Quality Of sulfadoxine/pyrimethamine tablets marketed In Dar es Salaam, Tanzania

Abstract

The quality of brands of Sulfadoxinc/pyrimethamine tablets, from nine different manufacturers, was assessed, by determining the content of active ingredients and their dissolution profile. All nine brands complied with the USP requirement for the content of sulfadoxine and pyrimethamine. However, only four brands passed the dissolution test, which according to the USP; requires that more 'than 60% of each active ingredient should be in solution in' 30 minutes. One brand failed the dissolution test, with respect to both active ingredients, for which only 19.9°;;, and 56.9% of pyrimethamine and sulfadoxine, respectively, were in solution, in 30 minutes. The remaining four brands, failed with respect to pyrimethamine, for which less than 60% was in solution in 30 minutes. These findings clearly indicate that, in addition to parasite resistance to sulfadoxinel pyrimethamine, failure of this drug combination to cure malaria could also be due to the sub-standard products available on the market. It is recommended that pharmaceutical manufacturers should ensure that their products meet the required standards by adherence to good manufacturing practice. Statutory drug control bodies should also ensure that each product, imported or locally manufactured, meets the required compendial standards before being permitted to be on the market