ABSTRACT:
The objective of present study was to prepare positively charged Besifloxacin – loaded ocular nanoparticles, providing a controlled release formulation. Quadratic model was applied for optimization of nanoparticles using factorial design. Polymer (A), surfactant (B) and organic phase (C), each at two levels and three replicates were selected as independent variables while % yield and entrapment efficiency as response variable. Nanoparticles were prepared by nanoprecipitetion technique followed by solvent evaporation method by using non-biodegradable positively charged polymer Eudiragit® RL100, poly (lactic-co-glycolic acid) or PLGA and surfactant poloxmer - 188. Amount of polymer, organic solvent and surfactant was selected as formulation variable. Characterization of the nanoparticles was performed by measuring particle size, zeta potential, Fourier Transform infrared spectroscopy (FTIR), Differential scanning calorimetry (DSC), drug entrapment efficiency, In- vitro release study evaluated for it’s the determination of release profile. In addition, optimized stability study was performed according to ICH guidelines. The formulated nanoparticles were found to be spherical and uniform in particle size with less than one polydispersity index. The zeta potential of nanoparticles was found to + 40 (mv) represent higher stability of colloidal dispersion and was suitable for ophthalmic applications. The release kinetics evaluation revealed the drug release follows Higuchi model, which ensures the possibility of long-term release profile from the nanoparticle’s formulations. The suspension of formulation was found more stable in refrigerated environment. By improving corneal penetration and prolonging retention on the ocular surface, these besifloxacin-loaded nanoparticles have the potential to increase therapeutic efficacy and provide a more effective means of treating bacterial conjunctivitis. This innovative approach aims to overcome the limitations of traditional ocular drug delivery systems, ultimately leading to better patient outcomes.