(605f) Scale-up of Roller Compaction Processes Using a Geometric Scaling Model

The key indicator of successful scaling of the roller compaction process of a drug product formulation is achieving similar ribbon density, which is the primary attribute measured that effects downstream processes, subsequent material properties of granules, and tablet critical quality attributes. The ribbon density is controlled by equipment parameters such as the roll force and gap. Prediction of the required roll force at targeted scale is key to enable efficient scale up of roller compaction processes. A novel methodology for the scale up of roller compaction processes has been developed that leverages a geometric scaling model. A relationship between roll forces and roll diameters of different scales is achieved through a calibration process. Case studies will be presented demonstrating the application of the geometric scaling model coupled with an equipment correlation term to predict scale-up of roller compaction processes.