Besenhard M O, Fathollahi S, Siegmann E, Slama E, Faulhammer E, Khinast J G
Research Center Pharmaceutical Engineering (RCPE), 8010 Graz, Austria.
Research Center Pharmaceutical Engineering (RCPE), 8010 Graz, Austria; Graz University of Technology, Institute of Process and Particle Engineering, 8010 Graz, Austria.
Int J Pharm. 2017 Mar 15;519(1-2):314-322. doi: 10.1016/j.ijpharm.2016.12.029. Epub 2016 Dec 14.
Robust and accurate powder micro-feeding (<100mg/s) and micro-dosing (<5 mg) are major challenges, especially with regard to regulatory limitations applicable to pharmaceutical development and production. Since known micro-feeders that yield feed rates below 5mg/s use gravimetric feeding principles, feed rates depend primarily on powder properties. In contrast, volumetric powder feeders do not require regular calibration because their feed rates are primarily determined by the feeder's characteristic volume replacement. In this paper, we present a volumetric micro-feeder based on a cylinder piston system (i.e., a powder pump), which allows accurate micro-feeding and feed rates of a few grams per hours even for very fine powders. Our experimental studies addressed the influence of cylinder geometries, the initial conditions of bulk powder, and the piston speeds. Additional computational studies via Discrete Element Method simulations offered a better understanding of the feeding process, its possible limitations and ways to overcome them. The powder pump is a simple yet valuable tool for accurate powder feeding at feed rates of several orders of magnitude.
可靠且精确的微量粉末进料(<100毫克/秒)和微量给药(<5毫克)是重大挑战,尤其是在适用于药物研发和生产的监管限制方面。由于已知的进料速率低于5毫克/秒的微量进料器采用重量进料原理,进料速率主要取决于粉末特性。相比之下,容积式粉末进料器不需要定期校准,因为它们的进料速率主要由进料器的特征体积置换决定。在本文中,我们展示了一种基于气缸活塞系统(即粉末泵)的容积式微量进料器,即使对于非常细的粉末,它也能实现精确的微量进料和每小时几克的进料速率。我们的实验研究探讨了气缸几何形状、散装粉末的初始条件和活塞速度的影响。通过离散单元法模拟进行的额外计算研究有助于更好地理解进料过程、其可能的限制以及克服这些限制的方法。粉末泵是一种简单而有价值的工具,可在几个数量级的进料速率下实现精确的粉末进料。