DEVELOPMENT AND CHARACTERIZATION OF GLICLAZIDE SOLID DISPERSION USING MIXED SOLVENCY CONCEPT

The present study focuses on the development and characterization of gliclazide solid dispersions employing the mixed solvency concept to enhance solubility and dissolution rate of the drug. Gliclazide, a second‑generation sulfonylurea used in the management of type 2 diabetes mellitus, suffers from poor aqueous solubility, which limits its bioavailability. Solid dispersions of gliclazide were prepared using a combination of hydrotropic agents, cosolvents, and solubilizers to exploit the synergistic effect of mixed solvency. Various formulations were developed and evaluated for drug content, solubility enhancement, dissolution behavior, and physicochemical properties. Characterization techniques such as Fourier Transform Infrared Spectroscopy (FTIR), were employed to assess drug–excipient compatibility, crystallinity changes, and thermal behavior. The mixed solvency approach significantly improved the solubility of gliclazide compared to pure drug and conventional solid dispersions. Optimized formulations demonstrated enhanced dissolution rates, reduced crystallinity, and stable drug–excipient interactions. Stability studies confirmed that the solid dispersions maintained their physicochemical integrity under accelerated conditions. These approaches potentially enhance oral bioavailability and therapeutic efficacy, offering a cost‑effective and industrially feasible solution for formulation scientists. Keyword: Gliclazide, Solid dispersions, Mixed solvency concept, Enhance solubility