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灵活建模直接压缩片的溶解性能

Natalie Maclean¹, John A Armstrong¹, Mark A Carroll¹

¹Centre for Continuous Manufacturing and Advanced Crystallisation (CMAC), University of Strathclyde, Glasgow, UK; Strathclyde Institute of Pharmacy & Biomedical Sciences, University of Strathclyde, Glasgow, UK.

International journal of pharmaceutics

|April 5, 2024

概括

一个新的模型通过追踪药物颗粒通过分解和溶解阶段来预测药片溶解. 这种方法有助于早期药物开发和制造业的实时质量控制.

科学领域:

制药科学制药科学
药物输送系统药物输送系统
物理药房物理药房

背景情况:

从直接压缩的片子中准确预测药物溶解对于药物开发至关重要.
现有的模型可能无法完全捕捉平板电脑分解和药物溶解之间的复杂相互作用.
了解制造对平板电脑性能的影响对于质量控制至关重要.

研究的目的:

提出和评估一种新的隔间模型,用于预测平板电脑的分解和溶解.
在直接压缩的剂量形式中,将原材料特性与片剂性能联系起来.
探索模型在连续制造中实时释放测试的实用性.

主要方法:

开发一种用于活性药物成分颗粒的三部分模型 (结合,分解,溶解).
整合了三个配合参数 (β0,βt,0,α) 来描述药片分解动态.
在USP II装置中将Nernst-Brunner方程与水力动力学效应集成到溶解速率计算中.

主要成果:

该模型成功地描述了直接压缩的片的分解和溶解性能.
模型的关键参数与平板电脑的孔隙性有很强的相关性,这表明对制造变量的敏感性.
该模型利用基本的活性药物成分特性 (溶解度,颗粒大小,密度) 进行早期预测.

结论:

拟议的隔间模型为评估平板电脑溶解性能提供了一个强大的框架.
该模型与制造参数相关的能力支持其在实时释放测试中用于连续直接压缩的应用.
这种方法通过利用固有的药物物质特征来促进早期发展.

关键词:

溶解建模的溶解模型.固体口服剂型固体口服剂型药片分解药片分解药片溶解剂药片溶解剂

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