Quality equivalence and in-vitro antibiotic activity test of different brands of amoxicillin/clavulanic acid tablets in Mwanza, Tanzania: A cross sectional study. Doi: 10.1016/j.heliyon.2023.e23418

Abstract

ABSTRACT Background: Each film coated tablet of amoxicillin/clavulanic acid contains 500 mg of amoxicillin as an active pharmaceutical ingredient and 125 mg of clavulanic acid. Different brands have the same active ingredients but different excipients, which may cause differences in efficacy. With the emergence of generic antibiotics post-patent expiration, the antibiotic activity of generics is in question in comparison to the innovator. This study aims at determining the pharmaceutical quality and in-vitro antimicrobial activity of different brands of amoxicillin/clavulanate. Methodology: The study was a cross-sectional laboratory-based experimental study conducted at the TMDA (Tanzania Medicines and Medical Devices Authority) Lake Zone laboratory and the CUHAS Microbiology Laboratory from in May 2021. The study samples were four brands of amoxicillin/clavulanate and sixty archived isolates, thirty of which were E. coli and the remaining thirty K. pneumoniae. Determination of minimum inhibitory concentrations, assay and dissolution test results were used to make conclusions for the study: Results All tablets samples complied with the British pharmacopeia (BP) specifications, however sixty archived isolates which were tested in this study showed resistance towards the standard AMC disc (68 %). The innovator brand (AC1) showed significant mean difference from 2 out of 3 generics (p-values <0.05) while the first generic brand (AC2) showed significant superiority among the generics. Conclusion: Thus, the four samples that were used all complied with the specifications according to BP on dissolution and assay tests but there was an overall resistance towards amoxicillin/clavulanate, and this was moreover seen by generic brands in comparison to the innovator which proved to be of superior activity.