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Correlation of dissolution and disintegration results for an immediate-release tablet
Beverly Nickerson1, Angela Kong2, Paul Gerst1
1Pfizer Worldwide Research and Development, Analytical Research and Development, 558 Eastern Point Road, Groton, CT 06340, United States.
Journal of Pharmaceutical and Biomedical Analysis
|December 30, 2017
Summary
Tablet disintegration rate controls drug release for rapidly dissolving formulations. Disintegration testing effectively distinguishes manufacturing variations and correlates with dissolution, making it a suitable quality control method per ICH Q6A guidelines.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Formulation Development
Background:
- Rapidly dissolving immediate-release tablets with highly soluble drugs often rely on disintegration for controlled drug release.
- Evaluating tablet quality requires reliable methods to assess manufacturing consistency and formulation integrity.
Purpose of the Study:
- To investigate the role of tablet disintegration rate in controlling drug release for immediate-release formulations.
- To establish the suitability of disintegration testing as a quality control method for such drug products.
- To demonstrate the correlation between disintegration and dissolution profiles.
Main Methods:
- Development and application of disintegration and dissolution testing methods.
- Evaluation of tablet batches manufactured with process variations.
- Comparative analysis of disintegration and dissolution data.
Main Results:
- Disintegration and dissolution tests effectively discriminated between tablets with different manufacturing processes and compositions.
- A significant correlation was established between the disintegration rate and the drug dissolution rate.
- The study confirmed that disintegration testing can serve as a surrogate for dissolution testing.
Conclusions:
- Tablet disintegration rate is a critical parameter for controlling drug release in rapidly dissolving formulations.
- Disintegration testing is a suitable and effective quality control method for this drug product, aligning with ICH Q6A guidelines.
- This approach simplifies quality control while ensuring product consistency and performance.
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