Controlled release oxycodone compositions
    59.
    发明申请
    Controlled release oxycodone compositions 审中-公开
    对照释放羟考酮组合物

    公开(公告)号:US20070275065A1

    公开(公告)日:2007-11-29

    申请号:US11824855

    申请日:2007-07-03

    IPC分类号: A61K31/34 A61K9/22

    摘要: A method for substantially reducing the range in daily dosages required to control pain in approximately. 90% of patients is disclosed whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg of oxycodone or a salt thereof is administered to a patient. The formulation provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean,of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from about 10 to about 14 hours after repeated “q12h” (i.e., every 12 hour): administration through steady-state conditions. Another embodiment is directed to a method for substantially reducing the range in daily dosages required to control pain in substantially all patients by administering an oral solid controlled release dosage formulation comprising up to about 160 mg of oxycodone or a salt thereof, such that a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of up to about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after repeated “q12h” (i.e., every 12 hour) administration through steady-state conditions are achieved. Controlled release oxycodone formulations for achieving the above are also disclosed.

    摘要翻译: 用于大大减少大约减少控制疼痛所需的日剂量范围的方法。 公开了90%的患者,其中向患者施用具有约10至约40mg羟考酮或其盐的口服固体控制释放剂量制剂。 所述制剂提供了从施用后约2至约4.5小时的平均值约6至约60ng / ml的羟考酮的平均最大血浆浓度,并且从约3至约30ng / ml的平均最小血浆浓度为约3至约30ng / 重复“q12h”(即每12小时)10〜14小时:通过稳态条件给药。 另一个实施方案涉及通过施用包含高达约160mg羟考酮或其盐的口服固体控制释放剂量制剂来显着降低在基本上所有患者中控制疼痛所需的日剂量范围的方法,使得平均最大值 在给药后平均高达约2至约4.5小时,羟考酮的血浆浓度高达约240ng / ml,重复“q12h”后约10至约14小时的平均最小血浆浓度高达约120ng / ml “(即每12小时一次)通过稳态条件实现。 还公开了用于实现上述目标的控释羟考酮制剂。