a Institute of Pharmaceutics and Biopharmaceutics , Heinrich Heine University , Duesseldorf , Germany.
Drug Dev Ind Pharm. 2018 Aug;44(8):1295-1306. doi: 10.1080/03639045.2018.1446444. Epub 2018 Mar 16.
Ribbons from microcrystalline cellulose (MCC), mannitol, and their 50:50% mixture were produced using the roll compactors AlexanderWerk BT120, Hosokawa Alpine Pharmapaktor C250, L.B. Bohle BRC 25, and Gerteis Mini-Pactor in the frame of multilevel full factorial experimental plans. The specific compaction force (SCF)/hydraulic pressure (HP), gap width (GW), roll speed, and fraction of MCC were analyzed as quantitative factors, whereas the roll surface and sealing system were examined as qualitative factors. Ribbon relative density was investigated as response of the models. The SCF/HP is found to be the most significant factor in each model. A significant inverse effect of the GW is obtained in the models of AlexanderWerk BT120, Pharmapaktor C250, and BRC 25 roll compactors, using smooth rolls. The principle of the establishment of a conversion factor (c) is introduced based on the obtained data sets of AlexanderWerk BT120 and Mini-Pactor. This can facilitate the transfer of a roll compaction process between different types of roll compactors.
使用 AlexanderWerk BT120、Hosokawa Alpine Pharmapaktor C250、L.B. Bohle BRC 25 和 Gerteis Mini-Pactor 滚压机,在多层次全因子实验设计的框架内,制备了微晶纤维素(MCC)、甘露醇及其 50:50%混合物的带状物。作为定量因素分析了比压(SCF)/液压(HP)、间隙宽度(GW)、轧辊速度和 MCC 分数,而轧辊表面和密封系统则作为定性因素进行了检查。作为模型的响应,研究了带状物的相对密度。在每个模型中,SCF/HP 被发现是最显著的因素。在用光滑轧辊的 AlexanderWerk BT120、Pharmapaktor C250 和 BRC 25 轧光机模型中,GW 存在显著的反向影响。基于 AlexanderWerk BT120 和 Mini-Pactor 获得的数据集,引入了转换因子(c)建立的原理。这可以促进不同类型的轧光机之间的轧光过程的转移。