Preparation and characterization of Domperidone- β-cyclodextrin complexes prepared by kneading method

Enhancement of the solubility and dissolution of domperidone using dispersion complex with β-cyclodextrin and hydroxy propyl cellulose by kneading technique. The physical mixtures (PM) of drug with β-cyclodextrin and hydroxypropyl cellulose were prepared by mixing appropriate amounts using the geometric dilution technique. Dispersion complexes (DC) were prepared by kneading method using minimum quantity of water. Infrared (IR) spectroscopy and Differential Scanning Calorimetry (DSC) were performed to identify physiochemical interaction between the drug and carrier and its effect on dissolution behavior. Morphology of the DC was studied using Scanning Electron Microscopy (SEM). A comparative evaluation of the dissolution of domperidone - β-cyclodextrin - hydroxy propyl cellulose dispersion complex, physical mixture, pure drug and marketed formulation (tablet) was carried out. Results: Dissolution of domperidone (DMP) improved significantly in dispersion complex as compared to pure drug and physical mixtures. DMP exhibited better aqueous solubility in presence of both hydroxy propyl cellulose (HPC) and β-cyclodextrin (β-CD). The percentage of DMP dissolved after 60 min was 71.11±2.22, for pure drug compared with 85.24±2.26 %, 90.27±2.12, 89.97±1.39, 92.06±1.78, and 83.86±1.12 for the drug in physical mixtures PM1, PM2, PM3, dispersion complex and marketed formulation (tablet).There was no significant change in inclusion efficiency with the addition of HPC with drug and β-cd. IR spectroscopy and DSC showed no change in crystal structure of domperidone. Dispersion complex technique of solid dispersion by kneading method can be successfully used for improvement of dissolution of domperidone.Keywords: dispersion complex, domperidone, β-cyclodextrins, hydroxypropyl cellulose, kneading