Preparation and Evaluation of a Sustained Release Niosomal Dispersion Containing Niflumic Acid

Abstract

Objective: This work aims to create and characterize niosomal dispersions for long-term delivery of the anti-inflammatory drug niflumic acid that may be adapted to give a localized effect, prevent gastrointestinal side effects and hepatic metabolism, leading to improve efficacy and patient compliance. Method: The thin film hydration technique was used to make niflumic acid-loaded niosomes. The effects of different concentrations of a non-ionic surfactant, cholesterol, dicetyl phosphate (DCP), sonication time and the effects of drug concentration on encapsulation efficiency were investigated in order to improve the process. Differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FTIR), and transmission electron microscopy (TEM) were used to analyze the formulations. The niosomal dispersion formulations were evaluated for entrapment efficiency, in-vitro drug release, particle size, polydispersity index (pdI), zeta potential, pH and stability study. Results: The optimum niosomal preparation (F15) exhibited pH (7.2), size of the particles (1.04 μm), pdI (0.374), surface charge (-47.4) and efficiency of trapping (91.55%). It gave a rapid release in 15 minutes and increased sustainably over time until reach 96.9% within 24 hours. Conclusion: This research was successful in producing an optimal niosomal dispersion for niflumic acid using different surfactant/cholesterol ratios. The optimum formula provides a sustained release with the initial fast effect of niflumic acid and can be used with a topical dosage form to provide immediate relief that lasts for up to 24 h.