Amorphous levonorgestrel, solid dispersion and process for producing them

2014 
Provided are a novel form of levonorgestrel useful as an emergency contraceptive and the like, a solid dispersion of levonorgestrel, a method for producing the same, and a pharmaceutical composition. The amorphous levonorgestrel of the present invention has an exothermic peak at 51 to 61 ° C. in the differential scanning calorimetry spectrum. In the solid dispersion of the present invention, levonorgestrel is dispersed in an amorphous form in the polymer. The polymer may be a pharmacologically acceptable water-soluble polymer. The polymer / levonorgestrel weight ratio may be about polymer / levonogestrel = 90 / 10-50 / 50.
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