Prediction of tablet characteristics from residual stress distribution estimated by the finite element method.

Tablet characteristics of tensile strength and disintegration time were predicted using residual stress distribution, simulated by the finite element method (FEM). The Drucker-Prager Cap (DPC) model was selected as the method for modeling the mechanical behavior of pharmaceutical powders composed of lactose (LAC), cornstarch (CS), and microcrystalline cellulose (MCC). The DPC model was calibrated using a direct shear test and analysis of the hardening law of the powder. The constructed DPC model was fed into the analysis using the FEM, and the mechanical behavior of pharmaceutical powders during compaction was analyzed using the FEM. The results revealed that the residual stress distribution of the tablets was uniform when the compression force increased. In particular, the residual stress distribution of tablets composed of equal amounts of LAC, CS, and MCC was more uniform than the tablets composed of 67% LAC and 33% CS, with no MCC. The tensile strength and disintegration time were predicted accurately from the residual stress distribution of tablets using multiple linear regression analysis and partial least squares regression analysis. This suggests that the residual stress distribution of tablets is related closely to the tensile strength and disintegration time.