251354 Modeling of Fluid Bed Granulation Process for Aqueous Systems

Monday, October 29, 2012: 1:20 PM
Allegheny II (Westin )
Rajan Gupta, Pharmaceutical Commercialization Technology, Merck, Summit, NJ

This presentation discusses the development of a fluid bed granulation model and how it can be applied in the context of QbD.  The model uses mass and heat balance to predict a complete profile of bed humidity, product temperature, and exhaust conditions during granulation and drying steps.  It also incorporates empirical relations built from actual product data to account for heat losses, tortuosity aspects (particularly important during falling rate period), and sub-saturated conditions.  The only inputs required in the model are typical batch parameters (such as spray rate, inlet air temperature / airflow, etc.), thus removing the need to know equipment (e.g., heat transfer coefficients) and formulation related factors (e.g., particle size) in advance. 

The finalized model was tested on over 40 historical and new batches, and good agreement was observed between the theoretical predictions and the actual values.  The model developed in the current work can be used as a valuable tool in feasibility studies (choosing appropriate parameters as starting points), process scaling-up (lab to commercial), and design space studies.

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