ПАРК Джае Хан (US),ЭЙЗЕНХАУЭР Тиффани (US),ДХАНАРАДЖАН Аниш (US),ГУПТА Вишал К. (US),ОВЕРХОЛТ Стивен (US)
申请号：
RU2013132138/15
公开号：
RU2013132138A
申请日:
2011.06.22
申请国别(地区):
RU
年份:
2015
代理人:
摘要：
1. granule substantially resistant to oxidative degradation of oxycodone comprising an inner portion substantially comprising oxycodone, and an outer portion substantially comprising at least one auxiliary substance selected from the group consisting of a binding agent, filler antioxidant, chelating agent, and combinations thereof, wherein said outer portion surrounding said inner portion, and the granule has less than about 0.5 wt.% of a compound formed as a result of degradation, selected from 10-gidroksioksiko it digidroksioksikodona and oxycodone N-oxide, the total weight of the oxycodone after storage for 6 months at 40 ° C and relative humidity of 75% .2. Granule according to claim 1, wherein less than about 20% by weight of oxycodone granuly.3 exposed to the surface. Granule according to claim 1, further comprising at least one additional excipient selected from the group consisting of agents to maintain the pH, antimicrobial agents and their kombinatsiy.4. Granule according to claim 1, which comprises microcrystalline cellulose, pregelatinized starch, Na-EDTA and citric kislotu.5. Granule according to claim 1, in which oxycodone has dmenshee value than the value dvspomogatelnogo veschestva.6. Granule according to claim 1, wherein doksikodona value is less than about 80% of the value dvspomogatelnogo veschestva7. Granule according to claim 1, wherein the oxycodone is oxycodone gidrohlorid.8. Granule according to claim 1, further comprising at least one additional pharmaceutically active agent.9. Granule according to claim 8, wherein at least one additional pharmaceutically active agent comprises atsetaminofen.10. D1. Гранула, по существу устойчивая к окислительной деградации оксикодона, содержащая внутренний участок, по существу содержащий оксикодон, и внешний участок, по существу содержащий по меньшей мере одно вспомогательное вещество, выбранное из группы, состоящей из связующего агента, наполнителя антиоксиданта, хелатирующего агента и их комбинаций, где у
