LAUSR

Abstract Aim The research focussed on development and evaluation of ethosome as an effective delivery of antigen that eliminates need for frequent dose of antigen while improving patient compliance for Hepatitis B. Method Prepared a single dose HBsAg ethosomal vaccine using a cold method and applied a central composite design optimisation using particles size, zeta potential and entrapment efficiency as dependent variables. Further, selected batch was assessed for their morphology, in vitro release, interaction, haemocompatibility, histological (ex vivo skin permeation) and stability studies. Further, proceeded for in-vivo study, administered in BALB/c mice via nasal route to check the immunological activity and compared with single and multiple doses of ethosome to booster doses of alum-HBsAg vaccine. Immunological marker like immunoglobulin (IgG and IgA) and cytokines (interleukin-2 and interferon-Y) were measured by ELISA techniques. Results The prepared ethosome showed minimum particle size (93.98 ± 4.6), 15.0 ± 2.83 mV zeta potential, with maximum entrapment efficiency (66.25 ± 8.6%). Physicochemical characterisation reveal the sustained release, haemocampatibile, and stable nature of ethosome. Further, ex-vivo skin permeation showed safely administration of drug by nasal route without toxicity. The in vivo study, found the higher immunological response observed in BALB/c mice, compare to alum-HBsAg vaccine. The single dose of ethosome showed sufficient effective and measurable immunoglobulin and cytokines levels. Conclusion A single dose of ethosome is sufficient for the complete immunological response not require booster administration. The potency of ethosomes have to produce a protective immune response, as well as their ability to explore and target the immunological environment through nasal route.