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Does a powder surface contain all necessary information for particle size distribution analysis?
Niklas Laitinen1, Osmo Antikainen, Jouko Yliruusi
1Pharmaceutical Technology Division, Department of Pharmacy, P.O. Box 56, University of Helsinki, 00014, Helsinki, Finland. niklas.laitinen@helsinki.fi
Summary
Digital images can accurately characterize pharmaceutical powder particle size distributions. This novel, non-destructive method offers a fast, sample-efficient alternative to traditional techniques like sieve analysis.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Analytical Chemistry
Background:
- Accurate particle size distribution (PSD) is crucial for pharmaceutical powder performance.
- Traditional methods like sieve analysis and laser diffraction can be time-consuming and require sample preparation.
Purpose of the Study:
- To evaluate a novel digital image analysis approach for pharmaceutical powder PSD characterization.
- To determine if stereometric parameters from digital images correlate with established PSD measurements.
Main Methods:
- A new optical setup captured digital images of pharmaceutical powder surfaces.
- Stereometric parameters were calculated from images.
- Multivariate modeling connected image data to particle size.
- 40 granule batches with varying sizes and compositions were analyzed.
- Results were compared against sieve analysis and laser diffraction.
Main Results:
- The digital image analysis models showed strong correlation with sieve analysis and laser diffraction results.
- Digital images contain sufficient data for comprehensive PSD analysis.
- Optimal imaging conditions are essential for accurate data extraction.
Conclusions:
- Digital image analysis is a powerful, non-destructive method for pharmaceutical powder PSD determination.
- The technique is rapid, requires minimal sample size, and is suitable for particles in the 20-1500 micrometer range.
- Further research is needed to define the full scope and limitations across diverse powder types.