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    DOSAGE FORMS COMPRISING CELECOXIB PROVIDING BOTH RAPID AND SUSTAINED PAIN RELIEF
    4.
    发明申请
    DOSAGE FORMS COMPRISING CELECOXIB PROVIDING BOTH RAPID AND SUSTAINED PAIN RELIEF 审中-公开
    包含CELECOXIB提供两种快速和持续的疼痛缓解的剂型

    公开(公告)号：US20100233272A1

    公开(公告)日：2010-09-16

    申请号：US12743215

    申请日：2008-11-06

    申请人： Leah Elizabeth Appel ,  Dwayne Thomas Friesen ,  Scott M. Herbig ,  Rodney James Ketner ,  Sheri L. Shamblin

    发明人： Leah Elizabeth Appel ,  Dwayne Thomas Friesen ,  Scott M. Herbig ,  Rodney James Ketner ,  Sheri L. Shamblin

    IPC分类号： A61K9/14 ,  A61K31/415

    CPC分类号： A61K9/146 ,  A61K9/2077 ,  A61K9/209

    摘要： A pharmaceutical dosage form comprising celecoxib and a pharmaceutically acceptable carrier, the dosage form when initially administered to at least 12 human patients in the fasted state in a crossover study providing: (a) a mean blood plasma concentration of celecoxib within 0.5 hour after administration (C0.5) of at least about 0.9 ng/ml per mg of celecoxib dosed; (b) a mean blood plasma concentration of celecoxib 12 hours after administration (Ci2) of at least about 0.6 ng/ml per mg of celecoxib dosed; (c) a mean area under the blood plasma concentration versus time curve for the 12 hour period following administration (AUC12) of at least 19 ng-hr/mL per mg of celecoxib dosed; and (d) a mean maximum blood plasma concentration (Cmax) of celecoxib of less than about 4.9 ng/ml per mg of celecoxib dosed.

    摘要翻译： 包含塞来昔布和药学上可接受的载体的药物剂型，当在交叉研究中最初向禁食状态的至少12个人类患者施用时的剂型，其提供：（a）给药后0.5小时内塞来昔布的平均血浆浓度 C0.5）为至少约0.9ng / ml / mg塞来考昔剂量; （b）施用后12小时塞来昔布的平均血浆浓度（Ci2）为至少约0.6ng / ml / mg塞来考昔剂量; （c）施用后12小时血浆血浆浓度对时间曲线的平均面积（AUC12）为每mg塞来昔布至少19ng-hr / mL; 和（d）塞来昔布的平均最大血浆血浆浓度（C max）小于约4.9ng / ml / mg塞来昔布给药。