Original Articles: 2012 Vol: 4 Issue: 12
Quality assessment of amoxicillin-clavulanate potassium tablets in Lagos, Nigeria
Abstract
Amoxicillin clavulanate potassium is a broad spectr um antibiotic used in the management of most bacter ial infections. The innovator brand, Augmentin, is expe nsive, hence the need to substitute them with much cheaper generic brands. This brings about the question of b ioequivalency, an essential biopharmaceutic factor that provides option for generic substitution especially in under developed countries such as ours. A study on qualit y assessment of six generic brands in comparison with the innovator brand was carried to ascertain the quality of the generic brands that are available in Nigerian drug market. Assessment of their bioequivalence was done vis-a-v is the evaluation of physicochemical characteristics such as uniformity of weight, friability, hardness, disi ntegration, dissolution rate and assay of the brands, using bot h official and non-official methods. All the brands studied complied with the official specifications on unifor mity of weight and friability but the brands AC-2 a nd AC-7 failed the disintegration time test. Brand AC-7 exhibited a very high crushing strength which consequently af fected it's dissolution rate negatively and did not comply with USP specification on dissolution. Out of the six g eneric brands tested, five of them were considered bioequivalent with the innovator brand with the exception of bra nd AC-7. Any reported case of therapeutic failure concerning the brands that complied with specification most likel y, might be related to bad patient compliance, physiological an d pharmacokinetic conditions relating to the patien ts using the drug and inadequate advice to patients on the part of the healthcare professionals.