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 a broad-spectrum penicillin, active against certain Gram negative and Gram-positive organisms, and is a widely used. There are currently 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 suspensions sourced from different retail Pharmacy outlets in Addis Ababa, Ethiopia market and to study the effect of tropical storage conditions on the their quality with respect to the USP and BP requirements using the WHO guidelines. The assessment included the evaluation of uniformity of weight, identification, moisture content, dissolution profiles 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-months and six months after storage under tropical condition.