(287f) Continuous Crystallization of Carbamazepine in Oscillatory Baffled Crystallizer

Authors: 
Zhang, J., U.S. Food and Drug Administration
Yang, X., U.S. Food and Drug Administration
Acevedo, D. A., U.S. Food and Drug Administration
Naimi, S., University of Maryland
Wu, J., University of Maryland
Mazumder, S., Office of Testing and Research, U.S. Food and Drug Administration
Cruz, C. N., U.S. Food and Drug Administration
O`Connor, T., U.S. Food and Drug Administration
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 FDA’s views or policies

References

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