Quality and in vitro bioequivalence evaluation of different brands of amoxicillin + clavulanic acid (500 + 62.5) mg tablets distributed in Burkina Faso

Abstract

In a previous study, we reported the evaluation of the physicochemical quality and in vitro bioequivalence of different brands of amoxicillin capsules 500 mg marketed in Burkina Faso. As our goal was to document the quality and biopharmaceutical performance of essential antibiotics marketed in resource-limited countries, we investigated here, the interchangeability with the originator of five brands of amoxicillin + clavulanic acid (500mg+62.5mg) tablets distributed in Burkina Faso. The physicochemical quality of the different brands was first verified according to the USP monograph. The comparative evaluation of the in vitro dissolution profiles was performed in three different pH environments (1.2 - 4.5 - 6.8) using statistical calculations of the difference (f1) and similarity (f2) factors. All brands of amoxicillin + clavulanic acid (500mg+62.5mg) tablets, including the originator, met USP specifications for weight uniformity, identification, content and dissolution of active ingredients. However, the similarity and difference factor values showed that two generic brands (B and E) did not have similar amoxicillin dissolution profiles to the comparator product in pH 4.5 media (f1 = 23,54 and 17.02; f2=35.96 and 46.90, respectively). Therefore, these two products cannot be used interchangeably with the originator. The other three generic brands were similar to the originator and can therefore probably be used interchangeably.

Keywords

• Amoxicillin, Clavulanic acid, Tablets, Physicochemical quality, Dissolution, in vitro equivalence