Author(s): Agrawal S, Panchagnula R
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Abstract Rifampicin exhibits variable bioavailability from solid oral dosage forms and this problem is more apparent when it is formulated as fixed dose combination (FDC) in presence of other first-line anti-tuberculosis drugs. To determine the cause of variable bioavailability, the aging effect on physical and chemical performance of rifampicin from FDC formulations after real time storage at the ambient conditions was investigated. For this purpose, six FDC formulations from different manufacturers were stored at ambient conditions (20-35 degrees C, with no control of humidity) in the final packing for a period of 16-38 months and its in vitro quality control tests for rifampicin were compared with the initial performance of these tablets. None of the formulations have shown significant weight gain/loss and the assay values were within the pharmacopeial limits when evaluated by a stability indicating method. Further storage had no effect on physical performance of FDC tablets as indicated by unaltered dissolution profiles. Formulation reevaluation after real time storage at the ambient conditions for 16-38 months indicated that rifampicin containing FDC formulations are stable throughout its shelf life and instability is not a cause of variable bioavailability.
This article was published in Pharmazie
and referenced in Journal of Bioequivalence & Bioavailability