Abstract

Biowaiver Strategies for BCS-1 / BCS-3 Oral Solid Dosage Forms

Gour Mukherji, Senior Pharmaceutical Consultant, Consultancy

US-FDA has released a revised draft guideline in May 2015 wherein immediate release tablets and capsules containing BCS Classes 1 and 3 drugs can claim waiver from human bioavailability / bioequivalence studies. These two drug classes have to meet stringent solubility, permeability and formulation dissolution characteristics.

Introduced in 1995 by Gordon Amidon and co-workers, BCS has given clearer insight into drug behavior in-vivo based on their above mentioned physical attributes. Subsequently, modified version of BCS has been published which correlated the four BCS class drugs with their disposition, drug-drug interaction and distribution inside body organs, like, intestine, liver, kidney and brain, among others. Based on this finding it is being suggested that drug permeability be measured as drug metabolized, instead of drug absorbed.

Other related aspects of this guideline and formulation excipients affecting drug absorption will be discussed in this presentation.