title: In vitro Dermal Absorption: Sample Application and Seal Quality in a Franz Diffusion Cell System.
abstract: One of the known drawbacks of in vitro dermal absorption methods is their high interlaboratory variation. Although often attributed to biological skin differences, it has been shown that validation of other parameters such as temperature and stirring speed can reduce the high variability observed. The Organisation for Economic Co-operation and Development (OECD) and, at the EU level, the Scientific Committee on Consumer Safety (SCCS) have published guidance documents of how to perform these in vitro tests. For the parameter 'sample application' and 'adequate seal', it is indicated to apply the sample homogeneously and provide an adequate seal between the donor chamber and the membrane on which the sample is applied. Here, a simple and visual densitometer-based method is provided, which makes evaluation possible of any application protocol used.
authors.affiliation: Division of Food, Medicines and Consumer Safety, Section Medicinal Products, Scientific Institute of Public Health (IPH), Brussels, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Desmedt
authors.forename: Patricia
authors.initials: P
authors.lastname: Courselle
authors.forename: Jacques O
authors.initials: JO
authors.lastname: De Beer
authors.forename: Vera
authors.initials: V
authors.lastname: Rogiers
authors.forename: Eric
authors.initials: E
authors.lastname: Deconinck
authors.forename: Kristien
authors.initials: K
authors.lastname: De Paepe
mesh_terms: D000279:Administration, Cutaneous; D003720:Densitometry / Q000379:methods*; D004058:Diffusion; D015194:Diffusion Chambers, Culture; D006801:Humans; D066298:In Vitro Techniques; D012867:Skin / Q000378:metabolism*; D012869:Skin Absorption; D013696:Temperature