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IbD PU Deliverable 3.1 5.3.4 Crystallization in dual impinging jet mixers Crystal size distribution (CSD) of active pharmaceutical ingredients (API) has dominant effects on many aspects of pharmaceutical processes and products, therefore good control of the CSD is desirable. Dual impinging jet (DIJ) mixers have been demonstrated to produce small crystals with narrow CSDs in reactive and antisolvent crystallization. This was made possible by the generation of high intensity micromixing of fluids to achieve an almost homogeneous composition of high supersaturation before the onset of nucleation. It was found that a key factor in controlling CSD is the jet Reynolds number – lower Re numbers tend to result in higher crystal sizes and wider CSDs (Mahajan and Kirwan, 1996). Jiang et al. (2015) recently investigated the production of a drug compound via the combination of cooling and antisolvent crystallization in a DIJ mixer (Figure 46) with varied jet velocity. It was found that as the inlet velocity of the DIJ mixer increased – the mean crystal size decreased, the CSD narrowed, and the CSD changed into unimodal from bimodal (Figure 47). The crystals produced were also sufficiently small to eliminate milling after drying. It is a promising approach for the manufacture of pharmaceutical crystals with solubility highly dependent upon the antisolvent’s temperature and composition. DIJ in general is advantageous compared to competing technologies e.g. wet milling due to its high throughput with inexpensive small volume setup. However, this technology is not suitable for drug/solvent combinations with insufficient supersaturation to nucleate crystals at a high enough rate within the mixer. Figure 46. A Y-shaped DIJ mixer used in the combined cooling-antisolvent crystallization experiments by Jiang et al. (2015). 46PDF Image | Solids handling for intensified process technology
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