Pfizer Inc., Groton, Connecticut 06340.
J Pharm Sci. 2019 Jan;108(1):457-463. doi: 10.1016/j.xphs.2018.10.019. Epub 2018 Oct 23.
Data from wall friction testing and physical property characterization of over 100 pharmaceutical powders, blends, and granulations have been analyzed. The analyses focused on data for stainless steel surfaces with the most common finishes for pharmaceutical powder processing equipment, either a 2B cold rolled mill finish or an electropolished 2B surface. Active pharmaceutical ingredients exhibited the highest friction against these surfaces, whereas active granulations exhibited the least friction. The typical (median) wall friction angle for an active blend on 2B stainless steel was 22° versus 18° for an active granulation. Typical wall friction values on electropolished 2B surfaces were about 17° and 12° for active blends and granulations, respectively. Blends typically exhibited larger wall friction angles than the granulations suggesting that simple blends will usually require hoppers or bins with steeper walls to achieve mass flow. Lower wall friction angles were consistently observed against the smoother electropolished 2B surface, and, thus, the wall surface finish should be considered when designing bins and hoppers for use with pharmaceutical powders. The wall friction angles of blends and granulations did not show any definite trend as the percentage of active pharmaceutical ingredient increased.
对超过 100 种药物粉末、混合物和颗粒的壁面摩擦测试数据和物理特性进行了分析。分析主要集中在具有制药粉末加工设备最常见表面处理的不锈钢表面的数据上,这些表面处理通常是 2B 冷轧光亮退火表面或电抛光 2B 表面。活性药物成分与这些表面的摩擦最大,而活性颗粒的摩擦最小。在 2B 不锈钢上,活性混合物的典型(中位数)壁面摩擦角为 22°,而活性颗粒的壁面摩擦角为 18°。在电抛光 2B 表面上,活性混合物和颗粒的典型壁面摩擦值分别约为 17°和 12°。混合物通常表现出比颗粒更大的壁面摩擦角,这表明简单的混合物通常需要具有更陡峭壁面的料斗或料仓才能实现质量流动。在更光滑的电抛光 2B 表面上,壁面摩擦角始终较低,因此,在设计用于药物粉末的料仓和料斗时,应考虑壁面表面处理。混合物和颗粒的壁面摩擦角随着活性药物成分百分比的增加没有表现出任何明确的趋势。