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Improving the content uniformity of a low-dose tablet formulation through roller compaction optimization.
Mary T am Ende1, Sara K Moses, Anthony J Carella
1Pfizer Global Research & Development, Groton, CT, USA. Mary.T.am.Ende@pfizer.com
Pharmaceutical Development and Technology
|September 1, 2007
Summary
Optimizing roller compaction parameters improved drug content uniformity in granules and tablets. This study minimized segregation potential by enhancing potency distribution across granule sizes, ensuring consistent dosing.
Area of Science:
- Pharmaceutical Technology
- Chemical Engineering
- Materials Science
Background:
- Drug potency distribution in granules is critical for tablet content uniformity.
- Initial roller compaction parameters led to undesirable U-shaped potency profiles.
- Segregation potential impacts final drug product quality and efficacy.
Purpose of the Study:
- To optimize roller compaction parameters for improved content uniformity of a low-dose drug.
- To minimize segregation potential by controlling potency variation across granule sizes.
- To establish robust operating parameters for consistent granulation and tablet manufacturing.
Main Methods:
- Two-part statistically designed experiments were employed.
- Study I: Full factorial design (Roll Force, Gap Width).
- Study II: D-optimal response surface design (Roll Force, Gap Width, Sieve Size, Granulator Speed).
Main Results:
- Gap width below 2.6 mm minimized ribbon splitting and bypass.
- Sieve size of 0.8 mm optimized granulation potency and uniformity.
- Higher roll force improved sieve cut uniformity and tablet consistency.
- Optimal parameters: RF=9 kN, GW=2.3 mm, SS=0.8 mm, GS=50 rpm.
Conclusions:
- Optimized roller compaction and milling parameters significantly reduce segregation potential.
- Improved granulation potency variability leads to enhanced tablet content uniformity.
- The established parameters ensure consistent drug dosing in the final tablet product.
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