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采用PROMIS生产线连续制造片剂——连续进料、混合和压片的介绍及案例研究。

Continuous manufacturing of tablets with PROMIS-line - Introduction and case studies from continuous feeding, blending and tableting.

作者信息

Simonaho Simo-Pekka, Ketolainen Jarkko, Ervasti Tuomas, Toiviainen Maunu, Korhonen Ossi

机构信息

University of Eastern Finland, School of Pharmacy, PROMIS-Centre, FI-70211 Kuopio, Finland.

VTT Technical Research Center of Finland, Photon Devices & Measurement Solutions, P.O. Box 1199, FI-70211 Kuopio, Finland.

出版信息

Eur J Pharm Sci. 2016 Jul 30;90:38-46. doi: 10.1016/j.ejps.2016.02.006. Epub 2016 Feb 13.

Abstract

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.

摘要

药物制造技术正在经历现代化,药品的连续制造尤其受到高度关注。采用新的制造方法需要行业、监管机构、学术界和设备制造商之间进行广泛合作。在本文中,我们介绍了PROMIS生产线,它是一条建于芬兰东芬兰大学药学院PROMIS中心的连续压片生产线。PROMIS生产线是模块化的,可以通过干法制粒或直接压片来生产片剂。在三个案例研究中,对连续进料、混合和片剂性能进行了研究,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制造基本原理的绝佳工具。

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