公开(公告)号：US08586094B2

公开(公告)日：2013-11-19

申请号：US10428007

申请日：2003-05-02

申请人： Michael Vachon ,  Mishra K. Awadesh ,  Robert A. Snow ,  Pol-Henri Guivarc'H

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

IPC分类号： A61K9/16 ,  A61K9/20 ,  A61K9/48 ,  A61K9/50

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。