预测平板电脑解体的机制框架:整合代表性毛细管进化模型 (RCEM) 和动态空隙分数进化模型 (DVFEM)
Jongmin Lee1, Jessica Hancock1, Daniel J Goodwin2
1Department of Chemical Engineering and Biotechnology, University of Cambridge, Philippa Fawcett Drive, Cambridge CB3 0AS, UK.
International journal of pharmaceutics
|October 15, 2025
概括
通过新的框架,现在可以预测药物片的分解. 这种方法结合了先进的成像和计算模型,将材料特性和加工与药物释放性能联系起来.
科学领域:
- 制药科学 制药科学
- 计算机建模 计算建模
- 材料科学 材料科学 材料科学
背景情况:
- 平板电脑的分解对于药物释放至关重要,但很难预测.
- 目前的方法缺乏对复杂的解体过程的机制理解.
研究的目的:
- 开发一种新的,基于机制的框架,用于预测即时释放片的分解.
- 整合实验数据与计算模型,以实现全面的方法.
主要方法:
- 利用特拉赫兹脉冲成像 (TPI) 来实时监测液体运输和矩阵侵蚀.
- 采用了代表性毛细血管进化模型 (RCEM) 和动态空隙分数进化模型 (DVFEM).
- 采用代表性毛细管 (RC) 概念的综合模型,并提出了一种代校准策略.
主要成果:
- 该框架成功地将关键材料属性 (CMA) 和关键处理参数 (CPP) 与分解联系起来.
- 展示了一种方法来考虑同时发生的矩阵侵蚀和液体运输动力学.
- 在模型校准中展示了机器学习增强的潜力.
结论:
- 开发的框架为预测平板电脑解体行为提供了一条途径.
- 这种方法与设计质量 (QbD) 原则保持一致.
- 该框架有可能加速制药配方的开发,提高药物产品的性能.
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