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 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.
Tubic-Grozdanis
Marija
M
Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg-University, 55099 Mainz, Germany.
Bolger
Michael B
MB
Langguth
Peter
P
D001682:Biological Availability; D003198:Computer Simulation; D041981:Gastrointestinal Tract / Q000187:drug effects / Q000378:metabolism*; D007408:Intestinal Absorption / Q000187:drug effects / Q000502:physiology*; D010539:Permeability; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D015203:Reproducibility of Results; D012995:Solubility
D004364:Pharmaceutical Preparations