Assessment on the quality and influence of tropical storage conditions on amoxicillin formulations marketed in Ethiopia

Abstract

The quality of drugs in some less developed countries is inadequate. The quality of drugs in countries having a tropical climate may be adversely affected if their formulations have not been optimized for stability under these conditions. Amoxicillin is broad-spectrum penicillin active against certain gram negative and gram-positive organisms. It is a widely used antibiotic and there are several formulations of it in Ethiopia. The aim of the present study was to investigate the physicochemical equivalence of eight brands of amoxicillin capsules and five brands of amoxicillin for oral suspension sourced from different retail Pharmacy outlets in Addis Ababa, Ethiopia market and to study the effect of tropical storage condition’s on the their quality with respect to the USP and BP requirement’s using the WHO guidelines.The quality, physicochemical equivalence and the influence of tropical storage conditions of on the previously mentioned commercial dosage forms were assessed. The assessment included the evaluation of uniformity of weight, identification, water content, dissolution tests and the pH values of the reconstituted oral suspensions in addition to the quantitative determination of the amoxicillin content for the studied formulations. Almost all of the amoxicillin formulations examined met pharmacopoeial requirements at zero time, three-month and six month after storage under tropical condition.