(26e) Predictive Approach to Understand and Eliminate Tablet Breakage during Film Coating

Pharmaceutical tablets can be susceptible to damage such as edge chipping or erosion of the core during the tablet coating process. The intersection of certain process parameters, equipment design, and tablet properties may induce more significant tablet damage such as complete tablet fracture. In this work, we develop a hybrid predictive approach using discrete element method (DEM) modeling and lab-based experiments to identify conditions that may lead to tablet breakage events. The approach is extended to examine potential modifications to the coating equipment and process conditions in silico to mitigate the likelihood of tablet breakage in future batches. The approach is shown to enhance process understanding, identify optimal process conditions within development constraints, and de-risk the manufacture of future tablet coating batches.

All authors are employees of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication.