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Development Of Topical Gel Of Methotrexate Incorporated Ethosomes And Salicylic Acid For Treatment Of Psoriasis.

BACKGROUND
There is an unmet need for optimized drug delivery system of psoriasis therapy because of various issue like adverse reaction, permeation problem associated with convention treatment (oral and topical) available for psoriasis.


OBJECTIVE
The objective was to develop a ethosomal gel composed of methotrexate (MTX)-incorporated ethosomes and salicylic acid (SA) and to evaluate its potential in Imiquimod-induced psoriasis model to ameliorate symptoms of psoriasis.


MATERIALS AND METHODS
MTX-SA ethosomal gel was prepared by Cold method given by Touitou et al and optimized by comparing it with MTX ethosomal gel and drug solution. Particle size, zeta potential, entrapment efficiency and ex-vivo study were selected as the critical quality attributes. Antipsoriatic potential of MTX-SA ethosomal gel was evaluated by Psoriatic Area and Severity Index (PASI) score and histopathological examination in the imiquimod-induced psoriasis model.


RESULTS AND DISCUSSION
Optimized MTX-SA exhibited a particle size of 376.04±3.47nm, EE of 91.77± 0.02%. At the end of 24h, MTX-SA ethosomal gel exhibited a slow and prolonged release of MTX (26.13±1.61% versus 6.97±0.06%) compared to MTX drug solution. It also attributes of 43% retention study as compared to drug solution (13%). Furthermore, it significantly reduced the PASI score with the recovery of normalcy of the mice's skin, while the MTX-SA gel exhibited signs of mild hyper and parakeratosis at the end of the study as compared to blank gel.


CONCLUSION
The developed MTX-SA ethosomal gel formulation can be a promising alternative to existing MTX formulation in topically treating psoriasis.