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A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

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The developability classification system: application of biopharmaceutics concepts to formulation development.

James M Butler¹, Jennifer B Dressman

¹Pharmaceutical Development, GlaxoSmithKline R&D, Harlow, UK. james.m.butler@gsk.com

Journal of Pharmaceutical Sciences

|September 8, 2010

Summary

This summary is machine-generated.

A new drug classification system, the Developability Classification System (DCS), enhances the Biopharmaceutics Classification System (BCS) by focusing on drug developability for better prediction of in vivo performance.

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Area of Science:

Pharmacology
Drug Development
Physical Chemistry

Background:

The Biopharmaceutics Classification System (BCS) is widely used but has limitations in predicting drug developability.
Oral drug formulation requires understanding factors influencing in vivo performance.

Purpose of the Study:

To develop a revised drug classification system focusing on drug developability.
To improve the prediction of critical factors for in vivo oral drug performance.

Main Methods:

A revised classification system was developed, starting from the BCS.
Key factors considered include intestinal solubility, solubility-permeability compensation, and particle size for dissolution-limited absorption.
The system was validated against literature data on in vivo performance of test compounds.

Main Results:

The revised system, termed the Developability Classification System (DCS), was established.
DCS incorporates intestinal solubility, compensatory effects, and particle size considerations.
Validation showed DCS is more valuable than BCS in predicting critical factors for in vivo performance.

Conclusions:

The Developability Classification System (DCS) offers enhanced prediction of oral drug performance compared to BCS.
DCS provides a more comprehensive framework for assessing drug developability in early-stage research.