Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs.

Abstract

Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15 min) to be eligible for a biowaiver. Pharmacokinetic modeling of 32 BCS I drugs was performed to demonstrate that very rapid dissolution is not necessary to guarantee bioequivalence for them. Rapid dissolution and similar dissolution profiles are sufficient criteria for all BCS I drugs.

DOI: 10.1002/jps.21879

Cite this paper

@article{Kortejrvi2010VeryRD, title={Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs.}, author={Hanna Kortej{\"a}rvi and Ramzi Shawahna and Alissa D. Koski and Jussi Malkki and Krista Ojala and Marjo Yliperttula}, journal={Journal of pharmaceutical sciences}, year={2010}, volume={99 2}, pages={621-5} }