Journal of Pharmacy And Bioallied Sciences
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   Table of Contents - Current issue
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April-June 2015
Volume 7 | Issue 2
Page Nos. 87-159

Online since Wednesday, April 01, 2015

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REVIEW ARTICLE  

Good manufacturing practices for medicinal products for human use p. 87
Bruno G Gouveia, Patrícia Rijo, Tânia S Gonçalo, Catarina P Reis
DOI:10.4103/0975-7406.154424  
At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.
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ORIGINAL ARTICLES Top

Assessment of the structural and process aspects of pharmaceutical care at a university hospital in Ethiopia p. 97
Abdrrahman Shemsu Surur, Fitsum Sebsibe Teni, Genet Girmay, Elsabet Moges, Meseret Tesfa, Messele Abraha
DOI:10.4103/0975-7406.154427  
Objective: To assess the structural and process components of the pharmaceutical care at Gondar University Referral Hospital (GURH). Materials and Methods: An institution-based cross-sectional study was conducted on all the four pharmacies at GURH from October 1 to December 31, 2013. By adopting data collection instruments from a previously done study, the structural aspects of the pharmacies were assessed using an observation checklist and the process of pharmaceutical care delivery using a self-administered questionnaire. The data collected was entered to and analyzed using Statistical Packages for Social Sciences (SPSS) version 16.0. Results: none of the pharmacies had a private counseling room, fire extinguisher and meeting area. None of the pharmacy stores were equipped with fan and air ventilation system and had no cross aisles. The mean values for documentation, patient assessment and implementation of therapeutic objective were 12.14, 14.03 and 5.64 respectively. Many pharmacists (64.29%) did not participate in ward rotation with physicians. The overall pharmacy professionals' level of job satisfaction was found to be 2.77. Conclusion: There were gaps in the structure and the process of the provision of pharmaceutical care in GURH.
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Pharmacological evaluation of novel 5-HT 3 receptor antagonist, QCM-13 (N-cyclohexyl-3-methoxyquinoxalin-2-carboxamide) as anti-anxiety agent in behavioral test battery p. 103
Deepali Gupta, Mahesh Radhakrishnan, Devadoss Thangaraj, Yeshwant Kurhe
DOI:10.4103/0975-7406.154429  
Objective: In the last few decades, serotonin type-3 (5-HT 3 ) receptor antagonists have been identified as potential targets for anxiety disorders. In preclinical studies, 5-HT 3 antagonists have shown promising antianxiety effects. In this study, a novel 5-HT 3 receptor antagonist, QCM-13(N-cyclohexyl-3-methoxyquinoxalin-2-carboxamide) was evaluated for anxiolytic-like activity in rodent behavioral test battery. Materials and Methods: Mice were given QCM-13 (2 and 4 mg/kg, intraperitoneally [i.p.]) or diazepam (2 mg/kg, i.p.) or vehicle and after 30 min, mice were subjected to four validated behavioral test batteries viz. elevated plus maze, hole board, light-dark and open field tests. Interaction study of QCM-13 with m-chlorophenyl piperazine (mCPP) (mCPP, a 5-HT 2A/2C receptor agonist, 1 mg/kg, i.p.) and buspirone (BUS, a partial 5-HT 1A agonist, 10 mg/kg, i.p.) were performed to assess the pharmacological mechanism of the drug. Results: QCM-13 expressed potential anxiolytic effect with significant (P < 0.05) increase in behavioral parameters measured in aforementioned preliminary models. Besides, QCM-13 was unable to reverse the anxiogenic effect of mCPP, but potentiated anxiolytic affect of BUS. Conclusion: The results suggest that QCM-13 can be a potential therapeutic candidate for the management of anxiety-like disorders and combination doses of novel 5-HT 3 receptor antagonist with standard anxiolytics may improve therapeutic efficacy.
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Antibiotics self-medication among medical and nonmedical students at two prominent Universities in Benghazi City, Libya p. 109
Mohamed F Ghaieth, Sara R. M. Elhag, Mamoun E Hussien, Emad H. E. Konozy
DOI:10.4103/0975-7406.154432  
Background: Trivial use of antibiotics is a major reason for the spread of antibiotics resistance. The aim behind undertaking this investigation was to study the prevalence antibiotics self-medication among university students in Benghazi city. Methods: A questionnaire-based cross-sectional, survey was conducted at both Libyan International Medical University and Benghazi University. A total of 665 copies of questionnaires was distributed. A total of 363 forms were completed and returned (response rate 55%). Remaining responses were either with no antibiotics use history within the past 1 year or were provided incomplete. Results: Among the respondents, 45% were males and 55% females. Males practiced self-medication more compared to females. Approximately, 43% and 46% from medical and nonmedical students, respectively, were antibiotics self-medicated. A total of 153 students (42%) out of total respondents administered antibiotics for symptoms related to respiratory problems, among which 74 students (48%) took antibiotics based on doctor's prescription. Among the respondents, 94 students (27%) who had antibiotics, were covered under medical insurance, and 19 (29%) of the medically insured students had antibiotics without doctor's prescription. About 14% of students did not complete their antibiotics course. Of these, 57% were medical students, and 43% were nonmedical students. The rate of self-medication among higher classes was more as compared to lower classes. About 58% of students overdosed the antibiotic, while 15% had antibiotics for <3 days, for treatment of ailments such as acne, toothache, diarrhea, earache, and tonsillitis. About 75% of students purchased the antibiotics in consultation with a pharmacist. Conclusion: Self-medication is a frequent problem among university students in Benghazi city. There is a need for an immediate intervention to address this malpractice among both students and medical practitioners.
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Antibiotic prescription: An oral physician's point of view p. 116
Mahendra Patait, N Urvashi, M Rajderkar, S Kedar, Kinjal Shah, Reeta Patait
DOI:10.4103/0975-7406.154434  
Background: Antibiotics are important in the management and prophylaxis of infections in patients at a risk of experiencing microbial disease. Uses of systemic antibiotics in dentistry are limited since management of acute dental conditions is primarily based upon extraction of teeth or extirpation of the pulp. However, the literature provides evidence of inappropriate prescribing practices by practitioners, due to a number of factors from inadequate knowledge to social factors. Aim: The aim was to assess the therapeutic prescription of antibiotics in the dental office. Materials and Methods: In the current study, 42 faculty members of two dental colleges in the same vicinity were included. A questionnaire was drafted and sent to the dentists to collect data pertaining to the conditions in which antibiotics were prescribed and most commonly prescribed antibiotic. Results: During the study period, 42 faculty members from various departments in the institutes were surveyed, of which 41 questionnaires were completely filled. Amoxicillin was the most commonly prescribed antibiotic followed by other amoxicillin combinations; Metronidazole was most widely prescribed antibiotic for anaerobic infections. Conclusion: We have entered an era where cures may be few due to increasing microbial resistance. The biggest force for change will be if all practicing dentists looked at their prescribing and made it more rational.
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Effect of naringin on hemodynamic changes and left ventricular function in renal artery occluded renovascular hypertension in rats p. 121
Asjad Visnagri, Mohammad Adil, Amit D Kandhare, Subhash L Bodhankar
DOI:10.4103/0975-7406.154437  
Background: Renal artery occlusion (RAO) induced hypertension is a major health problem associated with structural and functional variations of the renal and cardiac vasculature. Naringin a flavanone glycoside derived possesses metal-chelating, antioxidant and free radical scavenging properties. Objective: The objective of this study was to investigate the antihypertensive activity of naringin in RAO induced hypertension in rats.Material and Methods: Male Wistar rats (180-200 g) were divided into five groups Sham, RAO, naringin (20, 40 and 80 mg/kg). Animals were pretreated with naringin (20, 40 and 80 mg/kg p.o) for 4 weeks. On the last day of the experiment, left renal artery was occluded with renal bulldog clamp for 4 h. After assessment of hemodynamic and left ventricular function various biochemical (superoxide dismutase [SOD], glutathione [GSH] and malondialdehyde [MDA]) and histological parameters were determined in the kidney. Results: RAO group significantly (P < 0.001) increased hemodynamic parameters at 15, 30 and 45 min of clamp removal. Naringin (40 and 80 mg/kg) treated groups showed a significant decrease in hemodynamic parameters at 15 min. after clamp removal that remained sustained for 60 min. Naringin (40 and 80 mg/kg) treated groups showed significant improvement in left ventricular function at 15, 30 and 45 min after clamp removal. Alteration in level of SOD, GSH and MDA was significantly restored by naringin (40 and 80 mg/kg) treatment. It also reduced histological aberration induced in kidney by RAO. Conclusion: It is concluded that the antihypertensive activity of naringin may result through inhibition of oxidative stress.
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Antibacterial and antispasmodic activities of a dichloromethane fraction of an ethanol extract of stem bark of Piliostigma reticulatum p. 128
Benoit Banga N'Guessan, Kassim Dosso, Boua Narcisse Gnangoran, Patrick Amoateng, Isaac Julius Asiedu-Gyekye, Angoue Paul Yapo
DOI:10.4103/0975-7406.154439  
Objectives: This study presents the antispasmodic and antibacterial properties of an ethanol extract and fractions the of stem bark of Piliostigma reticulatum. Materials and Methods: The antispasmodic effects of the extract and its fractions were performed on isolated rabbit duodenum. The antibacterial properties were determined as minimal inhibitory and bactericidal concentration of the extract and fractions of P. reticulatum on susceptible and resistant strains of Escherichia coli, Vibrio cholerae, Staphylococcus aureus, Shigella dysenteriae and Salmonella tiphymurium. Results: The ethanol extract of P. reticulatum and fractions (except for heptane) produced concentration-dependent relaxant effects on isolated duodenum preparations. The IC 50 of the extract and dichloromethane, ethyl acetate, butanol and aqueous fractions are 0.88452, 0.2453, 0.2909, 0.3946 and 0.3231 mg/ml respectively. The extract was found to significantly antagonize acetylcholine-induced contraction. The susceptible strains E. coli and V. cholerae were the most inhibited by the dichloromethane fraction at 60 mg/mL, as shown by their diameter of inhibition of 13.2 ± 0.76 and 13.3 ± 0.67 mm respectively. Conversely, the dichloromethane fraction, the most active antibacterial fraction, did not inhibit the resistant strains S. dysenteriae and S. tiphymurium. Conclusion: The results showed that P. reticulatum stem bark possesses spasmolytic and antibacterial properties and this may contribute to its traditional medicinal use for the treatment of diarrhea.
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Knowledge, attitude, practice, and management of traditional medicine among people of Burka Jato Kebele, West Ethiopia p. 136
Akawak Gari, Raghavendra Yarlagadda, Messay Wolde-Mariam
DOI:10.4103/0975-7406.148782  
Background: Traditional medicine (TM) has maintained its popularity in all regions of the developing world. Even though, the wide acceptance of TM is a well-established fact, its status in a population with access to modern health is not well clear in the whole country. This study was carried out to assess the knowledge, attitudes, practice and management of TM among the community of Burka Jato Kebele, West Ethiopia. Methodology: A descriptive cross-sectional study was conducted on a total of 282 sampled individuals' selected using systematic random sampling from January 28, 2013 to February 8, 2013 in Burka Jato Kebele, Nekemte town, East Wollega Zone, West of Ethiopia. Results: The majority (94.22%) of people in the study area relied on TM. Most of them were aware of medicinal herbs (55.7%). About half (40.79%) of the respondents were aware of the major side-effects of TM such as diarrhea (36.64%). About 31.85% of them prefer traditional medical practices (TMP) because they are cheap. Most (50%) of the species were harvested for their leaves to prepare remedies, followed by seed (21.15%) and root (13.46%) and the methods of preparation were pounding (27.54%), crushing (18.84%), a concoction (15.95%) and squeezing (13.04%). About 53.84% of them were used as fresh preparations. Remedies were reported to be administered through oral (53.85%), dermal or topical (36.54%), buccal (3.85%) and anal (5.77%). Conclusion: The study revealed that the use of TMs were quite popular among the population and a large proportion of the respondents not only preferred, but also used TMs notwithstanding that they lived in the urban communities with better access to modern medical care and medical practitioners. To use TM as a valuable alternative to conventional western medicine, further investigation must be undertaken to determine the validity, efficacy of the plants to make it available as an alternative medicine to human beings.
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Effects of methanolic extracts from edible plants on endogenous secretory receptor for advanced glycation end products induced by the high glucose incubation in human endothelial cells p. 145
Yoshinori Okada, Mizue Okada
DOI:10.4103/0975-7406.148783  
Background: In diabetic populations, endogenous secretory receptor for advanced glycation end products (esRAGE) levels may be related to the degree of diabetic complications or to the protection from diabetic complications. Objective: We investigated the impact of 29 methanolic extracts from edible plants on esRAGE production in human umbilical vein endothelial cells (HUVECs) cultured in high (4.5 g/L) glucose. Materials and Methods: Edible plants were minced, and extracts were obtained with methanol overnight. The methanolic extracts from 29 edible plants were evaporated in a vacuum. For screening study purposes, HUVECs were seeded in culture dishes (1.5 × 10 5 cells). Then, HUVECs were incubated with 1 g/L or 4.5 g/L of glucose in SFM CS-C medium treated with methanolic extracts from edible plants (MEEP) for 96 h. Determination of esRAGE production in the cell culture-derived supernatants was performed by colorimetric ELISA. The 8-hydroxydeoxyguanosine (8-OHdG) level was determined by using the 8-OHdG Check ELISA kit. Peroxynitrite-dependent oxidation of 2', 7'- dichlorodihydrofluorescein to 2', 7'-dichlorofluorescein was estimated based on the method described by Crow. Because MEEP were methanolic extracts, we measured their total phenolic content (TPC). TPC was measured with a modified version of the Folin-Ciocalteu method. Results: The results showed eight extracts increased esRAGE production. The extract from white radish sprouts showed the highest esRAGE production activity, and then eggplant, carrot peel, young sweet corn, Jew's marrow, broad bean, Japanese radish and cauliflower. In order to understand the mechanism of esRAGE production, the eight extracts were examined for DNA damage, peroxynitrite scavenging activity, and TPC in correlation with their esRAGE production. The results showed esRAGE production correlates with the peroxynitrite level and TPC. Conclusion: This study supports the utilization of these eight extracts in folk medicine for improved treatment of diabetic complications.
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Socioeconomic characteristics of alcohol and other substance users, seeking treatment in Sikkim, North East India p. 151
Sunil Kumar Pandey, Debranjan Datta, Sanjiba Dutta, Yogesh Verma, Amit Chakrabarti
DOI:10.4103/0975-7406.148778  
Objectives: The present study was conducted to generate information for better understanding of socioeconomic and CAGE characteristics of alcohol and other substance users who were undergoing treatment in Sikkim. Subjects and Methods: Socioeconomic and CAGE questionnaire was administered to alcohol and other substance abusers of Sikkim (n = 241) who were undergoing treatment in different treatment centers of Sikkim. Information was collected on printed instrument after taking participant's consent and data was statistically analyzed. Results: Male participants (93.8%) outnumbered female (6.2%). Majority of the sample were either in the school dropout group or school completed (36.1%) group. Most of the samples were occupationally unemployed, urban residents, Nepali by ethnicity, single, and Hindu (48.5%) by religion. Minimum age for starting of alcohol and drug was 5 years and 7 years respectively. Knowledge about AIDS and its transmission was satisfactory. All the four CAGE characteristics were present in majority of samples. Conclusions: Climate, geographical location, wide and easy availability of alcohol in Sikkim make this state vulnerable for alcohol abuse. Alcohol drinking among parents, sibling and friends found to be important risk factor. Outreach to the community for better acceptability of treatment is an important area to fill the gap of treatment demand and treatment supply.
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SHORT COMMUNICATION Top

Effect of fruits of Opuntia elatior Mill on mast cell degranulation p. 156
Sanjay P Chauhan, NR Sheth, BN Suhagia
DOI:10.4103/0975-7406.148779  
Background: The presence of potentially active nutrients and their multifunctional properties make prickly pear a perfect candidate for the production of phytopharmaceutical products. Among the numerous Opuntia species, bioactive compounds have been isolated and characterized primarily from Opuntia ficus-indica, Opuntia polycantha, Opuntia stricta, Opuntia dilleni for various medicinal properties. Objective: Based on the traditional use of prickly pear for enhancement of immune function, the objective of the present study to evaluate the effect of prickly pear on mast cell degranulation function. Materials and Methods: The Opuntia fruit juice (OFJ) (10-200 μl/ml) were studied for the effect on sensitized rat peritoneal mast cell degranulation induced by immunological (egg albumin), and nonimmunological (compound 48/80) stimuli and compared with that of the reference standard, sodium cromoglycate and ketotifen (10 μg/ml). Results and Conclusion: The OFJ exhibited significantly (P < 0.001) concentration dependent inhibition of mast cell degranulation. The IC 50 value of OFJ was found 12.24 and 18 μl/ml for immunological and nonimmunological induced mast cell degranulation, respectively. The betacyanin is an active principle compound in prickly pear that may responsible for mast cell stabilizing action.
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