制药工业中结晶过程的最新进展

工程（英文） ›› 2017, Vol. 3 ›› Issue (3) : 343-353.

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工程（英文） ›› 2017, Vol. 3 ›› Issue (3) : 343-353. DOI: 10.1016/J.ENG.2017.03.022
研究论文
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制药工业中结晶过程的最新进展

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Recent Developments in the Crystallization Process: Toward the Pharmaceutical Industry

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Abstract

Crystallization is one of the oldest separation and purification unit operations, and has recently contributed to significant improvements in producing higher-value products with specific properties and in building efficient manufacturing processes. In this paper, we review recent developments in crystal engineering and crystallization process design and control in the pharmaceutical industry. We systematically summarize recent methods for understanding and developing new types of crystals such as co-crystals, polymorphs, and solvates, and include several milestones such as the launch of the first co-crystal drug, Entresto (Novartis), and the continuous manufacture of Orkambi (Vertex). Conventional batch and continuous processes, which are becoming increasingly mature, are being coupled with various control strategies and the recently developed crystallizers are thus adapting to the needs of the pharmaceutical industry. The development of crystallization process design and control has led to the appearance of several new and innovative crystallizer geometries for continuous operation and improved performance. This paper also reviews major recent progress in the area of process analytical technology.

Keywords

Crystallization / Crystal engineering / Polymorphism / Crystallization process design and control / Crystal size distribution

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. . Engineering. 2017, 3(3): 343-353 https://doi.org/10.1016/J.ENG.2017.03.022

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Acknowledgements

The authors acknowledge the financial support provided by the China Scholarship Council and the Natural Science and Engineering Research Council (NSERC) of Canada.

Compliance with ethics guidelines

Zhenguo Gao, Sohrab Rohani, Junbo Gong, and Jingkang Wang declare that they have no conflict of interest or financial conflicts to disclose.

版权

2017 2017 THE AUTHORS. Published by Elsevier LTD on behalf of the Chinese Academy of Engineering and Higher Education Press Limited Company. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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