Abstract
Purpose: The aim of the present study is to investigate the physicochemical equivalence of eight brands of tablets containing sulfadoxine-pyrimethamine (antimalarial drug combination) sourced from different retail Pharmacy outlets in the Nigerian market. Method: The quality and physicochemical equivalence of eight different brands of sulfadoxine-pyrimethamine combination tablets were assessed. The assessment included the evaluation of uniformity of weight, friability, crushing strength, disintegration and dissolution tests as well as chemical assay of the tablets. Results: All the eight brands of the tablets passed the British Pharmacopoeia (BP) standards for uniformity of weight, disintegration and crushing strength. Three of the eight brands failed the friability test. One of the brands did not comply with the standard assay of content of active ingredients while another brand did not comply with the USP specifications for dissolution test for sulfadoxine-pyrimethamine tablets. There were no significant differences in the amounts of pyrimethamine and sulfadoxine released from the different brands (P>0.05). Conclusion: Only three brands (registered by NAFDAC) out of the eight brands of sulfadoxine-pyrimethamine tablets that were analysed passed all the BP quality specifications and were physically and chemically equivalent. This study highlights the need for constant market monitoring of new products to ascertain their equivalency to the innovator product. Keywords: Chemical equivalence, comparative study, pyrimethamine-sulfadoxine tablets Tropical Journal of Pharmaceutical Research 2003; 2(1): 161-167
Highlights
The increase in the number of generic drug products from multiple sources has placed people involved in the delivery of health care in a position of having to select one from among several seemingly equivalent products
In 1975 approximately 9% of all prescription drugs dispensed in the United States were generic versions[1]
Four out of the eight brands of the sulfadoxine-pyrimethamine tablets have been registered by NAFDAC
Summary
The increase in the number of generic drug products from multiple sources has placed people involved in the delivery of health care in a position of having to select one from among several seemingly equivalent products. Over 80% of the approximately 10,000 prescription drugs available in 1990 were obtained from more than one source and variable clinical responses to these dosage forms supplied by two or more drug manufacturers is documented[2]. These variable responses may be due to formulation ingredients employed, methods of handling, packaging and storage and even the rigors of inprocess quality control. There is need to determine their pharmaceutical and therapeutic equivalence in order to ensure interchangeability
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