The Developability Classification System: Application of Biopharmaceutics Concepts to Formulation Development

Abstract

A revised classification system for oral drugs was developed
using the biophar- maceutics classification system (BCS) as a starting point.
The revised system is designed to have a greater focus on drug developability.
Intestinal solubility, the compensatory nature of solubility and permeability in
the small intestine and an estimate of the particle size needed to overcome
dissolution rate limited absorption were all considered in the revised system.
The system was then validated by comparison with literature on the in vivo
performance of a number of test compounds. Observations on the test
compounds were consistent with the revised classification, termed the
developability classification system (DCS), showing it to be of greater value in
predicting what factors are critical to in vivo performance than the widely
used BCS.