Large-scale fluid bed coating operations using Wurster coaters are common in the pharmaceutical industry. Experimental measurements of the coating thickness are usually analyzed for just few particles. To better predict the coating uniformity of the entire batch, computational techniques can be applied for process understanding of the key process parameters that influence the quality attributes. Recent advances in computational hardware, such as graphics processing unit, have enabled simulations of large industrial-scale systems. In this work, we perform coupled computational fluid dynamics-discrete element method simulations of a large-scale coater that model the actual particle sizes. The influence of process parameters, inlet air flow rate, atomizing air flow rate, bead size distribution, and Wurster gap height is studied. The focus of this study is to characterize the flow inside the coater; eventually, this information will be used to predict the coating uniformity of the beads. We report the residence time distribution of the beads inside the Wurster column, that is, the active coating zone, which serves as a proxy for the amount of coating received by the beads per pass. The residence time provides qualitative and quantitative measurements of the particle-coating uniformity. We find that inlet air flow rate has the largest impact on the flow behavior and, hence, the coating uniformity.

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http://dx.doi.org/10.1016/j.xphs.2018.10.016DOI Listing

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