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Updated: Jun 20, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy.
Andrea Heinz1, Clare J Strachan, Keith C Gordon
1School of Pharmacy, University of Otago, New Zealand.
Vibrational spectroscopy techniques like Raman and near-infrared spectroscopy can detect and quantify solid-state transformations in pharmaceutical manufacturing. These methods are crucial for ensuring drug product quality and bioavailability by monitoring changes in drug form.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Materials Science
Background:
- Solid-state transformations are critical during pharmaceutical processing and storage.
- The physical form of active pharmaceutical ingredients impacts processing and biopharmaceutical properties.
- Early detection of these changes is vital for product quality and efficacy.
Purpose of the Study:
- To review vibrational spectroscopic techniques for detecting and monitoring solid-state transformations in pharmaceuticals.
- To discuss the theoretical basis of solid-state transformations and vibrational spectroscopy.
- To highlight common experimental approaches and recent data analysis methods.
Main Methods:
- Utilizes vibrational spectroscopic techniques including infrared, near-infrared, Raman, and terahertz pulsed spectroscopy.
- Employs fiber-optic probes for in-line characterization of solid-state conversions.
- Applies multivariate data analysis for simultaneous detection of multiple solid-state forms, even with overlapping spectral bands.
Main Results:
- Vibrational spectroscopy offers fast, non-destructive analysis at the molecular level.
- Raman and near-infrared spectroscopy, requiring no sample preparation, are effective for in-line monitoring.
- Multivariate approaches enable the analysis of complex spectral data and the detection of multiple forms.
Conclusions:
- Vibrational spectroscopy is a powerful tool for analyzing solid-state forms (polymorphs, hydrates, amorphous) in pharmaceutical compounds.
- These techniques are essential for controlling and understanding solid-state changes during drug development and manufacturing.
- Advanced data analysis methods enhance the capability to monitor and quantify solid-state transformations.
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