(496b) Smart Design and Virtual Product Analysis for 3D Printing Pharmaceutical Tablets for Patient Centric Product Development
In this work, two mathematical models were developed and validated by experimental data:
The first model is a solid mechanics model by Finite Element Method technique. The model studies the various internal geometry and design of the tablet on tablet axial and radial strength. The sensitivity analysis demonstrates how changing the printing parameters and internal structure of the tablet will impact the tablet hardness. Experimental data for tablet axial and radial strength are in confirmation with the modelâs results.
The second model is a dissolution and drug release profile simulation. Effects of formulation variabilities (soluble to insoluble ingredients ratio) and tablet geometry on drug release profile have been studied. The model is developed based on unsteady diffusion of water to the solid tablet and swelling (moving boundary PDEs) of the tablet, and unsteady diffusion of drug from the tablet to the dissolution medium.
The models demonstrate how the smart design and virtual product analysis for the 3D printed tablets could be used for patient centric product development.
Disclaimer: This scientific publication reflects the views of the authors and should not be construed to represent FDAâs views or policies.