Evaluation of Heat Flux Measurement as a New Process Analytical Technology Monitoring Tool in Freeze Drying.

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作者： Ilona,Vollrath ^[1] ; Victoria,Pauli ^[1] ; Wolfgang,Friess ^[2] ; Angelika,Freitag ^[3] ; Andrea,Hawe ^[3] ; Gerhard,Winter ^[4]

作者单位： Coriolis Pharma Research GmbH, Martinsried 82152, Germany; Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University, Munich 81377, Germany. ^[1] Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University, Munich 81377, Germany. ^[2] Coriolis Pharma Research GmbH, Martinsried 82152, Germany. ^[3] Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University, Munich 81377, Germany. Electronic address: gerhard.winter@lrz.uni-muenchen.de. ^[4]

关键词 freeze drying/lyophilization lyophilization process analytical technology processing quality by design

主题词干燥法(Desiccation);能量传递(Energy Transfer);冷冻干燥法(Freeze Drying);热温度(Hot Temperature);血清白蛋白, 牛(Serum Albumin, Bovine);蔗糖(Sucrose);工艺学, 制药(Technology, Pharmaceutical)

DOI 10.1016/j.xphs.2016.12.030

PMID 28063826

发布时间 2018-04-05

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