Continuous manufacturing of tablets with PROMIS-line - Introduction and case studies from continuous feeding, blending and tableting.
Continuous manufacturing of tablets with PROMIS-line - Introduction and case studies from continuous feeding, blending and tableting.
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使用 PROMIS-line 连续生产片剂 - 连续喂料、混合和压片的介绍和案例研究。
DOI：
10.1016/j.ejps.2016.02.006
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
O. Korhonen
中科院分区：
文献类型：
--
作者：
S. Simonaho;J. Ketolainen;T. Ervasti;M. Toiviainen;O. Korhonen
药物制造技术正处于现代化的过程中，药物产品的连续制造尤其受到极大关注。采用新的制造方法需要工业界、监管机构、学术界和设备制造商之间的广泛合作。在本文中，我们介绍了PROMIS-line，这是一个连续压片线建于东芬兰大学，药学院，PROMIS-centre。PROMIS-line是模块化的，片剂可以通过干法制粒或直接压片生产。通过三个案例研究，研究了连续进料、混合和压片性能，以说明PROMIS生产线的一些基本特征。总之，PROMIS生产线是研究片剂连续生产基本原理的绝佳工具。
Drug manufacturing technology is in the midst of modernization and continuous manufacturing of drug products is especially the focus of great interest. The adoption of new manufacturing approaches requires extensive cooperation between industry, regulatory bodies, academics and equipment manufacturers. In this paper we introduce PROMIS-line which is a continuous tableting line built at the University of Eastern Finland, School of Pharmacy, PROMIS-centre. PROMIS-line is modular and tablets can be produced via dry granulation or direct compression. In three case studies, continuous feeding, blending and tablet performance is studied to illustrate some basic features of PROMIS-line. In conclusion, the PROMIS-line is an excellent tool for studying the fundamentals of continuous manufacturing of tablets.