Modeling and Monitoring of Polymorphic Transformations During the Drying Phase of Wet Granulation Article DOI:
Cite this article as: Davis, T.D., Peck, G.E., Stowell, J.G. et al. Pharm Res (2004) 21: 860. doi:10.1023/B:PHAM.0000026440.00508.cf Abstract The purpose of this work was to monitor polymorphic transformations of glycine during the drying phase of a wet granulation and model the polymorphic conversions using a time-based reconciliation model. Purpose. Near-infrared spectroscopy (NIR) was used for quantitation of polymorphs, and X-ray powder diffraction (XRPD) was used for qualitative analysis of polymorphs. Methods. The data show that the faster the granulation was dried, the more kinetic trapping of the metastable Results. α-glycine polymorph, as predicted by reconciliation of the time scales of both the drying rate and the rate of the solution-mediated conversion. By knowing basic properties of the drug substance (solubility of the polymorphic forms and the rate of the solution-mediated conversion), processing conditions, such as the drying rate, can be adjusted to anticipate and prevent potential polymorphic transformations. Conclusions. fluid-bed drying glycine near-infrared spectroscopy polymorphism tray drying references
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