2015 年 63 巻 4 号 p. 295-299
In order to enhance the dissolution rate of dronedarone hydrochloride (DRN), a novel soluplus® (polyethyleneglycol–polyvinyl caprolactam–polyvinyl acetate grafted copolymer)-based solid dispersion (SD) was formulated using a hot melt extrusion technique. The physical characteristics determined using scanning electron microscopy and X-ray powder diffraction, revealed that the active compound was molecularly dispersed in the amphiphilic polymer in a stable amorphous form. The dissolution rate of DRN from the tablet dosage form of SD extrudate consisted of the drug and Soluplus® in a weight ratio of 1 : 1, and was obviously more rapid and higher than that of the intact drug and marketed product (Multaq®, Sanofi, U.S.A.) at pH 1.2, 4.0 and 6.8. This suggests that Soluplus®-based SD formula can be a promising approach for enhancing the dissolution and oral absorption of DRN with a simple preparation process.
