Macho Oliver, Gabrišová Ľudmila, Peciar Peter, Juriga Martin, Kubinec Róbert, Rajniak Pavol, Svačinová Petra, Vařilová Tereza, Šklubalová Zdenka
Institute of Process Engineering, Faculty of Mechanical Engineering, Slovak University of Technology in Bratislava, Námestie Slobody 17, 812 31 Bratislava, Slovakia.
Department of Analytical Chemistry, Faculty of Natural Sciences, Comenius University in Bratislava, Ilkovičova 6, 842 15 Bratislava 4, Slovakia.
Pharmaceutics. 2021 Nov 8;13(11):1894. doi: 10.3390/pharmaceutics13111894.
The aim of the work was to analyze the influence of process parameters of high shear granulation on the process yield and on the morphology of granules on the basis of dynamic image analysis. The amount of added granulation liquid had a significant effect on all monitored granulometric parameters and caused significant changes in the yield of the process. In regard of the shape, the most spherical granules with the smoothest surface were formed at a liquid to solid ratio of ≈1. The smallest granules were formed at an impeller speed of 700 rpm, but the granules formed at 500 rpm showed both the most desirable shape and the highest process yield. Variation in the shape factors relied not only on the process parameters, but also on the area equivalent diameter of the individual granules in the batch. A linear relationship was found between the amount of granulation liquid and the compressibility of the granules. Using response surface methodology, models for predicting the size of granules and process yield related to the amount of added liquid and the impeller speed were generated, on the basis of which the size of granules and yield can be determined with great accuracy.
这项工作的目的是基于动态图像分析，分析高剪切制粒工艺参数对工艺收率和颗粒形态的影响。添加的制粒液体量对所有监测的粒度参数都有显著影响，并导致工艺收率发生显著变化。就形状而言，在液固比约为1时形成了表面最光滑的最球形颗粒。最小的颗粒是在叶轮转速为700转/分钟时形成的，但在500转/分钟时形成的颗粒显示出最理想的形状和最高的工艺收率。形状因子的变化不仅取决于工艺参数，还取决于批次中单个颗粒的面积等效直径。发现制粒液体量与颗粒的可压缩性之间存在线性关系。使用响应面方法，生成了与添加液体量和叶轮转速相关的预测颗粒尺寸和工艺收率的模型，据此可以非常准确地确定颗粒尺寸和收率。
