Polymeric Recrystallized Agglomerates of Cefuroxime Axetil Prepared by Emulsion Solvent Diffusion Technique

Purpose: To study the effect of different polymers on the solubility and dissolution rate of cefuroxime axetil (CFU) prepared by emulsion solvent diffusion (ESD) technique. Methods: The ESD technique employed involved three test solvents: first, substance dissolution medium-good solvent (acetone); second, partial dissolution medium for the substance-bridging liquid (dichloromethane), and third, immiscible with the substance-poor solvent (distilled water). The pure CFU and the prepared agglomerates were characterized in terms of production yield, drug content, solubility, in vitro release profile, flowability, density, wettability, as well as by thin layer chromatography (TLC), differential scanning calorimetry (DSC), x-ray diffraction (XRD), Fourier transforms infra red spectroscopy (FTIR) and stability test. Results: DSC showed a decrease in the melting enthalpy indicating disorder in the crystalline content. XRD also indicated changes in crystallinity, FTIR revealed that there were no chemical changes in the recrystallized agglomerates while dissolution data demonstrated a marked increase in the dissolution rate (>55 % in 45 min) compared with the pure drug (35% in 45 min). The improvement in the dissolution rate of CFU from optimized crystal formulation was attributed to the wetting effect of the polymers, change in drug crystallinity, altered surface morphology and micronization. The recrystallized agglomerates also exhibited higher wettability and flowability. Conclusion: The optimised recrystallized agglomerates exhibited good solubility, wettability, dissolution rate and other physicochemical properties compared to the unmodified CFU.