Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
Fette Compacting Belgium, Schaliënhoevedreef 1 b, B-2800 Mechelen, Belgium.
Int J Pharm. 2021 Jun 1;602:120603. doi: 10.1016/j.ijpharm.2021.120603. Epub 2021 Apr 20.
In this study, a quantitative relationship between material properties, process settings and screw feeding responses of a high-throughput feeder was established via multivariate models (PLS). Thirteen divergent powders were selected and characterized for 44 material property descriptors. During volumetric feeder trials, the maximum feed capacity (FCC), the relative standard deviation on the maximum feed capacity (RSD), the short term variability (STRSD) and feed capacity decay (FC) were determined. The gravimetric feeder trials generated values for the mass flow rate variability (RSD), short term variability (STRSD) and refill responses (V and RSD). The developed PLS models elucidated that the material properties and process settings were clearly correlated to the feeding behavior. The extended volumetric feeder trials pointed out that there was a significant influence of the chosen screw type and screw speed on the feeding process. Furthermore, the process could be optimized by reducing the feeding variability through the application of optimized mass flow filters, high frequency vibrations, independent agitator control and optimized top-up systems. Overall, the models could allow the prediction of the feeding performance for a wide range of materials based on the characterization of a subset of material properties greatly reducing the number of required feeding experiments.
在这项研究中,通过多元模型(PLS)建立了材料性能、工艺参数与高通量给料机螺杆给料响应之间的定量关系。选择了 13 种不同的粉末,并对 44 种材料性能描述符进行了表征。在容积式给料机试验中,确定了最大给料能力(FCC)、最大给料能力的相对标准偏差(RSD)、短期变异性(STRSD)和给料能力衰减(FC)。在重量式给料机试验中,生成了质量流率变异性(RSD)、短期变异性(STRSD)和再填充响应(V 和 RSD)的值。所开发的 PLS 模型阐明了材料性能和工艺参数与给料行为明显相关。扩展的容积式给料机试验指出,螺杆类型和螺杆速度的选择对给料过程有显著影响。此外,通过应用优化的质量流率过滤器、高频振动、独立搅拌器控制和优化的补料系统来降低给料变异性,可以对工艺进行优化。总的来说,这些模型可以根据材料性能的子集进行表征,对广泛的材料的给料性能进行预测,从而大大减少所需的给料实验数量。