Development, Optimization and Characterization of Glimepiride Nanosuspension with Improved Solubility and Dissolution

Abstract

Current work describes the development of nanoparticulate suspension (NPs) of glimeperide (GLMP) with enhanced solubility and bioavailability. Using the ultrasonication-assisted precipitation method, GLMP-NP was developed and optimized through the use of a three-factor two-level full factorial design methodology. Drug release, size of a particle, and encapsulation efficiency from nanoparticles were considered as dependent variables while the concentration of Hydroxy propyl cellulose (HPC SSL), Kollicoat IR, and sonication time were considered as independent variables. According to the study, every independent variable significantly affected the dependent variables (p <0.05). The size of the particle GLMP-NP ranged between 159 (F2) to 505 nm (F8) while EE varied from 32 (F8) to 75% (F2). The DR of the GLMP-NP observed at 10 min ranged between 35 (F8) to 100% (F2). A significant enhancement in dissolution rate was observed in GLMP-NPs (F1-F8) in comparison to pure GLMP. It was discovered that pure GLMP dissolved in 27.25 ± 6.8 μg/mL of double-distilled water, while GLMP-NP exhibited 3.50 to 6.58-fold enhancement in saturation solubility. FTIR and DSC analysis revealed excellent compatibility between GLMP and excipients. XRD study confirmed the amorphous nature of the nanoparticles while SEM analysis revealed a smooth surface. In conclusion, this study demonstrates the substantial improvement in dissolution rate and solubility of pure GLMP when formulated as nanoparticles.