(219f) Predictive Model of Powder Compaction Using Finite Element Analysis

The tablet is currently the most widely used dosage form for oral drug delivery. Despite the various advantages of the tablet over other dosage forms, such as superior physical or chemical stability, tablets remain challenging to formulate because their properties depend strongly on the powder composition and details of the compaction process. Powder compaction is a critical process in manufacturing the tablet dosage form. Although this process has been used routinely for over a century, problems related to powder compaction in pharmaceutical formulation development and manufacturing persist. Common problems include tablet failures, such as capping and lamination, high friability, powder sticking to punch surfaces or the die wall, and insufficient mechanical strength to withstand stress in downstream processing.

In this work a workflow was created to de-risk and better understand the behavior of Powder compaction, using the Finite Element Analysis (FEA) by using the density-dependent Drucker-Prager Cap (DPC) model using ANSYS Mechanical. This paper presents a full description of the DPC model for the compaction behavior of microcrystalline cellulose (MCC). In this paper, Finite Element Modelling (FEM) and Design of Experiment (DoE) techniques are adopted to find the impact on optimal shape which has more uniform mechanical properties and less capping and chipping tendency. Response Surface Methodology (RSM) was employed to establish the relationship between the design variables, represented by the geometrical parameters and the friction coefficient, and compaction responses of interest including residual die pressure, the variation of relative density within the tablet, and the relative shear stress of the edge of the tablet.

The results showed that the finite element model will be able to accurately predict the compaction behavior of the MCC powder. Furthermore, the FE predictions of stress and density distributions of the powders during the compaction were used to analyze the failure mechanisms associated with tableting.