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Biorelevant in-vitro performance testing of orally administered dosage forms
Christos Reppas1, Maria Vertzoni
1Department of Pharmaceutical Technology, Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.
The Journal of Pharmacy and Pharmacology
|June 13, 2012
Summary
Biorelevant media and hydrodynamics have advanced, improving in vitro testing for oral drug delivery. These advancements help predict how dosage forms perform in the gastrointestinal tract, aiding formulation development.
Area of Science:
- Pharmacokinetics and Drug Metabolism
- Pharmaceutical Technology
- Gastrointestinal Physiology
Background:
- Significant advancements in understanding the gastrointestinal environment over the past 15 years.
- Refinement of biorelevant media composition and hydrodynamics for in vitro testing.
Purpose of the Study:
- To review the evolution and current status of biorelevant media and hydrodynamics.
- To discuss the utility of biorelevant performance testing for intralumenal processes.
Main Methods:
- Review of scientific literature on biorelevant media and hydrodynamics.
- Analysis of the application of biorelevant dissolution/release testing.
Main Results:
- Biorelevant testing effectively evaluates formulation and food effects on plasma levels for immediate-release and extended-release products.
- Accurate forecasting of lumenal disintegration times and resin activity is achievable with biorelevant in vitro testing.
Conclusions:
- Biorelevant in vitro performance testing is crucial for assessing intralumenal dosage form behavior.
- Continued efforts to enhance biorelevant test predictability are vital for challenging oral drug formulation.
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