ENHANCING SOLUBILITY AND DISSOLUTION OF RESERPINE THROUGH OPTIMIZED SOLID DISPERSION AND FAST- DISSOLVING FILM FORMULATION: A QUALITY BY DESIGN APPROACH

This study aims to enhance the therapeutic effectiveness of reserpine, an essential anti-hypertensive agent, by addressing its poor solubility and dissolution properties. Employing a Quality by Design (QbD) methodology, the research systematically optimized the formulation using solid dispersion technology and fast-dissolving films. Characterization of reserpine included its physical properties, such as melting point and partition coefficient, along with the establishment of a validated UV method for accurate quantification. The optimized solid dispersion (DRPSD14) achieved a theoretical solubility of 14.94% and dissolution of 96.88% at 20 minutes. Subsequently, a fast-dissolving film was developed from the optimized solid dispersion. Among twelve formulations, DRPSD14FDF11 exhibited promising characteristics, with 98.977±0.253% reserpine content. In-vitro dissolution studies demonstrated rapid dissolution for all formulations, with DRPSD14FDF11 displaying the highest dissolution rate. Release kinetics modeling and Fourier-transform infrared spectroscopy (FTIR) confirmed uniform drug distribution in the film, which also exhibited stability under various storage conditions. Guided by QbD principles, this comprehensive approach successfully optimized reserpine’s pharmaceutical properties, offering a promising formulation for hypertension treatment. The study provides valuable insights into formulation variables, enhancing therapeutic outcomes and extending reserpine’s clinical applications.