Dermal Delivery of Meloxicam Nanosuspensions based Gel: Optimization with Box Behnken Design Experiment Approach: Ex Vivo and In Vivo Study

Background: Transdermal delivery of meloxicam is advantageous than the oral route in the treatment of pain management. Objective: The goal of the present study is to formulate and evaluate meloxicam (MX) loaded nanosuspensions based gel for transdermal application. Methods: The formulation parameters were optimized using Box Behnken design (BBD) taking three independent variables and three responses. Formulations were evaluated for particle size (nm), polydispersity index (PDI), zeta potential (mV), ex vivo permeation, in vivo study, morphology, FTIR, skin irritation and, stability study. Optimized formulation having Poloxamer 188 (0.4 mg), PVP K30 (0.5 mg) and sonication time (60 min.) demonstrated smaller particle size (159.2 ± 3.5 nm), low PDI (0.120 ± 0.01) and higher zeta potential value (-29 ± 4mV). Results: In the ex vivo study, MX-NG showed a significant increase (p<0.05) in the flux (24.40 ± 2.6 μg/cm2/h) of meloxicam through the human cadaver skin as compared to other formulations. In the in- vivo study, MX-NG showed a significant (p<0.05) increase in anti-inflammatory activity as compared to marketed gel. Conclusion: Thus, it is concluded that the developed meloxicam loaded nanosuspensions based gel showed maximum therapeutic effects in rats.