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Published on: October 26, 2019
Advancing pharmaceutical tablet analysis with laser direct infrared (LDIR) imaging
Yeakub Zaker1, Huzeyfe Yilmaz1, Timothy R Lex1
1Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research II (DPQR II), 645 S. Newstead Ave., St. Louis, MO 63110, United States.
Laser direct infrared (LDIR) spectroscopy imaging rapidly analyzes pharmaceutical tablets. Careful method development, especially wavenumber selection, is crucial for accurate physicochemical property analysis.
Area of Science:
- Analytical Chemistry
- Spectroscopy
- Materials Science
Background:
- Laser direct infrared (LDIR) spectroscopy imaging is an emerging vibrational spectroscopic technique for rapid surface analysis.
- It captures physicochemical properties like chemical identity, particle size, shape, and distribution.
- LDIR imaging is still developing, with challenges in optimizing method parameters for pharmaceutical analysis.
Purpose of the Study:
- To assess the effects of method development options in LDIR imaging for pharmaceutical analysis.
- To investigate the relationship between step size and data acquisition time in LDIR imaging.
- To compare LDIR imaging data with Raman microscopy for validation.
Main Methods:
- Analysis of in-house prepared and commercial pharmaceutical tablets using LDIR imaging.
- Collection of hyperspectral reflectance mode LDIR images.
- Comparison of LDIR images with Raman microscopy mapping data.
Main Results:
- Careful wavenumber selection is essential for effective method development in LDIR imaging.
- LDIR images showed good agreement with Raman mapping and hyperspectral data.
- LDIR imaging consistently reported smaller mean Feret diameters for active pharmaceutical ingredients (APIs) (14-40%) compared to Raman.
Conclusions:
- LDIR imaging demonstrates significant potential as a valuable spectroscopic tool for pharmaceutical applications.
- Optimization of method parameters, particularly step size and wavenumber selection, is critical for accurate analysis.
- Further validation and development are needed to address discrepancies in particle size measurements.
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