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Percutaneous absorption in man: in vitro-in vivo correlation
P A Lehman1, S G Raney, T J Franz
1Pre-Clinical Dermatology, Cetero Research, Fargo, N. Dak., USA.
Skin Pharmacology and Physiology
|April 2, 2011
Summary
Human skin absorption studies using excised skin models closely match living skin results when protocols are harmonized. This in vitro-in vivo correlation is crucial for accurate percutaneous absorption data.
Area of Science:
- Dermatology
- Pharmacokinetics
- Toxicology
Background:
- Percutaneous absorption is vital for drug delivery and chemical safety assessment.
- In vitro models using excised human skin offer a potential alternative to in vivo studies.
- Standardizing in vitro and in vivo methodologies is essential for reliable data.
Purpose of the Study:
- To evaluate the correlation between percutaneous absorption data from excised human skin and living subjects.
- To identify factors influencing the accuracy of in vitro-in vivo extrapolation (IVIVE).
Main Methods:
- Systematic literature review of studies measuring percutaneous absorption in vitro and in vivo.
- Calculation of the in vitro-in vivo (IVIV) ratio using total absorbed dose.
- Analysis of data sets (n=92) from 30 published studies.
Main Results:
- The overall average IVIV ratio was 1.6, with up to 20-fold differences in individual data sets.
- Excluding non-harmonized studies significantly improved the correlation (average IVIV ratio 0.96).
- Protocol harmonization, particularly regarding skin site and vehicle composition, is critical for accurate IVIV correlation.
Conclusions:
- Excised human skin models provide reliable percutaneous absorption data comparable to living subjects.
- Appropriate matching of in vitro and in vivo study protocols is paramount for successful extrapolation.
- Harmonized in vitro-in vivo methods enhance the predictive value of skin absorption models.
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