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PHARMACEUTICAL COMPOSITION AND ITS INTRODUCTION
专利权人:
ВЕРТЕКС ФАРМАСЬЮТИКАЛЗ ИНКОРПОРЕЙТЕД (US)
发明人:
ДОКОУ Элени (US),ДЖАМЗАД Шахла (US),КАЕСАР Джон П. Мл. (US),ФАВАЗ Маджед (US),ДАС Лаура (US),ГУ Чун-Хой (US),ХЕРТЕР Патрисия Нелл (US),ИСРАНИ Мегхна Джай (US),ДЖОНСТОН Меган М. (US),КНЕЗИЧ Драгутин (U
申请号:
RU2014139006
公开号:
RU2014139006A
申请日:
2013.02.27
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. A pharmaceutical composition comprising about 35 wt.% Solid dispersion by weight of the composition, wherein said dispersion contains about 80 wt.%, Essentially amorphous or amorphous compound 1 by weight of the dispersion, about 19.5 wt.% HPMCAS by weight of the dispersion and approximately 0.5% by weight of SLS by weight of dispersion; approximately 13.5% by weight of mannitol by weight of the composition; approximately 41% by weight of lactose by weight of the composition; approximately 2% by weight of sucralose by weight of the composition; approximately 6% by weight of croscarmellose sodium by weight of the composition; with about 1 wt.% colloidal silicon dioxide by weight of the composition; and about 1.5 wt.% magnesium stearate by weight of the composition. 2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a unit dosage form comprising one or more of granules, pellets, particles, or mini-tablets, and wherein the unit dosage form contains from about 1 mg to about 100 mg, essentially amorphous or amorphous compounds 1.3. The pharmaceutical composition of claim 2, wherein the unit dosage form contains from about 50 mg of a substantially amorphous or amorphous compound 1.4. The pharmaceutical composition of claim 2, wherein the unit dosage form contains from about 75 mg of a substantially amorphous or amorphous compound 1.5. The pharmaceutical composition of claim 2, wherein the unit dosage form contains from about 25 to about 40 granules. The pharmaceutical composition of claim 2, wherein the solid dispersion is present in an amount of about 35% by weight of the pharmaceutical composition and the unit dosage form contains from about 26 granules. The pharmaceutical composition according to claim 6, where1. Фармацевтическая композиция, содержащаяприблизительно 35 мас.% твердой дисперсии по массе композиции, где указанная дисперсия содержит приблизительно 80 мас.%, по существу, аморфного или аморфного соединения 1 по массе д
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