Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, A. Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Eur J Pharm Sci. 2012 Jan 23;45(1-2):211-5. doi: 10.1016/j.ejps.2011.11.012. Epub 2011 Nov 23.
Problems related to the blending of a cohesive powder with a free flowing bulk powder are frequently encountered in the pharmaceutical industry. The cohesive powder often forms lumps or agglomerates which are not dispersed during the mixing process and are therefore detrimental to blend uniformity. Achieving sufficient blend uniformity requires that the blending conditions are able to break up agglomerates, which is often an abrasion process. This study was based on the assumption that the abrasion rate of agglomerates determines the required blending time. It is shown that the kinetic energy density of the moving powder bed is a relevant parameter which correlates with the abrasion rate of agglomerates. However, aspects related to the strength of agglomerates should also be considered. For this reason the Stokes abrasion number (St(Abr)) has been defined. This parameter describes the ratio between the kinetic energy density of the moving powder bed and the work of fracture of the agglomerate. The St(Abr) number is shown to predict the abrasion potential of agglomerates in the dry-mixing process. It appeared possible to include effects of filler particle size and impeller rotational rate into this concept. A clear relationship between abrasion rate of agglomerates and the value of St(Abr) was demonstrated.
在制药行业中,经常会遇到将粘性粉末与自由流动的散装粉末混合的问题。粘性粉末经常形成团块或团聚物,在混合过程中不会分散,因此不利于混合均匀度。要达到足够的混合均匀度,需要混合条件能够破坏团聚物,这通常是一个磨损过程。本研究基于这样的假设,即团聚物的磨损速率决定了所需的混合时间。研究表明,移动粉末床的动能密度是与团聚物磨损速率相关的一个相关参数。然而,还应该考虑与团聚物强度有关的方面。为此,定义了斯托克斯磨损数(St(Abr))。该参数描述了移动粉末床的动能密度与团聚物断裂功的比值。研究表明,St(Abr)数可预测干混过程中团聚物的磨损潜力。似乎可以将填充颗粒大小和叶轮转速的影响纳入这一概念。团聚物的磨损速率与 St(Abr)值之间存在明显的关系。