Biowaiver Study On Three Generic Brands of Amlodipine 10mg Tablets Marketed In Sudan

Abstract

Abstract
Amlodipine besylate is a BCS class I drug used in treatment of hypertension and coronary artery diseases. In this study we determined the bioequivalence of four different brands of amlodipine besylate 10 mg tablets [Norvasc (brand A), Amilodipine (brand B), Amlozal (brand C) and Amlo(brand D)] using Biowaiver, first the pharmaceutical equivalence was evaluated for the four brands using the official standards according to USP pharmacopeia including diameter, hardness, thickness, disintegration, assay and dissolution, then the biowaiver study was done according to WHO guidelines and the dissolution profiles were studied using three different buffer solutions: pH 1.2, 4.5 and 6.8, then the results were evaluated according to specifications of class 1 drugs as Amlodipine is accepted class 1. The four brands complied with requirements of the official tests of diameter, hardness, thickness, disintegration, assay and dissolution. The three brands (B, C and D) were found to be bioequivalent to innovator (Brand A) as they qualify for WHO criteria for Biowaiver (both tests and reference were very rapidly dissolving in the three medias, i.e released more than 85% in 15 minutes), so similarity factor (f2) was not needed to be calculated to evaluate the interchangeability of the four brands.