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Quantification of Process Induced Disorder in Milled Samples Using Different Analytical Techniques.

Ulrike Zimper1, Jaakko Aaltonen2,3, Cushla M McGoverin4

  • 1School of Pharmacy, University of Otago, 18 Frederick Street, 9016 Dunedin, New Zealand. ulrike.zimper@otago.ac.nz.

Pharmaceutics
|October 11, 2016
PubMed
Summary
This summary is machine-generated.

Analytical methods like X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), and Raman spectroscopy yield different crystalline disorder measurements for milled drugs. The chosen analytical method and calibration standard significantly impact quantification results.

Keywords:
DSCRaman spectroscopyXRPDamorphousball millingindomethacinmultivariate analysispartial least squares regression (PLS)principal component analysis (PCA)process induced disordersimvastatin

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Milling processes can induce crystalline disorder or amorphousness in drug substances.
  • Accurate quantification of amorphous content is crucial for drug formulation and stability.
  • Different analytical techniques may provide varying results for amorphous content determination.

Purpose of the Study:

  • To compare X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), and Raman spectroscopy for quantifying milling-induced crystalline disorder in model drugs.
  • To evaluate the influence of analytical method and calibration standards on amorphous content quantification.
  • To assess the impact of milling conditions on the crystalline disorder of indomethacin and simvastatin.

Main Methods:

  • X-ray powder diffraction (XRPD) and Raman spectroscopy utilized partial least squares regression (PLS) for calibration.
  • Differential scanning calorimetry (DSC) quantified amorphousness via changes in heat capacity at the glass transition.
  • Principal component analysis (PCA) was used to compare differently prepared amorphous standards.

Main Results:

  • XRPD generally reported higher crystalline disorder percentages compared to Raman spectroscopy and DSC for the same samples.
  • For indomethacin milled under harsh conditions, crystalline disorder was 44.0% (XRPD), 10.8% (Raman), and 17.8% (DSC).
  • For simvastatin, crystalline disorder was 18.3% (XRPD), 15.5% (Raman), and 0% (DSC, no glass transition detected).

Conclusions:

  • The quantification of crystalline disorder in milled drugs is method-dependent and influenced by the calibration standard and the drug's properties.
  • Significant discrepancies exist between XRPD, Raman, and DSC in quantifying amorphous content.
  • Careful selection of analytical methods and standards is essential for reliable amorphous content assessment in pharmaceuticals.