Solid dispersion of amorphous apremilast and preparation method of solid dispersion

2015 
The invention provides a solid dispersion of amorphous apremilast and a preparation method of the solid dispersion. The solid dispersion contains apremilast and two or more pharmaceutical adjuvants, wherein the weight ratio of apremilast to all the pharmaceutical adjuvants is 1: (0.1-100), apremilast in the solid dispersion is in the amorphous state, and in the X-ray powder diffraction spectrum of the solid dispersion, besides the background peak of the pharmaceutical adjuvants, the characteristic peak of the apremilast crystal does not exist. The solid dispersion of apremilast is good in stability and dispersibility, the dissolution rate of apremilast is increased, the bioavailability of the medicinal preparation and the absorption of the medicine in the body are favorably improved, and under the condition of the acceleration test, the good physical stability and chemical stability can be maintained. The preparation method of the amorphous solid dispersion is easy to operate, low in cost, good in reproducibility, easy to realize, and suitable for industrial production.
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