Combined Models for Data from In Vitro–In Vivo Correlation Experiments

Abstract

A method is presented to describe the in vitro–in vivo correlation (IVIVC) of an extended release drug formulation. This extended release drug product is overencapsulated with immediate release material. The heterogeneity of the capsule is modelled using a combined model of an extended release and an immediate release pharmacokinetic profile. Whereas an IVIVC is conventionally performed using a two-stage procedure, the model uses a one-stage convolution-based method. The method is applied to a Galantamine controlled release formulation, an acetylcholinesterase inhibitor for the treatment of Alzheimer's disease. The average percentage prediction error indicated a good fit of the new model.

Key Words:

• Controlled release
• Convolution
• Dissolution curve
• IVIVC
• One-stage model fitting

ACKNOWLEDGMENTS

Financial support from the IAP research network nr P5/24 of the Belgian government (Belgian Science Policy) is gratefully acknowledged.

The authors would like to thank the editor and the anonymous referees for their valuable comments, which have greatly improved the manuscript.