Scale up and Optimization of Fluid Bed Coating and Layering Processes Using In-Situ Particle Characterization
Andrew Birkmire1, Kim T. Walter1, Eric Dycus2, Benjamin Smith2, and Frederic Prulliere2. (1) Niro Pharma Systems, Columbia, MD 21045, (2) Particle Systems Characterization, METTLER TOLEDO, Redmond, WA 98052
Fluidized pellet coating processes are commonly used when developing a novel solid formulation. Yet there are often process inefficiencies and inconsistencies during scale-up. A successful fluid bed coating process establishes a repeatable endpoint particle distribution to achieve repeatable content uniformity and dissolution profiles. However, inconsistencies occur during scale-up with varying raw materials or changing process dynamics such as segregation, agglomeration, or attrition. The application of in-situ particle monitoring techniques, Lasentec FBRM and PVM is demonstrated to track a series of spray coating batches while varying the batch volume, column diameter, spray rate, humidity, temperature, atomization pressure and excipients. FBRM and PVM allow a user to link process control parameters to the particle size distribution and product quality. Target particle distributions were obtained by controlling critical control parameters during scale up.