Sulphadoxine/Pyrimethamine Tablet Products on the Kenyan Market: Quality Concerns

I O Kibwage; J K Ngugi

I O Kibwage Department of Pharmaceutical Chemistry, Faculty of Pharmacy, College of Health Sciences, University of Nairobi, PO Box 19676, Nairobi
J K Ngugi Department of Pharmaceutical Chemistry, Faculty of Pharmacy, College of Health Sciences, University of Nairobi, PO Box 19676, Nairobi

Keywords: Sulfadoxine/Pyrimethamine, Content, Dissolution

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 the 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 should be a cause for concern to the drug regulatory authority and the Malaria Control Program.