Dissolution Profile Evaluation of Seven Brands of Amoxicillin-Clavulanate Potassium 625 mg Tablets Retailed in Hawassa Town, Sidama Regional State, Ethiopia

Abstract

Abstract Back-ground: Poor quality Amoxicillin-clavulanate potassium tablets have been recently discovered in generic drugs related to Augmentin-like medicines containing amoxicillin and clavulanic acid, as well as its derivatives containing falsified active ingredients. One of the most important dosage form characteristics is a detailed API dissolution profile obtained through dissolution testing. The dissolution test is used in the development of both brand-name and generic drugs. Prior to beginning bioequivalence studies, it is critical to compare the dissolution profiles of various pharmaceutical products. As a result, dissolution is a critical quality control parameter for drugs because it has a direct impact on absorption. Objective: Dissolution Profile Evaluation of Seven Brands of Amoxicillin-Clavulanate Potassium Tablets Retailed in Hawassa Town, Sidama Regional State, Ethiopia. Methods: The seven brands of amoxicillin-clavulanate potassium tablets were collected from Hawassa town, Sidama Regional State, Ethiopia. The dissolution study was conducted as per USP40-NF35, and the dissolution profile was compared by One-way ANOVA Dunnett’s test, model independent, and model dependent method Results: All of the included tablet brands complied with single-point dissolution study specification. Statistical comparisons of the dissolution profile by one-way ANOVA revealed that all brands had similar dissolution profiles (p > 0.05). All brands had difference factor (f1) < 15%. However, the f2 (similarity factor) value justify that all tested brands of Amoxicillin and clavulanate potassium tablet values were outside of an acceptable range of USFDA (< 50%). The evaluated brands followed the Korsmeyer peppas- followed by Weibull curve approach (the highest coefficient of determination) for the release of drug substances from the dosage forms. Based on the fit factor f2 (similarity), all tested brands may be not be considered interchangeable with the innovator drug. Therefore, Researcher, the national Medicine regulatory bodies, and the manufacturer should conduct a properly designed dissolution test as proof of in vitro bioequivalence study supported by an in vivo bioavailability data.