An Evaluation of Quality and Brands of Amoxicillin Formulations Marketed in Nairobi City County, Kenya
Koech, Lilian Chepngetich
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Antibiotics are among the most counterfeited anti-infectious medicines in developing countries due to high demand. Amoxicillin is among the most prescribed, affordable and easily accessible antibiotic in Kenya. It is a broad-spectrum antibiotic hence commonly used for chemotherapy. Administration of poor-quality medicine possess the potential risks of treatment failure, emergence of resistance, side effects, and /or death to patients. This study sought to determine the quality and identify the various brands of amoxicillin and its combination amoxicillin/clavulanic acid marketed in Nairobi County. Nairobi is the capital city of Kenya, gateway for imports and exports and the headquarters to most of the pharmaceutical distributors and wholesalers. Ten wards in Nairobi County representing different socio-economic settings were purposively sampled for the study. A detailed questionnaire was used to collect background data on brands of amoxicillin and amoxicillin/clavulanic acid in the market. A total of 106 different brands of amoxicillin and amoxicillin /clavulanic acid formulations were found in the market, 85 were imports while 21 were locally manufactured. Fifty-three samples were analyzed with reference to the United States Pharmacopoeia monograph. Amoxicillin and clavulanic acid content for oral suspensions were determined immediately after reconstitution and 7 days thereafter to determine their stability during prescription period. On day seven 23.1% (3 out of 13) of amoxicillin and 66.7% (8 out of 12) amoxicillin/clavulanic acid oral suspensions presented levels below recommended limits. Potency determination for amoxicillin capsules and amoxicillin/clavulanic acid tablets showed 33.3% (2 out of 6) and 13.6% (3 out of 22) failure rate. For capsule and tablets dissolution tests, there was 17.9% (5 out of 28) failure rate. Overall, 30.2% of the drugs analyzed failed to comply with pharmacopoeia limits. It is therefore worth noting that quality of some amoxicillin formulations in Nairobi County is not to standard. This affirms the need for regular post market surveillance to inform on the situation of antibiotics quality in the Kenyan market.