In vitro permeation tests
for Medical Devices and Supplements
Other articles about in vitro permeation tests:
We are experts of in vitro permeation tests according for medical devices according EU 745/2017, and supplements according ICH Q2 (R1) and OECD No. 428.
In vitro permeation tests play a vital role to understand how a dosage form interacts with biological membranes, unraveling the fundamental principles underlying the eventual permeation promotion or barrier effect of a formulation. This article explores the basics of permeation tests, including key concepts, methodologies, and applications.
What are in vitro permeation tests
In vitro permeation tests estimate the degree a dosage form promotes or inhibits the permeation of its ingredients across physiological mucosae. In vitro permeation tests are useful either to predict what is the most promising formula and when executed according the regulatory framework, they support the technical files submitted to the Notified Bodies (more about the regulatory framework for in vitro permeation tests).Â
How in vitro permeation tests are done
The most used model for permeation tests are the Franz cells. These make use of membranes to replicate the behave of the active ingredients of a dosage form when exposed to live mucosae. The membranes can be artificial or derived by animal tissues (more about membranes used for in vitro permeation tests). These latter provide the most reliable results.
The test starts with the product housed in the donor compartment, which is separated by the receiving compartment by the membrane. If the product formulation promotes the absorption of its ingredients these will permeate the membrane and diffuse in the receiving compartment. While if the formulation features a barrier effect, the permeation will be prevented and the the ingredients will stay in the donor compartment. At given time intervals a sample is collected from the donor compartment and analyzed to the detect and quantify the eventual presence of ingredients.
How in vitro permeation tests help your formulation
- Allow to screen several formulas to select those with the most favourable permeation profile.
- Support the review of the product technical file.
- Increases the success rate of expensive in vivo tests and clinical trials.
Technology Scientific is the SME born as an
 academic spin-off
our in vitro
permeation studies are used by
top companies and startups
Permeation study Packages Pricing
Every study includes
- Bibliographic research experimental protocol.
- Design, according to OECD guidelines.
- Franz cell selection, cell geometry.
- Selection of membranes, artificial or ex vivo.
- Test execution and permeation evaluation.
- Drafting of the report and delivery.
Development
1 analyte in 1 formulation
€ 3000
Updates: in real time
Email support: unlimited
Validation
Mobile assistence
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Evaluation
3 analytes in 1 formulations
€ 5799
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Line
6 analytes in 2 formulations
€ 8599
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Express
7
Working
Days
€ 7199
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Development
1 analyte in 1 formulation
€ 3000
Updates: in real time
Email support: unlimited
Validation
Mobile assistence
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Evaluation
3 analytes in 1 formulations
€ 5799
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Line
6 analytes in 2 formulations
€ 8599
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Express
7
Working
Days
€ 7199
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Development
1 analyte in 1 formulation
€ 3000
Updates: in real time
Email support: unlimited
Validation
Mobile assistence
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Evaluation
3 analytes in 1 formulations
€ 5799
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Line
6 analytes in 2 formulations
€ 8599
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Express
7
Working
Days
€ 7199
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Take the quiz below and find out now what is the best permeation package for you and receive a 10% discount for your next permeation study
What is your primary goal for this permeation study?
If you are developing a new formula and want to test the efficacy of the portotypes, or
if you want to increase customer product confidence with scienbtific data,
you can save time and money with a standrd protocol.
Formulating a new product
Optimizing the formula based on permeation studies.
Writing a technical file
Proving the permeation promotion or barrier effect for product authorization.
Building the product trust
Communicating the product's efficacy with laboratory data.
How many analytes do you need to test?
If you have a tentative number of analytes to test, move the sliders to the corresponding range.
If you know the exact number of analytes, overlap both sliders to the corresponding number.
How many formulations do you need to test?
If you have a tentative number of formulations to test, move the sliders to the corresponding range.
If you know the exact number of formulations, overlap both sliders to the corresponding number.
Receive 10% discount
Fill out the form to find out what the best permeation package is for you,
receive the results in your inbox,
along with a 10% discount on your next study.
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With Technology Scientific in vitro permeation studies,
