By Institute for Advanced Chemistry of Catalonia (IQAC-CSIC)
The Dermocosmetic Assessment Service (DC) offers penetration assays of topical products in the skin, with GLP certification using vertical diffusion cells (Franz cell assay). These assays are aimed at developers and manufacturers of topical and generic products who need characterization of dermal formulations, cosmetic safety, or biobased products for topical generics through in vitro bioequivalence studies. Our main skin penetration assays, offered since 1998, are developed in accordance with OECD, FDA, and EMA guidelines on quality and equivalence of topical products. They are mainly divided into two sections: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT). In Vitro Release Test (IVRT) This IVRT test determines the fluxes and released amounts of drugs contained in transdermal topical products using artificial membranes in different topical applications: - Development and validation of methods to measure the release and fluxes of different topical formulations (Test of - Bioequivalence, SUPAC-SS) Bioequivalence of topical generics as an alternative approved by EMA/FDA to costly clinical studies. - In vitro release quality control of manufacturing batches of topical products. - Optimization and comparison of different formulations of topical products during the development phase. In Vitro Permeation Test (IVPT) This type of IVPT test allows determination of transdermal permeation amounts, diffusion fluxes, and distribution in the different layers of skin and other tissues (human and porcine ex vivo skin, buccal mucosa, nail plate) of active substances present in different topical applications (OECD 428, SCCS 2010): - Optimization and comparison of formulations. Selection of suitable excipients and lead candidate formulations for topical products. - Safety evaluations of topical cosmetic products. - Percutaneous absorption studies through skin, nails, mucosa, or cornea. - Compounds to be tested: chemicals, agrochemicals, cosmetics, pharmaceuticals (API), substance-based medical devices. The service is focused on those laboratories or companies that need in-depth knowledge of skin and hair substrates and that develop active ingredients, formulations, and finished products on them, mainly in the cosmetic, pharmaceutical, agrochemical, chemical, and textile industrial sectors. Certified according to UNE-EN ISO 9001:2008 Standard by AENOR since 2012 with reference ER-0430/2012 and by Good Laboratory Practice (GLP) for dermal penetration assays by GENCAT 2022 and ENAC 2023
