Evaluation of Physico-chemical Parameters of Selected Clotrimazole Pessaries from Pharmaceutical Importers and Accredited Drug Dispensing Outlets in Dar es Salaam, Tanzania

Abstract

Introduction: Quality assured medicines make an important contribution to a global reduction in morbidity and mortality. Tanzania imports approximately 70% of its medicines, some of which are manufactured in countries with different climatic conditions that may affect their stability. The prevalence of vaginal candidiasis amongst women seeking primary health care for genital infections in Dar es Salaam is 45%. Clotrimazole pessaries is the first-line drug for the treatment of vaginal candidiasis (VC). However, there are reports showing the existence of poor quality clotrimazole in the market as well as microbial resistance. Study Objectives: This study aimed to assess the quality of clotrimazole pessaries among pharmaceutical importers and Accredited Drug Dispensing Outlets (ADDOs) outlets in Dar es Salaam. Methods: The experimental study laboratory-based was conducted between October 2021 to July 2022. A total of 72 samples, 5 from pharmaceutical importers and 67 from ADDO outlets, were collected by mystery clients through the convenient method. Assay for the content of active ingredients and disintegration time were performed as described in the British Pharmacopoeia (BP). Results:  All samples passed the physical inspection and disintegration test. Among the collected samples, two of 72(2.78%) failed the assay test. The assay for an active pharmaceutical ingredient for samples from importers was significantly greater than that from ADDO outlets. Conclusion: Storage conditions may affect the drug content of clotrimazole pessaries. A few samples from ADDO without fan failed to meet the assay test as per British Pharmacopeia specification. Recommendations: The Pharmacy Regulation 2019, for Accredited Drugs, Dispensing Outlets, Standards, and Ethics for Dispensation of Medicines to be revitalized to include specification on ADDO outlets regarding the storage conditions to align with the pharmaceutical manufacturer’s recommendations. Also, regulatory inspections should be emphasized by the Regulatory Authority including Pharmacy Council and TMDA so as to ensure the registered pharmaceutical outlets continue complying with standards required like the presence of air conditions so that the medicines continue to be of desired quality throughout their shelf life.