Title:
延長された放出抑制性を有するオピオイド製剤
Document Type and Number:
Japanese Patent JP4712099
Kind Code:
B2
Abstract:
A solid, controlled release, oral dosage form, the dosage form comprising an analgesically effective amount of an opioid analgesic or a salt thereof, coated with a controlled-release coating or in a controlled-release matrix, wherein the dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method at 100 rpm at 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37° C is from about 12.5% to about 42.5% (by wt) opioid released after 1 hour, from about 25% to about 65% (by wt) opioid released after 2 hours, from about 45% to about 85% (by wt) opioid released after 4 hours and greater than 60% (by wt) opioid released after 8 hours, the in-vitro release rate being substantially independent of pH and chosen such that the peak plasma level of said opioid obtained in-vivo occurs from about 2 to about 6 hours after administration of the dosage form.
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Inventors:
Richard Sackler
Paul Goldenheim
Robert silkworm
Benjamin Oshurak
Mark chaisin
Frank Pedey
Paul Goldenheim
Robert silkworm
Benjamin Oshurak
Mark chaisin
Frank Pedey
Application Number:
JP2009047848A
Publication Date:
June 29, 2011
Filing Date:
March 02, 2009
Export Citation:
Assignee:
Euro-Certique S.A.
International Classes:
A61K9/52; A61K9/16; A61K9/58; A61K9/20; A61K9/22; A61K9/28; A61K9/50; A61K9/62; A61K31/445; A61K31/485; A61K31/522; A61K47/32; A61K47/36; A61K47/38; A61K47/42; A61K47/44; A61P25/04
Domestic Patent References:
| JP3002114A | ||||
| JP4505059B2 | ||||
| JP3061474B2 |
Other References:
月刊薬事,1989年,31(7),P.65-70
Attorney, Agent or Firm:
Hiroshi Kobayashi
Eiji Katayama
Junko Kobayashi
Norio Omori
Kyoei Sugiyama
Yasuhito Suzuki
Eiji Katayama
Junko Kobayashi
Norio Omori
Kyoei Sugiyama
Yasuhito Suzuki