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Scale-Agnostic Models Based on Dimensionless Quality by Design as Pharmaceutical Development Accelerator
Miquel Romero-Obon1, Virginia Sancho-Ochoa1, Khadija Rouaz-El-Hajoui1,2
1Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, Spain.
Quality by Design (QbD) and the Pi-Buckingham theorem enhance pharmaceutical product development. This synergy improves process optimization and manufacturing outcomes by controlling critical quality attributes.
Area of Science:
- Pharmaceutical Science
- Chemical Engineering
- Process Systems Engineering
Background:
- Quality by Design (QbD) is a regulatory paradigm for pharmaceutical development.
- The Pi-Buckingham theorem is a fundamental tool in dimensional analysis for simplifying complex systems.
- Integrating QbD with dimensional analysis offers a novel approach to process understanding.
Purpose of the Study:
- To explore the synergistic application of QbD and the Pi-Buckingham theorem.
- To enhance pharmaceutical product development and process optimization.
- To improve the control of critical quality attributes (CQAs).
Main Methods:
- Reviewing the principles of Quality by Design.
- Applying dimensional analysis using the Pi-Buckingham theorem to pharmaceutical processes.
- Analyzing the impact of dimensionless parameters on CQAs.
Main Results:
- The synergy allows for a more systematic understanding of process variables.
- Identification of key dimensionless groups that influence CQAs.
- Improved ability to predict and control manufacturing variability.
Conclusions:
- The integrated approach provides a robust framework for pharmaceutical process optimization.
- This methodology facilitates the development of safer and more effective pharmaceutical products.
- Enhanced control over CQAs leads to improved manufacturing consistency and product quality.
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