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    Spray drying process and compositions of fenofibrate
    1.
    发明授权
    Spray drying process and compositions of fenofibrate 有权
    喷雾干燥工艺和非诺贝特组合物

    公开(公告)号：US06696084B2

    公开(公告)日：2004-02-24

    申请号：US09838593

    申请日：2001-04-20

    申请人： Gary W. Pace ,  Awadesh K. Mishra ,  Robert A. Snow ,  Indu Parikh ,  Pol-Henri W. Guivarc'h

    发明人： Gary W. Pace ,  Awadesh K. Mishra ,  Robert A. Snow ,  Indu Parikh ,  Pol-Henri W. Guivarc'h

    IPC分类号： A61K914

    CPC分类号： A61K31/66 ,  A61K9/145 ,  A61K9/1623 ,  A61K31/216 ,  A61K31/22 ,  A61K31/365 ,  A61K31/40 ,  A61K31/405 ,  A61K31/44 ,  A61K31/505 ,  A61K45/06 ,  A61K31/215 ,  A61K2300/00

    摘要： The present invention relates to a novel spray drying process for the preparation of pharmaceutical compositions containing small particles of phospholipid-stabilized fenofibrate. This invention also relates to spray dried powdered compositions prepared according to this process, and to dosage forms of fenofibrate (capsules, tablets, powders, granules, and dispersions) prepared from these powdered compositions. The powdered compositions and dosage forms are useful in the treatment of dyslipidemia and dyslipoproteinemia and have the advantage that they provide reduced in vivo variability in the bioavailability of fenofibrate active species among fed and fasted patients when administered orally.

    摘要翻译： 本发明涉及一种用于制备含有磷脂稳定的非诺贝特的小颗粒的药物组合物的新型喷雾干燥方法。 本发明还涉及根据该方法制备的喷雾干燥的粉末组合物，以及由这些粉末状组合物制备的非诺贝特（胶囊，片剂，粉末，颗粒剂和分散体）的剂型。 粉末组合物和剂型可用于治疗血脂异常和血脂异常，并且具有这样的优点：当口服给药时，它们在进食和禁食患者中提供非诺贝特活性物质的生物利用度的体内变异性降低。

    Injectable dispersion of propofol
    2.
    发明授权
    Injectable dispersion of propofol 失效
    异丙酚注射分散体

    公开(公告)号：US06726919B2

    公开(公告)日：2004-04-27

    申请号：US09880104

    申请日：2001-06-14

    申请人： Gary W. Pace ,  Michael G. Vachon ,  Awadesh K. Mishra ,  Robert A. Snow

    发明人： Gary W. Pace ,  Michael G. Vachon ,  Awadesh K. Mishra ,  Robert A. Snow

    IPC分类号： A61F1300

    CPC分类号： A61K31/7016 ,  A61K9/0019 ,  A61K9/1075 ,  A61K31/05 ,  A61K31/14 ,  A61K47/10 ,  A61K47/12 ,  A61K47/14 ,  A61K47/24 ,  A61K47/26 ,  A61K47/44 ,  Y02A50/473

    摘要： A sterile, injectable homogenized dispersion of micromatrices or microdroplets having a mean diameter from about 50 nm to about 1000 nm comprising about 1% to about 7.5% of propofol, about 1% to about 8% of a propofol-soluble diluent, and about 0.67% to about 5% of a surface stabilizing amphiphilic agent suspended in an aqueous medium containing a synergetic quantity of antimicrobial agent and a tonicity modifying amount of a pharmaceutically acceptable water-soluble hydroxyl-group-containing excipient, wherein the ratio of propofol to diluent is in the range of about 0.25 to about 7.5 while the ratio of propofol to amphiphilic agent is in the range from about 0.4 to about 1.5, and wherein the viscosity of the dispersion is in the range of 1.1 to 8 cps, processes for the formation of the dispersion, and methods of use are disclosed.

    摘要翻译： 平均直径约50nm至约1000nm的微量或微滴的无菌注射匀浆分散体，其包含约1％至约7.5％的异丙酚，约1％至约8％的异丙酚可溶性稀释剂和约0.67 悬浮在含有协同量的抗微生物剂的水性介质中的表面稳定两亲剂的百分比至约5％，以及药学上可接受的水溶性含羟基赋形剂的张力调节量，其中异丙酚与稀释剂的比例为 在约0.25至约7.5的范围内，而丙泊酚与两亲剂的比例在约0.4至约1.5的范围内，并且其中分散体的粘度在1.1至8cps的范围内，形成 公开了分散体和使用方法。

    Water-insoluble drug particle process
    3.
    发明授权
    Water-insoluble drug particle process 有权
    水不溶性药物颗粒过程

    公开(公告)号：US06682761B2

    公开(公告)日：2004-01-27

    申请号：US09838540

    申请日：2001-04-20

    申请人： Gary W. Pace ,  Awadesh K. Mishra

    发明人： Gary W. Pace ,  Awadesh K. Mishra

    IPC分类号： A61K914

    CPC分类号： A61K9/1688 ,  A61K9/145

    摘要： This invention relates to process for the preparation of small particles containing a poorly water soluble drug comprising (a) mixing at high shear an admixture of a poorly water soluble drug and one or more than one surface active substance in an aqueous carrier in the absence of an organic solvent within a first temperature range at or above the melting point of the poorly water soluble drug to form a heated suspension containing the drug, then (b) homogenizing said heated suspension in a first pressure range and within said first temperature range to form a heated homogenate containing the drug, then (c) cooling said heated homogenate to a second temperature range below the melting temperature of the poorly water soluble drug to form a transiently stable cooled homogenate containing the drug, then (d) applying a particle stabilizing energetic process to said cooled homogenate within a second temperature range below the melting point of the drug and in a second pressure range to form a cooled dispersion of stabilized small particles containing the drug, and then (e) optionally drying the cooled dispersion to form dried small particles containing the poorly water soluble drug.

    摘要翻译： 本发明涉及制备含水难溶性药物的小颗粒的方法，其包括（a）在高剪切下混合水不溶性药物与一种或多于一种表面活性物质在水性载体中的混合物， 在低水溶性药物的熔点以上的第一温度范围内的有机溶剂，形成含有药物的加热悬浮液，然后（b）在所述第一压力范围内并在所述第一温度范围内使所述加热的悬浮液均化，形成 含有药物的加热匀浆，然后（c）将所述加热的匀浆冷却至低于难溶性水溶性药物的熔融温度的第二温度范围，以形成含有药物的瞬时稳定的冷却匀浆，然后（d） 在低于药物熔点的第二温度范围内和在形成的第二压力范围内对所述冷却的匀浆进行处理 含有药物的稳定的小颗粒的冷却分散体，然后（e）任选地干燥冷却的分散体以形成干燥的含水难溶性药物的小颗粒。