New perspectives for visual characterization of pharmaceutical solids

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Process Analytical Technology

Background:

• Descriptive image information use in pharmaceutical powder technology is limited.
• Physical characterization of pharmaceutical solids presents development challenges.
• Effective monitoring of granule growth and tableting behavior is crucial.

Purpose of the Study:

• To develop and evaluate a visual characterization approach for monitoring granule growth in fluidized-bed granulation.
• To utilize generated image information for predicting granule tableting behavior.
• To establish an effective process analytical tool for pharmaceutical solids.

Main Methods:

• Continuous surface image capture during fluidized-bed granulation.
• Gray Scale Difference Matrix (GSDM) derivation from images.
• Partial Least Square (PLS) modeling for particle size calculation and Principal Component Analysis (PCA) for data visualization.

Main Results:

• The visual approach accurately measured granule particle size throughout the granulation process.
• It effectively monitored various granule growth behaviors and enabled batch-to-batch comparisons.
• Granule tableting behavior was successfully predicted using image-derived particle size information.

Conclusions:

• The developed visual characterization method is a powerful process analytical tool for pharmaceutical solids.
• It enhances particle size analysis and product quality evaluation in granulation processes.
• Characterizing bulk surface images offers new avenues for pharmaceutical solid analysis.