Pharmaceutical Manufacturing Technology Centre, Bernal Institute, University of Limerick, Limerick, Ireland; Department of Chemical Sciences, Bernal Institute, University of Limerick, Limerick, Ireland.
Department of Chemical Sciences, Bernal Institute, University of Limerick, Limerick, Ireland.
Int J Pharm. 2020 Feb 25;576:118737. doi: 10.1016/j.ijpharm.2019.118737. Epub 2019 Nov 18.
In this study, a compartmental population balance model (CPBM) is developed as a predictive tool of particle size distribution (PSD) for wet granulation in co-rotating twin-screw granulator (TSG). This model is derived in terms of liquid to solid ratio (L/S) and screw speed representing the main process parameters of the TSG. The mathematical model accounts for aggregation and breakage of the particles occurring in five compartments of the TSG with inhomogeneous screw configurations (3 conveying zones and 2 kneading zones). Kapur's aggregation kernel is implemented in granulation and finite volume numerical method is adapted for solving the mathematical model. The results show a dramatic improvement in solution accuracy compared to the cell average numerical method. Moreover, Kriging interpolation is used to interpolate for new values of empirical parameters at different L/S and screw speeds. Finally, the CPBM model is calibrated and validated using the experimental data.
在这项研究中,开发了一种隔室人口平衡模型 (CPBM),作为预测共旋转双螺杆造粒机 (TSG) 中湿法制粒过程粒径分布 (PSD) 的工具。该模型是根据液体与固体的比例 (L/S) 和螺杆速度推导出来的,这两个参数代表了 TSG 的主要工艺参数。该数学模型考虑了在 TSG 的五个隔室中发生的颗粒聚集和破碎现象,其中螺杆配置不均匀(3 个输送区和 2 个捏合区)。在造粒过程中采用了 Kapur 的聚集核,采用有限体积数值方法求解数学模型。结果表明,与单元平均数值方法相比,该方法在求解精度上有了显著提高。此外,Kriging 插值法用于在不同的 L/S 和螺杆速度下插值新的经验参数值。最后,使用实验数据对 CPBM 模型进行了校准和验证。