Formulation, Evaluation, and Characterization of Zolmi triptan-loaded Niosomal Tablet for the Treatment of Migraine

Objective: Zolmitriptan, classified as a BCS Class II drug, exhibits low solubility and poor bioavailability. By formulating niosomes, their lipid bilayer structure allows for controlled and sustained drug release over an extended period. Sustained release minimizes the need for frequent dosing. Method: Niosomes of Zolmitriptan were prepared by the thin-film hydration technique. Different formulation and process variables like the selection of surfactant (Span 20), Drug: Surfactant: Cholesterol ratio (1:3:1), solvent system (DMSO: DCM, 1:1), hydration volume (5 ml), hydration temperature (50℃), hydration time (60 minutes), annealing time (2hrss.) were optimized by various parameters. Optimized Niosomal dispersion was lyophilized and converted into a tablet. evaluated for physical appearance, thickness, hardness, weight variation, friability, disintegration time, and in-vitro dissolution profile. The residual solvent analysis was confirmed by gas chromatography. The stability study of lyophilized Niosomal tablets was performed according to ICH Q1A (R2) guidelines Results: The optimized batch was characterized for various parameters such as particle size (0.077µm), zeta potential (-38.15 mV), %entrapment efficiency (75.68±1.002%). The in-vitro drug release study of optimized formulation shows 99.05% in 14 hrs as compared to pure drug dispersion 60% in 14 hrs, transmission electron microscopy, infrared absorption spectroscopy, etc. From the gas chromatography, it was confirmed that the concentration of residual solvents was in an acceptable range. Conclusion: Zolmitriptan-loaded Niosomes give batter absorption as compared to pure drug dispersion which shows batter permeability of Niosomes through the biological barriers which may improve the bioavailability.