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PH-dependent controlled release pharmaceutical opioid composition resistant to the effects of ethanol
专利权人:
エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング
发明人:
ハンス ベーア,トーマス フュアスト,ゲアハート レナー,ミヒャエル ゴットシャルク
申请号:
JP2011528191
公开号:
JP5453433B2
申请日:
2008.09.24
申请国别(地区):
JP
年份:
2014
代理人:
摘要:
The invention relates to a pH-dependent controlled release pharmaceutical composition, comprising a core, and an opioid, wherein the core is coated at least by one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95% by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer, and ii) 5-60% by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0, characterized in that the coating layer further comprises 110 to 250% by weight of a non-porous inert lubricant, 1 to 35% by weight of a neutral cellulosic compound and 1 to 25% by weight of an emulsifier, each calculated on dry weight of the polymer mixture.
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