(260f) Application of Fracture Mechanics Model for the Characterization of Bilayer Tablets

Application of Fracture Mechanics Model for the Characterization of Bilayer Tablets

Bilayer tablets are generating great interest recently in the pharmaceutical industry as they offer several advantages over conventional single layer tablets. However, the production of bilayer tablets has been facing great challenges as the layered tablets are prone to delaminate at the interface and fracture in the individual layers due to insufficient bonding strength. In the pharmaceutical industry, the process of bilayer design has been heavily dependent on the trial-and-error approach during the formulation and process development stages. To overcome this hurdle, it is critical to estimate and understand the impact of mechanical properties (bulk modulus and Poisson’s ratio) on the performance of bilayer tablets and to develop a predictive model for the characterization of bilayer tablets.

This presentation will focus on the methodology and the model that has been developed based on the principles of fracture mechanics for the characterization of bilayer tablets. As part of this endeavor, interfacial stress intensity factor was determined. The estimated stress intensity factor using the fracture mechanics model will provide insight into the interplay of material properties, bilayer interfacial topography, and processing parameters on the performance of bilayer tablets. The mechanistic understanding and the methodology developed will enable to move away from the existing “trial-and-error” approach during the design and development of bilayer tablets. The new paradigm of bilayer tablet development will incorporate the principles of the quality by design by leveraging the a priori knowledge.