РОУ Уилльям (US),ХЕРТЕР Патрисия (US),ЯНГ Кристофер Р. (US),ДАЙНХАРТ Кирк (US),ВЕРВЕЙС Маринус Якобус (US),ОВЕРХОФФ Кирк (US),ГРОТЕНХЕЙС Петер Д. Й. (US),БОТФИЛД Мартин (US),ГРОССИ Альфредо (US),ЗЛОКА
申请号：
RU2012109390/15
公开号：
RU2012109390A
申请日:
2010.02.18
申请国别(地区):
RU
年份:
2013
代理人:
摘要：
1. A pharmaceutical composition containing about 34.1 wt.% Solid dispersion by weight of the composition, said dispersion containing about 80 wt.% Of essentially amorphous or amorphous N- [2,4-bis (1,1-dimethylethyl) - 5-hydroxyphenyl] -1,4-dihydro-4-oxoquinoline-3-carboxamide (compound 1) by weight of the dispersion, approximately 19.5 wt.% HPMCAS by weight of the dispersion and approximately 0.5 wt.% SLS by weight of the dispersion / approximately 30.5 wt.% microcrystalline cellulose based on the weight of the composition； approximately 30.4 wt.% lactose by weight of the composition； about 3 wt.% croscarmellose sodium based on the weight of the composition； approximately 0.5 wt.% SLS by weight of the composition； approximately 0.5 wt.% colloidal silicon dioxide by weight of the composition； and about 1 wt.% magnesium stearate based on the weight of the composition； for use in treating or alleviating the severity of cystic fibrosis in a patient； and in this patient with cystic fibrosis has a transmembrane receptor (CFTR) with a mutation ΔF508 on both alleles. 2. The pharmaceutical composition according to claim 1, where the pharmaceutical composition contains 150 mg of compound 1.3. A pharmaceutical composition containing approximately 34.1% by weight of a solid dispersion by weight of the composition, said dispersion containing approximately 80% by weight of substantially amorphous or amorphous N- [2,4-bis (1,1-dimethylethyl) -5- hydroxyphenyl] -1,4-dihydro-4-oxoquinoline-3-carboxamide (compound 1) by weight of the dispersion, approximately 19.5% by weight of HPMCAS by weight of the dispersion and approximately 0.5% by weight of SLS by weight of the dispersion； approximately 30 5 wt.% Microcrystalline cellulose based on the weight of the composition； approximately 30.4 wt.% lactose by weight of the composition； about 3 wt.% croscar1. Фармацевтическая композиция, содержащая приблизительно 34,1 вес.% твердой дисперсии от веса композиции, при этом указанная дисперсия
