician and 84% pharmacologist were in favour of bed side case study. 77% clinician and 92% pharmacologist were in favour of teaching some topics of pharmacology in final year again. 62% clinician and 74% pharmacologist were in favour of partial handouts before lectures. However, their opinion differed whether undergraduate training in pharmacology has equipped me to prescribe rationally or safely and improved training could have prevented adverse drug reaction (ADR). Conclusion: The current study has shown that certain aspects of undergraduate pharmacological curriculum required some modifications.
MIS-54
Observational Comparative Study on Efficacy and Tolerability of Tapentadole with Tramadol
Joshi KG, Dabhi PA, Bhalodia PN
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Introduction: Chronic pain is the most common problem in all age group of the patients. Opioids are the preferred effective drugs but have limitations of severe adverse effects. However newer opioid analgesic Tapentadol is supposed to have more efficacy and less side effects. Thus, Objectives of study was to compare its efficacy and tolerability with Tramodol which is currently most prescribed drug of this class. Materials and Methods: 60 patients were enrolled in the study after getting approval from IHEC. 27 patients were treated with Tramadol 50 mg tablet and 33 patients with Tapentadol 50 mg tablet as per their clinical condition for 120 days. Efficacy and tolerability of both drugs were compared using comparative pain scale and severity scale respectively. Results: Tapentadol drug therapy was found to produce quick pain relief in 63.63% patients, adverse events like constipation, Dizziness, Vomiting, Dryness, Sleepiness and Addiction were found to be non-significant while, withdrawal syndrome was found significantly decrease in Tapentadol patients as compare to Tramadol patients. Conclusion: Patients suffering from low back pain, osteoporosis and joint pain were more satisfied by Tapentadol therapy and experienced less adverse effects as compare to Tramadol therapy.
MIS-55
Diatriazoate Meglumine and Diatriazoate Sodium Induced Blisters: A Rare Adverse Drug Reaction: A Need for Materiovigilance
Rao AV, Khan I, Kartheek S, Reddy SS
Department of Pharmacology, Kakatiya Medical College, Warangal, Telangana, India
Diatriazoate meglumine and diatriazoate sodium (Trazograf 76%) alone rarely causes blisters. We present a case who had developed painful blisters after injecting a radio contrast dye after performing intravenous pyelography (IVP) for the detection of obstructive renal disease. This case report highlights the fact that some caution should be exercised while performing IVP with contrast dyes and to strengthen materiovigilance.
MIS-56
Self-medication Practice Amongst Undergraduate Nursing Students in Government Nursing College Nanded, Maharashtra
Bhagunde LK, Tamboli SB, Chhabra RR
Department of Pharmacology, Dr. Shankarrao Chavan Government Medical College, Vishnupuri, Nanded, Maharashtra, India
Objectives: Self-medication is defined as selection and use of medicines by individuals to treat self-recognized or self-diagnosed conditions or symptoms. Though practiced throughout the world there are limited studies regarding the prevalence of self-medication practices among nursing students. To determine the pattern of self-medication practices among nursing college students. Materials and Methods: A cross sectional questionnaire based study was conducted on the nursing students in a government nursing college attached to a tertiary care district hospital in Nanded, Maharashtra. A questionnaire consisting of both open and close ended questions related to various aspects of self-medication were handed out to the students. The students who willingly gave consent filled up the questionnaire anonymously. Results: Of a total of 84 students, 4 were excluded due to incomplete entries, remaining 80 students were analysed. A total of 91.25% of nursing students practiced self-medication. The most common indications for self-medication were fever (91.8%), headache (65.8%) and pain abdomen (47.9%). The classes of drugs used commonly for self-medication were antipyretics (72.6%), analgesics (67.1%) and antibiotics (37%). Similar past experiences (54.8%), mildness of infection (30.1%) and long waiting line in the OPD (11%), were the most common reasons for self-medication. Source of drug information most commonly cited by the students was from textbooks (42.5%), old prescription (27.4%) and parents or other family members (24.7%). Conclusion: Our study shows that self-medication is a very common practice amongst nursing students. The government and the health authorities need to ensure that it is done in a responsible manner.
MIS-57
Assessment of Knowledge of Pharmacovigilance Amongst the Nurses of Tertiary Care Hospital
Wadivkar PP 1 , Zad VR 1 , Shah KU 1 , Mankar NN 2 , Vakharia MP 1
1 Department of Pharmacology, Dr. V.M. Government Medical College, Solapur, Maharashtra, India, 2 Department of Pharmacology, LTMMC, Sion, Mumbai, Maharashtra, India
Objectives: The Pharmacovigilance programme of India envisages that "ALL" health care professionals will play an important role in making the programme a success. Nurses and Midwives have better population outreach as compared to physicians alone. To assess the knowledge of pharmacovigilance amongst the nurses of a tertiary care hospital. Materials and Methods : The study was conducted from month of March 2015 to July 2015. Nurses were provided pre-structured questionnaire for filling after explaining the aim and Objectives of the study. Responses were pooled and analysed. Results: 100 nurses returned completed forms. 63% respondents had heard about the term pharmacovigilance. 41% of these could correctly define it. All the respondents had heard about ADR, 39% could correctly define it. 35% of the participants were of the opinion that both doctors and nurses should report ADR. 76% were not aware of any national programme of pharmacovigilance. 72% of nurses claimed to be aware of common ADRs of the drugs they routinely administered by them. 81% of the nurses were not routinely informed to be on lookout for specific drug reactions by the treating physicians. 91% of nurses were of the opinion that periodic pharmacovigilance training will benefit ADR reporting with 58% favouring yearly workshops. Conclusion: The present study focused on the major lacunae in efficient ADR reporting. Nurses being a major stakeholder in healthcare delivery, can be mobilised in the field of ADR reporting, which currently isn't the norm, albeit with adequate training.
MIS-58
Knowledge and Attitude About HIV Infection Among Medical Students at Government General Hospital, Ananthapuramu
Kushbu D, Santha K, Naik PS
1 Department of Pharmacology, GMC, Anantapur, Andhra Pradesh, India, 2 Department of DVL, GGH, Anantapur, Andhra Pradesh, India
Objectives: To assess the knowledge and attitudes of medical students towards patients suffering with HIV/AIDS. To determine if students felt adequately prepared to deal with medical and psychological aspects of HIVIAIDS. Materials and Methods: the study was conducted in a questionnaire based pattern at Government Medical College, Anantapuramu, including MBBS students of all the semesters. A structured questionnaire was distributed to all the medical. Students of each year. The questionnaires regarding knowledge were focused on various Methods of transmission, high risk behaviours and preventive measures. Attitude towards HIV/AIDS patients, sexual behaviours, condom usage, sex education and resource allocation for HIV/AIDS patients were assessed. Results: A change in the knowledge from 1 st to 4 th year was seen in the following aspects: knowledge regarding vertical transmission (78% to 93.3%), transmission through Breast feeding (31.9% to 85.3%), tuberculosis as the most common opportunistic infection in HIV/AIDS (26.9% to 70%), correct time of initiation of PEP (5% to 46.7%), facility for getting HIV test done confidentially (0.6% to 42.7%). An increasing trend in the negative attitude towards HIV patients was seen from 1 st to 4 th year when it came to right to refuse surgical treatment to HIV patient (40% to 56%) and an increasing trend in the favourable response towards HIV patients were seen from 1 st year to 4 th year when it came to their opinion whether HIV patients can be kept in general Ward (57.5% to 78%). Conclusion: From the above study we conclude that the knowledge level on HIV/AIDS improved based on year of study. Discriminatory attitude towards. HIV patients still persisted among students of all the years.
MIS-59
Formulation and Characterization of Terbutaline Sulphate Microspheres for Treating Nocturnal Asthma in Pulsincap Drug Delivery System
Kashyap S 1,2 , Godbole AM 2 , Iliger S 2 , Singh A 1
1 Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India, 2 Department of Pharmaceutics, SET's College of Pharmacy, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
Objectives: To investigate colon specific, oral pulsincap device to achieve time or site specific release of terbutaline sulphate for better management of nocturnal asthma. Materials and Methods: Eudragit microspheres containing terbutaline sulphate were prepared by emulsion solvent evaporation technique using liquid paraffin (100 ml) containing 1% (w/w) span 80. The obtained microspheres were analysed for average particle size, carried out by optical microscopy. SEM studies were carried out by using JEOL JSM T-330. In vitro dissolution profile for microspheres were determined by employing USP XXIII rotating basket Methods (TDT 08L) Electro lab, India (900 ml of pH 6.8-phosphate buffer, 100 rpm, 37 ± 0.5°C). Pulsincap device was formulated by filling microspheres equivalent to 15 mg of terbutaline sulphate into cross-linked capsule body. The capsule body was then plugged with different hydrogel plugs with varying amounts of (70, 80 and 90 mg) of hydrophilic polymers i.e., HPMC K4M, HPMC K400 and Xanthan gum. The entire device was coated by dip coating Methods using 5% CAP solution. In vitro drug release profile from pulsincap device was carried out by using USP XXIII dissolution test apparatus (paddle Methods, TDT 08L Electro lab, India). Results: The average mean particle size of the microspheres were found to be 168.33, 190.04, 217.95, and 258.41 μm for formulations TS-1, TS-2, TS-3 and TS-4 respectively. The overall cumulative% drug release for formulations TS-1, TS-2, TS-3 and TS-4 were found to be 92.05%, 90.2%, 89.1% and 87.8% at the end of 12 th hour. Pulsincap device showed 5.33% (F1), 4.26% (F2), 0.0% (F3), 9.57% (F4), 6.12% (F5), 4.44% (F6), 6.38% (F7), 2.15% (F8) and 0.0% (F9) of drug release at the end of 5 th hour. By the end of 20 th hour 94.47%, 90.42%, 86.43%, 98.97%, 94.12%, 92.23%, 92.22%, 94.14%, 87.18% of drug was released from formulations F1, F2, F3, F4, F5, F6, F7, F8 and F9 respectively. Conclusion: Pulsatile drug release was observed over a period starting from 2-24 hrs from formulations (F1-F9) and the parameters for an ideal chronopharmaceutical drug delivery have been met.
MIS-60
Patterns of Drug Utilization in Neonatal Intensive Care Unit in Tertiary Care Hospital
Kumbhar AV, Ramanand SJ, Pore SM, Shah RD, Patil PT
Department of Pharmacology, Government Medical College, Miraj, Maharashtra, India
Objectives : (1) To study drug utilization in neonatal patients admitted to neonatal intensive care unit (NICU non-surgical) ward in tertiary care hospital. (2) To identify inappropriate use of medications in neonatal intensive care. Materials and Methods : The study was conducted in tertiary care hospital at periphery. All neonates of either sex admitted during February 2015 to July 2015 in the NICU (nonsurgical) ward were enrolled in the study. Prescription pattern was assessed by calculating WHO core drug use prescribing indicators. One admission was counted as one encounter. Results: Total 24 neonates were studied out of which 13 were male and 11 were females. Nineteen neonates were preterm born (<37 weeks) and 5 were term neonates (38-42 wks). Low birth weight (1.5-2.499 kg) neonates were 62.5% whereas 20.83% were very low birth weight (1-1.499 kg). An average of 7.46 drugs were prescribed per encounter. The encounters with injectable were 95.83% and encounters with antibiotics were 91.67%. Total 77.09% of the drugs were prescribed as generics and 69.83% of the drugs were from National list of essential medicines (NLEM). Most common drug used was injection Amikacin (91.67%) followed by injection ceftriaxone (87.5%). Out of 24 patients, antibiotics were used in 22 (91.67%). Conclusion : Antibiotics were used excessively in NICU. Good number of drugs prescribed in generic form. Improvement efforts should be targeted to rational antibiotic use.
MIS-61
Knowledge of Antibiotic Prophylaxis for Infective Endocarditis Among Dental Students, Interns and PGs at S. Nijalingappa Dental College, Kalaburagi
Sharanabasappa, Kanaki AR, Vardhamane SH, Patil BV, Jeevangi SR, Kunnoor N
Department of Pharmacology, MR Medical College, Kalburgi, Karnataka, India
Objectives : Infective endocarditis (IE) is due to microbial infection of heart values, lining of cardiac chamber or lining of blood vessel, congenital anamoly. IE is difficult to treat and has poor prognosis. Dentists play a major role in preventing IE in susceptible patients. In this study, we evaluate knowledge of antibiotic prophylaxis for IE among dental students, interns and PGs at S. Nijalingappa Dental College, Kalaburagi. Materials and Methods : A cross-sectional study was done by survey using questionnaire. Questionnaire was distributed to 159 dental students, interns and PGs at S. Nijalingapp Dental College, Kalaburagi. Questionnaire included questions regarding demographic information and knowledge of participants about antibiotic prophylaxis for IE. Results : Out of 159 participants 135 provided response, giving a response rate of 85%. Average of 52.7% of the participants had a good level of awareness regarding the cardiac conditions that require antibiotic prophylaxis. Participants also had better knowledge regarding dental procedures that require prophylaxis with an average of 75.7%. But only 37.2% correctly knew drug, dosage and regime of antibiotic prophylaxis. Conclusion : The level of knowledge about antibiotics prophylaxis of IE among dental students, interns and PGs at the study site was not at an acceptable level. Awareness is essential because of the cardiac risks associated with the lack of appropriate prophylaxis. All dental students, interns and PGs who treat patients on daily basis must be given up to date and proper knowledge on antibiotic prophylaxis. There is need for continuous education and inclusion of the prophylaxis guidelines in the student's curriculum.
MIS-62
Online Survey of Knowledge, Attitude and Practise of Yoga in Treatment of Hypertension and Obesity Among Nonmedical Personals
Saxena U, Lakhani P, Tutu S, Kumar R, Singh D, Dixit RK
Department of Pharmacology and Therapeutics, King George Medical University, Lucknow, Uttar Pradesh, India
Objectives : To evaluate the pattern of self-medication for acne among undergraduate medical students at tertiary care teaching hospital. Materials and Methods: This cross sectional study was conducted in II MBBS (Group A), IIIMBBS part - I (Group B) and IIIMBBS part - II (Group C) students. Validated questionnaire was administered to participants, which include questions regarding knowledge, attitude and practice for self-medication of acne. Data was analysed using one way analysis of variance (ANOVA) and Chi-square test. Results: Out of 582 students who responded to questionnaire, 518 suffered from acne. Self-medication practice was observed in 59% students with significantly higher number of female students (P < 0.0001). Most common source for information was seniors/friends/family members (34.2%). The common reason of self-medication for acne was mildness of illness (42.3%). The total mean score of knowledge was 2.10 ± 1.1, 2.32 ± 1.2 and 2.72 ± 1.2 in Group A, B and C, respectively which was significantly higher in group C as compared to group A (P < 0.001) and B (P < 0.05). Allopathic medication was preferred by 69.8% students. Topical preparation (76.9%) either alone or in combination without consultation was preferred. Ninty one percent students used antibiotics for acne and among them clindamycin gel was used by 113 (58.2%) either alone or in combination. Practice to read leaflet/package insert/label instruction and expiry date was present in about 75% students. Conclusion: The knowledge about self-medication in acne was inadequate. Adequate knowledge and awareness about disease can reduce complications associated with medication.
MIS-63
Self-medication for Acne Among Undergraduate Medical Students in a Tertiary Care Teaching Hospital
Karamata VV, Sisodiya MM, Gandhi AM, Patel PP, Desai MK
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India
Objectives: To evaluate the pattern of self-medication for acne among undergraduate medical students at tertiary care teaching hospital. Materials and Methods: This cross sectional study was conducted in II MBBS (Group A), IIIMBBS part - I (Group B) and IIIMBBS part - II (Group C) students. Validated questionnaire was administered to participants, which include questions regarding knowledge, attitude and practice for self-medication of acne. Data was analysed using one way analysis of variance (ANOVA) and Chi-square test. Results: Out of 582 students who responded to questionnaire, 518 suffered from acne. Self-medication practice was observed in 59% students with significantly higher number of female students (P < 0.0001). Most common source for information was seniors/friends/family members (34.2%). The common reason of self-medication for acne was mildness of illness (42.3%). The total mean score of knowledge was 2.10 ± 1.1, 2.32 ± 1.2 and 2.72 ± 1.2 in Group A, B and C, respectively which was significantly higher in group C as compared to group A (P < 0.001) and B (P < 0.05). Allopathic medication was preferred by 69.8% students. Topical preparation (76.9%) either alone or in combination without consultation was preferred. Ninty one percent students used antibiotics for acne and among them clindamycin gel was used by 113 (58.2%) either alone or in combination. Practice to read leaflet/package insert/label instruction and expiry date was present in about 75% students. Conclusion: The knowledge about self-medication in acne was inadequate. Adequate knowledge and awareness about disease can reduce complications associated with medication.
MIS-64
A Survey on the Knowledge, Attitude and Practice of Multi Drug Resistant Tuberculosis Among Medical Interns and Postgraduate in Tertiary Care Hospital
Patil K, Patil BV, Vardhamane SH
Department of Pharmacology, M R Medical College, Kalaburgi, Karnataka, India
Objectives : Tuberculosis bacilli are constantly evolving, enabling them to efficiently adapt to new environments and gain multidrug resistance. As a Results, treatment of drug resistant tuberculosis is becoming a challenge. Young medical graduates are the future of healthcare workforce in a country. The present study was undertaken with Objectives to study the Knowledge, Attitude and Practice associated with multidrug resistance in TB among Medical interns & postgraduates at M. R. Medical College, Kalaburagi. Materials and Methods : This was a cross-sectional survey conducted by means of questionnaire. Data was collected from 167 medical interns & postgraduates and included socio-demographic information and responses to questions about knowledge, attitude and practices regarding multidrug resistance in TB. Results: Out of the 167 participants, 157 of study subjects completed the questionnaire (response rate 94%). Out of them 69% were female. The participants had sound knowledge about MDR TB, but 67% (n = 101) had poor awareness about recent updates in RNTCP. Few participants (34%) were counseling patients regarding MDR TB and fewer (27%) were sending sample for drug sensitivity testing in resistant cases. Conclusion : Our survey revealed that most of the participants were aware about the concept of MDR TB. The matter of concern was poor awareness about RNTCP guidelines. Our study provides an overview of the knowledge, attitudes and practices regarding MDR TB and emphasized need for continuous educational interventions necessary to upgrade their understanding, recent knowledge, as well as change their attitude towards patients.
MIS-65
Prescription Pattern in Dermatology Outpatient Department of a Tertiary Care Rural Teaching Hospital in Central Gujarat
Gupta A, Shah H, Patel N
Department of Pharmacology, SBKS MI and RC, Sumandeep Vidyapeeth University, Vadodara, Gujarat, India
Objectives: Skin disease refers to disorders exclusively of the superficial layers of the skin. The commonest skin disorders seen in developing countries are infectious diseases, eczema, allergies and scabies, but they have not been regarded as a significant problem that could benefit from public health measures. Most skin diseases are chronic and require lifetime treatment. To study the prescription patterns in the Dermatology Out Patient Department of a Tertiary Care Rural Teaching Hospital in Central Gujarat. Materials and Methods: It is a prospective and observational type of study carried out at Dermatology Out Patient Department, Dhiraj General Hospital, Vadodara (Gujarat) from where 250 prescriptions were collected and analysed for drug use using statistical Methods and WHO drug use indicators. Results: A total of 250 prescriptions were analysed from 200 patients. Average drugs prescribed were 2.39/prescription. Topical drugs (62.7%) were most commonly prescribed than systemic drugs (37.3%). Topical drugs were mostly in combination (26.66%) followed by antifungals (20.51%) and steroids (17.44%) alone. Antihistaminics (33.62%) commonly prescribed systemically followed by antifungals (22.41%) and antibiotics (20.69%). In 43.47% instances high potency steroids were prescribed while mild potency (15.22%) were least prescribed. A great majority of drugs were prescribed in brand names Conclusion: Topical drugs more commonly prescribed and higher preference for brand names was observed.
MIS-66
Doctor's Perception on Integrated Medicine: A Survey
Asha B, Lella M, Sarala N
Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education, Tamaka, Kolar, Karnataka, India
Objectives : To assess attitude and practice of the allopathic doctors towards integration of modern medicine (MM) and traditional medicine (TM) using questionnaire. Materials and Methods: A cross sectional questionnaire based study was conducted to assess the knowledge, attitude and practice among doctors regarding integrated medicine. 207/250 filled questionnaires were received from various doctors from in and around Kolar and Bangalore. Data was analyzed using descriptive statistics and chi-square test. Results: A total of 82.8% responded to the questionnaire, of which 69 were general practitioners and 138 consultants from various specialties. Among them 56.5% accessed the information regarding TM and they had better (47%) knowledge regarding integrated medicine compared to those who didn't (13%) access (p =< 0.001). More than 57% opined that TM were cheap and easily accessible, in spite of that majority (74.5%) believed MM to be more popular. The disadvantages of TM were minimum training (63.7%), unqualified traditional medicine practitioners (TMPs) (63.7%), inadequate dose calculation (52.1%), lack of scientific evidence (57%), toxicity (42%) and unreliable diagnostic techniques (74.3%). 71.5% doctors took history of TM from their patients and (85.9%) treated them. Majority (77%) did not prescribe any TM. Though 81.6% had never collaborated with TMPs, 55.6% supported integration of TM with MM and believed this integrated approach would have positive impact on patients. Conclusion: Majority of allopathic doctors were not aware of integrated medicine. They believed that adequate scientific evidence and training of TMPs is required to accept and integrate TM with MM which may help in better patient care.
MIS-67
Assessment of Impact of Drug Price Control Order 2013 for Essential Medicines in India
More SR, Ghongane BB
Department of Pharmacology, B.J. Government Medical College and SGH, Pune, Maharashtra, India
Objectives: DPCO 2013 is issued by central government to make available essential medicines at reasonable cost. Present study is planned to estimate economic and perceived impact of this order. Materials and Methods: It is cross sectional, observational study. Prices of 348 essential medicines were collected from CIMS and MIMS; before and after DPCO 2013 implementation. Percentage change in drug prices was calculated to measure economic impact. Questionnaires were filled by clinicians, pharmacists, patients, postgraduate medical students, interns to assess perceived impact (n = 60). Results: The price reduction during Oct-Dec 2013 as compared to Oct-Dec 2012 quarter was calculated. The maximum percentage reduction was seen for chlorambucil (80.64%) followed by Vitamin A (79.33%). 122 drugs were showing percentage reduction above 40% while 46 drugs show only 0-5%. Awareness and knowledge of DPCO 2013 was highest amongst pharmacists (100%) followed by clinicians (80%), postgraduate students (68.33%), interns (58.33) and least in patients (21.66). 35% of interns, 58% postgraduate medical students, 22% patients, 74% clinicians and 83% pharmacists were of opinion that beneficiary entity after DPCO 2013 implementation is patient. 88.33% pharmacists opined that essential medicines e.g. azithromycin, diclofenac were out of stock after implementation of DPCO 2013. Conclusion: The drug prices are reduced significantly with chlorambucil, nifedipine, famotidine, aspirin, amoxycillin + clavulanic acid, metformin, lamivudine but it Results in shortage of some drugs. Awareness of knowledge of DPCO 2013 implementation and updates should be given to postgraduate students and interns via seminars, lectures so that it will encourage prescribing affordable medicines.
MIS-68
Retrospective Analysis of Patients Covered Under RGJAY Scheme in a Tertiary Care Government Hospital: A Socioeconomic Study
Patel KN, Daswani BR, Chandanwale AS, Ghongane BB
Department of Pharmacology, B.J. Government Medical College and SGH, Pune, Maharashtra, India
Objectives : Rajiv Gandhi Jeevandayee Arogya Yojana is government funded insurance scheme for BPL/APL families, implemented in hospitals all over Maharashtra. This study is a retrospective analysis of implementation of the RGJAY scheme-categorization of beneficiaries, cost-benefit analysis and scope of improvement in scheme. Materials and Methods: Records of RGJAY patients were retrieved from November 2013 to August 2014. Data was analysed for parameters like distribution of cases by 30 specialized categories and geographic area; interval between Enrollment to case registration and case approval; percentage of approved claims getting paid; revenue generated versus expenditure. Results : Total 1976 claims analysed. Highest number of cases are registered under Cardiothoracic Surgery (20%) followed by Poly-trauma (13%). Dermatology (4 cases) and infectious diseases (1 case) has least number of cases. Nearly 43.27% were from outside Pune district and 63.53% of these were cardiothoracic surgery alone. Services like cardiovascular surgeries, spine surgery and cancer chemotherapy; which were not done free of cost in routine; could be provided under RGJAY. Average lag period from Enrollment to submission of preauthorization was 5.068 days while that from submission to case approval was 0.827 day. 55% claims have been paid, 23% were pending and 22% were cancelled and amount received till date is 3.3 crores while total amount spent is 2.3 crores. Conclusion: Special services have been provided to patients in cashless manner. Revenueis generated through cases which are otherwise also done. There is a need of application of RGJAY in all civil hospitals and enforcement of information dissemination.
MIS-69
Dysmenorrhoea: Prevalence, Impact and Knowledge Aspect of Treatment in Females of Reproductive Age in Tertiary Care Teaching Hospital
Patel PA, Karelia BN, Piparva KG
Department of Pharmacology, PDU Government Medical College, Rajkot, Gujarat, India
Objectives: To describe the prevalence, severity, impact and treatment aspects of dysmenorrhoea in females of reproductive age group in tertiary care teaching hospital. Materials and Methods: This was a questionnaire based survey type study. Detail information regarding demographic profile, menstrual history and dysmenorrhoea was analysed. Severity of dysmenorrhoea was evaluated by a Menstrual Distress questionnaire (MDS). Visual analogue scale (VASP) was used to measure pain. Analysis was done by mean, SD and Chi square. Results: Out of 350 females, 198 (56.57%) females had dysmenorrhea. Dysmenorrhoea was observed more common in unmarried females (93.43%) and in age group of 15-19 year (48.28%). Regularity of menstrual cycle had no statistically significant association with dysmenorrhea. Most common domain of MDS score was Pain (92.93%) followed by Negative affect (71.71%), Behavioural change (61.11%) and concentration (54.54%). By VAS score, severity of pain was mild to moderate in majority of females (82.33%). Only 27.78% females had taken treatment. Conclusion: Dysmenorrhea is a very common problem and affects quality of life in reproductive aged females. Dysmenorrhea will require the attention and can be better managed by appropriate change in lifestyle, assurance and medicine.
MIS-70
Prospective Study of Utilization of Antimicrobial Agents in Patients on Ventilator in MICU at SSG Hospital, Baroda
Khirasaria R, Kanani N
Department of Pharmacology, Government Medical College, Vadodara, Gujarat, India
Objectives: Patients admitted in ICUs, who are on ventilators are potential areas for emergence of antimicrobial resistance. This prospective, observational and analytical study was done to assess pattern of antimicrobial use in patients on mechanical ventilation in MICU, reason for use, selection criteria, antimicrobial susceptibility, efficacy and tolerability of antimicrobials and to evaluate antimicrobial treatment outcome. Materials and Methods: The study was carried out for 6 months period during which 480 patients aged between 18 to 65 years of either gender on mechanical ventilation admitted in MICU & receiving antimicrobials were included. Results: Total 26 antimicrobial preparations were used either single or FDC preparations. Frequently used antimicrobials were third-generation cephalosporins (58%) and extended-spectrum penicillins (32%), often treated with β-lactamase inhibitors as FDCs & metronidazole as combination therapy to cover anaerobic micro-organisms. Patients received antimicrobials either as monotherapy (35%) or combination therapy (65%), mainly by intravenous route (93%). Majority of patients were treated prophylactically and empirically; treatment in reference to antimicrobials was further modified in 11% cases based on clinical response and laboratory reports. Antimicrobials were effective in preventing or controlling infections in 31% of patients. Average duration of stay on mechanical ventilation was 3.6 days. Total 19 antimicrobials were prescribed in brand name, either as single or FDC preparations and only 7 drugs in generic name. Conclusion: Antimicrobial treatment in hospital appears to be substantial and increasing, justifying and warranting efforts to improve appropriateness of therapy in order to optimize treatment to control the severity of infections & their complications, to slowdown the emergence of drug resistant organisms and control expenditure.
MIS-71
Drug Price Control Order: The Impact on Pharmacoeconomics
Shah SM, Vachhani PK, Singh AP
Department of Pharmacology, PDU Government Medical College, Rajkot, Gujarat, India
Objectives : Analysis of prices of metformin, losartan, atorvastatin, paracetamol and aspirin for the doses of which are included in the list of DPCO 2013. Materials and Methods : Current Index Medical Specialities (CIMS) India, 37 th year, April-July 2015 issue was considered for analysis. The retail prices of the drugs in INR were tabulated in Microsoft Office Excel 2013. The prices of the above listed drugs were compared with prices of DPCO 2013 for the same doses of drugs. The analysis of drugs costing more than the prices listed in the DPCO with the margin of the difference was carried out. Results : Out of 25 brands of metformin 500 mg tablet, 11 (44%) brands have price higher than listed in DPCO 2013. Similarly prices for losartan 25 mg and 50 mg tablets, 8 (25%) out of 32 and 11 (31.42%) out of 35 are higher respectively. For atorvastatin 5 mg and 10 mg tablets, 2 (9.52%) out of 21 and 8 (13.55%) out of 59 brands have higher price respectively. For paracetamol 500 mg tablet, 12 (63.15%) out of 19 brands are pricing higher than DPCO list. For aspirin 100 mg tablet and 325 mg tablet, 3 (100%) out of 3 and 1 (100%) out of 1 brands have higher prices respectively as compared to DPCO 2013. Conclusion : Many of the brand formulations have higher prices than the Drug Price Control Order (2013) issued by government of India. The clinicians prescribing these drugs should be aware of these brand formulations to reduce the cost of the drug therapy.
MIS-72
Evaluation of Scientific and Ethical Status of Drug Promotional Literatures Using WHO Guidelines
Vyas P, Bhave A
Department of Pharmacology, Medical College Baroda, Vadodara, Gujarat, India
Objectives: The study was aimed to evaluate scientific and ethical status of Drug Promotional Literatures (DPLs) using WHO guidelines. This would help to create awareness about DPLs amongst healthcare providers thus encouraging the improvement of healthcare system. Materials and Methods : This cross sectional observational study was carried out at Department of Pharmacology, Medical College Baroda. DPLs were collected from Medical representative's associations, private practitioners and multispecialty hospitals. They were evaluated for consistency, accuracy, validity of the provided information as well as types of claims, catchy terms, pictorial content, and references cited in support of claims etc. Results: Out of total 616 DPLs collected, 371 satisfied the inclusion criteria. DPLs with single drug were 180 (48.5%) and 191 (51.5%) were FDCs, out of which only 31.9% were approved FDCs. None of the DPL was fulfilling all criteria according to WHO guidelines. Most common claim was "efficacy" (55.45%) followed by "pharmacological properties" (21.12%) &"safety" (11.83%). DPLs (51.22%) were without relevant references to claims. Of the DPLs with relevant references to claims the most common reference was "journal article". DPLs with Graphical presentations were only (18.87%) of which majority were bar diagrams (47.22%) followed by line diagrams (19.44%). Most common pictorial content was package of dosage form (41.36%). DPLs with polypharmacy were (64.96%). Conclusion: We hereby concluded that pharmaceutical companies didn't follow the WHO guidelines for ethical drug promotion, thus failing to fulfil the rational promotion of drugs. Given the present findings physicians should be cautious about drawing conclusion regarding medicine based on DPLs provided by pharmaceutical companies.
MIS-73
A Review of Current Status of Stem Cell Research in India
Vakharia MP, Zad VR, Mankar NN, Shah KU, Wadivkar PP
Department of Pharmacology, Dr. V. M.G.M.C, Solapur, Maharashtra, India
Stem cell research is a promising area of science, investigates the possibilities of cell based therapies to treat disease. The immense potential that has been shown by stem cells in treatment of diseases traditionally considered "degenerative, incurable and irreversible", has brought them into the spotlight. Until recently, developing countries like India are coming forward in stem cell research. India's Department of Biotechnology (DBT), believes there are more than 30 research institutes, hospitals, and firms involved in stem cell research. India's large research-intensive hospitals like AIIMS, conduct basic and applied research which creates a bridge between research and therapy, pivotal for Indian stem cell innovation. Some Indian companies working within the field of stem cells, have also begun to produce Materials, like growth factors, invest in an animal facility to conduct toxicology and preclinical efficacy studies for cell based therapies and nanobioMaterials-based cell culture. The Department of Biotechnology (DBT), the Indian Council for Medical Research (ICMR), the Department of Science and Technology, and the Council of Scientific and Industrial Research have been involved in infrastructure building and operational activities. ICMR also have framed the relatively permissive stem cell research and therapy guidelines with the participation of DBT. Conclusion: Although challenges in stem cell research in India are many, however, by enhancing the integration between researchers and clinicians, fostering high-quality education and training, increasing public awareness, and securing adherence to its new stem cell regulatory framework, India is likely to become one of the main contributors to this emerging field.
MIS-74
Helpline Facility for Reporting Adverse Drug Reactions in India
Kumari A, Mishra P, Kalaiselvan V, Singh GN
Indian Pharmacopoeia Commission, National Coordination Centre-Pharmacovigilance Programme of India, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
Objectives: Indian Pharmacopoeia Commission (IPC) is functioning as National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) under Ministry of Health and Family Welfare. IPC, NCC-PvPI has launched a toll free helpline (18001803024) on 11 th October 2013 to report adverse drug reaction (ADRs) by healthcare professionals (HCPs), pharmaceutical companies as well as consumers. India is the first Asian country to start toll free helpline facility for direct reporting of ADRs. Materials and Methods: Consumers, HCPs and pharmaceutical company representatives call on the helpline (1800-180-3024) to report the ADRs from any medicinal products or traditional medicines. Caller provides their details along with the details of the suspected medicine which cause the adverse reaction. Helpline also provides information about what, where and how to report ADRs. The calls are answered in English and Hindi in all working days from 9 am-5.30 pm. This service is staffed by a team of fully trained and experienced pharmacists. Results: Approximately four thousand five hundred calls and hundred ADRs have been received on helpline over the duration of twenty two months. Conclusion: Helpline is an important mode to directly report the ADRs from any type of medicine from any part of the country . This facility has been started to monitor all the adverse reactions of the medicines to provide better patient care.
MIS-75
Antiurolithiatic Screening of Isolated Compounds from Aerva lanata
Dinnimath BM, Jalalpure SS
Department of Pharmachemistry, KLES College of Pharmacy, Vidyanagar, Hubballi, Karnataka, India
Objectives : In Ayurveda system, Pashanabheda is used as anti urolithiatic. We have selected the plant Aerva lanata (L) Juss. Ex. Schult (Amaranthaceae) from Western Ghats of India for the present study. Bioactivity guided isolation of potent compounds for developing new lead molecules for urolithiasis. Materials and Methods : The hydro alcoholic extract (80-20%) Aerva lanata was subjected to bioactivity guided isolation using column chromatography. Two compounds were isolated and characterized as quercetin and betulin. Based on the LD 50 of the plant extract (2000 mg/kg b.w) equivalent dose was calculated from their yield. These two compounds screened for antiurolithiatic potentials in calculi induced (ethylene glycol 0.75% v/v) male Wistar Albino rats by administering 2 mg/kg b.w/day orally as test dose for 28 days. Results : The urine volume was found to be significantly increased from 12.76 ± 0.10 ml to 21.35 ± 0.20 ml in the rats treated by quercetin and 21.50 ± 0.21 ml in rats treated by betulin. Urine microscopy has revealed significant reduction (p < 0.001) in the size of calculi and enhanced significantly (P < 0.001) excretion of calcium, oxalate, phosphate, BUN whereas the level of magnesium was increased compared with disease induced group. SEM has revealed reduction in the calculi as well as less damage to the internal organs of the kidneys in animals treated by quercetin and betulin. Conclusion: The isolated quercetin and betulin have shown mild diuretic effect and Antiurolithiatic effect by significantly reducing the size of calculi in the kidneys. Hence these two molecules are good candidates for urolithiasis.
MIS-76
Design, Synthesis and Evaluation of In vitro Anti-malarial Efficacy of Knoevenagel Condensates of Curcumin
Dohutia C 1 , Chetia D 1 , Gogoi K 2 , Bhattacharyya DR 2 , Mohapatra PK 2 , Sarma K 2
1 Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh, Assam, India, 2 Regional Medical Research Centre NE (Indian Council of Medical Research), Dibrugarh, Assam, India
Objectives: To design, synthesize and assess the in vitro efficacy of Knoevenagel condensates of curcumin against Plasmodium falciparum. Materials and Methods: Thirty two curcumin derivatives were designed and docked against PfATP6 protein, the common receptor for anti-malarial action of artemisinin and curcumin. The compounds which showed better binding energy than curcumin were synthesized and screened for their anti-malarial activity against the sensitive 3D7 strain of Plasmodium falciparum. Two compounds with lower binding energy were considered as negative controls, synthesized and screened to validate the docking protocols. Results: Docking studies against PfATP6 showed 4-NB to have slightly higher binding energy to standard artemisinin (-6.75 and -6.73 respectively) while 2-HB, 4-MB, 3-HB, 4-FB, B displayed better binding energy against the secondary standard curcumin (-5.95, -5.89, -5.68, -5.35, -5.29 and -5.25 respectively). In vitro screening of the compounds at 50 μg/ml concentration showed 100% schizont inhibition in all the six compounds. At 5 μg/ml concentration, five showed more than 75% inhibition and better Results than curcumin while 4-NB showed comparable activity to artemisinin at that dose. The in vitro Results validate the Results obtained from in silico study. Conclusion: Curcumin has long been used as an anti-malarial in traditional medicine and its in vitro activity has been well established. Our study showed that six of the Knoevenagel condensates of curcumin showed better activity than the parent molecule and 4-NB showed at par activity to artemisinin at a concentration of 5 μg/ml. This indicates that the derivatives of curcumin can be further developed to produce inexpensive drug candidates with better anti-malarial activity.
MIS-77
Formulation and Optimization of Sustained Release Matrix Pellets of Aceclofenac
Gohel K, Sambad N, Koradia K
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives: Aceclofenac is from NSAID s class drug that exhibits analgesic and anti-inflammatory activities. The short biological half-life (about 4 hr) and dosing frequency more than one per day make aceclofenac an ideal candidate for sustain release. So the main aim of present investigation was to formulation and optimization of sustained release matrix pellets of aceclofenac. Materials and Methods: The pellets were prepared by extrusion-spheronization Methods. The effects of spheronization speed (RPM) and concentration of polymer and binder as important process and formulation parameters on spherical shape, uniform size and strength were investigated by preliminary studies while concentration of sustained release polymer (EC: HPMC), concentration of binder (PVP K-30), and spheronization speed (RPM) were optimized by Box-Behnken design in order to achieve desirable drug content, in-vitro drug release at 1 hour, 12 hour and 24 hour. Characterization of prepared pellets were done with respect to dissolution rate, drug content, morphology study (SEM), FT-IR, and DSC. FT-IR analysis was done to check the intermolecular interaction between drug and excipients. Differential scanning calorimetry (DSC) study was performed to check the crystalline state. Results: From the Results of Box-Behnken statically design it was concluded that both the factor having a significant effect on the depended variable and batch F10 selected as optimized batch and characterization study illustrate that spherical shape pellets with a uniform size was obtained by extrusion-spheronization Methods, which show the sustained release of the drug up to 24 hours. Conclusion: Sustained release matrix pellets seems to be promising approach for sustaining the drug release.
MIS-78
A Pharmacogenetic Study of Association of Transporter Polymorphisms with Response to Treatment in Patients of Metabolic Syndrome
Singh S, Salman MT, Rai RK, Tewari S, Qadeer F, Fatima F, Srivastava K
Department of Pharmacology, Era's Lucknow Medical College and Hospital, Lucknow, Uttar Pradesh, India
Objectives: To study the role of SLC22A1 and SLCO1B1 gene polymorphism encoding Organic Cation Transporter 1 (OCT1) and Organic Anion Transporter Polypeptide 1B1 (OATP1B1) with respect to pharmacodynamics response to Metformin and Atorvastatin, respectively. Materials and Methods: 80 patients diagnosed with MS corresponding to inclusion and exclusion criteria were recruited in the study. BMI, Blood Glucose (fasting and post prandial), HbA1c, Lipid Profile, Liver Function Test, Renal Function Test and Blood Pressure were measured at 0 week and after 8 weeks. DNA was isolated from 1 ml EDTA mixed blood using DNA Isolation Kit. Genotyping was done using PCR-RFLP Methods. The digested product was analysed using 3% Agrose Gel Electrophoresis and 8% PolyAcrylamide Gel Electrophoresis. Results: 56.25% of the patients had GG genotype, whereas 41.25% and 2.5% had AG and AA genotype for OCT1. Whereas 25%, 41.25, 35% had AA, GG and AGgenotype. There was a significant association between the presences of extra an allele and reduction in blood glucose. Similarly, there was greater reduction in total cholesterol, LDL and a greater increase in HDL in those, who had G allele. Conclusion: The presence of rs628031 (c.1222A>G, M408V) and rs2306283 (c.388A>G, N130D) polymorphism significantly affected the efficacy of Metformin and Atorvastatin.
MIS-79
Study of Effect of Educational Intervention on Ability of Medical Students to Identify Violations in Drug Promotional Literature as per WHO Guidelines
Sayyad HM, Ghongane BB
Department of Pharmacology, B.J. Government Medical College and SGH, Pune, Maharashtra, India
Objectives: To determine the effect of educational intervention on ability of MBBS medical students to identify violations in drug promotional literature as per who guidelines. Materials and Methods: A pre-knowledge testing of the Interns, 3 rd and 2 nd year students' on their ability to identify violations of existing WHO guidelines were assessed using 5 promotional literatures. Training session was conducted on critical appraisal of medicinal drug promotion viz mention of Brand & generic names, dosage form, ingredients causing problems, therapeutic uses, precautions, ADRs, DI, Address, and References. In the first session, lectures on critical appraisal Methodology and the existing WHO guidelines on medicinal drug promotion were given followed by small group discussions. This was followed by post training testing. The 2 nd year students were followed up after one year (3 rd year). Results: The post-test scores showed significant improvement over the pre-test scores in 2 nd year students (44.9 ± 6. 65 vs 21.5 ± 7.82, p < 0.05) as well as interns (43.5 ± 10.5 vs 17.5 ± 7.5, p < 0.05). On follow up, the 3 rd year students showed significantly higher (p < 0.05) awareness score (28.2 ± 6.91) pre-test scores as compared to their 2 nd year scores. However, post-training these students showed significant increase score in 8 headings. In 3 rd year, the students identified violations viz. relevance of photo, graph evaluation, exaggerated claims as compared to interns and their 2 nd year Results. Conclusion : Educational training programs should be a part of undergraduate medical education including interns. Training should include critical appraisal of drug advertisement which will promote rational drug use in future practice.
MIS-80
Influence of Gossypin and Quinic Acid on Doxorubicin Induced Nephrotoxicity in Adult Zebra Fish (Danio Rerio)
Joshi KJ, Saraf MN
Department of Pharmacology, Bombay College of Pharmacy, Mumbai, Maharashtra, India
Objectives: Determination of a dose of doxorubicin causing nephrotoxicity without causing significant mortality in adult zebra fish. Influence of gossypin and quinic acid on doxorubicin induced nephrotoxicity in adult zebra fish. To allievate dyslipidemia associated with nephrotoxicity. Materials and Methods: Development and standardization of adult zebra fish nephrotoxicity model. Treatment with test agents after induction of nephrotoxicity in adult zebra fish (Danio rerio). Estimation of various antioxidant and biochemical parameters. Results: Exposure to doxorubicin (20 mg/liter) for a period of 72 hours significantly decreased serum total protein, HDL-cholesterol, antioxidant enzymes (catalase, superoxide dismutase and reduced GSH) and increased in serum total cholesterol, triglycerides, creatinine, blood urea nitrogen, VLDL-cholesterol, LDL-cholesterol and all lipid ratios in adult zebra fish. Treatment with gossypin (10 mg/liter), quinic acid (15 mg/liter) and atorvastatin (10 mg/liter) for a period of another 72 hours significantly increased serum total protein, HDL-cholesterol, antioxidant enzymes (catalase, superoxide dismutase and reduced GSH) and decreased in serum total cholesterol, triglycerides, creatinine, blood urea nitrogen, VLDL-cholesterol, LDL-cholesterol and all lipid ratios in adult zebra fish. Conclusion: The present investigation demonstrated the utility of zebra fish (Danio rerio) as a model system to screen potential bioactive agents for nephrotoxicity. It also provided experimental evidence indicating potential application of gossypin and quinic acid in delaying dyslipidemia induced by nephrotoxicity or chronic kidney disease by decreasing oxidative stress.
MIS-81
Nutritional Aspects of Millet Fortified Animal Pellets
Agrawal A, Khan A
Faculty of Pharmaceutical Science and Technology, AKS University, Satna, Madhya Pradesh, India
Objectives : The present work is proposed to determine the effect of modifications of ingredient composition and consistency of feed pelletslab animals. Materials and Methods: The main purpose for performing this work is due to lack of animal pellets which have a high nutritional value at low cost. The ingredients studied were kodo-kutki, soya bean, sago, green gram and rice are a rich source of protein, fibers, and minerals and is highly energetic. The ingredients were powdered individually. Different combination of preparation of kodo-kutki millet based pellets in different combination of rice flour green gram flour sago flour and full fat soya flour were tested. There are following treatment: (1) Kodo: Kutki: Rice (40:40:20, 35:35:30, 30:30:40, 25:25:50). (2) Kodo: Kutki: Sago (40:40:20, 35:35:30, 30:30:40, 25:25:50). (3) Kodo: Kutki: green gram (40:40:20, 35:35:30, 30:30:40, 25:25:50). (4) Kodo: Kutki: full fat soya (40:40:20, 35:35:30, 30:30:40, 25:25:50). Results: On the basis of findings it was proposed that fortified pellets could be considered as good animal feed from nutritional point of view, as well as at lower cost. Conclusion: The present study was made on Nutritional attributes like moisture, proteins, Carbohydrate, ash values and fiber on animal pellets. Along with this the growth activity on animals can be checked by parameters like weight, Hb, alertness, Head bobbing, rearing.
MIS-82
More Effective Interventions for the Problem of Bone Loss in Astronauts During Spaceflights
Khajuria D 1,2 , Khalid MG 1 , Razdan R 1 , Mahapatra DR 2
1 Department of Pharmacology, Al-Ameen College of Pharmacy, Bengaluru, Karnataka, India, 2 Department of Aerospace Engineering, Laboratory for Integrative Multiscale Engineering Materials and Systems, Indian Institute of Science, Bengaluru, Karnataka, India
Objectives: The present study was conducted to investigate the therapeutic effects of zoledronic acid, alfacalcidol and propranolol as monotherapy and combination therapy in a hindlimb-unloading rodent model that is used across the world to mimic spaceflight. Materials and Methods: 3-month-old male Wistar rats had their right hind-limb immobilized (RHLI) for 10 weeks to induce osteopenia, then were divided into eight equal groups: (1) non-immobilized, negative control rats (saline, subcutaneously 5 days/week), (2) RHLI, positive control rats (saline, subcutaneously 5 days/week), (3) RHLI rats + zoledronic acid (50 μg/kg, intravenous single dose), (4) RHLI rats + alfacalcidol (0.5 μg/kg, per oral daily), (5) RHLI rats + propranolol (0.1 mg/kg, subcutaneously 5 days/week), (6) RHLI rats + zoledronic acid (50 μg/kg, intravenous single dose) + alfacalcidol (0.5 μg/kg, per oral daily), (7) RHLI rats + zoledronic acid (50 μg/kg, intravenous single dose) + propranolol (0.1 mg/kg, subcutaneously 5 days/week), (8) RHLI rats + zoledronic acid (50 μg/kg intravenous single dose) + alfacalcidol (0.5 μg/kg, per oral daily) + propranolol (0.1 mg/kg, subcutaneously 5 days/week), for another 10 weeks. At the end of treatment, the femurs were removed and tested for bone porosity and mechanical properties. Results: With respect to improvement in the femoral bone porosity and mechanical strength, the combination treatment with zoledronic acid, alfacalcidol and propranolol appears to be more effective than each drug administered as a monotherapy. Conclusion: The Results strongly that the problem of bone loss during spaceflights can be more effectively treated by combined treatment with zoledronic acid, alfacalcidol and propranolol.
MIS-83
Role of High Fat Diet and Hyperhomocysteinemia in Atherogenesis, Insulin Resistance and Nephropathy
Parikh FV, Gohil PC, Shah GB
Department of Pharmacology, K.B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India
Objectives: Development of a rat model which mimics pathological characteristics of atherosclerosis, Insulin resistance and nephropathy. Materials and Methods: Combined effect of high fat diet (HFD) and DL-methionine was observed on development and progression of atherogenesis, insulin resistance and nephropathy in rats. During 56 days of study period, rats were given HFD and DL-methionine. Different parameters related to glucose tolerance, lipid profile, renal function and oxidative stress were measured. In addition, serum homocysteine, tumor necrosis factor-alpha (TNF-α), interleukin-1-beta (IL-1β) and lipoprotein-a were also measured at different intervals. Results: A significant increase in fasting insulin levels, reduction in insulin sensitivity index, increase in low-density lipoprotein (LDL), triglyceride, homocysteine, TNF-α and IL-1β were observed in alone DL-methionine treated and HFD with DL-methionine treated animals. However, sorbitol and advanced glycation end products remained unaffected in all animals. Renal function parameters remained unaltered in all groups of animals. Thoracic aorta microscopic observation revealed presence of atheroma in both DL-methionine and HFD with DL-methionine treated animals. Renal morphology remained normal. Conclusion: The Results suggest HFD with DL-methionine treated animals develop atheroma and insulin resistance in 8 weeks but nephropathy is not developed. A longer duration of study may be required for producing nephrotoxicity.
MIS-84
Pharmacogenomics of Metformin: A Way to Personalised Medicine
Vakharia MP, Zad VR, Wadivkar PP, Shah KU
Department of Pharmacology, Dr. V. M.G.M.C, Solapur, Maharashtra, India
Objectives: Type 2 diabetes mellitus affects 62 million of the adults in India. The incidence of type 2 diabetes and its costs to the health care system continues to rise. Metformin remains the most widely used pharmacotherapy for its treatment. Inter-individual variability in response and few clinical or biomarker predictors of response reduces its optimal use. Personalized medicine promises a path for individually optimized treatment, but realizing this promise will require a more comprehensive characterization of disease and drug response. Understanding of the genetic determinants of metformin response may lead to the identification and development of effective targets for diabetes treatment. Pharmacogenomics as the most widely applied discovery-based approach to date has opened up the opportunity to understand the genetics underlying the inter individual variation in metformin responses so that the clinicians can prescribe treatment to the individuals for better efficacy and safety, metformin for those predicted to respond and alternative therapies for those predicted to be non-responders or who are at increased risk for adverse side effects. To review the research on metformin pharmacogenomics and its application in improving patient outcomes. Materials and Methods: Relevant articles were identified in PUBMED using MeSH terms Metformin, Pharmacogenomics and Personalized medicine. Results and Conclusion: SLC22A1 is associated with HbA1c reduction with metformin and increased lipid levels. SLC22A3 is associated with metformin pharmacokinetic changes. SLC47A1 is associated with increased HbA1c reduction with metformin and decreased incidence of DM. SLC47A2 responded poorly to oral metformin requiring change of medication.
MIS-85
A Prospective Study of Adverse Drug Reactions Monitoring in Department of Medicine at SGMH Rewa Madhya Pradesh
More P, Raj B, Singh P
Department of Pharmacology, S.S.M.C, Rewa, Madhya Pradesh, India
Objectives: To assess the pattern of ADR among outpatients and inpatients attending medicine department at SGMH, Rewa (M.P.) to assess the causality, severity, and preventability of reported ADRs. Materials and Methods: This prospective observational study was carried out from the Aug 2014-Aug 2015 in the department of medicine, SGMH Rewa (M.P.). All outpatients & Inpatients with suspected ADRs were included in this study. All the staff members of Medicine Department were encouraged to report/document the suspected ADRs. Data was collected through CDSCO, Suspected ADR Reporting Form. The causality assessment was done with Naranjo's scale, severity by using Modified Hartwig scale and preventability was assessed by using Modified Schumock and Thornton scale. Results: The clinical spectrum of ADRs ranged from the more common mild reactions like skin rashes, itching and vomiting to severe reactions like TEN & SJS. The predominant causative drugs were antimicrobial (mainly Cephalosporins, Penicillins & Quinolones) & NSAIDS. Majority of ADRs were probable in causality assessment, moderate in severity and probably preventable. Conclusion: Hospital based monitoring of ADR and reporting is important to identify and quantify the risks associated with the use of drugs. This information may be useful in identifying and minimizing preventable ADRs while generally enhancing the knowledge of the prescribers to deal with ADRs more efficiently. More awareness about the importance of spontaneous ADR reporting has to be provided among the health care professionals by way of ADR bulletins, seminars and workshops.
MIS-86
Study of Drug Use in Type 2 Diabetes Mellitus with and Without Co-morbidities in Patients Visiting a Tertiary Care Hospital
Patil VN, Pandit PT, Ghongane BB
Department of Pharmacology, B.J. Government Medical College and SGH, Pune Maharashtra, India
Objectives : This study was conducted to assess the prescribing pattern of drug use in type 2 diabetes mellitus without and with co-morbidities, and their drug-drug interactions with concomitant medications in outpatient department (OPD) of tertiary care hospital in Maharashtra. Materials and Methods : In this prospective observational study, data of 400 eligible patients visiting diabetic OPD during the study period of 1 year was taken. Then it was recorded in the proforma and analysed using Microsoft Excel 2013. Results: Among 55% males and 45% female patients, mean age was 47.17 years. Most of diabetics had no co-morbidity (41.75%), as compare to co-morbid conditions like hypertension (31.75%), epilepsy (11%), asthma (5%), and other co-morbidities (4.5%). There was change in anti-diabetic drug prescription pattern after 3 month follow up in 23.75% diabetes without co-morbidity, as compared to 5.5% in co-morbidity patients. 73.25% patients showed drug interactions. Average number of anti-diabetic drugs prescribed per patient was found to be 2.54. Metformin (98.72%), Glimepiride (32.9%) andGlibenclamide (31.32%) were most frequently prescribed drugs. 98.8%. Anti-diabetic drugs were from national list of essential medicines. Generic name of drugs (97.62%) and oral route of administration (99.2%) were preferred by physicians for prescribing anti-diabetic drugs. Conclusion: Anti-diabetic prescriptions were rational with respect to WHO drug use indicators in most patients. Prescription after 3 month changed in some patients due to deranged sugar level. The number of anti-diabetic drugs prescribed by generic names was high in OPD. Caution must be practiced to avoid drug-drug interactions.
MIS-87
A Retrospective Study Evaluating Treatment Patterns in Indian Women with breast Cancer
Pore SM, Gaidhankar SL, Shinde MP, Shah RD, Naik SN, Ramanand SJ
Department of Pharmacology, Government Medical College, Miraj, Maharashtra, India
Objectives: The Objectives of the study were to evaluate treatment patterns according to Indian Breast Cancer Guidelines (IBCG) in women with breast cancer, to assess the adverse drug reactions (ADR) to chemotherapy (CT) and/or radiotherapy (RT) and also to assess recurrence and metastasis in breast cancer. Materials and Methods: This retrospective, record based study involved 157 adult female patients with histologically confirmed breast cancer admitted for treatment during the period of 2005 to 2007. Results: Females of age 50 and above were most commonly affected (47.3%). According to IBCG majority of cases (43%) were of Operable Breast Cancer (T1T2, N0N1) (M0) followed by Large Operable Breast Cancer (T3/N0N1) (M0) (37%). About 8% were Locally Advanced Breast Cancer (T4 N0/N2N3) (M0) and remaining 12% were metastatic breast cancer. Treatment regimen was as follows: Surgery + CT + RT = 46%, Surgery + CT + RT + Hormonal = 22%, Surgery + CT + Hormonal = 20% and Palliative CT = 12%. About 67.3% women reported of adverse drug reactions. The most common ADR was nausea, vomiting and epigastric pain (68.4%) followed by cough and chest pain (54.6%). The mean ± standard deviation of follow up period was 25 months ± 27, range being 1 month to 6.5 years. Tumour recurred in 13.1% of women and metastasized in 19.7%. Conclusion: Most of Indian women are diagnosed at later stages and recurrence and metastasis was seen in substantial number of cases.
MIS-88
Knowledge, Attitude, and Practice of Adverse Drug Reactions Reporting Among Nurses in a Tertiary Care Centre
Survase PS, Date AP, Borkar AS, Mahajan HM
Department of Pharmacology, NKSIMS, Digdoh Hills, Nagpur, Maharashtra, India
Objectives: To evaluate the knowledge, attitude, and practice about ADR reporting among nurses in a tertiary care center. There is boom in number of new drugs entering the Indian market. Preclinical and Clinical studies are not able to detect the rare adverse drug reactions. Hence it is necessary to have full-bodied Pharmacovigilence system in place to identify and report rare adverse drug reaction. Nurses are vital for the reporting of adverse drug reactions. Materials and Methods: The present study was a cross-sectional questionnaire-based study, which included nurses of a tertiary care hospital in central India. We tried to identify the possible ways to perk up spontaneous reporting of ADR and factors responsible for scarce reporting of ADRs. Results: After analyzing the data, we observed few of responders were aware of the ADR reporting system and the most encouraging finding was that majority of the respondents were of the view that this reporting system is necessary. However, response to practice related questions was below average. Main factors which discouraged ADR reporting by nurses was thinking that reporting would lead to extra work and non-availability of forms. Conclusion: The deficiencies in ADR reporting require awareness so as to perquisite spontaneous reporting and improve safety of patients. Training to nurses would lead to improvement in reporting of ADR.
MIS-89
Development and Validation of Bio-analytical Methods for Simultaneous Estimation of Paracetamol and Pamabrom in Human Plasma Using LC-MS/MS Methods
Panchal A, Thumar KN, Vadia N
Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India
Objectives : The Objectives of proposed work is to develop and validate LC-MS/MD Methods for estimation of Paracetamol and Pamabromin human plasma. Materials and Methods: The proposed Methods was developed with Advance kromasil C18 column and mobile phase selected was mixture of acetonitril and methanol and 2 Mm ammonium formate buffer in the volume ratio of 90:10 v/v at a flow rate of 0.4 ml/min. Results: The develop Methods was found to be linear the concentration range of 40.00 ng/ml to 8000.00 ng/ml and 20.00 ng/ml to 4000 ng/ml for Paracetamol and pamabrom respectively. The %recovery was found to be 87.23%, 90.76% for Paracetamol and pamabrom respectively. Conclusion: This Methods can be used for quantification of Paracetamol and Pamabrom in human plasma for the use in bioavailability or bioequivalence studies in clinical trials.
MIS-90
Evaluation of Anti-oxidant and Anticoagulant Activity of Dicoumarol and Pyrazole Aldehyde Derivaties
Goswami PD 1 , Mehta RH 2 , Modi KP 1 , Manek RA 1 , Sheth DB 1 , Radadiya AK 2 , Shah AK 2
1 Department of Pharmacology, B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India, 2 Department of Chemistry, National Facility for Drug Discovery, Saurashtra University, Rajkot, Gujarat, India
Objectives: Aim of the present study is to Determine Antioxidant and Anticoagulant activity in newly developed molecules derived from combination of dicoumarol and pyrazole aldehyde. Materials and Methods: Different derivatives of dicoumarol and pyrazole aldehyde were screened through in-vitro assay. For determination of in-vitro antioxidant activity three Methods including DPPH radical scavenging activity, Ferric reducing antioxidant power and Superoxide radical scavenging activity and for anticoagulant activity, Prothrombin time test were performed. Among 19 derivatives, MRH 101 showed promising antioxidant as well as anticoagulant activity. Acute toxicity study was performed for MRH101 and was selected for in-vivo testing. In-vivo antioxidant activity was evaluated using 'Protection against CCl 4 induced oxidative stress' model. Efficacy of the drug was estimated by measuring level of oxidative stress marker including Malonaldehyde, Reduced glutathione, Superoxide dismutase and Catalase from serum and liver homogenate. In-vivo anticoagulant activity of the same compound was determined by measuring bleeding time, clotting time and prothrombine time after oral administration of the test compound in rats. Results: Present drug MRH101 produces prominent antioxidant activity by significant (p < 0.05) increasing the levels of SOD, CAT, GSH and protein while decreased the level of lipid peroxidation. Histological evaluation indicates that liver damage due to oxidative stress was restored towards normalization. In anticoagulant activity there was significant (P < 0.05) increase in bleeding time, clotting time and prothrombin time. Conclusion: From this study, it can be concluded that MRH101 (C 34 H 22 N 2 O 6 ) possesses significant antioxidant and anticoagulant activity. However, further research addressing the role in humans and the mechanisms for its activity is warranted.
MIS-91
Evaluation of Knowledge, Attitude and Practice of Consumers in India About Disposal of Unused Medicines
Sonowal S, Kapadia JK, Desai CK, Desai MK
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India
Objectives: To evaluate the knowledge, attitude and practice of consumersin India about disposal of unused medicines. Materials and Methods : A questionnaire comprising 11 questions evaluating the Knowledge (2), Attitude (3) and Practice (6) of unused medicines was prepared and pre validated before administering to200 consumers of medicines attending the outpatient department of Civil Hospital Ahmedabad, a tertiary care teaching hospital in Western India. Requisite permissions from Institutional Ethics Committee and informed consent were obtained prior to recruiting them for the study. Responses were recorded, in Microsoft Excel ® spreadsheet and evaluated for percentage response. Results : A total of 45 respondents (22.5%) disposed the unused medicines. Majority of the respondents (136, 68%) stored unused medicines at home for future use. Analgesics (26.5%), were the most common unused medicine stored. Safe disposal of medicine was considered necessary by majority respondents (160, 80%) for different reasons like prevention of illegal/unintended use (74, 37%), prevention of environmental pollution (32, 16%) or possible ADR caused by old drugs (54, 27%). Only 78 (39%) respondents were aware of appropriate Methods of disposal. Disposal in household trash (61, 30.5%) was the most common Methods used. Majority of respondents felt the need for a facility or programme to collect unused medicines (172, 86%) and an increased awareness among consumers regarding hazards and Methods of disposal of unused medicines (156, 77%). Conclusion: Majority of consumers are aware about the need for safe disposal of unused medicines. But the right attitude for and practice of safe disposal of medicines is lacking. A need for increased awareness regarding safe disposal of medicines is acknowledged by majority of consumers.
MIS-92
Self-medication Amongst Software Professionals
Sheshgiri R, Pundarikaksha HP
Department of Pharmacology, KIMS, Bengaluru, Karnataka, India
Objectives : The primary Objectives of the study was to assess the level of knowledge among the software professionals about the hazards of self-medication. The other Objectives were to see the source of information for these medications and observe which the most common group of drug for abuse was and to find out the gender prevalence. Materials and Methods : A 12 item cross sectional questionnaire to assess the level of knowledge about self-medication was prepared and distributed to 150 corporate workers across 6 companies by simple randomization in Bangalore. To maintain the discrepancy only the person's age and gender was asked to be mentioned. An oral consent was procured from all those who partook in the study. Results : The 150 samples were collected and were analysed. Out of the 150 professionals it was found that 64% of the study population was on self-medication. Only 20% knew the hazards of self-medication. Only 23% of the people actually consulted with a physician. Out of the medicines used the highest prevalence was seen with paracetamol (70%). The most common source of information was the internet (59%). Self-medication was more commonly seen with women and under the age of 38 years. Conclusion : The trend of self-medication is increasing at an alarming rate. With most of the software professionals following whatever they read on the net and the drugs made readily available to them without prescription. Leading to long term adverse effects. Consulting a physician regardless of his knowledge obtained from the net may prevent future complications.
MIS-93
Dapsone Induced Steven-Johnson Syndrome
Reddi H, Ushakiran P, Giri R, Avagadda S
Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India
Objectives: To report a case of Dapsone induced steven-johnson syndrome (SJS). Dapsone (4, 4'-diaminodiphenylsulfone) has been widely used in the treatment of leprosy and for a variety of dermatoses. It can rarely cause fatal effects such as agranulocytosis, DHS (Dapsone hypersensitivity syndrome), DRESS syndrome (Drug Rash with Eosinophilia and Systemic Symptoms) or Stevens-Johnson syndrome (SJS). SJS is a life-threatening, acute hypersensitivity reaction to drugs characterized by atypical targetoid lesions, confluent erythematous purpuric macules and mucocutaneous blisterings. There have been only few reports in the literature of SJS caused by dapsone. Case Report: We describe an 18 year old female who was provisionally diagnosed with lichen planus and medicated with Dapsone and other supportive therapy. After about four weeks the patient developed peeling and blistering of skin on the trunk, lower extremities, hands and also mucous membranes with no obvious internal organ involvement. Dapsone was discontinued and the patient was managed with conservative therapy. Resolution of the clinical manifestations was observed, helping us to arrive at a diagnosis of Dapsone induced SJS.
MIS-94
Quantification and In vitro Screening of Methanolic Extract of Costus Pictus
Sanaye MM, Deliwala R
Principal K.M. Kundnani College of Pharmacy, Mumbai, Maharashtra, India
Objectives: (1) Plant extraction. (2) Quantification of phenol in plant extract (Methanolic extract) 3-In vitro screening of extract for its antioxidant properties. Materials and Methods : Shade dried leaves of plant were extracted with 100% methanol using soxhlet extraction technique. Qualitative phytochemical screening was performed. The quantification of phenolic acid, p-coumaric acid in Costus pictus will be carried out using HPTLC technique. In vitro testing assay like DPPH (1,1-diphenyl-2-picrylhydrazyl), Reducing power assay, H 2 O 2 will be performed for methanolicextract of Costus pictus (MECP). Results: Preliminary phytochemical studies reveal presence of phenols and flavonoids. Quantification studies and in vitro antioxidant studies may provide guidelines for further in vivo evaluation of plant extract in future. Conclusion: Quantification of p-coumaric acid from plant will provide basis for screening many pharmacological effects. Reactive oxygen species (ROS) plays a key role in most of physiological disorders. Many of stress related neurological disorders involve generation of ROS. Presence of phenols in Costus pictus imparts it an ability to provide protection against oxidative stress by scavenging ROS. Hence attempts have been made in this study to explore therapeutic use of Costus pictus in stress related disorders by understanding its antioxidant potential.
MIS-95
Crystallo-co-agglomeration: A Dynamic Approach for Tailor-made Particle
Nirju Patel
Faculty of Pharmacy, RK University, Rajkot, Gujarat, India
Crystallo-co-agglomeration (CCA) is dynamic particle engineering approach to improve physicochemical and mechanical properties of APIs. This method is developed by Kadam et al. This is a single step enlargement technique which does not need any specific and sophisticated instrumentation. It involves simultaneous crystallization and agglomeration of drug/s with or without excipients from good solvent and/or bridging liquid by addition of a non-solvent. It can be used for size enlargement of single, two or more, small dose or large dose drugs, in combination with or without diluents. The agglomerates obtained by CCA can be used as beads or directly compressible tablet intermediates having satisfactory micromeritic (flow ability), mechanical (friability, crushing), compression (compressibility, compatibility) properties. Bioavilability and dissolution characteristics also improves to great extent. It reduces time and cost by making operation quite faster, involvement of less machinaries and manpower. Thus, it can be concluded that, CCA is a simple and cost effective process, which can improve the particle design of all majority of drugs and combinations as well.
MIS-96
Formulation Development of Matrix Tablets by Lornoxicam by Using Hydrophilic and Hydrobhobic Polymer
Shikha Singh, Arti Bagada, Mihir Raval
Department of Pharmaceutical Science, SaurashtraUniversity, Rajkot, Gujarat, India
Objective : The present work was based on "To Formulate, evaluate and optimization of Matrix Tablets of Lornoxicam by using Hydrophilic and Hydrophobic Polymers for marketing benefits and having same dissolution profiles." Drug lornoxicam has a selective analgesic and non-steroidal anti-inflammatory effect. This once a daily formulation of Lornoxicam comprises at one extended release (SR) component comprising a release controlling material (HPMC-K100M and EUDRAGIT RS 100). Materials and Methods : Preformulation study was carried out for measurement of drug solubility, particle size, and micrometric property and drug-excipient compatibility study. Sustain release part was prepared by wet granulation method. In vitro drug release profile for optimized formulation was at least 99% after 24 hours. Batch 30 selected as the optimize batch and check the reproducibility for this batch as batch no. 35. In vitro release profiles of all the batches were performed with the kinetic model studies. Result: Response surface graph were presented to examine the effects of independent variables on the responses studied. In final batch drug release decrease with increase in concentration of polymer. But at one point the decrease stopped than increase in the release so that point batch is selected as final batch. Conclusion: Double-layer tablet formulation of lornoxicam based on HPMC K 100M and Eudragit RS100 mixture is suitable for the treatment of inflammatory and painful conditions.
MIS-97
Off-label and Unlicensed Drug Use in Hospitalized Paediatric Patients at a Tertiary Care Teaching Hospital
Vachhani PM, Solanki MN, Desai MK
Department of Pharmacology, B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India
Objectives: To determine the extent and nature of off-label and unlicensed use of drugs in hospitalized paediatric patients. Materials and Methods : Children admitted in pediatric wards and neonatal intensive care units (NICU) who met inclusion and exclusion criteria were enrolled. Patient's demographic data, clinical diagnosis and details of drugs prescribed were recorded. Prescribed drugs were analysed for their off-label and unlicensed drug use with the help of National Formulary of India (NFI) and compared between different age groups by applying chi-square test. Results: 1164 patients included in the study received a total of 5362 drugs, out of these, 1480 (27.6%) were prescribed in off-label manner and 1300 (24.2%) were prescribed in unlicensed manner. The extent of unlicensed use was significantly higher in neonates while extent of off-label use was significantly higher in other pediatric patients as compared to other groups (p < 0.0001). Alteration in dosage (35.3%) was the commonest reason for off-label use while absence of pediatric information in NFI (56.3%) was the commonest reason for unlicensed use. According to WHO-ATC classification, anti-infective class contributed highest proportion for off-label use while alimentary tract & metabolism for unlicensed use. Ceftriaxone, paracetamol and ondansetron were the three commonest off-label drugs used while calcium gluconate, piperacillin-tazobactum and levofloxacin were the three commonest unlicensed drugs used. Conclusion: Off-label and unlicensed drug use is common in hospitalized paediatric patients. More extensive studies with special emphasis on use of off-label and unlicensed drugs and their consequences are recommended.
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