ЛАФЛИН Шарон М. (US),СИЗЕНСКИ Майкл Дж. (US),СИНГХ Сурендра П. (US),УИЛКИНСОН Скотт Х. (US),ХУАНГ Чай Гу (US),БОНЭЙСИЯ Филип Джеймс (US),Д'САУЗА Сьюзан С. (US),ДСАУЗА Сьюзан С. (US)
申请号：
RU2012127777/15
公开号：
RU2012127777A
申请日:
2010.12.03
申请国别(地区):
RU
年份:
2014
代理人:
摘要：
1. A pharmaceutical composition comprising transnorsertraline or a pharmaceutically acceptable salt or solvate thereof, and mannitol or xylitol. The pharmaceutical composition of claim 1, further comprising talc, kaolin or bentonite. The pharmaceutical composition of claim 2, further comprising magnesium stearate, calcium stearate, zinc stearate, or stearic acid. The pharmaceutical composition of claim 1, wherein the composition comprises a transnorsertraline hydrochloride salt or a hydrate thereof, mannitol, magnesium stearate, talc and sodium starch glycolate. The pharmaceutical composition according to claim 1, which is in the form of a tablet or capsule. The pharmaceutical composition of claim 1, wherein the composition comprises at least 10% by weight of mannitol or xylitol. The pharmaceutical composition of claim 1, wherein the composition comprises at least 10% by weight of mannitol. The crystalline hydrochloride salt of transnorsertraline or its hydrate, which is characterized by a powder X-ray diffraction pattern including peaks in the region of 14.9, 17.8, 19.2, 23.3, 24.6, and 25.2 degrees 2θ. 9. The salt of claim 8, which is characterized by a powder X-ray diffraction pattern, further comprising peaks in the range of about 5.0 and 21.8 degrees 2θ. 10. The salt according to claim 9, which is characterized by a calculated powder X-ray diffraction pattern, including peaks in the range of 5.1, 15.0, 18.0, 19.5, 22.0 23.5, 24.8 and 25.4 degrees 2θ based on data obtained at approximately 173 K on a single crystal. 11. The salt of claim 9, which has approximate following unit cell parameters: a = 16.8 Å, b = 5.2 Å, c = 19.1 Å, α = 90.0 °, β = 113.1 ° and γ = 90.0 ° .12. Salt according to claim 9, which has the approximate following unit cell parameters1. Фармацевтическая композиция, включающая транснорсертралин или его фармацевтически приемлемую соль или сольват, и маннит или ксилит.2. Фармацевтическая композиция по п.1, дополнительно включающая тальк, каолин и
