Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds

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...

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Bibliographic Details
Published inThe AAPS journal Vol. 10; no. 1; pp. 213 - 226
Main Authors Tubic-Grozdanis, Marija, Bolger, Michael B., Langguth, Peter
Format Journal Article
LanguageEnglish
Published Boston Springer US 2008
Subjects
Beyond Guest Editors: James E. Polli
Biochemistry
Biological Availability
Biomedical and Life Sciences
Biomedicine
Biopharmaceutics Classification System
Biotechnology
Computer Simulation
Gastrointestinal Tract - drug effects
Gastrointestinal Tract - metabolism
Intestinal Absorption - drug effects
Intestinal Absorption - physiology
Permeability
Pharmaceutical Preparations - metabolism
Pharmacology/Toxicology
Pharmacy
Reproducibility of Results
Research Article/Themed Issue: Bioequivalence
Solubility
Themed Issue: Bioequivalence, Biopharmaceutics Classification System, and Beyond Guest Editors: James E. Polli
solubility
absorption
bioavailability
biowaiver
bioequivalence
permeability
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Summary: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.
ISSN:1550-7416
1550-7416
DOI:10.1208/s12248-008-9023-x