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Multiphase versus single pot granulation process: influence of process and granulation parameters on granules
1GEFSOD EA 2631, Faculté de Pharmacie, 2 rue du Docteur Marcland, Limoges cedex 87025, France. karine.giry@etu.unilim.fr
Drug Development and Industrial Pharmacy
|May 25, 2006
Summary
This review examines how equipment, process, and formulation parameters affect pharmaceutical granules properties during high-shear wet granulation and drying. Understanding these factors is crucial for successful manufacturing across different equipment types.
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Materials Science
Background:
- High-shear wet granulation is a key process in pharmaceutical manufacturing for creating solid dosage forms.
- Existing granulation and drying equipment vary significantly, leading to challenges in process transfer and product consistency.
- Formulation development is often equipment-specific, hindering flexibility and scalability.
Purpose of the Study:
- To review the influence of equipment design, process parameters, and formulation variables on granule properties.
- To compare multiphase (separate granulation and drying) and single-pot granulation/drying processes.
- To provide insights for facilitating equipment changes in pharmaceutical manufacturing.
Main Methods:
- Literature review focusing on high-shear wet granulation and drying processes.
- Analysis of parameters influencing granule properties in both multiphase and single-pot systems.
- Synthesis of information on equipment, process, and formulation effects.
Main Results:
- Granule properties are significantly impacted by equipment design, operational parameters, and formulation composition.
- Differences exist between multiphase and single-pot processes regarding granule formation and drying.
- Parameter optimization is essential for consistent granule quality regardless of the equipment used.
Conclusions:
- A comprehensive understanding of granulation and drying parameters is vital for robust pharmaceutical manufacturing.
- Knowledge of parameter interactions aids in adapting formulations to different equipment.
- This review offers a foundation for improving process transferability and equipment flexibility.
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