(404a) Application of QbD Principles for Tablet Coating Process Development, Scale-Up, and Transfer

Film coating is extensively used in the pharmaceutical industry for either functional or aesthetic purposes.  In addition to numerous empirical approaches, some mathematical models have been reported to predict coating performance in various coaters.  However, most of these models are limited to the thermodynamic aspect of the process.  The kinetics/dynamics of the coating process is believed to play an equally important role in determining the final product quality.   Kinetic/dynamic models can also ensure that the content uniformity of the coating film is achieved. 

The combination of a dynamic/kinetic model and a thermodynamic model ensures consistent product quality being maintained across different equipment and/or different manufacturing scales.  Such mythology has been shown to be an effective tool to enable successful tablet coating process development, scale-up, and transfer with minimal experimentation. Case studies will be presented to highlight the broad applications of this scale-independent and equipment-independent approach for the film coating process development.