title: Transungual Gel of Terbinafine Hydrochloride for the Management of Onychomycosis: Formulation, Optimization, and Evaluation.
abstract: The present study was aimed to optimize, develop, and evaluate microemulsion and microemulsion-based gel as a vehicle for transungual drug delivery of terbinafine hydrochloride for the treatment of onychomycosis. D-optimal mixture experimental design was adopted to optimize the composition of microemulsion having amount of oil (X1), Smix (mixture of surfactant and cosurfactant; X2), and water (X3) as the independent variables. The formulations were assessed for permeation (micrograms per square centimeter per hour; Y1), particle size (nanometer; Y2), and solubility of the drug in the formulation (milligrams per milliliter; Y3). The microemulsion containing 3.05% oil, 24.98% Smix, and 71.96% water was selected as the optimized formulation. The microemulsion-based gel showed better penetration (∼5 folds) as well as more retention (∼9 fold) in the animal hoof as compared to the commercial cream. The techniques used to screen penetration enhancers (hydration enhancement factor, ATR-FTIR, SEM, and DSC) revealed the synergistic effect of combination of urea and n-acetyl cysteine in disruption of the structure of hoof and hence, leading to enhanced penetration of drug.
authors.affiliation: Pharmaceutics Division, Department of Pharmaceutical Sciences, Punjabi University, Patiala, India.
authors.forename: Purva
authors.initials: P
authors.lastname: Thatai
authors.affiliation: Pharmaceutics Division, Department of Pharmaceutical Sciences, Punjabi University, Patiala, India. bhartijatin2000@yahoo.co.in.
authors.forename: Bharti
authors.initials: B
authors.lastname: Sapra
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods; D016503:Drug Delivery Systems; D004655:Emulsions; D009281:Naphthalenes / Q000008:administration & dosage*; D014009:Onychomycosis / Q000188:drug therapy*; D010316:Particle Size; D012995:Solubility; D000077291:Terbinafine
chemical_list: D004655:Emulsions; D009281:Naphthalenes; D000077291:Terbinafine
keywords: differential scanning calorimetry; hydration; microemulsion; nail; scanning electron microscopy; terbinafine hydrochloride; transungual drug delivery