Phytosome-Based Nano-Enhanced Lutein: Combating Oxidative Stress and Age-Related Macular Degeneration

Introduction: The current research aims to design, develop, and optimize a luteinloaded phytosomal nanoformulation to enhance its effectiveness in treating age-related macular damage (AMD) and other conditions. The oral administration of the lutein phytosomal formulation, utilizing lecithin and ethanol as solvents, may demonstrate outstanding lymphatic uptake through the Peyer's patches, thereby enhancing bioavailability at the targeted site. materials and methods: Lutein was obtained from Nutratech Pvt Ltd., Lecithin was sourced from Sonic Biochem Indore, M.P., Isopropyl alcohol, ethanol, butanol, n-octanol, and n-hexane solvents were acquired from the SD Fine Chem. All other chemicals used in this study were of pharmaceutical grade.Anti-solvent precipitation method was utilized for the phytosomal formulations. Methods: As determined by photon correlation spectroscopy, the anti-solvent precipitation method was employed, resulting in particles with a measured particle size of 213 ± 0.22 nm. Results: The optimized formulation exhibited a higher drug content of 96.76 ± 0.65% and an entrapment efficiency of 87.32 ± 0.68%. An in vitro study confirmed a controlled release over a prolonged duration of up to 12 hours, with 67.8 ± 0.75% drug release, indicating a 2-fold enhancement over the plain drug at 31.7 ± 0.55%. The IC50 value for the hydroxy free radical scavenging assay against standard gallic acid was found to be 4.798 ± 0.169 μM compared to 9.968 ± 0.027 μg/ml of gallic acid. In comparison, superoxide anion radicals (O₂⁻) were measured at 105.2 ± 0.152 μM against 6.671 ± 0.021 μg/ml of gallic acid. Discussion: In Formulation L_Ph_P5, the drug: phospholipid molar ratio was 1:2.5, exhibiting the highest entrapment & drug content with the lowest particle size. An in vitro dissolution study confirmed a 2-fold improvement in drug release with the phytosomes formulation compared to plain lutein. Stability data of the optimized formulation confirmed that the lutein phytosomes formulation is stable. The results of the in vitro antioxidant activity of the optimized formulation were detected to be effective against the hydroxyl radical and superoxide radical. Thus, the lutein- loaded phytosome revealed the antioxidant property. Moreover, this formulation could be efficient for the age-related macular damage, & various eye conditions, and other health benefits. Conclusion: Lutein-Phytosomes significantly improved solubility and bioavailability, effectively managing oxidative stress.