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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.

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PubMed
Summary
This summary is machine-generated.

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.

Keywords:
Pi–BuckinghamQuality by Designdesign of experimentsdesign spacedimensional analysispharmaceutical process development

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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.