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通过施加外部下冲头振动来避免压帽和/或叠层的新方法。

A novel approach to avoid capping and/or lamination by application of external lower punch vibration.

机构信息

Division of Pharmaceutical Technology, University of Hamburg, Bundesstr. 45, 20146 Hamburg, Germany.

Fette Compacting GmbH, Grabauer Str. 24, 21493 Schwarzenbek, Germany.

出版信息

Int J Pharm. 2020 Apr 30;580:119195. doi: 10.1016/j.ijpharm.2020.119195. Epub 2020 Mar 2.

Abstract

Capping as well as lamination are two common problems, which affect the resulting product quality of the tablet. Usually, capping and lamination occur during or after tablet manufacturing, and may therefore influence follow-up processes such as the coating. In this context, there is an urgent need for approaches to overcome the occurrences of capping and lamination. In the present study, a novel lower punch vibration technique was used to decrease the capping or lamination tendency of different powder formulations. Different microcrystalline cellulose types, as well as an API (acetaminophen), were selected as model powders. The powders were investigated regarding their powder flow, density, particle morphology, and surface area. Moreover, the manufactured tablets were characterized regarding their tablet weight, tensile strength, and capping or lamination indices. It was shown that the capping or lamination tendency was strongly affected by the physical powder properties, the formulation composition, and the adjusted turret speed. In addition, the application of externally applied lower punch vibration led to a pronounced decrease of the capping or lamination tendency and improved mechanical stability of the manufactured tablets.

摘要

顶裂和分层是两种常见的问题,会影响片剂的最终产品质量。通常,顶裂和分层发生在片剂制造过程中或之后,因此可能会影响后续的涂层等过程。在这种情况下,迫切需要采取措施来克服顶裂和分层的发生。在本研究中,采用了一种新的下冲头振动技术来降低不同粉末配方的顶裂或分层倾向。选择了不同类型的微晶纤维素以及一种 API(对乙酰氨基酚)作为模型粉末。研究了粉末的流动性能、密度、颗粒形态和比表面积。此外,还对所制得的片剂的片剂重量、拉伸强度和顶裂或分层指数进行了表征。结果表明,顶裂或分层倾向强烈受到物理粉末性质、配方组成和调整的转塔速度的影响。此外,施加外部下冲头振动会显著降低顶裂或分层倾向,并提高所制得的片剂的机械稳定性。

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