用于制造药物颗粒的基于原子化的过程的CFD建模和模拟:一篇综述
Mohamad Baassiri1, Vivek Ranade2, Luis Padrela1
1SSPC Research Centre, Department of Chemical Sciences & Chemical Engineering, Bernal Institute, University of Limerick, Limerick V94 T9PX Ireland.
International journal of pharmaceutics
|January 10, 2025
概括
计算流体动力学 (CFD) 建模对于理解制药原子化过程和控制药物颗粒质量至关重要. 本次审查评估了当前的CFD模型,并建议改善设计制造质量.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 化学工程是化学工程的重要组成部分.
- 计算科学 计算科学
背景情况:
- 原子化技术对于生产具有控制关键质量属性 (CQA) 的精细药物颗粒至关重要.
- 颗粒CQAs受到喷雾流体动力学,混合,热量/质量转移和颗粒形成过程的影响.
- 计算流体动力学 (CFD) 模型对于理解这些多尺度现象至关重要.
研究的目的:
- 批判性地审查目前关于CFD模拟用于制药原子化的研究.
- 评估用于制药颗粒生产的CFD应用的最新情况.
- 为提升差价合约模型及其应用提供建议.
主要方法:
- 药物颗粒生产的原子化方法的概述.
- 原子化中的关键物理过程和概念的概述.
- 对现有的CFD模型进行批判性审查,以了解流程需求.
- 讨论对制药应用的CFD模型的需求.
主要成果:
- 目前的CFD模型需要增强,以在多相流,流和干燥中获得更高的保真度.
- 药品原子化中CFD模型的验证方法需要改进.
- 需要更多的数值原子化研究,特别是在制药领域.
结论:
- CFD 建模在优化药物颗粒制造的原子化过程中发挥着关键作用.
- 未来的方向包括积极控制和机器学习策略,以推进制药生产中的设计质量 (QbD).
- 增强的CFD模型是实现精确控制药物颗粒CQAs的关键.
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