title: Development and characterization of film forming polymeric solutions for skin drug delivery.
abstract: Film forming polymeric solutions as a novel approach for skin drug delivery were developed and characterized concerning their mechanical properties and water vapor permeability. They were developed by varying type and content of the film forming polymer as well as nature and content of the plasticizer. The resulting formulations were evaluated according to five criteria: drying time, cosmetic attractiveness, outward stickiness, integrity on skin (after 18 h) and viscosity. Among the 14 tested polymers 10 film formers yielded formulations with a positive evaluation in all five test criteria. Selected formulations were then investigated for tensile strength and elongation at break in vitro and for water vapor permeability in vitro (WVP) and in vivo (TEWL). Their mechanical properties determined in vitro were found to be not predictive for the flexibility and abrasion resistance observed on living skin. Similar to this, the results derived from the WVP and the TEWL methods were not in accordance with each other. Obviously, the investigated in vitro methods do not characterize the properties of the thin films on living skin satisfactorily. Nevertheless, the identified film forming solutions are a promising approach and will provide the basis for the further development of this novel dosage form.
authors.affiliation: Pharmaceutical Development, INTENDIS GmbH, Berlin, Germany.
authors.forename: Ines
authors.initials: I
authors.lastname: Zurdo Schroeder
authors.forename: Patrick
authors.initials: P
authors.lastname: Franke
authors.forename: Ulrich F
authors.initials: UF
authors.lastname: Schaefer
authors.forename: Claus-Michael
authors.initials: CM
authors.lastname: Lehr
mesh_terms: D000268:Adhesiveness; D000279:Administration, Cutaneous; D000328:Adult; D004337:Drug Carriers / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D006813:Humidity; D008297:Male; D010539:Permeability; D010968:Plasticizers / Q000008:administration & dosage / Q000737:chemistry* / Q000494:pharmacology; D011108:Polymers / Q000008:administration & dosage / Q000737:chemistry* / Q000494:pharmacology; D012867:Skin / Q000187:drug effects; D012879:Skin Physiological Phenomena / Q000187:drug effects*; D012997:Solvents / Q000008:administration & dosage / Q000737:chemistry* / Q000494:pharmacology; D013696:Temperature; D013718:Tensile Strength; D013997:Time Factors; D014783:Viscosity; D014835:Volatilization; D014867:Water / Q000737:chemistry; D014870:Water Loss, Insensible / Q000187:drug effects
chemical_list: D004337:Drug Carriers; D010968:Plasticizers; D011108:Polymers; D012997:Solvents; D014867:Water