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    Controlled release formulations of opioid and nonopioid analgesics
    10.
    发明申请
    Controlled release formulations of opioid and nonopioid analgesics 审中-公开
    阿片样物质和非阿片类止痛剂的控制释放制剂

    公开(公告)号：US20050158382A1

    公开(公告)日：2005-07-21

    申请号：US10949141

    申请日：2004-09-24

    申请人： Evangeline Cruz ,  Atul Ayer ,  Brenda Pollock ,  Carmelita Garcia ,  Sherry Li ,  Alfredo Wong ,  Lawrence Hamel ,  Cheri Klein ,  Yihong Qiu ,  Ye Huang

    发明人： Evangeline Cruz ,  Atul Ayer ,  Brenda Pollock ,  Carmelita Garcia ,  Sherry Li ,  Alfredo Wong ,  Lawrence Hamel ,  Cheri Klein ,  Yihong Qiu ,  Ye Huang

    IPC分类号： A61K9/00 ,  A61K9/20 ,  A61K9/24 ,  A61K9/48 ,  A61K9/50 ,  A61K9/52 ,  A61K31/00 ,  A61K31/16 ,  A61K31/165 ,  A61K31/485 ,  A61K45/06 ,  A61K9/22

    CPC分类号： A61K9/2086 ,  A61K9/0004 ,  A61K9/209 ,  A61K9/4808 ,  A61K9/5084 ,  A61K31/00 ,  A61K31/16 ,  A61K31/165 ,  A61K31/167 ,  A61K31/485 ,  A61K45/06 ,  A61K2300/00

    摘要： Sustained release dosage forms for twice daily oral dosing to a human patient for providing relief from pain are provided. The sustained release dosage form comprises an immediate release component and a sustained release component, wherein the immediate release component and the sustained release component collectively contain a therapeutically effective amount of an opioid analgesic and a therapeutically effective amount of nonopioid analgesic. In a preferred embodiment, the nonopioid analgesic is acetaminophen and the opioid analgesic is hydrocodone and pharmaceutically acceptable salts thereof, and in preferred embodiments, the pharmaceutically acceptable salt is bitartrate. The dosage forms produce plasma profiles in a patient characterized by a Cmax for hydrocodone of between about 0.6 ng/mL/mg to about 1.4 ng/mL/mg and an AUC for hydrocodone of between about 9.1 ng*hr/mL/mg to about 19.9 ng*hr/mL/mg (per mg hydrocodone bitartrate administered) and a Cmax for acetaminophen of between about 2.8 ng/mL/mg and 7.9 ng/mL/mg and an AUC for acetaminophen of between about 28.6 ng*hr/mL/mg and about 59.1 ng*hr/mL/mg (per mg acetaminophen administered) after a single dose.

    摘要翻译： 提供了持续释放剂型，每天两次口服给予患者以缓解疼痛。 持续释放剂型包括速释组分和持续释放组分，其中速释组分和持续释放组分共同含有治疗有效量的阿片样镇痛剂和治疗有效量的非阿片类止痛剂。 在优选的实施方案中，非阿片类镇痛剂是对乙酰氨基酚，阿片类镇痛剂是氢可酮及其药学上可接受的盐，并且在优选的实施方案中，药学上可接受的盐是酒石酸氢盐。 剂型在患者中产生血浆曲线，其特征在于氢可酮的C max为约0.6ng / mL / mg至约1.4ng / mL / mg，氢可酮的AUC为约9.1ng * hr / mL / mg至约 19.9ng * hr / mL / mg（每毫克给予的氢可酮酮可乐酮），对乙酰氨基酚的C max为约2.8ng / mL / mg至7.9ng / mL / mg，对乙酰氨基酚的AUC为约28.6ng * hr / mL / mg和约59.1ng * hr / mL / mg（施用每mg对乙酰氨基酚）。