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失重给料、粉末流动和静电评估用于直接压片羟丙甲纤维素(HPMC)以支持连续制造。

Loss-in-weight feeding, powder flow and electrostatic evaluation for direct compression hydroxypropyl methylcellulose (HPMC) to support continuous manufacturing.

机构信息

Bristol-Myers Squibb, 1 Squibb Dr., New Brunswick, NJ 08901, United States.

Bristol-Myers Squibb, Reeds Lane, Moreton Merseyside CH46 1QW, UK.

出版信息

Int J Pharm. 2021 Mar 1;596:120259. doi: 10.1016/j.ijpharm.2021.120259. Epub 2021 Jan 21.

Abstract

Minimizing variability in the feeding process is important for continuous manufacturing since materials are fed individually and can impact the final product. This study demonstrates the importance of measuring powder properties and highlights the need to characterize the feeding performance both offline with multiple refills and in the intended configuration for the continuous manufacturing equipment. The standard grade hydroxypropyl methylcellulose (HPMC) had material buildup on the loss-in-weight feeder barrel from triboelectric charging and resulted in more mass flow excursions and failed refills which were not observed with the direct compression grades. The location of the electrostatic buildup changed when the feeder was connected to a hopper instead of feeding offline into a collection bucket. Overall, the direct compression HPMC exhibited better flow which resulted in more accurate loss-in-weight feeding with less excursions from the target mass flow and all refills were completed in the first attempt. The improvements with the direct compression HPMC would be beneficial when running any continuous process (wet granulation, roller compaction, or direct compression) or other processes where loss-in-weight feeding is utilized, such as melt extrusion or twin screw granulation.

摘要

在连续制造中,尽量减少给料过程中的变化非常重要,因为物料是单独给料的,这会影响最终产品。本研究证明了测量粉末特性的重要性,并强调了需要对给料性能进行离线的多次填充和在连续制造设备的预期配置下进行特性描述。标准级羟丙基甲基纤维素(HPMC)由于摩擦带电,在失重给料器料桶上有物料堆积,导致更多的质量流量偏移和填充失败,而直接压缩级则没有观察到这种情况。当给料器与料斗连接而不是离线进料到收集桶中时,静电堆积的位置会发生变化。总体而言,直接压缩 HPMC 表现出更好的流动性,从而使失重给料更准确,质量流量偏移更少,并且所有的填充都在第一次尝试中完成。当运行任何连续工艺(湿法制粒、辊压或直接压缩)或其他使用失重给料的工艺(如熔融挤出或双螺杆制粒)时,直接压缩 HPMC 的改进将是有益的。

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