Dissolution testing is integral to pharmaceutical development, from early formulation through commercial manufacturing.
Role in Development Stages
Preformulation
Dissolution studies help:
- Characterize drug solubility
- Identify potential formulation challenges
- Guide excipient selection
Formulation Development
Testing enables:
- Optimization of release profiles
- Comparison of formulation alternatives
- Establishment of in vitro-in vivo correlations
Scale-Up
Dissolution testing verifies:
- Consistent performance at larger batch sizes
- Process parameter effects
- Equipment transfer success
Commercial Manufacturing
Routine testing ensures:
- Batch-to-batch consistency
- Specification compliance
- Stability throughout shelf life
Bioequivalence Applications
Generic Development
Dissolution testing supports:
- Demonstration of similarity to reference product
- Biowaiver applications where appropriate
- Regulatory submissions
IVIVC Development
In vitro-in vivo correlation allows:
- Prediction of clinical performance
- Reduced need for human studies
- Efficient formulation optimization
Regulatory Expectations
Specification Development
Dissolution specifications must be:
- Scientifically justified
- Clinically relevant
- Achievable in manufacturing
Stability Testing
Dissolution is a key stability indicator, monitoring:
- Changes over time
- Storage condition effects
- Package integrity
Quality by Design
Modern development incorporates dissolution testing in:
- Design space definition
- Control strategy development
- Continuous process verification
Advanced Applications
Biorelevant Media
Media simulating GI conditions improve:
- In vivo prediction
- Food effect assessment
- Formulation optimization
Real-Time Release
Dissolution data may support:
- Parametric release
- Reduced end-product testing
- Faster batch release