БАЧИНСКИ Мария Оксана (US),РАШЕД Мохаммад (US),САМТАК Пол Антони (US),ШАХ Навнит Харговиндас (US)
申请号：
RU2011129205/15
公开号：
RU2011129205A
申请日:
2009.12.07
申请国别(地区):
RU
年份:
2013
代理人:
摘要：
1. A pharmaceutical film-coated composition comprising capecitabine and at least one disintegrating agent comprising a composition comprising mannitol (90%), crospovidone (5%) and polyvinyl acetate (5%), where the composition breaks down in an evaluation device Disintegration according to the US Pharmacopoeia standard in water at 37 ° C for less than 2.5 minutes and is characterized by a hardness of approximately 8-23 Cobb hardness units (SCU) .2. The composition according to claim 1, comprising capecitabine in an amount of from about 10% to about 50% based on the total core weight of the composition. The composition of claim 2, wherein the capecitabine content is from about 50 mg to about 1500 mg. The composition of claim 3, wherein the capecitabine content is from about 100 mg to about 750 mg. The composition according to claim 3, in which the content of capecitabine is 125 mg, 175 mg, 250 mg, 350 mg or 500 mg. The pharmaceutical composition according to claim 1, which in addition to the composition containing mannitol (90%), crospovidone (5%) and polyvinyl acetate (5%), includes an additional disintegrating agent selected from the group comprising crospovidone with a particle diameter in the range of from less than 15 μm (90%) to less than 400 μm (90%), croscarmellose sodium, starch glycolate sodium, low substitution hydroxypropyl cellulose, or any combination of the above disintegrating agents. 7. The composition of claim 6, wherein the content of the disintegrant is from about 10% to about 50% based on the weight of the unit dosage form. The composition according to claim 6, in which the content of disintegrating agent1. Фармацевтическая композиция с пленочным покрытием, включающая капецитабин и, по крайней мере, один дезинтегрирующий агент, содержащий состав, включающий маннит (90%), кросповидон (5%) и поливинилацетат (5%), где указанная композиция распадается в приборе для оценки распадаемости, соответствующем стандарту фармакопеи США, в воде при 37°С в течен
