(697a) Computational Predictive Models Applied to Scale-up of Solid Oral Drug Products

Bharadwaj, R., Pfizer Inc.
Doshi, P., National Chemical Laboratory
Am Ende, M. T., Pfizer Global Manufacturing
Garcia-Munoz, S., Pfizer Inc.
Ketterhagen, W. R., Pfizer Worldwide Research and Development
Prpich, A., Pfizer Global Research & Development

The budget-restricted pharmaceutical environment is countered by the heightened expectations for drug products to be developed using science-based principles. These two opposing factors have created a crucial opportunity for engineering principles to be applied and implemented across the industry. In this presentation, modeling techniques applied to formulation and processing operations are discussed as support to the design, development, and scale-up for solid oral drug products. These process modeling techniques are discussed and exemplified with case studies ranging from raw material specifications and formulation property predictions to process parameter predictions. The major processing to produce tablets include i) powder processing; ii) dry and wet granulation; iii) tablet compression; and iv) film coating. Specific consideration has been given to transfer and scale-up issues along with general process design related challenges to pharmaceutical process R&D.