A Comparative In Vitro Evaluation Of Anti Hypertensive Drugs Products (methyldopa Furosemide And Propranolol Tablets) From Local Market Addis Ababa

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Recent studies show that there is unusual high incidence and prevalence of hypertension inrndeveloping countries especially in eastern Africa; many scientists refer the problem to change ofrnlife style. To combat such problem or to improve health condition of hypertensive patients,rntherapeutic agents are the most important components. Thus pharmaceuticals being the prominentrnactors in the health care system, they have to be save, effective, proven quality and havernaffordable cost. This time great concern of regulatory authorities is directed to control ofrncirculation of counterfeit and substandard drugs. Many countries are adopting the law that permitsrngeneric substitution of brand products so as to make health care affordable. But there arerncontroversies of the use of multisource products; the most important one is the problem ofrnbioequivalence.rnTaking these situations into consideration, the present work is aimed to evaluate the quality asrnwell as the physicochemical equivalence of different products of anti hypertensive drugsrn(methyldopa, furosemide and propranolol) and their generic versions from differentrnmanufacturers marketed locally in Addis Ababa.rnIn this study, two brands of methyldopa (Aldomet and Dopegyt) and generic product (Cyprusrnproduct), two brands of furosemide (Lasix and Fusix) and generic product (Ethiopian product),rntwo brands of propranolol (Inderal and Emforal) and generic product (Indian products) werernincluded.rnAll products showed positive identification test and acceptable hardness except Lasix, Fusix andrnpropranolol generic product, which showed hardness below 50 N, but their friability, is found inrnthe tolerance limit. All products disintegrate before 15 min., which is as per the specification inrnBritish Pharmacopoeia indicating that properties of tablet are well optimized. Chemical assay ofrneach product, which is done using compendial methods, was found to be within the specificationrndescribed in the specific monographs of each product except generic product of methyldopa,rnwhich was found to be above the tolerance limit. With statistical treatment, there is significantrndifference between generic products of furosemide and its brand products; in methyldopa therndifference between one of the brands (Aldomet) and generic product was found to be significant.rnAmong the products of propranolol, Emforal has shown extremely significant difference.rnThe products are expected not only complying the assay limits but also to have active constituentsrndistributed uniformly. The uniformity of dosage units of methyldopa was demonstrated by weightrnvariation and that of furosemide and propranolol was done with content uniformity test and allrnproducts showed results within the tolerance limit in pharmacopoeias.rnThe other important property of a drug formulated as tablet is its dissolution profile, which hasrnstrong relation with in vivo bioavailability of the product. The dissolution profile of methyldoparnand propranolol showed that all products released the labeled amount of drug as per the specificrnmonograph while among the brands of furosemide only Lasix is found to release the labeledrnamount of drug in the specified time. There is statistically significant active pharmaceuticalrningredient release with differences in brands for each class of drug; this has to be further assessedrnby in vivo studies.

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A Comparative In Vitro Evaluation Of Anti Hypertensive Drugs Products (methyldopa Furosemide And Propranolol Tablets) From Local Market Addis Ababa

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