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用于分析吸入性药物膜式溶出试验的模型。

Model for the Analysis of Membrane-Type Dissolution Tests for Inhaled Drugs.

机构信息

Department of Pharmacy and the Swedish Drug Delivery Center (SweDeliver), Uppsala University, P.O. Box 580, 751 23 Uppsala, Sweden.

Inhaled Product Development, Pharmaceutical Technology & Development, AstraZeneca, 43183 Gothenburg, Sweden.

出版信息

Mol Pharm. 2020 Jul 6;17(7):2426-2434. doi: 10.1021/acs.molpharmaceut.0c00163. Epub 2020 Jun 15.

DOI:10.1021/acs.molpharmaceut.0c00163
PMID:32463245
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7467770/
Abstract

Impactor-type dose deposition is a common prerequisite for dissolution testing of inhaled medicines, and drug release typically takes place through a membrane. The purpose of this work is to develop a mechanistic model for such combined dissolution and release processes, focusing on a drug that initially is present in solid form. Our starting points are the Noyes-Whitney (or Nernst-Brunner) equation and Fick's law. A detailed mechanistic analysis of the drug release process is provided, and approximate closed-form expressions for the amount of the drug that remains in solid form and the amount of the drug that has been released are derived. Comparisons with numerical data demonstrated the accuracy of the approximate expressions. Comparisons with experimental release data from literature demonstrated that the model can be used to establish rate-controlling release mechanisms. In conclusion, the model constitutes a valuable tool for the analysis of in vitro dissolution data for inhaled drugs.

摘要

撞击式剂量沉积是吸入式药物溶解测试的常见前提条件，药物释放通常通过膜进行。这项工作的目的是开发一种针对此类溶解和释放过程的机械模型，重点是最初以固体形式存在的药物。我们的起点是 Noyes-Whitney（或 Nernst-Brunner）方程和 Fick 定律。对药物释放过程进行了详细的机械分析，并推导出了剩余固体药物量和已释放药物量的近似闭式表达式。与数值数据的比较证明了近似表达式的准确性。与文献中释放实验数据的比较表明，该模型可用于确定控制释放机制。总之，该模型是分析吸入式药物体外溶解数据的有力工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/06bed6880f87/mp0c00163_0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/533fe3601098/mp0c00163_0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/c441ba0c93d2/mp0c00163_0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/ce3a5eafbf04/mp0c00163_0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/ad63d749a855/mp0c00163_0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/06bed6880f87/mp0c00163_0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/533fe3601098/mp0c00163_0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/c441ba0c93d2/mp0c00163_0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/ce3a5eafbf04/mp0c00163_0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/ad63d749a855/mp0c00163_0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd4/7467770/06bed6880f87/mp0c00163_0005.jpg

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