Formulation, Characterization, and Evaluation of Naringin-Loaded Phytosomal Gel and it’s in vivo Anti-Inflammatory Activity by Carrageenan Animal Model

Abstract

Objective: The present study aimed to formulate, optimize, and evaluate a Naringin-loaded phytosomal gel using a 3² factorial design and to assess its anti-inflammatory activity.Materials and Methods: Phytosomes were prepared via the thin-film hydration method using soya lecithin and cholesterol and were characterized for vesicle size, Polydispersity Index (PDI), and entrapment efficiency.Results: Vesicle sizes ranged from 126 to 207.4 nm, with PDI values between 0.119 and 0.312, indicating uniform particle distribution. Entrapment efficiency ranged from 80.08% to 90.66%, with the optimized formulation (F6) exhibiting a vesicle size of 198.9 nm, PDI of 0.236, and the highest entrapment efficiency of 90.66%. This optimized formulation was incorporated into a gel base and evaluated for physicochemical properties, including pH, spreadability, viscosity, and drug content. The Naringin Phytosomal Gel (NG-PH gel) showed a viscosity of 1462±12 cPs and a drug content of 97.18±0.94%. The phytosomal gel demonstrated superior drug diffusion and permeation compared to the plain and standard gels. Skin irritancy tests revealed no erythema or edema, confirming its safety for topical application.Conclusion: Moreover, the phytosomal gel exhibited significant anti-inflammatory activity and maintained stability throughout the study period, highlighting its potential as an effective transdermal delivery system for targeted anti-inflammatory therapy

Keywords: Naringin; Phytosomes; Anti-inflammatory activity; Quality by Design