Bioequivalence trials of rifampicin containing formulations: extrinsic and intrinsic factors in the absorption of rifampicin

Pharmacological Research : the Official Journal of the Italian Pharmacological Society
S AgrawalR Panchagnula

Abstract

Rifampicin shows variable bioavailability from solid oral dosage forms and the reasons for this variable absorption reported in literature varies from extrinsic formulations factors to intrinsic variability in rifampicin absorption. Hence, we have undertaken a systematic and comprehensive evaluation of all the factors to study contribution of all the factors on rifampicin absorption. As a first step, data from eight bioequivalence studies conducted at National Institute of Pharmaceutical Education and Research (NIPER) bioavailability center was compared across the trials to understand the effect of extrinsic/intrinsic factors on the bioavailability of rifampicin, isoniazid and pyrazinamide. Out of eight fixed dose combination (FDC) formulations, six formulations were bioequivalent for rifampicin to separate formulations whereas one formulation was below and one was above the limits of bioequivalence. It was observed that more variability in rifampicin blood levels is associated with FDC formulations when compared to rifampicin-only formulations and was attributed to complexity involved in the manufacturing of FDCs. Further, one of the rifampicin-only capsule showed unexpectedly lower plasma levels indicating role of physical ch...Continue Reading

Citations

Sep 21, 2007·Journal of Pharmaceutical Sciences·Lisa Claire du ToitClement Penny
Jan 23, 2009·Journal of Pharmaceutical Sciences·C BeckerD M Barends
Apr 24, 2008·Journal of Biomedical Materials Research. Part a·G Chimote, R Banerjee
Jun 22, 2015·Journal of Molecular Graphics & Modelling·Reinaldo G BelliniBruno A C Horta
Jun 1, 2017·Frontiers in Pharmacology·Sonam ChoudharyUmesh Gupta

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