title: Adhesive backing foil interactions affecting the elasticity, adhesion strength of laminates, and how to interpret these properties of branded transdermal patches.
abstract: Standard tensile strength and peel adhesion tests were carried out to investigate interactions of pressure-sensitive adhesives (PSAs) with several backing foils used for transdermal patches. Seven branded transdermal patches (Alora, Cutanum, Estraderm MX 50, Estraderm TTS 50, Fem7 -50 micrograms, Menorest, Oesclim) were included in the investigation. Their skin adhesion measured in several clinical trials was compared with the results of the laboratory measurements according to PSTC-1 (Peel Adhesion for Single Coated Tapes 180 degrees Angle, Pressure Sensitive Tape Council, Illinois, 1996), such as Young's modulus at 3% elongation and peel adhesion to stainless steel. Data obtained for the PSA-coated backings (laminates) show increasing elasticity with increasing PSA thickness. Interactions of PSAs with backing foil became evident in significant changes in Young's modulus by low PSA thickness, as seen for the silicone adhesive. The Young's moduli of the laminates were found to be influenced not only by the elasticity of the backing foil but also by the chemical structure of the PSA. There was no correlation between the elasticity and peel adhesion of both the laminates and the branded patches. Likewise, for the branded patches the peel adhesion to stainless steel does not correlate with skin adhesion values obtained from clinical trials. The Young's modulus of the branded patches was between 4 N/mm2 (Oesclim) and 501 N/mm2 (Fem7). For the branded transdermal patches no correlation was found between Young's modulus and both the peel force on stainless steel and the skin adhesion reported in studies.
authors.affiliation: Jenapharm GmbH & Co. KG, D07745 Jena, Germany. christiane.fauth@jenapharm.de
authors.forename: C
authors.initials: C
authors.lastname: Fauth
authors.forename: S
authors.initials: S
authors.lastname: Wiedersberg
authors.forename: R H H
authors.initials: RH
authors.lastname: Neubert
authors.forename: M
authors.initials: M
authors.lastname: Dittgen
mesh_terms: D000269:Adhesives / Q000009:adverse effects*; D000279:Administration, Cutaneous; D004958:Estradiol / Q000008:administration & dosage; D006801:Humans; D012867:Skin / Q000187:drug effects*; D013678:Technology, Pharmaceutical
chemical_list: D000269:Adhesives; D004958:Estradiol