Title:
オピオイドおよび非オピオイド鎮痛薬の制御放出製剤
Document Type and Number:
Japanese Patent JP2007506766
Kind Code:
A
Abstract:
Sustained release dosage forms for twice daily oral dosing to a human patient for providing relief from pain are provided. The sustained release dosage form comprises an immediate release component and a sustained release component, wherein the immediate release component and the sustained release component collectively contain a therapeutically effective amount of an opioid analgesic and a therapeutically effective amount of nonopioid analgesic. In a preferred embodiment, the nonopioid analgesic is acetaminophen and the opioid analgesic is hydrocodone and pharmaceutically acceptable salts thereof, and in preferred embodiments, the pharmaceutically acceptable salt is bitartrate. The dosage forms produce plasma profiles in a patient characterized by a Cmax for hydrocodone of between about 0.6 ng/mL/mg to about 1.4 ng/mL/mg and an AUC for hydrocodone of between about 9.1 ng*hr/mL/mg to about 19.9 ng*hr/mL/mg (per mg hydrocodone bitartrate administered) and a Cmax for acetaminophen of between about 2.8 ng/mL/mg and 7.9 ng/mL/mg and an AUC for acetaminophen of between about 28.6 ng*hr/mL/mg and about 59.1 ng*hr/mL/mg (per mg acetaminophen administered) after a single dose.
Inventors:
Cruz, evangeline
Ator, ator day
Polok, Brenda
Garcia, Carmelita
Lee, Chierry
Wong, Alfredo M
Hamel, Larry Gee
Han, you
Ator, ator day
Polok, Brenda
Garcia, Carmelita
Lee, Chierry
Wong, Alfredo M
Hamel, Larry Gee
Han, you
Application Number:
JP2006528230A
Publication Date:
March 22, 2007
Filing Date:
September 24, 2004
Export Citation:
Assignee:
Alza Corporation
International Classes:
A61K31/485; A61K9/00; A61K9/24; A61K9/28; A61K9/48; A61K9/52; A61K31/00; A61K31/16; A61K31/165; A61K31/167; A61K45/06; A61K47/14; A61P25/04; A61P43/00; A61K9/20; A61K9/50
Domestic Patent References:
| JPS63297319A | 1988-12-05 | |||
| JP2002505274A | 2002-02-19 |
Foreign References:
| US4946685A | 1990-08-07 | |||
| US20030092724A1 | 2003-05-15 |
Attorney, Agent or Firm:
Heikichi Odashima