Sulphadoxinel/pyrimethamine tablet products on the Kenyan market: Quality Concerns

Abstract

Sulfadoxine/Pyrimethamine tablets preparations were recently made the first line antimalarial drug. In response to reports on falciparum malaria resistance to such products, sulfadoxine/pyrimethamine tablets in Kenya were evaluated for their in¬vitro performance using tbe parameters of content and dissolution test for the Active Pharmaceutical Ingredient. One brand product had a content of both sulfadoxine and pyrimethamine well below allowed limits. Amongst the brands analysed only 44% had batches that released more than Q = 60% of labelled dose in 30 minutes. Batches of some brands had wide variations in content with some failing the dissolution test. Other brands released less than 60% in 60 minutes. Most brands failed the dissolution test for pyrimethamine and 33% for both sulfadoxine and pyrimethamine. The quality of sulfadoxine/pyrimethamine products on the Kenyan market sbould be a cause for concern to the drug regulatory authority and the Malaria Control Program