Improvement of the Dissolution Behavior of Dabigatran Etexilate by Three-dimensional Ordered Macroporous Starch Material

OBJECTIVE To improve the dissolution rate of dabigatran etexilate (DBET) by prepared three-dimensional ordered macroporous starch material (3DOMS). METHODS 3DOMS was prepared by hard template method, loaded DBET by solvent evaporation method. The dispersal state of DBET in DBET-3DOMS sample was characterized by X-ray diffraction, differential scanning calorimetry and fourier transform infrared spectroscopy. Dissolution test was used to investigate the dissolution of DBET. RESULTS Macroporous ordered interconnected structure of 3DOMS had the spatial restriction effect which could effectively limit the crystallinity of DBET. The dispersal state of DBET in DBET-3DOMS sample was amorphous state. In vitro dissolution test showed the dissolution effect of DBET was enhanced obviously. CONCLUSION 3DOMS can improve the dissolution of DBET and as biodegradable material exhibit promising potential in improving the water solubility of poorly soluble drugs.