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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/951

Authors: Dires, Teshome
Advisors: Prof. Dr.Farghaly Addel-Hamid Omar
Copyright: 2005
Date Added: 24-Apr-2008
Publisher: Addis Ababa University
Abstract: Recent studies show that there is unusual high incidence and prevalence of hypertension in developing countries especially in eastern Africa; many scientists refer the problem to change of life style. To combat such problem or to improve health condition of hypertensive patients, therapeutic agents are the most important components. Thus pharmaceuticals being the prominent actors in the health care system, they have to be save, effective, proven quality and have affordable cost. This time great concern of regulatory authorities is directed to control of circulation of counterfeit and substandard drugs. Many countries are adopting the law that permits generic substitution of brand products so as to make health care affordable. But there are controversies of the use of multisource products; the most important one is the problem of bioequivalence. Taking these situations into consideration, the present work is aimed to evaluate the quality as well as the physicochemical equivalence of different products of anti hypertensive drugs (methyldopa, furosemide and propranolol) and their generic versions from different manufacturers marketed locally in Addis Ababa. In this study, two brands of methyldopa (Aldomet and Dopegyt) and generic product (Cyprus product), two brands of furosemide (Lasix and Fusix) and generic product (Ethiopian product), two brands of propranolol (Inderal and Emforal) and generic product (Indian products) were included. All products showed positive identification test and acceptable hardness except Lasix, Fusix and propranolol generic product, which showed hardness below 50 N, but their friability, is found in the tolerance limit. All products disintegrate before 15 min., which is as per the specification in British Pharmacopoeia indicating that properties of tablet are well optimized. Chemical assay of each product, which is done using compendial methods, was found to be within the specification described in the specific monographs of each product except generic product of methyldopa, which was found to be above the tolerance limit. With statistical treatment, there is significant difference between generic products of furosemide and its brand products; in methyldopa the difference between one of the brands (Aldomet) and generic product was found to be significant. Among the products of propranolol, Emforal has shown extremely significant difference. The products are expected not only complying the assay limits but also to have active constituents distributed uniformly. The uniformity of dosage units of methyldopa was demonstrated by weight variation and that of furosemide and propranolol was done with content uniformity test and all products showed results within the tolerance limit in pharmacopoeias. The other important property of a drug formulated as tablet is its dissolution profile, which has strong relation with in vivo bioavailability of the product. The dissolution profile of methyldopa and propranolol showed that all products released the labeled amount of drug as per the specific monograph while among the brands of furosemide only Lasix is found to release the labeled amount of drug in the specified time. There is statistically significant active pharmaceutical ingredient release with differences in brands for each class of drug; this has to be further assessed by in vivo studies.
Description: A thesis presented to school of graduate studies of Addis Ababa University in partial fulfillment of the degree of masters of Science in Pharmaceutical analysis and quality assurance.
URI: http://hdl.handle.net/123456789/951
Appears in:Thesis - Pharmaceutical Analysis & Quality Assurance

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