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Related Experiment Videos

Establishing quantitative in-line analysis of multiple solid-state transformations during dehydration.

Karin Kogermann1, Jaakko Aaltonen, Clare J Strachan

  • 1Division of Pharmaceutical Technology, University of Helsinki, Finland. karin.kogermann@helsinki.fi

Journal of Pharmaceutical Sciences
|March 21, 2008
PubMed
Summary
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This study quantifies solid-state forms of piroxicam (PRX) and carbamazepine (CBZ) during dehydration using vibrational spectroscopy and partial least squares (PLS) regression, enabling in-line analysis during fluidized bed drying.

Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry
  • Analytical Chemistry

Background:

  • Understanding solid-state transformations is crucial for drug stability and efficacy.
  • Isothermal dehydration is a common process affecting pharmaceutical solid forms.
  • Quantitative analysis of solid-state forms requires precise analytical methods.

Purpose of the Study:

  • To quantitatively analyze piroxicam (PRX) and carbamazepine (CBZ) solid-state forms during isothermal dehydration in situ.
  • To develop and validate quantitative models using vibrational spectroscopy and partial least squares (PLS) regression.
  • To apply these models for in-line analysis of solid-state transformations during fluidized bed drying.

Main Methods:

  • Quantitative solid-phase analysis using near-infrared (NIR) and Raman spectroscopy.

Related Experiment Videos

  • Development of quantitative models based on partial least squares (PLS) regression.
  • Validation of spectroscopic quantification with isothermal thermogravimetric analysis (TGA) and X-ray powder diffractometry (XRPD).

    • Main Results:

    • Hot-stage spectroscopy quantification showed good agreement with TGA and XRPD.
    • NIR and Raman spectroscopy provided complementary results for PRX solid-state quantification.
    • Raman spectroscopy successfully quantified carbamazepine (CBZ) dihydrate dehydration forms, while NIR could not differentiate anhydrous forms.

    Conclusions:

    • Vibrational spectroscopy combined with PLS regression is effective for in situ and in-line quantitative analysis of pharmaceutical solid-state transformations.
    • Raman spectroscopy is more suitable than NIR for differentiating anhydrous solid-state forms of CBZ during dehydration.
    • The developed models enable real-time monitoring of solid-state changes in fluidized bed drying processes.