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 poorquality co-trimoxazole medicines that could compromise the treatment of infectious diseases. Therefore, regular surveillance and stringent penalties that ensure quality medicines are essential.