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PHARMACEUTICAL COMPOSITIONS COMPRISING HYDROMORPHONE AND NALOXONE
专利权人:
Purdue Pharma
发明人:
Ricardo Alberto Vargas Rincon
申请号:
US16165915
公开号:
US20190224130A1
申请日:
2018.10.19
申请国别(地区):
US
年份:
2019
代理人:
摘要:
Disclosed is a prolonged release pharmaceutical dosage form comprising a plurality of coated beads, each comprising a granule, a first layer coated on the granule comprising hydromorphone, naloxone, an antioxidant compound and a chelatmg compound; and a second layer coated on the first layer comprising a prolonged release agent. The dosage form has improved stability and dissolution properties. Also disclosed is the use of a combination of an antioxidant, such as sodium metabisulfite, and a chelatmg agent, such as EDTA, to improve the stability and/or dissolution properties of a prolonged release dosage form comprising hydromorphone and naloxone.
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