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Investigating the penetrating potential of nanocomposite β-cycloethosomes: development using central composite design, in vitro and ex vivo characterization

Abstract Context: Atopic dermatitis (AD) is a chronic skin disease characterized by inflammation of the skin and has exhibited remarkable repercussions on human life across the globe. Fluocinolone acetonide (FA), a topical corticosteroid is employed in the treatment of atopic dermatitis, but suffers from limited penetration into deeper epidermis of atopic skin. Objective: The present investigation was focused to explore the utility of β-cylcoethosomes in improvising the penetration deep into the skin. Materials and methods: β-Cylcoethosomes developed using β-cycloamylose by injection method were evaluated for vesicle size, entrapment efficiency and in vitro release. Central Composite design employed for the preparation depicted FA8 as an optimized formulation which was then formulated as dermatological gel using carbomer 934P as a gel base. The gels were characterized for pH, viscosity, drug content and in vitro permeability. Results and discussion: Optimized formulation (FA8) showed maximum desirability (0.795) with vesicle size of 228.33 ± 1.23 nm), EE (82.49 ± 1.21%) and CDR (90.90 ± 0.29%). FA8-loaded gels showed maximum in vitro permeability as found in BG and BGP (83.22 ± 0.72% and 84.02 ± 0.87). BG was selected as an optimized gel and compared with optimized reference ethosomal gel and control gel. CLSM studies depicted deeper uniform penetration of fluorescent dye deep into the epidermis via BG. Improved penetration was observed due to the synergistic effect exerted by ethanol and β-cycloamylose. Conclusion: β-cylcoethosomes proved to be a promising carrier for improvised penetration of fluocinolone acetonide via topical gel.