In Vitro Skin Absorption and Dermal Penetration Testing
Evaluate the permeability of your formulations with precision. Our OECD 428 compliant studies provide critical data on how chemicals, cosmetics, and medical devices interact with the skin barrier.
Understanding the percutaneous permeation of molecules is essential for the development of safe and effective dermal or transdermal delivery systems. Whether you are developing a topical pharmaceutical, a cosmetic ingredient, or a medical device, knowing the rate and extent of skin absorption is a regulatory necessity. At EBI, we utilize advanced ex vivo models and Franz Diffusion Cells to provide a high-fidelity simulation of human skin behavior.
Why Dermal Penetration Testing is Essential
Assessing skin absorption is a key requirement across multiple industries:
- Medical Devices (MDR 2017/745): Testing the penetration of a device or its extract is vital for the correct classification of a medical device according to Rule 21 of the MDR.
- Cosmetics (Regulation 1223/2009): Since 2013, in vivo assessment for cosmetic products are prohibited in the EU. OECD 428 provides the mandatory alternative.
- Pharmaceuticals: Crucial for early-phase development of transdermal drug delivery systems (TDDS) to determine systemic vs. local drug delivery.
- Agrochemicals: Evaluating the safety of pesticides and herbicides following accidental skin contact.
Our Methodology: Franz Diffusion Cells
The gold standard for in vitro permeation studies is the Franz Diffusion Cell system. This method effectively imitates the physiological behavior of substances applied to the skin.
- Model Selection: We utilize ex vivo human skin (typically obtained from plastic surgery).
- The Process: Skin discs are fixed in glass Franz Diffusion Cells between a donor and a receptor compartment. The test item is applied to the skin surface (donor side).
- Simulation: The receptor compartment is filled with a receiving solution HPLC pure water), jacketed with controlled-temperature water flow and continuous stirring using a magnetic stirrer to maintain physiological heat.
- Analysis: The rate of transfer is determined by collecting samples from the receptor compartment after 24±1 hours. These samples are analyzed using electron-oscillation-rotation (UV-Vis) spectrum in the light wavelength range from 240 to 700 nm
Regulatory Compliance
EBI conducts all skin absorption studies in strict accordance with international guidelines:
- OECD 428: Skin Absorption: In Vitro Method.
- OECD GD 428: Guidance Document for the Conduct of Skin Absorption Studies.
- WHO/IPCS (2006): Global guidelines on dermal absorption assessment.
- MDR 2017/745: Supporting device classification and safety profiles.
Sample Requirements & Timeline
- Turnaround Time: Standard completion in 8 weeks.
- Model Selection: We utilize ex vivo human skin models to ensure full compliance with OECD guidelines.
- Note: While alternative models (e.g., animal skin or epithelial tissues) may be available for internal screening, only human skin models are recognized for official OECD-compliant reporting.
- Data Output: Comprehensive reports including flux, permeability coefficients, and total absorption percentages.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Frequently Asked Questions
How does this test help with MDR Classification?
Under the Medical Device Regulation (MDR), devices that are composed of substances intended to be absorbed by or locally dispersed in the human body must be classified appropriately (often Class IIa, IIb, or III). This test provides the empirical evidence to prove whether your device’s components penetrate the skin barrier.
Why use ex vivo human skin instead of synthetic membranes?
Synthetic membranes are useful for quality control, but they lack the complex lipid structure and protein matrix of real skin. Ex vivo human skin remains the most accurate predictor of how a substance will behave on a living patient.
Can you test penetration through nails?
Yes. We utilize specialized bovine nail sheet models to study the penetration of antifungal treatments or medicated nail lacquers.
Note: While these models provide valuable data for product development, please be aware that nail penetration studies fall outside the scope of standard OECD skin absorption guidelines.
How does this test help with MDR Classification?
Under the Medical Device Regulation (MDR), devices that are composed of substances intended to be absorbed by or locally dispersed in the human body must be classified appropriately (often Class IIa, IIb, or III). This test provides the empirical evidence to prove whether your device’s components penetrate the skin barrier.
Why use ex vivo human skin instead of synthetic membranes?
Synthetic membranes are useful for quality control, but they lack the complex lipid structure and protein matrix of real skin. Ex vivo human skin remains the most accurate predictor of how a substance will behave on a living patient.
Can you test penetration through nails?
Yes. We utilize specialized bovine nail sheet models to study the penetration of antifungal treatments or medicated nail lacquers.
Note: While these models provide valuable data for product development, please be aware that nail penetration studies fall outside the scope of standard OECD skin absorption guidelines.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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