Kozo Takayama, Visiting Professor, Faculty of Pharmaceutical Sciences, Josai University
Tablets are an important dosage form that accounts for approximately 50% of pharmaceutical application forms. Except for special cases, tablets are manufactured by compacting powders or granules in a mortar and pestle. Therefore, stresses with various vectors remain inside the tablet even after decompression. It is known that residual stress is closely related to tableting failures such as capping and lamination. It may also have a significant effect on important characteristics related to the quality of tablets. We modeled the compaction process of powders and granules using the Drucker-Prager-Cap model and estimated the residual stress inside the tablet using the finite element method. As a result of applying a generalized regression model (JMP Pro 14) to these stress values, the quality characteristics of the tablet were predicted with high accuracy, and the stress sites that affect the quality characteristics were identified. In this presentation, we will introduce examples of tablet research with different formulations and shapes, and discuss the possibilities and limitations of quality characteristic prediction using the generalized regression model.