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  • Title: Preparation of solid dispersion of dronedarone hydrochloride with Soluplus(®) by hot melt extrusion technique for enhanced drug release.
    Author: Han SD, Jung SW, Jang SW, Jung HJ, Son M, Kim BM, Kang MJ.
    Journal: Chem Pharm Bull (Tokyo); 2015; 63(4):295-9. PubMed ID: 25832024.
    Abstract:
    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.
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