Quality Evaluation of Amoxicillin/Clavulanate Potassium Tablets Marketed in Mekelle, Ethiopia

Abstract

Background: The combination of amoxicillin and clavulinic acid (agumentin) is a widely used oral antibiotic consisting of semisynthetic aminopenicillin amoxicillin and a beta-lactamase inhibitor - clavulinate potassium. This comniation has a number of generics marketed in different brands in the Ethiopian market.  Studies indicate that microbial resistance is becoming common phenomenon for agumentin. Frequent observation of therapeutic failures of medicinal products, especially the generics necessitates regular review and postmarketing quality control of medicines circulating in the Ethiopian drug market and developing countries at large.
Objective: The aim of this study was to evaluate the in-vitro quality of Amoxicillin-Clavulinate potassium tablet combinations marketed in Mekelle, Ethiopia.
Methods: Qulaity attributes such as identification, weight uniformity, drug content, hardness, disintegration and dissolution tests were performed based on the British and United States pharmacopoeias. Comparisons among the generic brands and with the innovator product was made statistically using one-way-ANOVA. Dissolution profiles were compared using the similarity factor (f2).
Results: All products passed the United States Pharmacopeia requirements for weight uniformity, identification and disintegration tests. Some products such as brand E for amoxicillin, brand B and brand F for clavulanic acid failed to meet pharmacopoeial specifications for drug content. However, all products complied with the requirements for in vitro release studies except product E. In addition, the similarity factor f2 of all brands, except product E, was greater than 50 showing the similarity of their dissolution profiles as recommended by Food and Drug Administration.
Conclusions: The findings of this study imply that consistent quality assessment of drug products circulated in the market is essential to ensure the quality and interchangeability of generic brands of augmnetin.