Powder Technology ( IF 4.5 ) Pub Date : 2023-04-07 , DOI: 10.1016/j.powtec.2023.118528 Keirnan LaMarche , David Trinkle , Brian Zacour , Sherif Badawy
A model of the compaction process that has come into increasing use with the pharmaceutical industry is the Drucker-Prager Cap model (DPC). It has long been used in conjunction with the finite element methods to simulate the density and stress distributions in compacts. More recently the calibrated parameters that make up the model have been used to characterize the material properties of many compounds. This work will summarize the findings from the collection of DPC parameters from 60 materials. From this dataset several important conclusions can be drawn about typical and extreme behaviors of formulations and excipients. From these findings key signals of program risk can be determined and utilized early in the formulation development process to avoid costly manufacturing and scale-up issues.
中文翻译:
药物材料 Drucker-Prager Cap 模型参数的分布
Drucker-Prager Cap 模型 (DPC) 是越来越多地用于制药行业的压实过程模型。长期以来,它一直与有限元方法结合使用来模拟压坯中的密度和应力分布。最近,构成模型的校准参数已被用于表征许多化合物的材料特性。这项工作将总结从 60 种材料中收集 DPC 参数的结果。从这个数据集中,可以得出关于制剂和赋形剂的典型和极端行为的几个重要结论。根据这些发现,可以在配方开发过程的早期确定和利用项目风险的关键信号,以避免昂贵的制造和放大问题。