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"Soft tableting": a new concept to tablet pressure-sensitive materials.
1Institute of Pharmaceutical Technology and Biopharmacy, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany. picker@pharmazie.uni-halle.de
Pharmaceutical Development and Technology
|March 6, 2004
Summary
Soft tableting, using excipients with high elastic deformation, minimizes damage to pressure-sensitive drugs. This study confirms that soft tableting with specific excipients like polyethylene oxides improves drug performance and tablet integrity.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Tableting pressure-sensitive drugs often causes damage, reducing drug performance.
- Excipients with high elastic deformation offer a potential solution through 'soft tableting'.
Purpose of the Study:
- To validate the hypothesis that excipients with greater elastic deformation improve the performance of pressure-sensitive drugs.
- To introduce and validate the concept of 'soft tableting'.
Main Methods:
- Mechanical characterization using 3D modeling and elastic recovery analysis.
- Analysis of tablet crushing force, drug inactivation (alpha-amylase), and physical changes (FT Raman spectroscopy).
- Evaluation of pellet integrity via drug release studies and scanning electron microscopy.
Main Results:
- A ranking order for soft tableting suitability based on general plasticity (GP) was established: GP(carrageenans)
- Experimental validation confirmed this theoretical ranking for pressure-sensitive materials.
- Soft tableting minimized process-induced damage to drugs and maintained pellet integrity.
Conclusions:
- The concept of soft tableting using highly elastic excipients is valid and beneficial for pressure-sensitive drugs.
- Carrageenans, chitosans, and polyethylene oxides show potential as effective soft tableting excipients.
- This approach enhances drug performance and tablet integrity compared to traditional tableting methods.