(496b) Smart Design and Virtual Product Analysis for 3D Printing Pharmaceutical Tablets for Patient Centric Product Development

Yazdanpanah, N., U.S. Food and Drug Administration
Cruz, C. N., U.S. Food and Drug Administration
O'Connor, T., U.S. Food and Drug Administration
Zidan, A., U.S. Food and Drug Administration
Alayoubi, A., U.S. Food and Drug Administration
Asfari, S., U.S. Food and Drug Administration
Ashraf, M., Office of Testing and Research, U.S. Food and Drug Administration
The Additive Manufacturing is an innovative and promising method that is suitable for the fabrication of personalized dosage forms of tablets. The formulation selection and geometry design of the tablets are key elements for product design. Tuning the formulations and geometry and design of tablet would be based on personalized dose and release profile, and tablets can be smartly designed to provide adequate physical strength and desired drug release profile.

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 model’s 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 FDA’s views or policies.