Development of Suitable Plant-Scale Drying Conditions That Prevent API Agglomeration and Dehydration

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• 作者：Julie Adamson ; Neil Faiber ; Alex Gottlieb ; Lexi Hamsmith ; Frederick Hicks ; Christopher Mitchell ; Bhavi Mittal ; Kouji Mukai ; Charles D. Papageorgiou
• 刊名：Organic Process Research & Development
• 出版年：2016
• 出版时间：January 15, 2016
• 年：2016
• 卷：20
• 期：1
• 页码：51-58
• 全文大小：403K
• ISSN：1520-586X

文摘

Alisertib sodium, an investigational oral oncology drug, posed some challenges toward developing a robust and scalable drying process employing an agitated filter dryer that manifested themselves during the technical transfer to a new manufacturing site. The API studied was a monohydrate that was found to readily dehydrate and agglomerate, impacting both drug product (DP) manufacture and in vitro dissolution. A scale down agitated filter dryer was designed that was used to study the drying unit operation and identify key process parameters. Through a combination of lab- and pilot plant-scale experiments, suitable drying conditions were developed that minimized agglomeration, eliminated dehydration, and produced API that behaved acceptably in downstream DP manufacture.