(337b) A System Model for a Dry-Granulated Tablet Manufactured from a Spray Dried Dispersion Intermediate: Use in Process Development and Tech Transfer

This presentation addresses the development of an end-to-end model for an oral dosage form manufactured via dry granulation and utilizes a drug product intermediate manufactured by spray dried dispersion.

The model is built to predict key quality attributes of the tablet (such as dissolution and breaking force needed to crush the tablet) as a function of the processing parameters of the entire train of unit operations and the physical properties of the incoming SDD material. The multivariable relationships across material, process and product are thus captured by the model. The model was used to derive a multi-dimensional design space using flexibility analysis and was also used to de-risk unexpected variability in the properties of the SDD material. The presentation will address mathematical aspects of the model, such as the over-parameterization of the well-accepted Johansson model, how to solve these and extend the model to be a function of the physical properties of the raw materials. Practicalities regarding the implementation and use will also be discussed.