WO2004037222A3 - Sustained-release tramadol formulations with 24-hour efficacy - Google Patents

Sustained-release tramadol formulations with 24-hour efficacy Download PDF

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Publication number
WO2004037222A3
WO2004037222A3 PCT/CA2003/001638 CA0301638W WO2004037222A3 WO 2004037222 A3 WO2004037222 A3 WO 2004037222A3 CA 0301638 W CA0301638 W CA 0301638W WO 2004037222 A3 WO2004037222 A3 WO 2004037222A3
Authority
WO
WIPO (PCT)
Prior art keywords
sustained
release tramadol
tramadol formulations
hour efficacy
efficacy
Prior art date
Application number
PCT/CA2003/001638
Other languages
French (fr)
Other versions
WO2004037222A2 (en
Inventor
Vincent Lenaerts
Patricia Laure Ouadji-Njiki
Jonathan Bacon
Rachid Ouzerourou
Sonia Gervais
Miloud Rahmouni
Damon Smith
Original Assignee
Labopharm Inc
Labopharm Barbados Ltd
Labopharm Europe Ltd
Vincent Lenaerts
Patricia Laure Ouadji-Njiki
Jonathan Bacon
Rachid Ouzerourou
Sonia Gervais
Miloud Rahmouni
Damon Smith
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32179487&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2004037222(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to UAA200504852A priority Critical patent/UA84277C2/en
Priority to DK03809237T priority patent/DK1594460T3/en
Priority to DE60320039T priority patent/DE60320039T2/en
Priority to BR0315659-1A priority patent/BR0315659A/en
Priority to JP2004545655A priority patent/JP2006507277A/en
Priority to CA002503155A priority patent/CA2503155A1/en
Priority to NZ539870A priority patent/NZ539870A/en
Priority to MXPA05004412A priority patent/MXPA05004412A/en
Priority to SI200331256T priority patent/SI1594460T1/en
Priority to EP03809237A priority patent/EP1594460B1/en
Priority to AU2003275855A priority patent/AU2003275855B2/en
Priority to CN2003801076188A priority patent/CN1942175B/en
Application filed by Labopharm Inc, Labopharm Barbados Ltd, Labopharm Europe Ltd, Vincent Lenaerts, Patricia Laure Ouadji-Njiki, Jonathan Bacon, Rachid Ouzerourou, Sonia Gervais, Miloud Rahmouni, Damon Smith filed Critical Labopharm Inc
Publication of WO2004037222A2 publication Critical patent/WO2004037222A2/en
Priority to IL168114A priority patent/IL168114A/en
Priority to US11/112,008 priority patent/US7988998B2/en
Priority to NO20052479A priority patent/NO20052479D0/en
Publication of WO2004037222A3 publication Critical patent/WO2004037222A3/en
Priority to HK07109421.3A priority patent/HK1101355A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin

Abstract

A sustained-release tramadol formulation oral administration is provided which, upon initial administration of one dose, provides an analgesic effect within 2 hours, which analgesic effect continues for at least 24 hours after administration.
PCT/CA2003/001638 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy WO2004037222A2 (en)

Priority Applications (16)

Application Number Priority Date Filing Date Title
DK03809237T DK1594460T3 (en) 2002-10-25 2003-10-27 Extended release tramadol formulations and 24 hour efficacy
EP03809237A EP1594460B1 (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy
SI200331256T SI1594460T1 (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy
BR0315659-1A BR0315659A (en) 2002-10-25 2003-10-27 Oral pharmaceutical composition for once daily administration for controlled release of tramadol or a salt thereof
JP2004545655A JP2006507277A (en) 2002-10-25 2003-10-27 24 hour sustained release tramadol formulation
CA002503155A CA2503155A1 (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy
NZ539870A NZ539870A (en) 2002-10-25 2003-10-27 Sustained-release solid dosage tramadol formulations with 24-hour efficacy
MXPA05004412A MXPA05004412A (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy.
DE60320039T DE60320039T2 (en) 2002-10-25 2003-10-27 TRAMADOL FORMULATIONS WITH DELAYED RELEASE AND 24 HOUR EFFICACY
UAA200504852A UA84277C2 (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy
CN2003801076188A CN1942175B (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy
AU2003275855A AU2003275855B2 (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy
IL168114A IL168114A (en) 2002-10-25 2005-04-19 Sustained-release tramadol formulations and a tablet containing same
US11/112,008 US7988998B2 (en) 2002-10-25 2005-04-22 Sustained-release tramadol formulations with 24-hour efficacy
NO20052479A NO20052479D0 (en) 2002-10-25 2005-05-23 Delayed release tramadol formulations and 24 hour efficacy
HK07109421.3A HK1101355A1 (en) 2002-10-25 2007-08-29 Sustained-release tramadol formulations with 24-hour efficacy 24

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US28102602A 2002-10-25 2002-10-25
US10/281,026 2002-10-25
US51037803P 2003-10-10 2003-10-10
US60/510,378 2003-10-10

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/112,008 Continuation US7988998B2 (en) 2002-10-25 2005-04-22 Sustained-release tramadol formulations with 24-hour efficacy

Publications (2)

Publication Number Publication Date
WO2004037222A2 WO2004037222A2 (en) 2004-05-06
WO2004037222A3 true WO2004037222A3 (en) 2005-09-22

Family

ID=32179487

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2003/001638 WO2004037222A2 (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy

Country Status (11)

Country Link
JP (1) JP2006507277A (en)
KR (1) KR20050083816A (en)
AR (1) AR045972A1 (en)
AU (1) AU2003275855B2 (en)
CA (1) CA2503155A1 (en)
IL (1) IL168114A (en)
NO (1) NO20052479D0 (en)
PT (1) PT1594460E (en)
RU (1) RU2328275C2 (en)
UA (1) UA84277C2 (en)
WO (1) WO2004037222A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8962019B2 (en) 2005-09-09 2015-02-24 Angelini Pharma, Inc. Sustained drug release composition

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US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
US8487002B2 (en) 2002-10-25 2013-07-16 Paladin Labs Inc. Controlled-release compositions
TWI319713B (en) 2002-10-25 2010-01-21 Sustained-release tramadol formulations with 24-hour efficacy
EP1905435A3 (en) * 2003-03-11 2008-05-14 Euro-Celtique S.A. Titration dosing regimen for controlled release tramadol
US7413749B2 (en) 2003-03-11 2008-08-19 Purdue Pharma L.P. Titration dosing regimen for controlled release tramadol
DE10336400A1 (en) 2003-08-06 2005-03-24 Grünenthal GmbH Anti-abuse dosage form
DE10361596A1 (en) 2003-12-24 2005-09-29 Grünenthal GmbH Process for producing an anti-abuse dosage form
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE102005005446A1 (en) 2005-02-04 2006-08-10 Grünenthal GmbH Break-resistant dosage forms with sustained release
EA013261B1 (en) * 2004-05-14 2010-04-30 Янссен Фармацевтика, Н.В. Carboxamido opioid compounds
DE102004032049A1 (en) 2004-07-01 2006-01-19 Grünenthal GmbH Anti-abuse, oral dosage form
DE102005005449A1 (en) 2005-02-04 2006-08-10 Grünenthal GmbH Process for producing an anti-abuse dosage form
US20090169617A1 (en) * 2006-04-26 2009-07-02 Panagiotis Keramidas Controlled Release Formulations Comprising Uncoated Discrete Unit(s) and an Extended Release Matrix
RU2493830C2 (en) 2008-01-25 2013-09-27 Грюненталь Гмбх Drug form
AU2009243681B2 (en) 2008-05-09 2013-12-19 Grunenthal Gmbh Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
EA022565B1 (en) 2008-05-27 2016-01-29 Дзе Юниверсити Оф Мельбурн Methods of treating mammals with eustachian tube dysfunctions
US20100104638A1 (en) * 2008-10-27 2010-04-29 Wei-Guo Dai Extended release oral acetaminophen/tramadol dosage form
EP2997965B1 (en) 2009-07-22 2019-01-02 Grünenthal GmbH Tamper-resistant dosage form for oxidation-sensitive opioids
PL2456427T3 (en) 2009-07-22 2015-07-31 Gruenenthal Gmbh Hot-melt extruded controlled release dosage form
ES2606227T3 (en) 2010-02-03 2017-03-23 Grünenthal GmbH Preparation of a pharmaceutical powder composition by an extruder
TWI516286B (en) 2010-09-02 2016-01-11 歌林達股份有限公司 Tamper resistant dosage form comprising an anionic polymer
MX2013002377A (en) 2010-09-02 2013-04-29 Gruenenthal Gmbh Tamper resistant dosage form comprising inorganic salt.
LT2736495T (en) 2011-07-29 2017-11-10 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
BR112014001091A2 (en) 2011-07-29 2017-02-14 Gruenenthal Gmbh tamper resistant tablet that provides immediate release of the drug
BR112014019988A8 (en) 2012-02-28 2017-07-11 Gruenenthal Gmbh BREAK-RESISTANT DOSAGE FORM COMPRISING A PHARMACOLOGICALLY ACTIVE COMPOUND AND AN ANIONIC POLYMER
AR090695A1 (en) 2012-04-18 2014-12-03 Gruenenthal Gmbh PHARMACEUTICAL DOSAGE FORM RESISTANT TO ADULTERATION AND RESISTANT TO IMMEDIATE RELEASE OF DOSE
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
CA2907950A1 (en) 2013-05-29 2014-12-04 Grunenthal Gmbh Tamper-resistant dosage form containing one or more particles
JP6466417B2 (en) 2013-05-29 2019-02-06 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング A tamper-resistant dosage form with a bimodal release profile
MX368846B (en) 2013-07-12 2019-10-18 Gruenenthal Gmbh Tamper-resistant dosage form containing ethylene-vinyl acetate polymer.
CA2931553C (en) 2013-11-26 2022-01-18 Grunenthal Gmbh Preparation of a powdery pharmaceutical composition by means of cryo-milling
CA2947786A1 (en) 2014-05-12 2015-11-19 Grunenthal Gmbh Tamper resistant immediate release capsule formulation comprising tapentadol
EP3148512A1 (en) 2014-05-26 2017-04-05 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
EP3285745A1 (en) 2015-04-24 2018-02-28 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
JP2018526414A (en) 2015-09-10 2018-09-13 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング Protection against oral overdose with abuse-inhibiting immediate release formulations
WO2017192923A1 (en) * 2016-05-05 2017-11-09 Monosol Rx, Llc Pharmaceutical compositions with enhanced permeation

Citations (3)

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EP0624366A1 (en) * 1993-05-10 1994-11-17 Euroceltique S.A. Controlled release formulation containing tramadol
US5776492A (en) * 1995-08-19 1998-07-07 Gruenenthal Gmbh Rapidly disintegrating medicinal form of tramadol or a tramadol salt
WO1999001111A1 (en) * 1997-07-02 1999-01-14 Euro-Celtique, S.A. Stabilized sustained release tramadol formulations

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US6607748B1 (en) * 2000-06-29 2003-08-19 Vincent Lenaerts Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture
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Patent Citations (3)

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Publication number Priority date Publication date Assignee Title
EP0624366A1 (en) * 1993-05-10 1994-11-17 Euroceltique S.A. Controlled release formulation containing tramadol
US5776492A (en) * 1995-08-19 1998-07-07 Gruenenthal Gmbh Rapidly disintegrating medicinal form of tramadol or a tramadol salt
WO1999001111A1 (en) * 1997-07-02 1999-01-14 Euro-Celtique, S.A. Stabilized sustained release tramadol formulations

Non-Patent Citations (2)

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L. ADLER ET AL.: "A Comparison of Once-Daily Tramadol with Normal Release Tramadol in the Treatment of Pain in Osteoarthritis", THE JOURNAL OF RHEUMATOLOGY, vol. 29, no. 10, 2002, pages 2196 - 2199, XP009029330 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8962019B2 (en) 2005-09-09 2015-02-24 Angelini Pharma, Inc. Sustained drug release composition
US9439866B2 (en) 2005-09-09 2016-09-13 Angelini Pharma, Inc. Trazodone composition for once a day administration

Also Published As

Publication number Publication date
RU2005115855A (en) 2006-01-20
UA84277C2 (en) 2008-10-10
JP2006507277A (en) 2006-03-02
NO20052479L (en) 2005-05-23
AU2003275855A1 (en) 2004-05-13
AU2003275855B2 (en) 2009-04-23
AR045972A1 (en) 2005-11-23
WO2004037222A2 (en) 2004-05-06
KR20050083816A (en) 2005-08-26
NO20052479D0 (en) 2005-05-23
IL168114A (en) 2011-05-31
PT1594460E (en) 2008-06-27
RU2328275C2 (en) 2008-07-10
CA2503155A1 (en) 2004-05-06

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