title: Development of an in vitro skin permeation model simulating atopic dermatitis skin for the evaluation of dermatological products.
abstract: Atopic dermatitis (AD) skin has a defective barrier function as indicated by increased transepidermal water loss (TEWL). In order to test potential new formulations for AD, it was our aim to develop a skin permeation model simulating AD skin by inducing barrier impairment to otherwise healthy skin simulating the barrier properties of AD skin as evaluated by TEWL measurements. Pig ear skin was mounted to Franz-type diffusion cells. Skin barrier impairment was induced by tape strippings. As the number of strips increased, higher TEWL values were obtained. By performing 25 tape strippings, the TEWL value within the range reported for involved skin of AD patients was reached. The in vitro skin permeation of fusidic acid and betamethasone-17-valerate was found to correlate with the number of tape strippings used to remove stratum corneum cell layers. A comparison of the permeability of fusidic acid and betamethasone-17-valerate from Fucicort cream to a new Fucicort Lipid formulation was studied with intact (0 strippings) and barrier-impaired skin simulating involved AD skin (25 strippings). As opposed to intact skin, no statistically significant difference through barrier-impaired skin was found for fusidic acid and betamethasone-17-valerate for the two formulations. This is in accordance with the clinical results of an international multicentre study and thus confirms the predictability of the model.
authors.affiliation: Pharmaceutical Formulation, LEO Pharma, Ballerup, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Simonsen
authors.forename: A
authors.initials: A
authors.lastname: Fullerton
mesh_terms: D000287:Administration, Topical; D000704:Analysis of Variance; D000818:Animals; D001624:Betamethasone Valerate / Q000493:pharmacokinetics; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000378:metabolism*; D004338:Drug Combinations; D005672:Fusidic Acid / Q000493:pharmacokinetics; D066298:In Vitro Techniques; D023421:Models, Animal; D010539:Permeability; D012867:Skin / Q000378:metabolism*; D012869:Skin Absorption; D013552:Swine
chemical_list: D004338:Drug Combinations; D005672:Fusidic Acid; D001624:Betamethasone Valerate