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Axial strength test for round flat faced versus capsule shaped bilayer tablets
Jason Franck1, Admassu Abebe, Rekha Keluskar
1Pharmaceutical Product Development, Inc. , New Brunswick, NJ , USA .
Pharmaceutical Development and Technology
|November 14, 2013
Summary
Tablet geometry significantly impacts bilayer tablet strength at higher compression forces. Using tooling that mimics commercial tablet shapes improves breakage force prediction for fixed dose combination therapies.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Fixed dose combination (FDC) therapy is gaining traction.
- Multi-layer tablets are a key technology for FDCs.
- Round flat tooling is common for tablet testing, but commercial products often use shaped tooling.
Purpose of the Study:
- To investigate the effect of tooling geometry on bilayer tablet strength.
- To compare the breaking force of capsule-shaped and round flat-faced bilayer tablets.
- To determine if tablet geometry influences strength predictions.
Main Methods:
- Bilayer tablets with varying geometries (capsule-shaped vs. round flat-faced) were manufactured.
- Tablets were tested using an axial compression device to determine breaking force.
- Tests were conducted using holders conforming to tablet topology and round flat-faced holders.
Main Results:
- Breaking force increased with higher second layer compression force, irrespective of holder design.
- At lower compression forces, tablet geometry had no significant impact on breaking force.
- At higher compression forces, a significant difference in breaking force was observed between capsule-shaped and round flat-faced geometries.
Conclusions:
- Tablet geometry significantly affects bilayer tablet strength, particularly at higher compression forces.
- Using test tooling that closely resembles the final commercial tablet shape is recommended for accurate breakage prediction.
- This finding is crucial for optimizing the manufacturing and quality control of multi-layer FDC tablets.
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