(585b) Application of Modeling to Scale-up Liquid Mixing Processes

Scale-up of liquid mixing is usually done empirically without considering the several factors like dissolution theory, equipment differences between scales and so on. In this work we present a systematic way to scale-up liquid mixing processes utilizing both Design of Experiment (DoE) approach to identify the operating space (effect of operating parameters) and Computational Fluid Dynamics modeling to scale the mixing dynamics from laboratory to commercial scale. Underlying principles of modeling and also experimental data on dissolution at different scales for model solutes will be presented. This work also serves as an example of utilizing Quality by Design principles in designing the operating space during drug product manufacturing process design.