Quality of different brands of clarithromycin tablets marketed in Ethiopia; implications for the future

Background: There are concerns with the availability of substandard antibiotics across Africa, including Ethiopia, exacerbating high levels of antimicrobial resistance (AMR). There are ongoing initiatives across Africa to reduce their availability to reduce AMR, including Pan-African registration, coordination with Interpol, and increasing surveillance. Consequently, the objective of the study was to evaluate the quality of different brands of clarithromycin tablets currently marketed in Ethiopia as a key antibiotic. Methods: A total of 120 tablets of 12 different brands of clarithromycin 500 mg tablets were purchased from 12 different community pharmacies. Quality control tests, including visual inspection, thickness, diameter, hardness, friability, weight variation, disintegration, dissolution, and assays, were conducted at the Ethiopian Pharmaceutical Company’s drug quality control laboratory on the sourced tablets. Tests were performed in accordance with the United States Pharmacopoeia (USP) and the World Health Organization's procedures. Results: The identification test results confirmed the presence of the active pharmaceutical ingredients. The weight variation tests showed compliance with the USP limits. All clarithromycin brands and tablets met the USP requirements for hardness and disintegration times. The percentage content of all brands and tablets ranged from 95.14% to 100.44%, meeting the USP specifications. The dissolution tests also met required USP limits alongside factor (f1) factor (f2) values, which were within acceptable ranges. Conclusion: As a result, all tested clarithromycin brands conformed with the required quality standards and were of acceptable quality. Consequently, these different brands of clarithromycin can be used to effectively treat patients and support ongoing national efforts to ensure antibiotic quality and strengthen AMR containment strategies.