Quality of Co-trimoxazole Tablets Marketed in Nairobi County, Kenya

Abstract

BACKGROUND Poor-quality medicines reduce the therapeutic efficacy of medicines, negatively impacting the treatment outcomes, prevention, and management of fatal infections. This cross-sectional study evaluated the quality of selected co-trimoxazole tablets marketed in Nairobi County, Kenya. METHODOLOGY A total of 42 samples categorized into ten brands were evaluated for active pharmaceutical ingredient (API) content and uniformity of weight following United State Pharmacopeia (USP). Additionally, a visual inspection of the packaging and labelling was performed to confirm whether they adhered to World Health Organization's Good Manufacturing Practice (GMP) guidelines. RESULTS The majority of the samples were of local origin (70%). By 23rd October 2019, the retention status of one of the ten brands documented was not documented in the Pharmacy and Poisons Board retention register. Of the 42 samples analyzed, 97.6% and 69.01% complied with United States Pharmacopeia (USP) specifications for uniformity of weight and API, respectively, while all samples adhered to packaging and labelling requirements. CONCLUSION This study has demonstrated that most co-trimoxazole tablets tested complied with USP requirements. Additionally, it has provided evidence of the presence of poor-quality co-trimoxazole medicines that could compromise the treatment of infectious diseases. Therefore, regular surveillance and stringent penalties that ensure quality medicines are essential.