胃肠道模拟在高渗透性化合物生物豁免扩展中的应用。
Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds.
作者信息
Tubic-Grozdanis Marija, Bolger Michael B, Langguth Peter
机构信息
Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg-University, 55099 Mainz, Germany.
出版信息
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.
摘要
本研究的目的是应用胃肠道模拟技术和生理参数整合来预测生物制药药物分类。使用GastroPlus软件结合实验测定的药物物理化学和药代动力学性质，模拟了几种弱酸和弱碱BCS II类化合物的吸收情况。根据药物物理化学性质和物理化学参数对口服药物吸收进行模拟，将有助于证明选定的BCS II类化合物生物豁免的合理性。
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