| 摘要 |
Provided herein are novel solid state forms of tapentadol salts, process for their preparation, pharmaceutical compositions, and method of treating thereof. The tapentadol salts include an L-(−)-camphorsulfonate salt, a dibenzoyl-(L)-tartrate salt, a dibenzoyl-(D)-tartrate salt, a malate salt, a maleate salt, or a salicylate salt. |
| 主权项 |
1. Solid state form of a salt of 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl] phenol (tapentadol salt), wherein the salt of tapentadol is a dibenzoyl-(D)-tartrate salt, characterized by one or more of the foregoing properties
i) a powder X-ray diffraction pattern in accordance with FIG. 5; ii) a powder X-ray diffraction pattern having peaks at about 8.52, 9.39, 11.81, 12.28, 13.46, 14.06, 17.77, 17.97, 18.33, 18.79, 19.58 and 20.05 ±0.2 degrees 2-theta; and iii) a powder X-ray diffraction pattern having peaks at about 8.52, 9.39, 11.81, 12.28, 13.46, 14.06, 17.77, 17.97, 18.33, 18.79, 19.58, 20.05, 10.69, 11.61, 14.76, 21.41, 21.66, 22.19, 22.96, 23.23, 24.38, 25.72, 26.42, 27.60, 27.82, 28.29, 28.46 and 30.65 ±0.2 degrees 2-theta. |
