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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Evaluation of dynamic image analysis for characterizing pharmaceutical excipient particles.
1Pfizer Global Research and Development, Eastern Point Road, MS 8156-007, Groton, CT 06340, USA. Weili.yu@pfizer.com
The QicPic dynamic image analysis instrument accurately measures spherical particles but shows discrepancies with rod-shaped particles, potentially due to porosity effects. This highlights differences in particle analysis techniques.
Area of Science:
- Materials Science
- Chemical Engineering
- Analytical Chemistry
Background:
- Dynamic image analysis offers advanced particle characterization.
- Accurate particle size and shape analysis are crucial in pharmaceutical and materials industries.
- Conventional methods like laser diffraction have limitations with non-spherical particles.
Purpose of the Study:
- To evaluate the performance of the QicPic dynamic image analysis instrument with a high-speed dry-powder disperser.
- To compare QicPic's particle size and shape analysis with conventional laser diffraction (HELOS) and scanning electron microscopy (SEM).
- To investigate the accuracy of QicPic in analyzing binary mixtures of spherical and rod-shaped particles.
Main Methods:
- Systematic investigation of MCC particles using the QicPic instrument.
- Cross-validation with a HELOS laser diffraction instrument for spherical and rod-shaped particles.
- Comparison of QicPic shape analysis with SEM images.
- Analysis of binary particulate systems and computational modeling.
Main Results:
- QicPic showed good agreement with HELOS for spherical particles but significant differences for rod-shaped particles.
- Semi-quantitative agreement was found between QicPic shape analysis and SEM.
- QicPic appeared to overestimate rod-shaped particles in binary mixtures.
- Discrepancies in binary mixtures may be attributed to particle porosity effects.
Conclusions:
- The QicPic instrument demonstrates distinct performance characteristics compared to laser diffraction, particularly for non-spherical particles.
- Particle shape and porosity significantly influence dynamic image analysis results.
- Further research is needed to address the overestimation of rod-shaped particles and the impact of porosity.
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