title: Preparation and evaluation of a novel dosage form for onychomycosis.
abstract: Onychomycosis is a common infection of the nail caused by dermatophyte affecting mostly toenails in adults being associated with limited treatment options. In this study novel dosage forms were prepared and evaluated for their suitability in treatment of onychomycosis. Films were prepared comprising polymeric excipients such as chitosan, (hydroxypropyl)methyl cellulose, hydroxyethyl-cellulose, carboxymethylcellulose according to solvent evaporation method. Developed formulations were evaluated in terms of physical appearance, stability and adhesiveness. Furthermore skin and nail irritation studies were conducted. Five potential formulations (F1-F5) were designed while F1 and F4 exhibited the most promising results in terms of stability with 26min and 40.67min, respectively, and suitability in nail application. F1 as the most favorable dosage form revealed with 2.9438kg/m/s in terms of adhesive force the most adhesive properties in contrast to the other preparations. All formulations were found to be non-skin irritating and safe to use. Taken together, these findings suggest novel designed films containing polymeric excipients as a fruitful platform for the treatment in onychomycosis.
authors.affiliation: Department of Pharmaceutical Technology, Institute of Pharmacy, Center for Molecular Biosciences Innsbruck, University of Innsbruck, Austria. Electronic address: Flavia.Laffleur@uibk.ac.at.
authors.forename: Flavia
authors.initials: F
authors.lastname: Laffleur
authors.affiliation: Department of Pharmaceutical Technology, Institute of Pharmacy, Center for Molecular Biosciences Innsbruck, University of Innsbruck, Austria.
authors.forename: Martin
authors.initials: M
authors.lastname: Ataii
mesh_terms: D000268:Adhesiveness; D000287:Administration, Topical; D000818:Animals; D002417:Cattle; D004304:Dosage Forms; D005079:Excipients / Q000737:chemistry* / Q000633:toxicity; D006801:Humans; D009262:Nails / Q000187:drug effects; D014009:Onychomycosis / Q000188:drug therapy; D011108:Polymers / Q000737:chemistry* / Q000633:toxicity; D012212:Rheology; D012867:Skin / Q000187:drug effects; D023422:Skin Irritancy Tests; D013718:Tensile Strength
chemical_list: D004304:Dosage Forms; D005079:Excipients; D011108:Polymers
keywords: Adhesiveness; Film; Nail; Onychomycosis; Polymers