Senior Research Fellow Boehringer Ingelheim Ridgefield, Connecticut
The proposed talk will address the suitability of mechanistic models for compaction property prediction. Few researchers reported compaction property prediction models which are empirical to semi-mechanistic in nature having lack of rigorous validation using practical APIs. Thus, identifying a suitable model relies on the applicability of inherent compaction mechanism delineated in the model. The talk will focus a specific mechanistic model after further modification and validation with practical APIs. The model workflow will be applicable to all three compaction property metrics (tabletability, compressibility and compactibility) for multicomponent mixtures. In addition, such properties for a challenging API (poorly compressible) can also be predicted by an inverse approach from the known properties of the API containing binary mixture and the corresponding excipients. Finally, the importance of these applicable workflows will be discussed along with other critical metrics of a formulation to optimize careful selection of excipients to enable robust formulation design.
Learning Objectives:
Upon completion, participant will be able to understand the relevance of suitable mechanistic models to predict compaction property of API and mixtures.
Upon completion, participant will be able to understand the robustness criteria of a model by considering diverse APIs and formulations.
Upon completion, participant will be able to realize the minimal resources required to apply the model workflow in their work/project.
Upon completion, participant will be able to optimize the formulation composition with regard to other critical quality attributes (such as flow, segregation etc) yet maintaining adequate compaction properties.
Upon completion, participant will be able to utilize this toolbox to predict compaction property of formulations irrespective of manufacturing route and develop internal database.