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首页> 外文期刊>Organic process research & development >Compact Crystallization, Filtration, and Drying for the Production of Active Pharmaceutical Ingredients
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Compact Crystallization, Filtration, and Drying for the Production of Active Pharmaceutical Ingredients

机译:紧凑的结晶,过滤和干燥,用于生产活性药物成分

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摘要

With the growing problem of drug shortages worldwide, a solution could be a centralized compact pharmaceutical manufacturing platform that produces API and finished drug product. In this paper, the development of a combined crystallization, hybrid filtration-drying-dissolution apparatus to be used in such a compact platform is discussed. Experiments were conducted to evaluate each unit operation. Crystallization experiments using a conventional stirred tank and the newly designed scraped surface crystallizer demonstrated the advantages of the new design in terms of crystallization rates, yields and the ease of automation. Postcrystallization operations were operated stepwise using the custom hybrid device that delivered satisfactory results for each operation, e.g. after filtration, Fluoxetine HC1 was dried in less than 20 min, with 99% yield after dissolution in the liquid excipient.
机译:随着全球药品短缺问题的日益严重,解决方案可能是生产API和成品药品的集中式紧凑型药品生产平台。在本文中,讨论了用于这种紧凑平台的组合结晶,混合过滤-干燥-溶解混合设备的开发。进行实验以评估每个单元的操作。使用常规搅拌釜和新设计的刮板表面结晶器进行的结晶实验证明了新设计在结晶速率,产率和自动化便利性方面的优势。后结晶操作使用定制的混合装置逐步进行,该混合装置对于每个操作例如过滤后,氟西汀HCl在不到20分钟的时间内干燥,溶解在液体赋形剂中后收率为99%。

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