Development and Characterization of Polymeric Idebenone Spherical Agglomerates by Quasi-emulsion Solvent Diffusion Technique

Idebenone spherical agglomerates were prepared to improve micromeritics properties and solubility. The polymeric spherical agglomerates of Idebenone were developed by Quasi-emulsion solvent diffusion technique comprising three different solvents, methanol (good solvent), dichloromethane (bridging liquid) and water (poor solvent). A Pseudo ternary phase diagram was utilized to select and optimize the solvent system. The hydrophilic polymer PVP K30 was used as a medium stabilizer. The spherical agglomerates underwent a series of physicochemical assessments, including measurements of the angle of repose, Carr's index, Hausner's ratio, % yield, and shape. The optimized formulation exhibited a favourable angle of repose of 29.4°±0.034, and the % drug release after 30 minutes reached 83.11±3.8, surpassing all other concentrations. The optimized batch was further subjected to thorough analysis, encompassing Gas Chromatography to detect residual solvent levels and SEM, FT-IR, XRPD, drug content, and in-vitro dissolution studies. Subsequently, fast dispersible tablets were prepared using the optimized batch. For assessing stability, the optimized formulation underwent accelerated stability studies over a month at 40±2°C / 75±5% RH. These tests revealed negligible alterations in flowability, drug content, % yield, and drug release profile. The findings suggest that the polymeric spherical crystal agglomerates improve the micrometric properties and solubility of Idebenone.