Box-behnken design approach to develop nano-vesicular herbal gel for the management of skin cancer in experimental animal model

Objective: To manage the increasing burden of skin cancer cases globally and to replace conventional invasive treatments and their side effects, the present study is aimed to develop a transfersomal herbal gel of Green Tea Catechins (GTC) extracted from indigenous green tea and evaluate it for in vivo management of skin cancer in an experimental animal model. Methods: GTC-loaded transfersomes (GTCTF) were prepared by the thin-film hydration method. After optimizing the GTCTFs using the Box-Behnken design, they were characterized for zeta potential, structure, in vitro drug release, and in vitro skin permeation. Carbopol 940 gel was developed for the topical delivery of GTCTF and characterized for pH, viscosity, spreadability and in vitro skin permeation. In vitro MTT assay and in vivo chemopreventive and anticancer efficacy of the GTCTF gel were evaluated in mice. Results: The GTCTF has shown a particle size of 151.4±1.9 nm, entrapment efficiency of 68.25±0.06 %, and drug loading of 10.41±0.02 %. The in vitro MTT assay in B16F10 melanoma cell lines showed promising anticancer efficacy of the GTCTF. GTCTF gel was found suitable for topical delivery with favorable pH, viscosity, spreadability, and permeability and effective in preventing and curing skin cancer in mice, with a significant reduction of tissue biochemical parameters like TNF-α, IL-1β, and IL-6. Conclusion: Collectively, successful prevention and curing of the induced skin cancer in the experimental animal model by the GTCTF gel have established a novel herbal nanomedicine approach for the management of skin cancer.