(159e) Application of Population Balance Model to Tablet Coating Process

Tablet coating is a common unit operation in the pharmaceutical industry. When the coating material contains the Active Pharmaceutical Ingredients (API), it is more important that the process be well understood, monitored and controlled. This investigation focuses on the development and application of a population balance model to predict both the potency and the content uniformity of the tablets in a pan coater. Content uniformity predictions from this model are in good agreement with experimental values from different coater sizes. We propose that in accordance with the FDA's cGMPs for the 21st Century Initiative, a predictive model based on mechanistic understanding of the process constitutes an embodiment of the process design space. A verified model can be used to reduce the total number of batches usually needed in a traditional scale-up and validation campaign.