Flowability of fine pharmaceutical powders

精细药粉的流动性

• 批准号: 340985-2006
• 负责人: Pugsley, Todd
• 金额: $ 1.18万
• 依托单位: University of Saskatchewan
• 依托单位国家: 加拿大
• 项目类别: Collaborative Research and Development Grants
• 财政年份: 2007
• 资助国家: 加拿大
• 起止时间: 2007-01-01 至 2008-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=361347
• 关键词: Flowability; fine; pharmaceutical; powders

Approximately 80% of pharmaceutical products are in the solid dosage form (i.e. tablets and capsules). Mass production of tablets involves the large-scale blending of the active drug ingredient with other compounds, all in fine powder form, followed by the transfer of the powder mixture into an automated tablet press. This is accomplished batchwise, with the powder blend fed from a bin or hopper into the tablet press. Problems can arise when the powder blend begins to flow poorly from the hopper or even stops flowing all together. This can have an adverse affect on product quality and lead to the rejection of batches of tablets that are worth hundreds of thousands of dollars at the production scale. Presently there is a lack of clear understanding with respect to how the powder physical properties of size and size distribution, density, and shape influence the powder flow. The present research aims to improve this understanding by fully characterizing various pharmaceutical powders in the state-of-the art particle characterization lab in the University of Saskatchewan Chemical Engineering Department. Standard measurements of flowability will also be performed for the individual powders and their ordered mixtures. The flowability will be related to the powder physical properties of size, shape, density and moisture content. The results will provide valuable new information to the pharmaceutical industry and provide the basis for improved process control in the manufacture of the solid dosage form.

大约80%的药品是固体剂型(即片剂和胶囊)。片剂的大规模生产包括将活性药物成分与其他化合物大规模混合，所有这些都是细粉形式，然后将粉末混合物转移到自动压片机中。这是分批完成的，将粉末混合物从料仓或料斗送入压片机内。当粉末混合物从料斗开始流动不良，甚至停止全部流动时，可能会出现问题。这可能对产品质量产生不利影响，并导致生产规模上价值数十万美元的批次平板电脑被拒之门外。目前，对于粉末的物理性质，如大小、粒度分布、密度和形状如何影响粉末流动，还缺乏明确的认识。本研究旨在通过在萨斯喀彻温大学化学工程系最先进的颗粒表征实验室中全面表征各种药物粉末来改善这种理解。还将对单个粉末及其有序混合物进行流动性的标准测量。流动性将与粉末的大小、形状、密度和含水率等物理性质有关。研究结果将为制药行业提供有价值的新信息，并为改进固体剂型生产过程控制提供依据。