Analysis of the polymorph changes of a drug candidate

•Relative stability investigation a model drug's polymorphs.•Slurry equilibration method.•Variable-temperature and humidity X-ray powder diffractometry.•Differential scanning calorimetry using different heating rates. The effects of solvents, temperature and humidity on the stability of a forme...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2015-01, Vol.102, p.229-235
Main Authors: Láng, P., Várkonyi, E., Ulrich, J., Szabó-Révész, P., Aigner, Z.
Format: Article
Language:English
Subjects:
Calorimetry, Differential Scanning
Drug Stability
DSC
Polymorphs
Relative stability
Suspensions
Temperature
Thermodynamic stability
VT/VH-XRPD
X-Ray Diffraction
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Summary:•Relative stability investigation a model drug's polymorphs.•Slurry equilibration method.•Variable-temperature and humidity X-ray powder diffractometry.•Differential scanning calorimetry using different heating rates. The effects of solvents, temperature and humidity on the stability of a former drug candidate obtained from Sanofi (Hungary) were examined by a slurry equilibration method, variable temperature and humidity X-ray powder diffractometry (VT/VH-XRPD) and differential scanning calorimetry (DSC). The VH-XRPD study showed that all 8 polymorphic forms of this material were stable in the interval 20–80 RH%. The VT-XRPD measurements indicated that all the polymorphs except Form II underwent changes in the range 30–200°C. The stable form was Form II, though Form IVb had almost the same stability. The investigation demonstrated that VT-XRPD is a very useful in situ method for relative stability studies.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2014.09.020