DESIGN AND DEVELOPMENT OF NANOSTRUCTURED LIPID CARRIERS BASED ANTI-INFLAMMATORY GEL FOR TOPICAL DRUG DELIVERY SYSTEM

Abstract

Objective: The present study aimed to formulate a transdermal delivery system using a optimize Meloxicam-loaded NLCs to enhance its topical delivery and minimize systemic side effects. Methods: NLCs were prepared using a modified hot high-speed homogenization technique and optimized via a 3² factorial design with response surface methodology using Design Expert® software. The solid lipid-to-liquid lipid ratio (X₁) and surfactant concentration (X₂) were selected as independent variables, while particle size (Y₁) and entrapment efficiency (Y₂) served as dependent responses. Based on the 3² factorial design, nine different formulations were developed and statistically evaluated. Characterization of the NLCs included analysis of particle size, zeta potential, polydispersity index (PDI), and drug entrapment efficiency. The optimized NLCs were incorporated into gel formulations for transdermal application, serving as a drug reservoir system. The prepared gels were evaluated for physical appearance, pH, viscosity, spreadability, homogeneity, in vitro drug diffusion and invivo study. Results: NLCs formulation comprising 2% of lipid (70:30) and surfactant (2%) was confirmed as a optimized batch having minimum values for particle size (334.0±1.41nm) with PDI value 0.319±0.11. The zeta-potential was found to be - 48.3±1.9, indicating good physical stability. The optimized batch also shows good percentage entrapment efficiency (EE) of 91.57 ± 1.1%. The pharmacokinetic parameters of the optimized Meloxicam transdermal system were significantly improved compared with the pure drug. Conclusion: The overall results of the present study clearly indicated promising potentials of NLC-based transdermal delivery system to deliver the Meloxicam for the extended period of time in a controlled manner.