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Particle size-based segregation of pharmaceutical powders in a vertical chute with a closed bottom: An experimental evaluation

机译:在封闭的底部垂直滑槽中基于粒径的药物粉末分离:一项实验评估

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摘要

Vertical chute transport is a common and widespread means of transporting powders and powder blends in the pharmaceutical industry; conversely, it is also a ready source of segregation. All components of powder mixtures (i.e., active pharmaceutical ingredients, as well as excipients) are subjected to particle size-based segregation, and therefore all properties of the final product, which depend on the particle size of its constituents, may be affected (e.g., compressibility, dissolution rate, API content, and content uniformity). Segregation of single-component pharmaceutical powders with continuous size distributions (excipients or model API) based on particle size was experimentally investigated. Single-component pharmaceutical powders were subjected to fall in a laboratory-scale vertical chute with a closed bottom, and powder samples from various powder bed heights were collected and analysed for particle-size distributions. The results show particle size-based segregation in all materials tested, and the segregation extent and pattern are material-specific. Certain segregation effects were explained with the flow patterns of falling powder and powder bulk properties. An interesting finding is that less cohesive materials with better flowability exhibit increased segregation of smaller sized-D(0.1) particles, which has been attributed to the vertical chute system with a closed, airtight bottom. The size limit, below which particles concentrate at the top of the sediment, and above which particles concentrate at the bottom of the sediment, seems to be universal at 0.46 of D(0.9) value for tested materials. (C) 2015 Elsevier B.V. All rights reserved.
机译:垂直溜槽运输是制药行业中运输粉末和粉末混合物的一种常见且广泛的方法。相反,它也是隔离的现成来源。粉末混合物的所有成分(即活性药物成分和赋形剂)均会受到基于粒度的分离,因此最终产品的所有性能(取决于其成分的粒度)都可能受到影响(例如,可压缩性,溶出度,API含量和含量均匀性)。实验研究了基于粒径的具有连续粒径分布的单组分药物粉末(赋形剂或API模型)的分离。将单组分药物粉末放入具有封闭底部的实验室规模的垂直溜槽中,并收集来自各种粉末床高度的粉末样品,并进行粒度分布分析。结果显示,在所有测试的材料中,基于颗粒的偏析,偏析程度和模式是特定于材料的。用下落的粉末的流动方式和粉末的松散特性解释了某些偏析作用。一个有趣的发现是,具有较小流动性的粘性较小的材料会表现出较小的D(0.1)颗粒增大的偏析,这归因于具有密闭气密底部的垂直滑道系统。对于被测材料,D(0.9)值的0.46普遍存在尺寸极限,低于该尺寸极限时颗粒会聚集在沉积物的顶部,而高于该尺寸极限时颗粒会沉积在沉积物的底部。 (C)2015 Elsevier B.V.保留所有权利。

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