In vitro permeation testing (IVPT) and in vitro release test (IVRT) with Franz Cells are well described in guidelines, such as OECD TG428, EMA, EFSA guidelines or EU Regulation 2017/745 for classification of medical devices. OECD TG428 guideline describes in detail this in vitro method for the use of ex vivo animal or human explants together with Franz Cells.
The measurement of chemical transport across full thickness or dermatomed animal or human ex vivo skin explants to a receptor fluid reservoir allows the estimation and extrapolation of in vivo absorption of chemical, agrochemical, cosmetic test compounds or topically applied pharmaceutical. Parameters, such as transdermal flux rates, layer distribution or quantity of a permeated chemical or topically applied pharmaceutical compound can be measured with the Franz Cells.
The passive diffusion of chemicals, i.e. the skin absorption is influenced by temperature. It is recommended that the diffusion chamber and skin are maintained at a constant temperature of 32 °C and a humidity of 30 – 70%. Jacketed Franz Cells allow the maintenance of the temperature and fulfill this purpose.
Characteristics
* The “orifice” refers to the area at the top of the receptor chamber that is exposed to the ex vivo explant through which the permeation is being studied.
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