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A Method for Determination and Simulation of Permeability and Diffusion in a 3D Tissue Model in a Membrane Insert System for Multi-well Plates

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The Phenion full-thickness skin model for percutaneous absorption testing.

K Ackermann¹, S Lombardi Borgia, H C Korting

¹Institut für Pharmazie, Pharmakologie und Toxikologie, Freie Universität Berlin, Berlin, Deutschland.

Skin Pharmacology and Physiology

|December 18, 2009

Summary

The new Phenion Full-Thickness Skin Model (FT model) shows promising barrier properties for in vitro dermal absorption studies. This animal-free model effectively retards chemical permeation, similar to human skin, supporting its use in safety assessments.

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Area of Science:

Toxicology
Dermal Absorption Studies
In Vitro Testing

Background:

Efforts to replace animal testing for dermal toxicity are ongoing.
Previous work validated in vitro protocols using reconstructed human epidermis and ex vivo skin.
A new reconstructed skin model, the Phenion Full-Thickness Skin Model (FT model), was developed.

Purpose of the Study:

To assess the barrier properties of the novel Phenion FT model.
To evaluate its suitability for percutaneous absorption studies.
To compare its performance against pig skin and previous reconstructed human epidermis data.

Main Methods:

Transferred an established in vitro test protocol to the Phenion FT model.
Quantified permeation of testosterone, caffeine, benzoic acid, and nicotine.
Utilized Franz-type diffusion cells for ex vivo skin analysis.
Compared results with pig skin and historical data.

Main Results:

The FT model demonstrated higher permeability than pig skin.
Its barrier properties align with reconstructed human epidermis data.
The FT model effectively retarded testosterone, the most lipophilic compound, due to its dermis equivalent reservoir.
The model's structure closely mimics human skin.

Conclusions:

The Phenion FT model shows suitability for percutaneous absorption studies in hazard analysis.
The model's barrier properties are comparable to human skin.
Further validation studies are recommended for the FT model.