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胶体二氧化硅和水分对粉末流动性能的影响:使用基于图像的分析预测过程性能。

Effect of colloidal silicon dioxide and moisture on powder flow properties: Predicting in-process performance using image-based analysis.

机构信息

Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, P.O. Box 56, (Viikinkaari 5E), FIN-00014, Finland.

Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, P.O. Box 56, (Viikinkaari 5E), FIN-00014, Finland.

出版信息

Int J Pharm. 2021 Mar 15;597:120344. doi: 10.1016/j.ijpharm.2021.120344. Epub 2021 Feb 2.

Abstract

The effect of colloidal silicon dioxide (CSD) on powder flow properties of poor-flowing excipient lactose 200 M was investigated. Binary mixtures of different ratios of CSD as glidant were examined using a modern image-based flow measuring technique. Special attention was placed to subtle variations in powder flow from small changes in glidant concentration (0.025% w/w). Understanding the modes of interaction of particles and their effects on flowability using the method predicted the die filling performance during tablet manufacture. In addition, the importance of moisture content on powder flow properties was empirically underlined. A more efficient range of CSD was detected from 0.10 to 0.50% w/w in most of the tested conditions, which revealed a significant improvement in powder flow performance compared to higher amounts typically handled in the pharmaceutical industry.

摘要

研究了胶体二氧化硅(CSD)对流动性差的辅料乳糖 200M 的粉末流动性能的影响。使用现代基于图像的流动测量技术,研究了不同比例的 CSD 作为助流剂的二元混合物。特别关注了助流剂浓度(0.025%w/w)的微小变化对粉末流动的细微变化。使用该方法可以了解颗粒的相互作用模式及其对可流动性的影响,从而预测片剂制造过程中的压模填充性能。此外,还从经验上强调了水分含量对粉末流动性能的重要性。在大多数测试条件下,从 0.10%w/w 到 0.50%w/w 范围内可以检测到更有效的 CSD,与制药行业中通常处理的更高量相比,这显著改善了粉末流动性能。

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