Permeation studies estimate the degree a dosage form promotes or inhibits the permeation of its ingredients across physiological mucosae. The most used model for permeation studies are the Franz cells.
Franz cells 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. These latter provide the most reliable results.
Permeation studies are useful to predict what is the most promising formula promoting or preventing the absorption of its ingredients, but no only. These studies are also pivotal in the technical files to present at the Notified Bodies.
- Allow to screen several formulas to select those with the most favourable permeation profile without the expenditure of an In vivo test.
- Increases the success rate of expansive in vivo tests and clinical trials.
- Support the technical file to present to the notified entity to achieve for the CE certification.
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Franz cells
Franz Cell (Pharmacopeia)
Vertical cell model
Horizontal cell model
Validation
Full validation (ICH guidelines)
Already validated protocols
Membranes
Ex vivo membranes
Artificial membranes
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