title: On the characterization of medicated plasters containing NSAIDs according to novel indications of USP and EMA: adhesive property and in vitro skin permeation studies.
abstract: Abstract This work aims to establish if the assays recently introduced by EMA (Guideline on quality of transdermal patches-draft) and USP (Specific tests for transdermal delivery systems) to characterize transdermal patches (TP) are suitable for medicated plasters (MP). Six approved MP differing for type and characteristics of adhesive and backing layer were selected and characterized in terms of adhesive performances by tack, shear adhesion, peel adhesion and release liner removal tests and in vitro skin permeation. As far as the adhesive properties are concerned, the major drawback is related to the measurement of shear adhesion of MP made of an adhesive hydrogel and/or a stretchable backing layer which could be solved by reducing the applied load. Moreover, a concern on the mass balance prescribed by EMA draft for the acceptance of the results of in vitro penetration studies remains. Indeed, the acceptance range is narrow than that reported by Ph. Eur. requirement for uniformity of content. Finally, a novel calculation for evaluating the in vitro efficiency of MP in releasing the loaded drug through the skin was proposed.
authors.affiliation: Department of Pharmaceutical Sciences, Università degli Studi di Milano , Milan , Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cilurzo
authors.forename: Chiara G M
authors.initials: CG
authors.lastname: Gennari
authors.forename: Francesca
authors.initials: F
authors.lastname: Selmin
authors.forename: Silvia
authors.initials: S
authors.lastname: Franzé
authors.forename: Umberto M
authors.initials: UM
authors.lastname: Musazzi
authors.forename: Paola
authors.initials: P
authors.lastname: Minghetti
mesh_terms: D000268:Adhesiveness; D000269:Adhesives; D000279:Administration, Cutaneous; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D016503:Drug Delivery Systems / Q000592:standards; D005060:Europe; D006801:Humans; D066298:In Vitro Techniques; D010602:Pharmacopoeias as Topic; D012869:Skin Absorption; D057968:Transdermal Patch / Q000592:standards*; D014481:United States
chemical_list: D000269:Adhesives; D000894:Anti-Inflammatory Agents, Non-Steroidal
keywords: In vitro skin permeation; medicated plaster; peel adhesion; shear adhesion; tack; transdermal patches