Development and applications of a material library for pharmaceutical continuous manufacturing of solid dosage forms

Area of Science:

• Pharmaceutical Sciences
• Chemical Engineering
• Materials Science

Background:

• Continuous manufacturing of solid dosage forms requires robust material understanding.
• Traditional material characterization may not capture process-relevant behaviors.
• Developing a comprehensive material library is crucial for process development and lifecycle management.

Purpose of the Study:

• To establish a pharmaceutical material library for continuous manufacturing.
• To identify process-relevant testing conditions and reduce characterization measurements.
• To correlate material properties with process performance, specifically feeding behavior.

Main Methods:

• Characterization of 20 pharmaceutical materials across 44 properties.
• Application of the Janssen model to calculate feeder hopper stress conditions.
• Multivariate analysis, including principal component and clustering analysis.
• Evaluation of material feeding performance using loss-in-weight feeders.

Main Results:

• A reduced set of characterization tests capturing >95% of relevant information was identified.
• Materials were grouped into six clusters with similar feeding performance within clusters.
• Consolidation stress significantly impacts material properties.
• Material similarity metrics correlated with feeding performance.

Conclusions:

• The established material library aids in the development and lifecycle management of continuous manufacturing processes.
• Process-relevant characterization and multivariate analysis are key to correlating material properties with process performance.
• Further understanding of flow properties may be necessary for optimal continuous manufacturing implementation.