发明公开
EP2263673A1 Opioid formulations having extended controlled release
失效
阿维西亚形容词Veriägergergesteuerter Wirkstoffabgabe
- 专利标题: Opioid formulations having extended controlled release
- 专利标题(中): 阿维西亚形容词Veriägergergesteuerter Wirkstoffabgabe
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申请号: EP10178499.9申请日: 1994-06-22
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公开(公告)号: EP2263673A1公开(公告)日: 2010-12-22
- 发明人: Sackler, Richard S. , Oshlack, Benjamin , Chasin, Mark , Goldenheim, Paul , Kaiko, Robert , Pedi, Frank Jr.
- 申请人: EURO-CELTIQUE S.A.
- 申请人地址: 2, avenue Charles de Gaulle 1653 Luxembourg LU
- 专利权人: EURO-CELTIQUE S.A.
- 当前专利权人: EURO-CELTIQUE S.A.
- 当前专利权人地址: 2, avenue Charles de Gaulle 1653 Luxembourg LU
- 代理机构: Maiwald Patentanwalts GmbH
- 优先权: US86248 19930701
- 主分类号: A61K31/485
- IPC分类号: A61K31/485 ; A61K9/50 ; A61K9/16 ; A61K9/20
摘要:
A solid, controlled release, oral dosage form, the dosage form comprising an analgesically effective amount of an opioid analgesic or a salt thereof, coated with a controlled-release coating or in a controlled-release matrix, wherein the dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method at 100 rpm at 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37° C is from about 12.5% to about 42.5% (by wt) opioid released after 1 hour, from about 25% to about 65% (by wt) opioid released after 2 hours, from about 45% to about 85% (by wt) opioid released after 4 hours and greater than 60% (by wt) opioid released after 8 hours, the in-vitro release rate being substantially independent of pH and chosen such that the peak plasma level of said opioid obtained in-vivo occurs from about 2 to about 6 hours after administration of the dosage form.
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