A Novel Cationic Niosome Formulation for Topical Delivery of Adapalene.

In this study, we developed and optimized an adapalene (Ada)-loaded niosomal hydrogel using the response surface methodology (RSM) and evaluated its efficacy for acne treatment. Ada-loaded niosomes (Ada-Nio) were prepared using the thin-film hydration (TFH) method, and their physicochemical characteristics, including particle size, zeta potential, entrapment efficiency (EE%), and morphology, were determined. After preparing the Ada-Nio hydrogel, its viscosity, pH, in vitro release behavior, and cytotoxicity were evaluated in the human dermal fibroblast (HDF) cell line using the MTT assay. The Draize test was performed to evaluate skin irritation caused by the Ada-Nio hydrogel in New Zealand rabbits. The particle size, zeta potential, polydispersity index (PDI), and EE% of the optimized Ada-Nio formulation were 168.8 ± 1.5 nm, -70.6 ± 1.05 mV, 0.273 ± 0.015, and 80.3 ± 2.8%, respectively. SEM images of Ada-Nio showed spherical morphology. The viscosity and pH of the Ada-Nio hydrogel were 33,840 ± 1200 cP and 6.5 ± 0.3, respectively. The in vitro release profile showed that 73 ± 2.1% of Ada was released from the niosomal hydrogel within 24 h. Results from the cell viability and Draize tests indicated that the Ada-Nio hydrogel can be considered a safe and effective dermal agent for acne treatment. Niosomal hydrogel formulations appear to be safe, effective, and promising nanocarriers for the dermal delivery of Ada.