(641c) Use of gPROMS for Film Coating Processes - Streamlined QbD Process Development

The film coating process is ubiquitous across the pharmaceutical industry and is an essential step in the manufacture of tablets. Film coating is desirable for numerous reasons, including for functional purposes (i.e. modified or delayed release), product identity/branding, aiding in patient ingestion, taste masking, containment of the active substance, and facilitating downstream packaging operations. Numerous process parameters are inter-related in the film coating process, thereby impacting the final coating appearance and quality. These parameters generally impact one or more of the following areas: the thermodynamic environment, the mechanical movement of the tablets, and the spray application. This presentation outlines an approach to identify a common film coating process space, that can be used as a target operational space for new products. Based on existing commercial processes, through the use of global sensitivity analysis in gFormulatedProducts and a model for the film coating process. Two common process envelopes were generated for the most common film coating polymer systems (HPMC and PVA). Application of this approach has the potential to save both time and material, avoiding the potentially lengthy and typically iterative process development cycle.