Faulhammer Eva, Llusa Marcos, Radeke Charles, Scheibelhofer Otto, Lawrence Simon, Biserni Stefano, Calzolari Vittorio, Khinast J G
Technical University Graz, Austria. Inffeldgasse 13, 8010, Graz; Research Center Pharmaceutical Engineering, Graz, Austria. Inffeldgasse 13, 8010, Graz.
Research Center Pharmaceutical Engineering, Graz, Austria. Inffeldgasse 13, 8010, Graz.
Int J Pharm. 2014 Aug 25;471(1-2):332-8. doi: 10.1016/j.ijpharm.2014.05.058. Epub 2014 Jun 2.
The goal of this work is to identify and understand the complex relationship between the material attributes, capsule fill weight and weight variability of capsules filled with a dosator nozzle machine. Six powders were characterized and filled into size-3 capsules in three volumes of dosing chambers and at two filling speeds. Subsequent multivariate data analysis was used to identify the influence of the material attributes on the capsule fill weight and weight variability. We observed a clear correlation between the capsule fill weight and the particle size, the air permeability and the compressibility. As the fill weight decreases, more factors affect capsule fill weight. For example, the wall friction angle, the tapped density, and the particle shape proved to be important factors. Larger fill weights were more affected by density while lower fill weights by flow and friction characteristics. No correlation was found between the material attributes and the weight variability. Rather, we could also see the major effect of process parameters on capsule fill weight and weight variability.
这项工作的目标是识别并理解使用定量给料喷嘴机器填充的胶囊的材料属性、胶囊填充重量和重量变异性之间的复杂关系。对六种粉末进行了表征，并在三种剂量腔体积和两种填充速度下填充到3号胶囊中。随后使用多变量数据分析来确定材料属性对胶囊填充重量和重量变异性的影响。我们观察到胶囊填充重量与粒径、透气率和可压缩性之间存在明显的相关性。随着填充重量的降低，更多因素会影响胶囊填充重量。例如，壁摩擦角、振实密度和颗粒形状被证明是重要因素。较大的填充重量受密度影响更大，而较低的填充重量受流动性和摩擦特性影响更大。未发现材料属性与重量变异性之间存在相关性。相反，我们也可以看到工艺参数对胶囊填充重量和重量变异性的主要影响。
