PERMEAÇÃO CUTÂNEA OU TESTE “IN VITRO” DE PERFORMANCE
SKIN PERMISSION analysis is used for: Creams (aqueous base), Ointment (oily base), Transdermal, Dermatological or Subpaconic Preparations, Stuffed Digital Substances, Transdermal Diffusers.
Skin Permeation, Transcutaneous Permeation, In-Test Performance, Penetration, or Cutaneous Absorption Test are the most common terms for the test to evaluate the passage of a substance when applied to the action of a systematic attempt to perform a percutaneous. Substances like penetrates even the deepest structures can reach a lymphatic and bloodstream. The attention of this penetration, if it is a blood count, the active will be transported to the organs according to the rules according to their affinities.
The study of Cutaneous Permeation uses the assay on the so-called cell of FRANZ, or Franz cell sets, which allows the product to be selected with the method selected through the membrane components. The time of contact is stipulated, as the collections for drug analysis are released through the medium through the membrane. The Franz cell system allows the diffusion of the substance into the skin, ie retention and percutaneous permutation.
According to DRC 31 of August 11, 2010, the dissolution profile of semisolid products is controlled by the cutaneous invasion assay, inserted in the SINEB and can only be performed by a method authorized by ANVISA in Pharmaceutical Equivalence.
Semi-solid products, such as ointment and cream, the comparative dissolution profile uses specific equipment called Transdermal Diffuser, which can be seen in the drawing below.
For the quantifications the analytical techniques will be in function of the molecule and the analytical resources employed, among the techniques most used are:
· Gas-phase Chromatography (GC-FID-ECD-TCD-MS-Head Space);
· Liquid phase chromatography (UPLC or HPLC-UV / Vis; Fluorescence; ELSD);
· LC-MS / MS: Mass Spectrometry coupled to HPLC or UPLC;
· ICP-OES (Induced-Simultaneous and Sequential Plasma);
· AA - (Atomic Absorption) and FC (photometry of flame), Hydride Generator;
· Determination of peak purity using DAD.
· Transdermal Diffuser;
· Ultraviolet and Visible Absorption;
Other techniques may be used, provided they are scientifically proven.