Horibe Masashi, Sonoda Ryoichi, Watano Satoru
Formulation Department, CMC Center, Kaken Pharmaceutical Co., Ltd.
Department of Chemical Engineering, Graduate School of Engineering, Osaka Prefecture University.
Chem Pharm Bull (Tokyo). 2018;66(5):548-553. doi: 10.1248/cpb.c17-01026.
A method for scale-up of a lubricant mixing process in a V-type blender was proposed. Magnesium stearate was used for the lubricant, and the lubricant mixing experiment was conducted using three scales of V-type blenders (1.45, 21 and 130 L) under the same fill level and Froude (Fr) number. However, the properties of lubricated mixtures and tablets could not correspond with the mixing time or the total revolution number. To find the optimum scale-up factor, discrete element method (DEM) simulations of three scales of V-type blender mixing were conducted, and the total travel distance of particles under the different scales was calculated. The properties of the lubricated mixture and tablets obtained from the scale-up experiment were well correlated with the mixing time determined by the total travel distance. It was found that a scale-up simulation based on the travel distance of particles is valid for the lubricant mixing scale-up processes.
提出了一种在V型混合器中扩大润滑剂混合工艺规模的方法。使用硬脂酸镁作为润滑剂,并在相同填充水平和弗劳德(Fr)数下,使用三种规模的V型混合器(1.45、21和130 L)进行润滑剂混合实验。然而,润滑混合物和片剂的性能与混合时间或总转数并不对应。为了找到最佳放大因子,对三种规模的V型混合器混合进行了离散元法(DEM)模拟,并计算了不同规模下颗粒的总行进距离。放大实验得到的润滑混合物和片剂的性能与由总行进距离确定的混合时间具有良好的相关性。结果发现,基于颗粒行进距离的放大模拟对于润滑剂混合放大过程是有效的。