(284b) Towards Enhanced Understanding of Sono-Crystallization for Pharmaceuticals

Sono-crystallization involves application of ultrasound waves to enable nucleation and/or breakage of crystals. It poses an alternate technology for in-situ seed generation and particle engineering in conjunction with the crystallization. Usage of this technology has been limited due to the lack of process understanding and the absence of appropriate scale-up rules along with the appropriate process equipment. In this study, breakage kinetics is measured as a function of sonication parameters on crystal slurries in saturated solutions. Particle size distribution (PSD) and chord length distribution (CLD) are measured as a function of time in a recirculation loop and single pass configuration of the ultrasonic horn. The relationship between sonication parameters and breakage kinetics is established by regressing the breakage model parameters by fitting the experimental data using population balance equations (PBE). The presentation will elaborate on the enhanced understanding of sono-crystallization process and its scale-up based on the combination of experiments and modeling using model compounds, Carbamazepine and Ibuprofen.

All authors are employees of AbbVie and may own AbbVie stock. AbbVie sponsored and funded the study; contributed to the design; participated in the collection, analysis, and interpretation of data, and in writing, reviewing, and approval of the final publication.