ABSTRACT:
Aim: To formulate, optimize, and characterize Morin-loaded PLGA nanoparticles (MOR-PLGA NPs) for controlled drug delivery, ensuring optimal particle size, entrapment efficiency, and drug release, and to evaluate their stability under ICH guidelines. Background: Morin (MOR) is a flavonoid with potent antioxidant, anti-inflammatory, and anticancer activities. Its clinical application is limited by poor solubility and low bioavailability. PLGA nanoparticles offer a strategy to enhance stability, control release, and improve therapeutic efficacy. Optimization of formulation parameters is critical to achieving NPs with desirable physicochemical properties and long-term stability. Materials and Methods: MOR-PLGA NPs were prepared using the emulsion–solvent evaporation method. Optimization was performed using Central Composite Design (CCD) targeting particle size, encapsulation efficiency, and drug release. Characterization included particle size, polydispersity index (PDI), zeta potential, and encapsulation efficiency measurements. FTIR assessed chemical compatibility, and SEM analyzed morphology. In vitro drug release was conducted in phosphate buffer, and stability studies were carried out over three months at 25±2 °C and 60±5% RH per ICH guidelines. Results: Optimized MOR-PLGA NPs had a particle size of approximately 200.9nm, PDI of 0.22, zeta potential of –27.8 mV, and entrapment efficiency of 89.9%. FTIR confirmed no chemical interaction, and SEM revealed spherical, smooth nanoparticles. The in vitro release studies showed a sustained drug release of 95.72±9.17% confirming the controlled-release potential of the system. Stability studies indicated minimal changes in physicochemical properties over three months, confirming formulation robustness. Conclusion: The study successfully developed a stable, optimized Morin-loaded PLGA nanoparticle system with controlled drug release, offering a promising platform to enhance Morin’s therapeutic potential and bioavailability.