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Initial moisture content in raw material can profoundly influence high shear wet granulation process.
Limin Shi1, Yushi Feng, Changquan Calvin Sun
1Department of Pharmaceutics, University of Minnesota, MN, USA.
International Journal of Pharmaceutics
|July 2, 2011
Summary
Uncontrolled initial moisture in microcrystalline cellulose (MCC) significantly impacts high shear wet granulation (HSWG). Even small moisture variations reduce tabletability by 50%, highlighting the need for strict moisture control in pharmaceutical manufacturing.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Microcrystalline cellulose (MCC) is a common excipient in pharmaceutical formulations.
- High Shear Wet Granulation (HSWG) is a critical process for improving powder properties and tablet manufacturing.
Purpose of the Study:
- To investigate the effect of initial moisture content in MCC on the HSWG process.
- To quantify the impact of moisture variations on granule properties, specifically tabletability and flowability.
Main Methods:
- Controlled variation of initial moisture content in MCC.
- Performance of High Shear Wet Granulation (HSWG) with consistent process parameters.
- Evaluation of granule tabletability and flowability at different initial moisture levels.
Main Results:
- Granule tabletability decreased by approximately 50% as initial MCC moisture content rose from 0.9% to 10.5%.
- Significant deterioration in tabletability was observed with moisture content increases from 2.6% to 4.9%.
- Granule flowability consistently improved with increasing initial moisture content, primarily due to granule size enlargement.
Conclusions:
- Initial moisture content in MCC is a critical process parameter that must be rigorously controlled during HSWG.
- Variations in MCC moisture content can lead to substantial changes in granule properties, affecting final product quality.
- Implementing quality-by-design principles necessitates careful monitoring and control of raw material moisture for robust pharmaceutical manufacturing.
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