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Dissolution of Oral Solid Dosage Formulations: Surrogate Models and Real-time Release
Melanie Dumarey1, Tessa M Carducci2, Matthew J Walworth3
1Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden. melanie.dumarey@astrazeneca.com.
The AAPS Journal
|June 27, 2025
Summary
Predictive dissolution models (PDMs) offer a faster, more sustainable alternative to traditional in vitro dissolution testing for oral solid dosage medicines. These models are increasingly accepted by regulatory bodies for drug product release testing.
Area of Science:
- Pharmaceutical Science
- Drug Delivery Systems
- Quality Control
Background:
- In vitro dissolution testing is crucial for ensuring oral solid dosage medicine quality and in vivo performance.
- Traditional dissolution testing is time-consuming and material-intensive.
- Predictive dissolution models (PDMs) are emerging as efficient alternatives.
Purpose of the Study:
- To describe methodologies for developing and validating fit-for-purpose PDMs.
- To demonstrate the implementation of PDMs as surrogate release tests for dissolution.
- To highlight the benefits of PDMs over traditional in vitro testing.
Main Methods:
- Development and validation of predictive dissolution models (PDMs).
- Implementation of PDMs as surrogate release tests.
- Case studies illustrating PDM application in drug product release.
Main Results:
- PDMs are viable and more sustainable than traditional in vitro dissolution testing.
- PDMs can significantly accelerate drug product release.
- Regulatory bodies are increasingly accepting PDMs for dissolution critical quality attribute testing.
Conclusions:
- PDMs offer a more sustainable and efficient approach to drug product release testing.
- The rise of continuous manufacturing favors real-time release testing using PDMs.
- Harmonized global expectations for PDM development, validation, and lifecycle management are needed.
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