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Models and Methods to Evaluate Transport of Drug Delivery Systems Across Cellular Barriers
Published on: October 17, 2013
Drug absorption modeling as a tool to define the strategy in clinical formulation development
1University of Applied Sciences Northwestern Switzerland, Institute of Pharma Technology, Gründenstr., 4132 Muttenz, Switzerland. martin.kuentz@fhnw.ch
Physiologically-based drug absorption modeling aids formulation development by predicting exposure changes. This approach helps optimize challenging drug formulations, reducing risks and costs.
Area of Science:
- Pharmacokinetics and Drug Metabolism
- Pharmaceutical Formulation Science
Background:
- Drug absorption modeling is crucial for effective formulation development.
- Predicting drug exposure is essential for successful clinical translation.
Purpose of the Study:
- To review the application of physiologically-based drug absorption modeling in guiding formulation development.
- To highlight the predictive capabilities of modeling for preclinical and clinical stages.
Main Methods:
- Introduction to physiologically-based drug absorption modeling principles.
- Presentation of case studies focusing on preclinical formulation development.
- Sensitivity analysis of key formulation parameters (particle size, dose, solubility).
Main Results:
- Demonstrated prediction of absolute exposure values and their changes.
- Established a basis for defining clinical formulation strategies through parameter sensitivity.
- Illustrated construction of the drug absorption design space using mefenamic acid.
Conclusions:
- Physiologically-based modeling offers advanced prediction for formulation development.
- This approach is expected to be increasingly adopted by formulators.
- It holds potential to minimize risks and costs in developing challenging drugs.
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