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    Dispersible phospholipid stabilized microparticles
    1.
    发明申请
    Dispersible phospholipid stabilized microparticles 有权
    分散磷脂稳定的微粒

    公开(公告)号：US20030206949A1

    公开(公告)日：2003-11-06

    申请号：US10443772

    申请日：2003-05-23

    申请人： SkyePharma Canada Inc.

    发明人： Indu Parikh ,  Awadhesh K. Mishra ,  Robert Donga ,  Michael G. Vachon

    IPC分类号： A61K009/127 ,  A61K009/20 ,  A61K009/14 ,  A61K031/19

    CPC分类号： A61K9/145 ,  A61K9/19 ,  A61K47/26

    摘要： Rapidly dispersing solid dry therapeutic dosage form comprised of a water insoluble compound existing as a nanometer or micrometer particulate solid which is surface stabilized by the presence of at least one phospholipid, the particulate solid being dispersed throughout a bulking matrix. When the dosage form is introduced into an aqueous environment the bulking matrix is substantially completely dissolves within less than 2 minutes thereby releasing the water insoluble particulate solid in an unaggregated and/or unagglomerated state. The matrix is composed of a water insoluble substance or therapeutically useful water insoluble or poorly water soluble compound, a phospholipid and optionally also at least one non-ionic, anionic, cationic, or amphipathic surfactant, together with a matrix or bulking agent and if needed a release agent. The volume weighted mean particle size of the water insoluble particle is 5 micrometers or less.

    摘要翻译： 快速分散固体干燥治疗剂型，其由存在于由至少一种磷脂存在而表面稳定的纳米或微米颗粒固体的水不溶性化合物组成，颗粒状固体分散在整个填充基质中。 当将剂型引入含水环境中时，膨胀基质在少于2分钟内基本上完全溶解，由此以非聚集和/或未聚集状态释放水不溶性颗粒固体。 基质由水不溶性物质或治疗上有用的水不溶性或水溶性差的化合物，磷脂和任选地至少一种非离子，阴离子，阳离子或两性表面活性剂以及基质或填充剂组成，如果需要 脱模剂。 水不溶性颗粒的体积加权平均粒径为5微米以下。

    Microparticles of water-insoluble substances
    3.
    发明申请
    Microparticles of water-insoluble substances 失效
    微溶于水的物质

    公开(公告)号：US20030180367A1

    公开(公告)日：2003-09-25

    申请号：US10260788

    申请日：2002-09-30

    申请人： SkyePharma Canada, Inc.

    发明人： Indu Parikh ,  Ulagaraj Selvaraj

    IPC分类号： A61K009/14 ,  B29B009/00

    CPC分类号： B82Y5/00 ,  A61K9/145

    摘要： The invention provides a composition comprising microparticles of a water-insoluble or poorly soluble compound, at least one phospholipid, and at least one surfactant, produced by applying an energy to a mixture comprising particles of the compound, the at least one phospholipid, and the at least one surfactant so as to obtain the microparticles. The invention also provides a process for preparing microparticles of a water-insoluble or poorly soluble compound. The process includes mixing particles of a water-insoluble or poorly soluble compound with at least one phospholipid and at least surfactant to form a mixture and applying energy to the mixture sufficient to produce microparticles of the compound. The methods of the invention allow for the production of microparticles smaller than particles produced through previously known methods and the microparticles exhibit advantageous properties including remarkable resistance to particle size growth during storage.

    摘要翻译： 本发明提供一种组合物，其包含水不溶性或难溶性化合物的微粒，至少一种磷脂和至少一种表面活性剂，其通过将能量施加到包含化合物颗粒，至少一种磷脂和 至少一种表面活性剂以获得微粒。 本发明还提供了制备水不溶性或难溶性化合物的微粒的方法。 该方法包括将水不溶性或难溶性化合物的颗粒与至少一种磷脂和至少表面活性​​剂混合形成混合物，并向混合物施加足以产生化合物微粒的能量。 本发明的方法允许生产比通过先前已知的方法制备的颗粒小的微粒，并且微粒表现出有利的性质，包括在储存期间显着抗性粒径生长。

    Insoluble drug particle compositions with improved fasted-fed effects
    4.
    发明申请
    Insoluble drug particle compositions with improved fasted-fed effects 审中-公开

    公开(公告)号：US20030194442A1

    公开(公告)日：2003-10-16

    申请号：US10440368

    申请日：2003-05-19

    申请人： SKYEPHARMA CANADA INC

    发明人： Pol-Henri Guivarch ,  Gary W. Pace ,  Robert A. Snow ,  Awadesh K. Mishra

    IPC分类号： A61K009/14 ,  A61K031/192

    CPC分类号： A61K31/44 ,  A61K9/145 ,  A61K9/1623 ,  A61K9/167 ,  A61K31/216 ,  A61K31/22 ,  A61K31/365 ,  A61K31/40 ,  A61K31/405 ,  A61K31/505 ,  A61K31/66 ,  A61K2300/00

    摘要： This invention discloses an orally administered pharmaceutical composition comprising microparticles of solid fenofibrate that are stabilized by a phospholipid surface active substance that is present during the preparation of the microparticles, wherein a therapeutically effective amount of the composition provides a quantity of fenofibrate active species to a fasted human patient in need of treatment by fenofibrate that is greater than 80% of the quantity of fenofibrate active species provided by the same amount of the composition when administered to the same patient who has been fed a high fat meal consisting of at least 1000 calories, 50% of which are from fat. The present invention also provides a method of treatment of dislipidemia and dislipoproteinemia in a mammal consisting of administering a therapeutically effective oral dosage form comprising microparticles of a solid fibrate that are stabilized by a phospholipid surface active substance wherein the dosage form provides into the blood of the patient in a fasted state a therapeutically effective amount of a fibrate active species that is at least 90% of the AUC amount of the fibrate active species provided by the same dosage form into the blood of the same patient when the patient is in a fed state.

    Coated tablets
    6.
    发明申请
    Coated tablets 有权
    涂层片剂

    公开(公告)号：US20040091535A1

    公开(公告)日：2004-05-13

    申请号：US10428007

    申请日：2003-05-02

    申请人： SKYEPHARMA CANADA INC.

    发明人： Michael Vachon ,  Awadhesh K. Mishra ,  Robert A. Snow ,  Pol-Henri Guivarc'H

    IPC分类号： A61K009/24 ,  A61K031/192

    CPC分类号： A61K9/14 ,  A61K9/145 ,  A61K9/146 ,  A61K9/148 ,  A61K9/16 ,  A61K9/1623 ,  A61K9/1629 ,  A61K9/167 ,  A61K9/1676 ,  A61K9/19 ,  A61K9/20 ,  A61K9/2077 ,  A61K9/282 ,  A61K9/284 ,  A61K9/2866 ,  A61K9/48 ,  A61K31/192 ,  A61K31/216 ,  A61K31/22 ,  A61K31/365 ,  A61K31/40 ,  A61K31/405 ,  A61K31/44 ,  A61K31/505 ,  A61K31/66 ,  A61K2300/00

    摘要： Disclosed is a pharmaceutically acceptable oral dosage form comprising fenofibrate, phospholipid, a buffer salt, a water-soluble bulking agent selected from maltodextrin, mannitol, and combinations thereof, a cellulosic additive, beads or crystals of a pharmaceutically acceptable water-soluble excipient support material, a polyvinylpyrrolidone or crospovidone, croscarmellose sodium, granular mannitol, sodium dodecyl sulfate, silicon dioxide, and a stearate, wherein the fenofibrate is in the form of microparticles, and wherein at least a portion of the phospholipid is coated on the surfaces of the fenofibrate microparticles, the phospholipid coated microparticles are embedded in a matrix comprising the water-soluble bulking agent, phospholipid that is not coated on the microparticles, the buffer salt and the cellulosic additive, and the matrix is coated on up to 100% of the surfaces of the beads or crystals of the excipient support material.

    摘要翻译： 公开了包含非诺贝特，磷脂，缓冲盐，选自麦芽糖糊精，甘露糖醇及其组合的水溶性填充剂的药学上可接受的口服剂型，纤维素添加剂，药学上可接受的水溶性赋形剂载体材料的珠粒或晶体 ，聚乙烯吡咯烷酮或交聚维酮，交联羧甲基纤维素钠，颗粒状甘露醇，十二烷基硫酸钠，二氧化硅和硬脂酸盐，其中非诺贝特为微粒形式，并且其中至少一部分磷脂被涂覆在非诺贝特 微粒，将包含磷脂的微粒嵌入包含水溶性填充剂的基质，未涂覆在微粒上的磷脂，缓冲盐和纤维素添加剂，并且将基质涂覆在至多100％的表面上 赋形剂载体材料的珠粒或晶体。