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Determining the Impact of Roller Compaction Processing Conditions on Granule and API Properties
James Clarke1, John F Gamble2, John W Jones3
1School of Chemical Engineering, University of Birmingham, Birmingham, B15 2TT, UK.
AAPS Pharmscitech
|August 4, 2020
Summary
Drug particle attrition during dry granulation impacts dosage form performance. This study found comminuted drug particles can remain free in roller compaction blends, aiding process optimization.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Chemical Engineering
Background:
- Drug particle attrition during dry granulation affects final dosage form performance.
- The fate of comminuted particles within granules is not fully understood.
- Understanding attrition and incorporation is key to optimizing granulation processes.
Purpose of the Study:
- To investigate drug particle attrition during dry granulation.
- To determine the incorporation of comminuted particles into granules using a Gerteis equipment train.
- To enhance the understanding of granulation performance and process modeling.
Main Methods:
- Examined attrition of Active Pharmaceutical Ingredient (API) particles.
- Utilized a Gerteis roller compaction equipment train for dry granulation.
- Analyzed post-milling blends to identify comminuted drug particles.
Main Results:
- Confirmed that comminuted drug particles can exist freely in post-milling blends.
- Demonstrated the presence of attrited API particles within the granulation mixture.
- Provided insights into particle behavior during roller compaction.
Conclusions:
- Comminuted drug particles are present in roller compaction blends.
- This finding aids in understanding granulation performance.
- Enables improved mechanistic models for process optimization.
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