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    DOSAGE FORMS COMPRISING CELECOXIB PROVIDING BOTH RAPID AND SUSTAINED PAIN RELIEF
    1.
    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。

    Spray dried formulation
    8.
    发明授权
    Spray dried formulation 有权
    喷雾干燥制剂

    公开(公告)号：US08372836B2

    公开(公告)日：2013-02-12

    申请号：US12311543

    申请日：2007-10-08

    申请人： Rodney James Ketner ,  Douglas Alan Lorenz ,  David Keith Lyon

    发明人： Rodney James Ketner ,  Douglas Alan Lorenz ,  David Keith Lyon

    IPC分类号： A61K31/50 ,  A61K31/501 ,  A61K31/52 ,  A01N43/90 ,  A01N25/00 ,  A01K47/00 ,  C07D401/00 ,  C07D403/00 ,  C07D405/00

    CPC分类号： A61K9/1652 ,  A61K9/1617 ,  A61K31/437 ,  A61K31/501 ,  A61K31/522 ,  C07D405/12 ,  C07D471/04 ,  C07D473/34

    摘要： Pharmaceutical compositions comprising a poorly water soluble ionizable drug, a cationic species and a dispersion polymer are disclosed, together with a process for forming the compositions. The neutral form of the drug has (i) a solubility of less than 1 mg/ml, in aqueous solution at a pH between 6 and 7, (ii) a solubility of less than 20 mg/mL in a volatile organic solvent, and (iii) an acidic pKa value of greater than 5. At least 90 wt % of the drug in the solid dispersion being in a non-crystalline form. The drug, the cationic species, and the dispersion polymer constitute at least 80 wt % of the solid dispersion.

    摘要翻译： 公开了包含难溶于水的可电离药物，阳离子物质和分散体聚合物的药物组合物以及用于形成组合物的方法。 药物的中性形式具有（i）在pH6-6之间的水溶液中溶解度小于1mg / ml，（ii）在挥发性有机溶剂中溶解度小于20mg / mL，以及 （iii）大于5的酸性pKa值。固体分散体中至少90重量％的药物是非结晶形式。 药物，阳离子物质和分散体聚合物构成固体分散体的至少80重量％。

    Spray dried formulation
    10.
    发明申请
    Spray dried formulation 有权
    喷雾干燥制剂

    公开(公告)号：US20100029667A1

    公开(公告)日：2010-02-04

    申请号：US12311543

    申请日：2007-10-08

    申请人： Rodney James Ketner ,  Douglas Alan Lorenz ,  David Keith Lyon

    发明人： Rodney James Ketner ,  Douglas Alan Lorenz ,  David Keith Lyon

    IPC分类号： A61K31/52 ,  A61K47/38 ,  A61K31/501 ,  C07D405/12

    CPC分类号： A61K9/1652 ,  A61K9/1617 ,  A61K31/437 ,  A61K31/501 ,  A61K31/522 ,  C07D405/12 ,  C07D471/04 ,  C07D473/34

    摘要： Pharmaceutical compositions comprising a poorly water soluble ionizable drug, a cationic species and a dispersion polymer are disclosed, together with a process for forming the compositions. The neutral form of the drug has (i) a solubility of less than 1 mg/ml, in aqueous solution at a pH between 6 and 7, (ii) a solubility of less than 20 mg/mL in a volatile organic solvent, and (iii) an acidic pKa value of greater than 5. At least 90 wt % of the drug in the solid dispersion being in a non-crystalline form. The drug, the cationic species, and the dispersion polymer constitute at least 80 wt % of the solid dispersion.

    摘要翻译： 公开了包含难溶于水的可电离药物，阳离子物质和分散体聚合物的药物组合物以及用于形成组合物的方法。 药物的中性形式具有（i）在pH6-6之间的水溶液中溶解度小于1mg / ml，（ii）在挥发性有机溶剂中溶解度小于20mg / mL，以及 （iii）大于5的酸性pKa值。固体分散体中至少90重量％的药物是非结晶形式。 药物，阳离子物质和分散体聚合物构成固体分散体的至少80重量％。