Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development.
Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development.
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了解 API 热气流静态干燥：干燥装置原型的设计和测试以及干燥建模开发。
DOI：
10.1021/acs.oprd.0c00035
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发表时间：
2020-11-20
影响因子：
3.4
通讯作者：
Mulheran PA
中科院分区：
文献类型：
--
作者：
Ottoboni S;Coleman SJ;Steven C;Siddique M;Fraissinet M;Joannes M;Laux A;Barton A;Firth P;Price CJ;Mulheran PA
开发连续分离工艺以生产纯净、干燥、自由流动的活性药物成分（API）是实施连续端到端制药生产的最后障碍。最近的工作导致了连续过滤和洗涤原型的开发，用于制药工艺开发和小规模生产。在这里，我们解决了在固定床中静态干燥溶剂润湿的结晶API的挑战，以促进用于药物开发的连续过滤干燥器的设计，而没有过度的颗粒破碎或形成导致结块的颗粒间桥。我们证明了在适合连续生产的时间尺度上干燥小批量的可行性，并通过开发干燥模型来补充，该模型为工艺开发提供了设计工具。我们还评估了替代洗涤和干燥方法对颗粒团聚的影响。我们的结论是，我们的方法产生有效的技术，与性能是服从预测建模。
Developing a continuous isolation process to produce a pure, dry, free-flowing active pharmaceutical ingredient (API) is the final barrier to the implementation of continuous end-to-end pharmaceutical manufacturing. Recent work has led to the development of continuous filtration and washing prototypes for pharmaceutical process development and small-scale manufacture. Here, we address the challenge of static drying of a solvent-wet crystalline API in a fixed bed to facilitate the design of a continuous filter dryer for pharmaceutical development, without excessive particle breakage or the formation of interparticle bridges leading to lump formation. We demonstrate the feasibility of drying small batches on a time scale suitable for continuous manufacturing, complemented by the development of a drying model that provides a design tool for process development. We also evaluate the impact of alternative washing and drying approaches on particle agglomeration. We conclude that our approach yields effective technology, with a performance that is amenable to predictive modeling.
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影响因子：
5.2
作者：
Lim, Hong Lee;Hapgood, Karen P.;Haig, Brian
通讯作者：
Haig, Brian
影响因子：
3.4
作者：
McWilliams, J. Christopher;Allian, Ayman D.;Braden, Timothy M.
通讯作者：
Braden, Timothy M.
影响因子：
4.7
作者：
Ruslim, Franky;Nirschl, Hermann;Carvin, Philippe
通讯作者：
Carvin, Philippe
影响因子：
3.4
作者：
Lamberto, David J.;Diaz-Santana, Anthony;Zhou, George
通讯作者：
Zhou, George
影响因子：
5.8
作者：
Lekhal, A;Girard, KP;Glasser, BJ
通讯作者：
Glasser, BJ