Compositions Comprising An Opioid And An Additional Active Pharmaceutical Ingredient For Rapid Onset And Extended Duration Of Analgesia That May Be Administered Without Regard To Food
    1.
    发明申请
    Compositions Comprising An Opioid And An Additional Active Pharmaceutical Ingredient For Rapid Onset And Extended Duration Of Analgesia That May Be Administered Without Regard To Food 审中-公开
    组合物包含阿片样物质和一种额外的活性药物成分,可快速开始,延长使用寿命,可以在不食用的情况下进行

    公开(公告)号:US20140275143A1

    公开(公告)日:2014-09-18

    申请号:US14188582

    申请日:2014-02-24

    申请人: MALLINCKRODT LLC

    摘要: The present disclosure provides pharmaceutical compositions comprising an opioid and an additional active pharmaceutical ingredient, wherein the composition exhibits gastric retentive properties which are achieved by a combination of a physical property of the composition and release of the opioid, wherein upon administration to a subject, the composition has at least one pharmacokinetic parameter that differs by less than about 30% when the subject is in a fasted state as compared to a fed state. The present disclosure further provides pharmaceutical composition comprising oxycodone and acetaminophen that provides a rapid onset of analgesia, and reduced levels of acetaminophen near the end of the dosing interval. Also provided are an extended release pharmaceutical composition comprising oxycodone and acetaminophen that provides reduced abuse potential.

    摘要翻译: 本公开提供了包含阿片样物质和另外的活性药物成分的药物组合物,其中所述组合物显示出通过组合物的物理性质和阿片样物质的释放的组合来实现的胃保持性质,其中在给予受试者时, 组合物具有至少一种药物动力学参数,当受试者处于禁食状态时与给药状态相比差异小于约30%。 本公开进一步提供了包含羟考酮和对乙酰氨基酚的药物组合物,其提供了止痛剂的快速开始,并且在给药间隔结束时接近对乙酰氨基酚的水平降低。 还提供了包含羟考酮和对乙酰氨基酚的延长释放药物组合物,其提供降低的滥用潜力。