title: Bilayered nail lacquer of terbinafine hydrochloride for treatment of onychomycosis.
abstract: The present study aimed to develop bilayered nail lacquer of terbinafine hydrochloride (TH) for treatment of onychomycosis. The composite nail lacquer formed an underlying drug-loaded hydrophilic layer and overlying hydrophobic vinyl layer. The hydrophilic lacquer made of hydroxylpropyl methylcellulose E-15 contained polyethylene glycol 400 (PEG 400) as a drug permeation enhancer. The vinyl lacquer was composed of poly (4-vinyl phenol) as a water-resistant film former. In vitro permeation studies in Franz diffusion cells indicated that the amount of TH permeated across the human cadaver nail in 6 days was 0.32 +/- 0.14, 1.12 +/- 0.42, and 1.42 +/- 0.53 microg/cm(2) from control (hydrophilic lacquer devoid of PEG 400), monolayer (hydrophilic lacquer alone), and bilayered nail lacquers, respectively. A higher nail drug load was seen in vitro with the bilayered lacquer (0.59 +/- 0.13 microg/mg) as compared to monolayer (0.36 +/- 0.09 microg/mg) and control (0.28 +/- 0.07 microg/mg) lacquers. The drug loss despite multiple washing was significantly low (p < 0.001) for the bilayered lacquer owing to the protective vinyl coating. Clinical studies demonstrated the efficacy of bilayered lacquer to achieve better drug load in the nail plate (1.27 +/- 0.184 microg/mg) compared to monolayer (0.67 +/- 0.18 microg/mg) and control (0.21 +/- 0.04 microg/mg) lacquers.
authors.affiliation: Department of Pharmaceutics, The University of Mississippi, University, Mississippi 38677, USA.
authors.forename: H N
authors.initials: HN
authors.lastname: Shivakumar
authors.forename: Siva Ram Kiran
authors.initials: SR
authors.lastname: Vaka
authors.forename: N V Satheesh
authors.initials: NV
authors.lastname: Madhav
authors.forename: Harish
authors.initials: H
authors.lastname: Chandra
authors.forename: S Narasimha
authors.initials: SN
authors.lastname: Murthy
mesh_terms: D000935:Antifungal Agents / Q000008:administration & dosage / Q000032:analysis / Q000627:therapeutic use*; D002102:Cadaver; D002152:Calorimetry, Differential Scanning; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D008297:Male; D009262:Nails; D009281:Naphthalenes / Q000008:administration & dosage / Q000032:analysis / Q000627:therapeutic use*; D014009:Onychomycosis / Q000188:drug therapy*; D000077291:Terbinafine
chemical_list: D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine