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    Opioid formulations having extended controlled release
    1.
    发明公开
    Opioid formulations having extended controlled release 失效
    阿维西亚形容词Veriägergergesteuerter Wirkstoffabgabe

    公开(公告)号：EP1243269A2

    公开(公告)日：2002-09-25

    申请号：EP02012074.7

    申请日：1994-06-22

    申请人： Euro-Celtique S.A.

    发明人： Sackler, Richard ,  Oshlack, Benjamin ,  Goldenheim, Paul ,  Chasin, Mark ,  Kaiko, Robert ,  Kaiko, Robert

    IPC分类号： A61K31/485 ,  A61K9/16 ,  A61K9/20 ,  A61K9/50

    CPC分类号： A61K9/1635 ,  A61K9/1617 ,  A61K9/2013 ,  A61K9/2054 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/2095 ,  A61K9/2866 ,  A61K9/5078 ,  A61K31/485 ,  A61K31/522

    摘要： Solid controlled-release oral dosage forms comprising a therapeutically effective amount of an opioid analgesic or a salt thereof which provide an extended duration of pain relief of about 24 hours, have a dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method of 100 rpm in 900 ml aqueous buffer at 37°C from about 12.5% to about 42.5% (by weight) active agent released after 1 hour, from about 25% to about 55% (by weight) active agent released after 2 hours, from about 45% to about 75% (by weight) opioid analgesic released after 4 hours and greater than about 60% (by weight) opioid analgesic released after 8 hours, the in-vitro release rate being substantially independent of pH and chosen such that the peak plasma level of active agent obtained in-vivo between about 2 and about 8 hours after administration of the dosage form.

    摘要翻译： 包含治疗有效量的阿片类止痛剂或其盐的固体控释口服剂型，其提供约24小时延长的疼痛缓解持续时间，当通过USP测量时，具有剂型的体外溶出速率 桨式法在900ml含水缓冲液中，在37℃下，约12.5％至约42.5％（按重量计）的活性剂在1小时后释放，约25％至约55％（重量）的活性剂在2 小时，约4小时后释放的约45％至约75％（重量）阿片样物质止痛剂，并且在8小时后释放大于约60％（重量）的阿片类止痛剂，体外释放速率基本上与pH无关并且选择 使得在施用剂型后约2至约8小时之间在体内获得的活性剂的血浆水平峰值。

    Opioid formulations having extended controlled release
    4.
    发明公开
    Opioid formulations having extended controlled release 失效
    阿维西亚形容词Veriägergergesteuerter Wirkstoffabgabe

    公开(公告)号：EP2263673A1

    公开(公告)日：2010-12-22

    申请号：EP10178499.9

    申请日：1994-06-22

    申请人： EURO-CELTIQUE S.A.

    发明人： Sackler, Richard S. ,  Oshlack, Benjamin ,  Chasin, Mark ,  Goldenheim, Paul ,  Kaiko, Robert ,  Pedi, Frank Jr.

    IPC分类号： A61K31/485 ,  A61K9/50 ,  A61K9/16 ,  A61K9/20

    CPC分类号： A61K9/1635 ,  A61K9/1617 ,  A61K9/2013 ,  A61K9/2054 ,  A61K9/2072 ,  A61K9/2081 ,  A61K9/2095 ,  A61K9/2866 ,  A61K9/5078 ,  A61K31/485 ,  A61K31/522

    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.

    摘要翻译： 一种固体，控制释放的口服剂型，所述剂型包含镇痛有效量的阿片类镇痛剂或其盐，涂覆有控释包衣或控释基质，其中体外溶出速率 当在37℃下以900rpm含水缓冲液（pH值在1.6和7.2之间）以100rpm测量时，剂型为1小时后释放的约12.5％至约42.5％（重量）的阿片样物质， 2小时后约25％〜约65％（重量）的阿片样物质释放，4小时后释放的约45％〜约85％（重量）阿片样物质，8小时后释放大于60重量％的阿片样物质， 体外释放速率基本上不依赖于pH，并且被选择为使得在给药剂型后约2至约6小时内在体内获得的所述阿片样物质的峰值血浆水平发生。

    Opioid formulations for treating pain
    5.
    发明公开
    Opioid formulations for treating pain 失效
    用于治疗疼痛的阿片制剂

    公开(公告)号：EP1023896A9

    公开(公告)日：2007-05-23

    申请号：EP00107670.2

    申请日：1994-11-22

    申请人： Euro-Celtique S.A.

    发明人： Sackler, Richard ,  Goldenheim, Paul ,  Kaiko, Robert

    IPC分类号： A61K9/54 ,  A61K31/137

    CPC分类号： A61K9/5078 ,  A61K9/2081 ,  A61K9/4808 ,  A61K9/5026 ,  A61K9/5073 ,  A61K31/485

    摘要： An oral sustained release opioid formulation comprises a plurality of substrates comprising a unit dose of an opioid analgesic which is tramadol or a salt thereof, each of said substrates comprising an inert bead coated with tramadol or a salt thereof and overcoated with a sustained release coating comprising a retardant material such that said unit dose provides therapeutically effective blood levels of said opioid analgesic for about 24 hours, said formulation providing an initially rapid rate of rise in the plasma concentration of said opioid characterised by providing an absorption half-life from 1 to 8 hours in the fasted state.

    Opioid formulations for treating pain
    7.
    发明公开
    Opioid formulations for treating pain 失效
    用于治疗疼痛的阿片制剂

    公开(公告)号：EP1776950A1

    公开(公告)日：2007-04-25

    申请号：EP06026995.8

    申请日：1994-11-22

    申请人： EURO-CELTIQUE S.A.

    发明人： Sackler, Richard ,  Goldenheim, Paul ,  Kaiko, Robert

    IPC分类号： A61K9/54 ,  A61K31/485

    CPC分类号： A61K9/5078 ,  A61K9/2081 ,  A61K9/4808 ,  A61K9/5026 ,  A61K9/5073 ,  A61K31/485

    摘要： Patients are treated with 24-hour oral sustained release opioid formulations which, upon administration, provide an initially rapid opioid absorption such that the minimum effective analgesic concentration of the opioid is more quickly achieved. These sustained release opioid formulations include an effective amount of at least one retardant material to cause said opioid analgesic to be released at such a rate as to provide an analgesic effect after oral administration to a human patient for at least about 24 hours, and are characterized by providing an absorption half-life from 1 to about 8 hours. A method of titrating a human patient utilizing these sustained release opioid formulations is also disclosed.

    Opiod formulations for treating pain
    9.
    发明公开
    Opiod formulations for treating pain 失效
    阿片样物质

    公开(公告)号：EP1470815A1

    公开(公告)日：2004-10-27

    申请号：EP04009845.1

    申请日：1994-11-22

    申请人： EURO-CELTIQUE S.A.

    发明人： Sackler, Richard ,  Goldenheim, Paul ,  Kaiko, Robert

    IPC分类号： A61K9/54 ,  A61K31/137

    CPC分类号： A61K9/5078 ,  A61K9/2081 ,  A61K9/4808 ,  A61K9/5026 ,  A61K9/5073 ,  A61K31/485

    摘要： An oral sustained release opioid formulation comprises a plurality of substrates comprising a unit dose of an opioid analgesic which is oxymorphone or a salt thereof and a retardant material such that said unit dose provides therapeutically effective blood levels of said opioid analgesic for about 24 hours, said formulation providing an initially rapid rate of rise in the plasma concentration of said opioid characterised by providing an absorption half-life from 1 to 8 hours in the fasted state.

    摘要翻译： 口服持续释放的阿片类药物制剂包括：阿片类止痛剂，其是以口服给药以提供镇痛作用的速率释放阿片类止痛剂的阻滞剂。 给人类患者24小时，当在人中施用时制剂提供血浆浓度最初升高的速率。 的阿片样物质，其特征在于提供1-8小时的吸收半衰期。 处于紧固状态。 用持续释放的口服阿片样物质制剂滴定人类患者的方法包括：1）每天一次向人类患者施用单位剂量的口服持续释放制剂，其包含阿片类镇痛剂和阻燃剂剂量为 2）监测该制剂在人类患者中引起的药代动力学和药效学参数，并确定药代动力学和/或药效学参数是否适合于重复治疗患者，3）通过调整患者的剂量 如果确定药代动力学和/或药效学参数不令人满意或以单位剂量维持阿片样物质镇痛剂的剂量，则通过施用单位剂量的持续释放的阿片样物质止痛剂制剂向患者施用阿片类止痛剂 管理的 如果药代动力学和/或药效学参数被认为是适当的，4）通过调整阿片样物质镇痛剂的剂量来继续步骤3滴定，直到在患者中达到适当的稳态药代动力学和/或药效学参数，以及5）继续施用。 的口服持续释放制剂中阿片样镇痛剂的剂量每天一次，直到治疗终止。