Existence of antimalarial formulations with low bioavailability in Tanzania
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Date
2006
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Tropical doctor
Abstract
Abstract
The main objective of this work was to assess the relative bioavailability of two tablet formulations containing sulfadoxine/pyrimethamine (SP) and marketed in Tanzania. Twelve healthy volunteers were randomized to receive a single oral dose of three SP tablets each containing 500 mg sulfadoxine (SDX) and 25 mg pyrimethamine (PYR) in a form of either A (a locally manufactured SP tablet formulation, manufactured by a local pharmaceutical industry in Tanzania) or B (Fansidar®, Hoffmann La Roche, Basel, Switzerland, an innovator's SP) after an overnight fasting. Serial blood samples (100 μL) were collected from a finger prick in duplicate up to 10 days and dried on Whatman® filter paper. The samples were assayed for SDX and PYR using high-performance liquid chromatographic methods. Pharmacokinetic parameters of SDX and PYR were estimated by single compartment method. The pharmacokinetics of formulation A - maximum plasma concentration, the areas under the plasma concentration - time curve and the relative bioavailability (A versus B) were significantly lower than those of formulation B (P<0.1). These observed differences indicate bioinequivalence between the two products.
Description
Keywords
Antimalarial, sulfadoxine, Pyrimethamine
Citation
Minzi, O.M., Massele, A., Justin-Temu, M., Ericsson, Ö. and Gustafsson, L.L., 2006. Existence of antimalarial formulations with low bioavailability in Tanzania. Tropical doctor, 36(2), pp.93-97.