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COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE L'HYDROMORPHONE ET DE LA NALOXONE
专利权人:
PURDUE PHARMA
发明人:
VARGAS RINCON, RICARDO ALBERTO
申请号:
CA2881144
公开号:
CA2881144A1
申请日:
2012.11.09
申请国别(地区):
CA
年份:
2014
代理人:
摘要:
There is described a prolonged release pharmaceutical dosage form comprising aplurality of coated beads, each of the coated beads comprising: (a) a granule;(b) a first layercoated on the granule, the first layer comprising: (i) hydromorphone or apharmaceuticallyacceptable salt thereof, (ii) naloxone or a pharmaceutically acceptable saltthereof, (iii) anantioxidant compound, and (iii) a chelating compound; and (c) a second layercoated on the firstlayer, the second layer comprising a prolonged release agent. The dosage formhas improvedstability and dissolution properties. Another aspect of the invention relatesto use of acombination of an antioxidant (such as sodium metabisulfite) and a chelatingagent (such asethyleneclinitrotetraacetic acid disodium salt dihydrate) to improve thestability and/ordissolution properties of a prolonged release dosage form comprising (i)hydromorphone or apharmaceutically acceptable salt thereof and (ii) naloxone or apharmaceutically acceptable saltthereof.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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