Recent bioequivalence studies on fixed-dose combination anti-tuberculosis drug formulations available on the global market
OBJECTIVE: To evaluate the relative bioavailability of rifampicin in various FDC formulations currently in use in tuberculosis control programmes in the global market.
DESIGN: A two-period randomised crossover bioequivalence study in healthy male volunteers, with a 1 week washout period between treatments. Plasma rifampicin concentrations were measured at 0, 1, 2, 4, 6, 8 and 12 hours after each drug administration.
RESULTS: The AUC0–8, AUC0–12 and Cmax for rifampicin in seven of 10 FDC formulations was not found to be bioequivalent to the reference administered as loose (separate) formulations. This was confirmed using parametric and non-parametric statistical methods.
CONCLUSIONS: The poor relative bioavailability of rifampicin from some FDCs has been documented. The implications for tuberculosis programmes are extremely serious and warrant urgent attention.
Document Type: Review Article
Affiliations: 1: Department of Pharmacology, University of Durban Westville, Durban, South Africa; and National Tuberculosis Research Programme, Medical Research Council, Pretoria, South Africa 2: National Tuberculosis Research Programme, Medical Research Council, Pretoria, South Africa 3: National Tuberculosis Research Programme, Medical Research Council, Pretoria, South Africa; and King George V Hospital, P O Dormeton, Dormeton, South Africa 4: Department of Pharmacology, Medical School, University of Cape Town, Cape Town, South Africa
Publication date: 1999-11-01
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