Existence of antimalarial formulations with low bioavailability in Tanzania

Trop Doct. 2006 Apr;36(2):93-7. doi: 10.1258/004947506776593512.

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 microL) 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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antimalarials / pharmacokinetics*
  • Area Under Curve
  • Biological Availability
  • Cross-Over Studies
  • Drug Combinations
  • Drugs, Generic / pharmacokinetics*
  • Female
  • Humans
  • Malaria, Falciparum / drug therapy
  • Male
  • Middle Aged
  • Pyrimethamine / pharmacokinetics*
  • Quality Control
  • Single-Blind Method
  • Sulfadoxine / pharmacokinetics*
  • Tanzania
  • Therapeutic Equivalency

Substances

  • Antimalarials
  • Drug Combinations
  • Drugs, Generic
  • fanasil, pyrimethamine drug combination
  • Sulfadoxine
  • Pyrimethamine