Super disintegrants are critical for rapid tablet disintegration, but their performance can be affected by processing conditions.
Common Super Disintegrants
Croscarmellose Sodium
- Cross-linked carboxymethylcellulose
- Works primarily by swelling
- Typical use level: 1-5%
Crospovidone
- Cross-linked polyvinylpyrrolidone
- Works by wicking and swelling
- Typical use level: 2-5%
Sodium Starch Glycolate
- Modified starch
- High swelling capacity
- Typical use level: 2-8%
Temperature Sensitivity
During Granulation
Elevated temperatures can:
- Partially activate disintegrants prematurely
- Reduce swelling capacity
- Affect final tablet performance
During Drying
Excessive drying temperature may:
- Damage disintegrant structure
- Reduce effectiveness
- Increase disintegration time
Recommendations
- Monitor granulation temperature
- Use appropriate drying conditions
- Validate temperature effects during development
Compaction Pressure Sensitivity
Over-Compression Effects
High compression force can:
- Compact disintegrant particles
- Reduce water penetration pathways
- Delay disintegration onset
Under-Compression Effects
Insufficient compression may:
- Result in friable tablets
- Cause premature disintegration
- Affect dissolution uniformity
Optimization
Balance hardness requirements with disintegration performance through compression force studies.
Formulation Strategies
Disintegrant Selection
Choose based on:
- Processing conditions
- Drug properties
- Release requirements
Concentration Optimization
Determine optimal level through:
- Disintegration time studies
- Dissolution profile comparison
- Stability assessment
Processing Controls
Implement controls for:
- Temperature monitoring
- Compression force limits
- In-process testing