Crystalline, anhydrous forms of oxymorphone hydrochloride

摘要

Crystalline, anhydrous hydrochloride salts of 4,5α-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one (oxymorphone) are disclosed and three polymorphic forms of these salts are reported. The invention further relates to a method for the production of such salts, a pharmaceutical composition comprising an effective amount of such a salt and such a salt as a medicament and for the treatment and/or prevention of pain.

主权项

1. A crystalline, anhydrous hydrochloride salt of 4,5α-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one according to formula (I):wherein the hydrochloride salt exhibits an X-ray powder diffractogram wherein peaks are observed at a grouping of peaks selected from the group consisting of A, B and C:
A) at (±0.2 in 2θ): 12.7, 14.7, 16.2, 17.1 and 19.0; B) at (±0.2 in 2θ): 6.0, 12.1, 13.1, 13.6, 15.3, 16.5, 22.4, 22.6, 24.1, 25.7 and 29.8; and C) at (±0.2 in 2θ): 8.3, 16.1, 18.6, 20.9, 28.0 and 29.9.