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.