M.B. Jande, O. Ngassapa and I.O. Kibwage. Quality of Sulfadoxine/Pyrimethamine tablets marketed in Dar es Salaam.

Citation:
"M.B. Jande, O. Ngassapa and I.O. Kibwage. Quality of Sulfadoxine/Pyrimethamine tablets marketed in Dar es Salaam. ." East Cent. Afr. J. Pharm. Sci.. 2000;3(1):20-34.

Abstract:

The quality of brands of Sulfadoxine/pvrirnethamine 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°/i, 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 sulfadoxine/
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.

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