A pharmaceutical roller compaction process was modelled using the Johanson powder mechanics model, which may be employed to achieve desired process performance. Mathematical modelling of the compaction of microcrystalline cellulose (PH102) was used to determine optimal process conditions for an industrial scale roll compactor (Freund, Model TF-MINI). The critical process parameters investigated were screw speed and roll pressure, while the rolls were kept at constant speed and the roll gap as variable. The roll-compacted ribbon density was considered the quality attribute of interest, as it is directly linked to the granule properties, particle size distribution and tablet mechanical properties. Experimental process data were used for model calibration and validation. This was followed by utilisation of the predictive capability of the model to achieve desired process performance of the compactor. The model findings indicated that the developed mechanistic model for the roller compactor can provide a design space to correlate the process parameters and materials properties to the critical quality attributes of granules which would be useful for implementation of Quality-by-Design paradigm in pharmaceutical manufacturing.

• Bernal Institute, University of Limerick

• odeling

1. critical quality attributes
2. Johnson powder mechanics
3. modeling
4. QbD
5. Research Article
6. roller compactor press