(645d) Practical Application of a Mechanistic Model for Twin Screw Granulation for Pharmaceutical Process Development

The scientific understanding of twin screw wet granulation processes has advanced in recent years, allowing for the development of mechanistic models that quantify the effects of design decisions on granule attributes. Beyond capturing the scientific understanding of these processes, mechanistic models can be used to solve practical problems in pharmaceutical process development. However, the workflows and best practices for model validation are not always clear, and the model’s capabilities for answering targeted, meaningful questions are not well tested.

In twin screw granulation process development, finding the optimal design and operational space for a new formulation can consume significant time and material due to the highly configurable screw layout in addition to the main process parameters. In this work, a case study will be presented that utilizes a mechanistic model of a twin screw granulation process to improve on the current, experimentally driven process development workflow. Model validation against experimental data will be presented, and data requirements will be discussed. Further, the ability of the model to reduce the experimental burden during process development will be explored. Finally, the incorporation of downstream processing models, such as dryers, mills, and tablet presses, will be investigated.