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Morphine controlled release system
专利权人:
发明人:
申请号:
EP10181692.4
公开号:
EP2301526B1
申请日:
2004.03.26
申请国别(地区):
EP
年份:
2016
代理人:
摘要:
A pharmaceutical composition for controlled release of at least one opioid into an aqueous medium by erosion of at least one surface of the composition, the composition comprising i) a matrix composition comprising a) a polymer or a mixture of polymers, wherein the polymer comprises a polyethylene glycol, a polyethylene oxide and/or a block copolymer of ethylene oxide and propylene oxide, b) an opioid as an active substance and, optionally, c) one or more pharmaceutically acceptable excipients, and ii) a coating having at least one opening exposing at the one surface of said matrix, the coating comprising a polymer selected from polyamide, polyethylene, polyethylene terephthalate, polypropylenem polyurethane, polyvinyl acetate, polyvinyl chloride, silicone rubber, latex, polyhydroxybutyrate, polyhydroxyvalerate, teflon, polylactic acid or polyglycolic acid and copolymers thereof, copolymers such as ethylene vinyl acetate (EVA), styrene-butadienestyrene (SBS) and styrene-isoprene-styrene (SIS), wherein the matrix composition has a conus-like shape so that the surface area exposed to the aqueous medium increases at least during initial erosion of the matrix composition, and the dissolution of the opioid - when tested in a Dissolution Test in accordance with the USP 24, NF 19, (711), Dissolution, apparatus 2 equipped with a paddle with or without application of sinkers - results in a zero order release of at least 80% of the opioid contained in the composition, and about 75% w/w of the opioid is released from the composition within 4-10 hours.
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