(557e) Developing a System Based Model for Continuous Direct Compression – Going Beyond Tablet Assay

The emergence of system based modelling for pharmaceutical manufacturing processes is providing an opportunity to holistically model the influence material and process parameters on intermediate and end product quality attributes. These models can be used to increase process understanding, identify critical process parameters, and support risk assessment and control strategy development. With an increase in the adoption of continuous processing, system models can also be used to understand system dynamics and serve as a basis for developing an integrated on-line control scheme.

For continuous direct compression (CDC) processes, where constituent formulation components are continuous fed, blended and compressed, system modelling efforts have focused on characterising the residence time distribution in separate unit operations and using this to model the influence of systematic changes and disturbances on intermediate blend uniformity and tablet assay. This type of model is very useful for simulating a relatively stable process and for developing and tuning a control scheme. In this paper we explore the development of additional models to complement this approach, extending prediction to additional quality attributes, such as tablet tensile strength. This type of system model can then be used holistically for process design and to explore sensitivity to material and process changes.