(333h) Utilising Science-Based Compaction Models for Drug Product Development: Tech Transfer and Flowsheet Simulations

Roller and tablet compaction are key process steps in the production of pharmaceutical tablets. Because experimental data is limited or costly at early stages of development, an efficient process development workflow is key to make efficient use of the data available. A range of modelling solutions are available to understand the process behaviour and predict suitable process conditions for the different stages of development. However, the selection of the most appropriate modelling and experimental methodology for a given problem remains a challenge in pharmaceutical process development. Additionally, flowsheet solutions are useful to investigate the effect on downstream process and determine the desired conditions of a production line. The overall objectives of employing these solutions are to design the production process with minimal experimental effort and to reduce process variability to meet product specifications.

In this work, we will present an efficient design workflow for compaction tech transfer from compaction simulator to production equipment. This design workflow is based on dimensionless numbers and science-based models that are calibrated using targeted experimentation, taking into account the typical data available at different stages of pharmaceutical development. A flowsheet model is constructed based on the calibrated models of the relevant process steps. This flowsheet model is applied for the holistic process design.