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PHARMACEUTICAL COMPOSITIONS COMPRISING HYDROMORPHONE AND NALOXONE
专利权人:
PURDUE PHARMA
发明人:
VARGAS RINCON, Ricardo Alberto
申请号:
PH12015501015
公开号:
PH12015501015B1
申请日:
2015.05.06
申请国别(地区):
PH
年份:
2015
代理人:
摘要:
There is described a prolonged release pharmaceutical dosage form comprising a plurality of coated beads, each of the coated beads comprising: (a) a granule; (b) a first layer coated on the granule, the first layer comprising: (i) hydromorphone or a pharmaceutically acceptable salt thereof, (ii) naloxone or a pharmaceutically acceptable salt thereof, (iii) an antioxidant compound, and (iii) a chelatmg compound; and (c) a second layer coated on the first layer, the second layer comprising a prolonged release agent. The dosage form has improved stability and dissolution properties. Another aspect of the invention relates to use of a combination of an antioxidant (such as sodium metabisulfite) and a chelatmg agent (such as ethylenedinitrotetraacetic acid disodium salt dihydrate) to improve the stability and/or dissolution properties of a prolonged release dosage form comprising (i) hydromorphone or a pharmaceutically acceptable salt thereof and (ii) naloxone or a pharmaceutically acceptable salt thereof.
来源网站:
中国工程科技知识中心
来源网址:
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