发明名称 |
Opioid formulations having extended controlled release |
摘要 |
<p>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 DEG 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. <IMAGE></p> |
申请公布号 |
EP1243269(A2) |
申请公布日期 |
2002.09.25 |
申请号 |
EP20020012074 |
申请日期 |
1994.06.22 |
申请人 |
EURO-CELTIQUE S.A. |
发明人 |
SACKLER, RICHARD;OSHLACK, BENJAMIN;GOLDENHEIM, PAUL;CHASIN, MARK;KAIKO, ROBERT;PEDI, FRANK, JR. |
分类号 |
A61K9/16;A61K9/20;A61K9/22;A61K9/28;A61K9/50;A61K31/445;A61K31/485;A61K31/522;A61K47/32;A61K47/36;A61K47/38;A61K47/42;A61K47/44;A61P25/04;A61K9/52;(IPC1-7):A61K31/485 |
主分类号 |
A61K9/16 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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