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Screening for differences in the amorphous state of indomethacin using multivariate visualization.

Marja Savolainen1, Andrea Heinz, Clare Strachan

  • 1Division of Pharmaceutical Technology, Faculty of Pharmacy, University of Helsinki, P.O. Box 56, 00014 Helsinki, Finland. marja.savolainen@helsinki.fi <marja.savolainen@helsinki.fi>

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|December 16, 2006
PubMed
Summary

Investigating amorphous indomethacin prepared by different methods revealed molecular differences. Raman spectroscopy and principal component analysis (PCA) effectively identified variations linked to preparation techniques and potential crystallinity.

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Area of Science:

  • Solid-state chemistry
  • Pharmaceutical sciences
  • Materials science

Background:

  • Indomethacin exists in multiple crystalline forms (polymorphs), impacting its properties.
  • The amorphous state of drugs can offer advantages in solubility and bioavailability.
  • Understanding molecular differences in amorphous forms is crucial for drug development.

Purpose of the Study:

  • To investigate molecular-level distinctions in amorphous indomethacin prepared via milling, quench cooling, slow cooling, and spray drying.
  • To compare the efficacy of various analytical techniques in characterizing these amorphous states.
  • To explore the influence of preparation methods on the amorphous structure and potential residual crystallinity.

Main Methods:

  • Preparation of amorphous indomethacin using milling, melt cooling (quench and slow), and spray drying from alpha- and gamma-polymorphs.
  • Characterization using X-ray powder diffraction (XRPD), polarizing light microscopy (PLM), differential scanning calorimetry (DSC).
  • Spectroscopic analysis via mid-infrared (MIR), near-infrared (NIR), and Raman spectroscopy, coupled with Principal Component Analysis (PCA).

Main Results:

  • XRPD and PLM confirmed amorphous nature for most samples, with spray-dried indomethacin showing residual crystallinity.
  • PCA of MIR, NIR, and Raman spectra differentiated milled amorphous indomethacin from others.
  • Raman spectroscopy proved most sensitive to preparation-induced differences and degradation, with PCA aiding visualization.

Conclusions:

  • Preparation methods significantly influence the molecular structure of amorphous indomethacin.
  • Milling may introduce subtle crystallinity or alter hydrogen bonding in the amorphous state.
  • Spectroscopic techniques combined with multivariate analysis are powerful tools for characterizing amorphous drug forms.