Analysis of the polymorph changes of a drug candidate

P. Láng, E. Várkonyi, J. Ulrich, P. Szabó-Révész, Z. Aigner

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)229-235
Number of pages7
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume102
DOIs
Publication statusPublished - Jan 5 2015

Keywords

  • DSC
  • Polymorphs
  • Relative stability
  • Thermodynamic stability
  • VT/VH-XRPD

ASJC Scopus subject areas

  • Analytical Chemistry
  • Pharmaceutical Science
  • Drug Discovery
  • Spectroscopy
  • Clinical Biochemistry

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