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

Journal Title: The AAPS Journal - Year 2008, Vol 10, Issue 1

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.

Authors and Affiliations

Marija Tubic-Grozdanis, Michael B. Bolger, Peter Langguth

Keywords

Related Articles

Anion-induced water flux as drug release mechanism through cationic Eudragit RS 30D film coatings

The objective of this study was to investigate the anion-controlled drug release mechanism through the cationic coating polymer Eudragit RS 30 D as a function of the anion attraction toward the polymer’s quartern...

Impact of Glycation on Antibody Clearance

Glycation of therapeutic proteins occurs during mammalian cell culture expression and upon administration to patients. Since the chemical attachment of mannose or other sugars via a chemical linker has been shown to incr...

Gene-Directed Enzyme Prodrug Therapy

As one targeting strategy of prodrug delivery, gene-directed enzyme prodrug therapy (GDEPT) promises to realize the targeting through its three key features in cancer therapy—cell-specific gene delivery and expre...

Virtual coupling of pyran protons in the 1H NMR spectra of C- and N-glucoronides: Dependence on substitution and solvent

We have observed that certain C-and N-glucuronides prepared as intermediates for breast cancer preventives demonstrate non-first order 1H NMR spectra that are not the result of impurities or degradation but are instead d...

Dual dopamine/serotonin releasers as potential medications for stimulante and alcohol addictions

We have advocated the idea of agonist therapy for treating cocaine addiction. This strategy involves administration of stimulant-like medications (eg, monoamine releasers) to alleviate withdrawal symptoms and prefent rel...

Download PDF file
  • EP ID EP681542
  • DOI  10.1208/s12248-008-9023-x
  • Views 66
  • Downloads 0

How To Cite

Marija Tubic-Grozdanis, Michael B. Bolger, Peter Langguth (2008). Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds. The AAPS Journal, 10(1), -. https://europub.co.uk/articles/-A-681542