The Pharmaceutical Drying Unit Operation: An Industry Perspective on Advancing the Science and Development Approach for Scale-Up and Technology Transfer
The Pharmaceutical Drying Unit Operation: An Industry Perspective on Advancing the Science and Development Approach for Scale-Up and Technology Transfer
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DOI：
10.1021/acs.oprd.6b00406
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发表时间：
2017-03-01
影响因子：
3.4
通讯作者：
Papageorgiou, Charles D.
中科院分区：
文献类型：
--
作者：
Conder, Edward W.;Cosbie, Andrew S.;Papageorgiou, Charles D.
干燥单元操作广泛用于制药行业，但通常缺乏对干燥工艺参数对活性药物成分关键质量属性影响的了解，可能会在开发过程中产生挑战。赋能技术联盟内的一个工作组确定了药物干燥开发中的共同挑战，包括扩大研究和转移到不同设备类型和尺寸的材料限制。本手稿调查了行业内与化学和物理稳定性，干燥动力学和粉末特性相关的干燥开发的当前实践，并强调了改善行业内干燥开发工作流程的常见开发差距。最终目标是鼓励进一步的基础研究和技术进步，以改善干燥开发工作流程。
The drying unit operation is used extensively in the pharmaceutical industry, but often a lack of understanding of the impact of the drying process parameters on active pharmaceutical ingredient critical quality attributes can create challenges during development. A working group within the Enabling Technologies Consortium identified common challenges in pharmaceutical drying development, including material constraints for scale-up studies and transferring to different equipment types and sizes. This manuscript surveys current practices within the industry for drying development related to chemical and physical stability, drying kinetics, and powder properties and highlights common development gaps for improving drying development workflows within the industry. The ultimate goal is to encourage further fundamental research and technological advancements for improving the drying development workflow.