在药物生产过程中开发和整合连续水平带式过器
Kornélia Tacsi1, Dorián László Galata1, András Domokos1
1Department of Organic Chemistry and Technology, Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Műegyetem rkp. 3., H-1111 Budapest, Hungary.
International journal of pharmaceutics
|September 21, 2024
概括
开发了一种新的连续水平带波器 (CHBF) 用于制药分离. 这种强大的过方法与连续结晶器相结合,可实现各种制药悬浮液的低剩余水分含量.
科学领域:
- 化学工程是化学工程的重要组成部分.
- 制药技术 制药技术 制药技术
- 分离过程 分离过程.
背景情况:
- 传统的制药过使用批量模式.
- 持续的制造需要持续的过策略.
- 与连续结晶器的整合至关重要.
研究的目的:
- 研究一个实验室规模的连续水平带波器 (CHBF) 用于制药分离.
- 评估不同制药悬浮剂和溶剂的CHBF性能.
- 评估CHBF与连续结晶器 (MSMPR和PFC) 的整合.
主要方法:
- 使用微晶纤维素 (MCC) /水,乳糖/乙醇和乙盐酸 (ASA) /水系统测试的CHBF.
- 不同的工艺条件和溶剂.
- 集成的CHBF与混合悬浮混合产品去除 (MSMPR) 和插头流结晶器 (PFC) 系统.
主要成果:
- 使用MCC/水 (残留水分为45-52%) 实现了强大的过.
- 其余水分含量 (<2%) 取决于溶剂和颗粒大小 (乳糖/乙醇,大型ASA颗粒).
- 与MSMPR和PFC集成的CHBF显示了类似的晶体大小和~20%的残留水分.
结论:
- CHBF是一种强大的连续过技术,用于制药应用.
- 它可以有效地与连续结晶器集成.
- 过器在测试范围内没有改变晶体形态.
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