Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds

AAPS J. 2008;10(1):213-26. doi: 10.1208/s12248-008-9023-x. Epub 2008 Apr 2.

Abstract

The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption of several weak acid and weak base BCS class II compounds. Simulation of oral drug absorption given physicochemical drug properties and physicochemical parameters will aid justification of biowaivers for selected BCS class II compounds.

Publication types

  • Comparative Study

MeSH terms

  • Biological Availability
  • Computer Simulation*
  • Gastrointestinal Tract / drug effects
  • Gastrointestinal Tract / metabolism*
  • Intestinal Absorption / drug effects
  • Intestinal Absorption / physiology*
  • Permeability
  • Pharmaceutical Preparations / metabolism*
  • Reproducibility of Results
  • Solubility

Substances

  • Pharmaceutical Preparations