Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
Institute of Automation and Control, Graz University of Technology, Graz, Austria.
Drug Dev Ind Pharm. 2020 May;46(5):775-787. doi: 10.1080/03639045.2020.1753063. Epub 2020 Apr 17.
We studied three lactose-based formulations in terms of bulk powder properties and capsule-filling behavior in a tamping-pin capsule filling system, to which several mechanical adaptions were made for process optimization in light of future continuous production. The model formulations were thoroughly characterized and filled into size 1 capsules according a well-defined design of experiments (DoE). Overall, the three entirely different formulations were successfully filled within the selected design space. The fill weight and fill weight variability can be adjusted by fine-tuning the process settings, like the pin immersion depth and the maximum compaction pressure (pneumatic or spring-controlled), and by using the appropriate powder bed height and mechanical adaptions. This study demonstrated that selection of process parameters and mechanical adaptions could enhance the filling performance, especially in continuous production, since they reduce the powder volume in the process. Moreover, we showed that a tamping-pin system is capable of successfully filling a broad range of powders with various material characteristics and can potentially be used in a continuous production mode.
我们研究了三种基于乳糖的配方,从散装粉末特性和胶囊填充行为方面,在一个压针胶囊填充系统中进行了研究,该系统针对未来的连续生产进行了多项机械适应性优化。对模型配方进行了全面的表征,并根据明确定义的实验设计(DoE)填充到 1 号胶囊中。总的来说,三种完全不同的配方都在所选设计空间内成功填充。通过微调工艺设置,如压针浸深和最大压缩压力(气动或弹簧控制),以及使用适当的粉末床高度和机械适应性,可以调整装量和装量变异性。这项研究表明,选择工艺参数和机械适应性可以提高填充性能,特别是在连续生产中,因为它们减少了生产过程中的粉末体积。此外,我们还表明,压针系统能够成功地填充具有各种材料特性的广泛范围的粉末,并有可能在连续生产模式下使用。