Pharmaceutical Research

, Volume 21, Issue 5, pp 860–866

Modeling and Monitoring of Polymorphic Transformations During the Drying Phase of Wet Granulation

  • Tiffani D. Davis
  • Garnet E. Peck
  • Joseph G. Stowell
  • Kenneth R. Morris
  • Stephen R. Byrn
Article

DOI: 10.1023/B:PHAM.0000026440.00508.cf

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

Purpose. 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.

Methods. Near-infrared spectroscopy (NIR) was used for quantitation of polymorphs, and X-ray powder diffraction (XRPD) was used for qualitative analysis of polymorphs.

Results. The data show that the faster the granulation was dried, the more kinetic trapping of the metastable α-glycine polymorph, as predicted by reconciliation of the time scales of both the drying rate and the rate of the solution-mediated conversion.

Conclusions. 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.

fluid-bed drying glycine near-infrared spectroscopy polymorphism tray drying 

Copyright information

© Plenum Publishing Corporation 2004

Authors and Affiliations

  • Tiffani D. Davis
    • 1
  • Garnet E. Peck
    • 1
  • Joseph G. Stowell
    • 1
  • Kenneth R. Morris
    • 1
  • Stephen R. Byrn
    • 1
  1. 1.Department of Industrial and Physical PharmacyPurdue UniversityWest Lafayette
  2. 2.Eli Lilly and CompanyIndianapolis

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