(645g) Drug Product Process Modeling

During the past decade, computational process models have become more common place in applying to pharmaceutical development of drug products. This new state of the art has been forged predominantly by the chemical and mechanical engineering community, members of PD2M in AIChE. In this presentation, recent examples of modeling techniques being applied to drug product 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 powder flow and segregation, encapsulation, and film coating mapped to process parameter predictions. The major processing to produce capsules/tablets include i) powder processing; ii) dry and wet granulation; iii) encapsulation or 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.