Skin PAMPA Permeability System

Topic: Skin permeability/penetration

Test Method Number:
TM2012-02 (EU)
Short Name of TM:
Skin PAMPA
Year received:
2012
Responsible Organisation:
General Comments:
Submission on hold.

Method Description

The Skin PAMPA is a method that measures the passive permeation of a substance, applied in solution or as a formulation, through an artificial membrane mimicking the human skin. The test is performed in a 96 well plate and the membrane is placed between a donor compartment, to which the test solution/formulation is applied, and a receptor compartment filled with buffer solution at pH 7.4 (simulation of blood pH). The permeation (passive diffusion) through the membrane is measured by determining the portion of substance appearing in the receptor compartment after incubation. Quantification is done with a suitable analytical method, such as UV-Vis spectrophotometry or Liquid-chromatography.

The applied artificial membrane has been specifically designed to mimic the human stratum corneum (SC) that forms the major barrier of skin. It contains a synthetic structural analogue similar to the ceramide component of the skin-lipid matrix and other components such as cholesterol...

The Skin PAMPA is a method that measures the passive permeation of a substance, applied in solution or as a formulation, through an artificial membrane mimicking the human skin. The test is performed in a 96 well plate and the membrane is placed between a donor compartment, to which the test solution/formulation is applied, and a receptor compartment filled with buffer solution at pH 7.4 (simulation of blood pH). The permeation (passive diffusion) through the membrane is measured by determining the portion of substance appearing in the receptor compartment after incubation. Quantification is done with a suitable analytical method, such as UV-Vis spectrophotometry or Liquid-chromatography.

The applied artificial membrane has been specifically designed to mimic the human stratum corneum (SC) that forms the major barrier of skin. It contains a synthetic structural analogue similar to the ceramide component of the skin-lipid matrix and other components such as cholesterol and free fatty acids.  The manufacturing technology used for the artificial membrane aims at creating a similar hydrophilic/lipophilic balance as found in the natural SC lipid matrix.  The production of the membrane does not require human or animal tissue.

Track Approval Status

  •  
    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Step
Submission Show status
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards