(287f) Continuous Crystallization of Carbamazepine in Oscillatory Baffled Crystallizer
Continuous crystallization is a hot topic in continuous pharmaceutical manufacturing. In general, there are two major approaches of the continuous crystallization processes: mixed suspension mixed product removal (MMSPR) and plug-flow (PF) crystallizations. Continuous oscillatory baffled crystallizer (COBC) is a relatively new type of PF crystallizer. Recently, kinetic1,2 and dynamic3 studies of COBC, as well as in-situ monitoring and characterization of PF crystallizers4 have been well demonstrated. Here, from the perspective of process robustness and product quality, we will share our experience on developing a continuous crystallization process of carbamazepine in ethanol. Process temperature, oscillation amplitude, frequency, and flow rates were studied. Offline characterization and in-line process analytical technology (PAT) tools were applied to analyze the CBZ particle shape, size, polymorph, and yield.
*This presentation only reflects the views of the authors and should not be construed to represent FDAâs views or policies
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