Dissolution Profiles of Twelve Brands of Sulphadoxine Pyrimethamine in the Nigerian Market

Abstract

With the introduction of artemisinin combination therapies (ACTs) as the standard recommended treatment for falciparum malaria by the World Health Organization (WHO) and its adoption by most malaria-endemic countries like Nigeria, the only available treatment option for pregnant women with malaria became sulphadoxine–pyrimethamine (SP). Several brands of SP have emerged in the local Nigerian and African market. An in vitro dissolution study was conducted on twelve brands of SP in three different dissolution media. The twelve brands of SP were obtained from both the public and private medicine outlets in Nigeria. They were subjected to dissolution in three dissolution media at pH values of 1.2, 4.5, and 6.8.The dissolution samples were assayed for the drug compounds using a double-beam ultraviolet spectrophotometer. The dissolution test results were subjected to analysis of variance (ANOVA) and analyses of difference (f1) and similarity factors (f2). Five of the selected twelve brands failed to meet the USP dissolution requirements for immediate-release tablets. Seven of twelve brands had dissimilar dissolution profiles.