A novel nanogel formulation of methotrexate for topical treatment of psoriasis: optimization, in vitro and in vivo evaluation

AbstractContext: Although several formulation strategies have been developed for the treatment of psoriasis, there is an unmet need for optimization of its therapy.Objective: The objective was to develop a nanogel composed of methotrexate (MTX)-loaded nanostructured lipid carrier (MTX-NLC) and to evaluate its potential in imiquimod-induced psoriasis model to ameliorate symptoms of psoriasis.Materials and methods: MTX-NLC nanogel was prepared by hot-homogenization method and optimized by Design of Experiments. Particle size, polydispersity index (PDI) and entrapment efficiency were selected as the critical quality attributes. Antipsoriatic potential of MTX-NLC nanogel was evaluated by Psoriatic Area and Severity Index (PASI) score and histopathological examination in the imiquimod-induced psoriasis model.Results and discussion: Optimized MTX-NLC exhibited particle size of 278 ± 10 nm, PDI of 0.231 ± 0.05 and EE of 22.29 ± 1.23%. At the end of 48 h, MTX-NLC gel exhibited slow and prolonged release of MTX (4...