Title:
安定化フィブレート微粒子
Document Type and Number:
Japanese Patent JP2004509146
Kind Code:
A
Abstract:
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.
Inventors:
Givarucci, Pol-Henry
Payce Gully
Snow A, Robert A
Payce Gully
Snow A, Robert A
Application Number:
JP2002528263A
Publication Date:
March 25, 2004
Filing Date:
April 20, 2001
Export Citation:
Assignee:
Skypharma Canada Inc.
International Classes:
A61K9/14; A61K9/16; A61K9/20; A61K9/48; A61K31/216; A61K31/22; A61K31/365; A61K31/40; A61K31/405; A61K31/44; A61K31/505; A61K31/66; A61K47/10; A61K47/24; A61K47/26; A61P3/06; (IPC1-7): A61K31/216; A61K9/14; A61K9/20; A61K9/48; A61K47/10; A61K47/24; A61K47/26; A61P3/06
Foreign References:
| WO2000030616A1 | 2000-06-02 |
Attorney, Agent or Firm:
Kazuo Shamoto
Tadashi Masui
Yasushi Kobayashi
Akio Chiba
Hiroyuki Tomita
Hiroaki Noya
Tadashi Masui
Yasushi Kobayashi
Akio Chiba
Hiroyuki Tomita
Hiroaki Noya