WO2001085150A3 - Opioid antagonist containing composition for enchaching the potency or reducing adverse side effects ofopioid agonists - Google Patents

Opioid antagonist containing composition for enchaching the potency or reducing adverse side effects ofopioid agonists Download PDF

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Publication number
WO2001085150A3
WO2001085150A3 PCT/US2001/014644 US0114644W WO0185150A3 WO 2001085150 A3 WO2001085150 A3 WO 2001085150A3 US 0114644 W US0114644 W US 0114644W WO 0185150 A3 WO0185150 A3 WO 0185150A3
Authority
WO
WIPO (PCT)
Prior art keywords
adverse side
potency
ofopioid
enchaching
agonists
Prior art date
Application number
PCT/US2001/014644
Other languages
French (fr)
Other versions
WO2001085150A2 (en
Inventor
Barry Sherman
Mary Remien
Remi Barbier
Kathleen Dumas
Grant Schoenhard
Original Assignee
Pain Therapeutics Inc
Einstein Coll Med
Barry Sherman
Mary Remien
Remi Barbier
Kathleen Dumas
Grant Schoenhard
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
Priority claimed from PCT/US2000/012493 external-priority patent/WO2000067739A2/en
Application filed by Pain Therapeutics Inc, Einstein Coll Med, Barry Sherman, Mary Remien, Remi Barbier, Kathleen Dumas, Grant Schoenhard filed Critical Pain Therapeutics Inc
Priority to JP2001581804A priority Critical patent/JP2004501094A/en
Priority to AU2001259560A priority patent/AU2001259560B2/en
Priority to EP01933110A priority patent/EP1280529A2/en
Priority to AU5956001A priority patent/AU5956001A/en
Priority to CA002408098A priority patent/CA2408098A1/en
Publication of WO2001085150A2 publication Critical patent/WO2001085150A2/en
Publication of WO2001085150A3 publication Critical patent/WO2001085150A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

0he invention generally relates to novel compositions and methods with an opioid agonist and an opioid antagonist to differentially dose a human subject so as to either enhance analgesic potency without attenuating an adverse side effect of the agonist, or alternatively maintain the analgesic potency of the agonist while attenuating an adverse side effect of the agonist. The invention additionally relates to novel opioid compositions and methods for the gender-based dosing of men and women.
PCT/US2001/014644 2000-05-05 2001-05-04 Opioid antagonist containing composition for enchaching the potency or reducing adverse side effects ofopioid agonists WO2001085150A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2001581804A JP2004501094A (en) 2000-05-05 2001-05-04 Novel compositions and methods for enhancing the efficacy of opioid agonists or reducing the deleterious side effects of opioid agonists
AU2001259560A AU2001259560B2 (en) 2000-05-05 2001-05-04 Opioid antagonist containing composition for enhancing the potency or reducing adverse side effects of opioid agonists
EP01933110A EP1280529A2 (en) 2000-05-05 2001-05-04 Opioid antagonist containing composition for enhancing the potency or reducing adverse side effects of opioid agonists
AU5956001A AU5956001A (en) 2000-05-05 2001-05-04 Novel compositions and methods for enhancing potency or reducing adverse side effects of opioid agonists
CA002408098A CA2408098A1 (en) 2000-05-05 2001-05-04 Opioid antagonist containing composition for enhancing the potency or reducing adverse side effects of opioid agonists

Applications Claiming Priority (16)

Application Number Priority Date Filing Date Title
US56607100A 2000-05-05 2000-05-05
US20222700P 2000-05-05 2000-05-05
US20226800P 2000-05-05 2000-05-05
USPCT/US00/12493WO 2000-05-05
US60/202,268 2000-05-05
US09/566,071 2000-05-05
US60/202,227 2000-05-05
PCT/US2000/012493 WO2000067739A2 (en) 1999-05-06 2000-05-05 Opioid antagonists containing compositions for enhancing analgesic potency of tramadol and attenuating its adverse side effects
US24448200P 2000-10-30 2000-10-30
US60/244,482 2000-10-30
US24511000P 2000-11-01 2000-11-01
US60/245,110 2000-11-01
US24623500P 2000-11-02 2000-11-02
US60/246,235 2000-11-02
US75633101A 2001-01-08 2001-01-08
US09/756,331 2001-01-08

Publications (2)

Publication Number Publication Date
WO2001085150A2 WO2001085150A2 (en) 2001-11-15
WO2001085150A3 true WO2001085150A3 (en) 2002-08-08

Family

ID=27573954

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/014644 WO2001085150A2 (en) 2000-05-05 2001-05-04 Opioid antagonist containing composition for enchaching the potency or reducing adverse side effects ofopioid agonists

Country Status (5)

Country Link
EP (1) EP1280529A2 (en)
JP (1) JP2004501094A (en)
AU (3) AU2001259560B2 (en)
CA (1) CA2408098A1 (en)
WO (1) WO2001085150A2 (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8846090B2 (en) 2002-04-05 2014-09-30 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
US8932630B1 (en) 1997-12-22 2015-01-13 Purdue Pharma L.P Opioid agonist/antagonist combinations
US8936808B1 (en) 1997-12-22 2015-01-20 Purdue Pharma L.P. Opioid agonist/opioid antagonist/acetaminophen combinations
US8969369B2 (en) 2001-05-11 2015-03-03 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9149436B2 (en) 2003-04-21 2015-10-06 Purdue Pharma L.P. Pharmaceutical product comprising a sequestered agent
US9271940B2 (en) 2009-03-10 2016-03-01 Purdue Pharma L.P. Immediate release pharmaceutical compositions comprising oxycodone and naloxone

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR031682A1 (en) * 1999-11-19 2003-10-01 Reckitt Benckiser Helthcare Uk PHARMACEUTICAL COMPOSITIONS
AU2002239427A1 (en) * 2000-10-30 2002-06-03 Pain Therapeutics, Inc. Inhibitors of ABC drug transporters at the blood-brain barrier
US20050245557A1 (en) * 2003-10-15 2005-11-03 Pain Therapeutics, Inc. Methods and materials useful for the treatment of arthritic conditions, inflammation associated with a chronic condition or chronic pain
CA2542395A1 (en) * 2003-10-15 2005-04-28 Pain Therapeutics, Inc. Treatment of arthritic conditions, chronic inflammation or pain
EP1702558A1 (en) 2005-02-28 2006-09-20 Euro-Celtique S.A. Method and device for the assessment of bowel function
WO2006126529A1 (en) * 2005-05-25 2006-11-30 Shionogi & Co., Ltd. 6,7-unsaturated-7-carbamoyl substituted morphinan derivative
US9226907B2 (en) * 2008-02-01 2016-01-05 Abbvie Inc. Extended release hydrocodone acetaminophen and related methods and uses thereof
WO2014210596A1 (en) * 2013-06-28 2014-12-31 Purdue Pharma L.P. Treating an arrhythmia with an opioid antagonist
NZ716267A (en) 2013-07-23 2017-05-26 Euro Celtique Sa A combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
EP3169315B1 (en) 2014-07-17 2020-06-24 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996002251A1 (en) * 1994-07-19 1996-02-01 Albert Einstein College Of Medicine Of Yeshiva University, A Division Of Yeshiva University Method of simultaneously enhancing analgesic potency and attenuating dependence liability caused by exogenous and endogenous opioid agonists
US5580876A (en) * 1992-09-21 1996-12-03 Albert Einstein College Of Medicine Of Yeshiva University, A Division Of Yeshiva University Method of simultaneously enhancing analgesic potency and attenuating dependence liability caused by morphine and other bimodally-acting opioid agonists
WO1999032119A1 (en) * 1997-12-22 1999-07-01 Euro-Celtique, S.A. Opioid agonist/antagonist combinations
WO1999032120A1 (en) * 1997-12-22 1999-07-01 Euro-Celtique, S.A. A method of preventing abuse of opioid dosage forms
WO2000001377A2 (en) * 1998-07-07 2000-01-13 David Lew Simon Nalmefene in combination with opioid analgesics

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5580876A (en) * 1992-09-21 1996-12-03 Albert Einstein College Of Medicine Of Yeshiva University, A Division Of Yeshiva University Method of simultaneously enhancing analgesic potency and attenuating dependence liability caused by morphine and other bimodally-acting opioid agonists
US5767125A (en) * 1992-09-21 1998-06-16 Albert Einstein College Of Medicine Of Yeshiva University, A Division Of Yeshiva University Method of simultaneously enhancing analgesic potency and attenuating dependence liability caused by morphine and other bimodally-acting opioid agonists
WO1996002251A1 (en) * 1994-07-19 1996-02-01 Albert Einstein College Of Medicine Of Yeshiva University, A Division Of Yeshiva University Method of simultaneously enhancing analgesic potency and attenuating dependence liability caused by exogenous and endogenous opioid agonists
WO1999032119A1 (en) * 1997-12-22 1999-07-01 Euro-Celtique, S.A. Opioid agonist/antagonist combinations
WO1999032120A1 (en) * 1997-12-22 1999-07-01 Euro-Celtique, S.A. A method of preventing abuse of opioid dosage forms
WO2000001377A2 (en) * 1998-07-07 2000-01-13 David Lew Simon Nalmefene in combination with opioid analgesics

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8936808B1 (en) 1997-12-22 2015-01-20 Purdue Pharma L.P. Opioid agonist/opioid antagonist/acetaminophen combinations
US9205082B2 (en) 1997-12-22 2015-12-08 Purdue Pharma L.P. Opioid agonist/antagonist combinations
US8932630B1 (en) 1997-12-22 2015-01-13 Purdue Pharma L.P Opioid agonist/antagonist combinations
US8969369B2 (en) 2001-05-11 2015-03-03 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9283216B2 (en) 2001-05-11 2016-03-15 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9511066B2 (en) 2001-05-11 2016-12-06 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9161937B2 (en) 2001-05-11 2015-10-20 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9168252B2 (en) 2001-05-11 2015-10-27 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9480685B2 (en) 2001-05-11 2016-11-01 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9358230B1 (en) 2001-05-11 2016-06-07 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9345701B1 (en) 2001-05-11 2016-05-24 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9283221B2 (en) 2001-05-11 2016-03-15 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US8846090B2 (en) 2002-04-05 2014-09-30 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
US8846091B2 (en) 2002-04-05 2014-09-30 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
US9555000B2 (en) 2002-04-05 2017-01-31 Purdue Pharma L.P. Pharmaceutical preparation containing oxycodone and naloxone
US9149436B2 (en) 2003-04-21 2015-10-06 Purdue Pharma L.P. Pharmaceutical product comprising a sequestered agent
US9271940B2 (en) 2009-03-10 2016-03-01 Purdue Pharma L.P. Immediate release pharmaceutical compositions comprising oxycodone and naloxone

Also Published As

Publication number Publication date
AU5956001A (en) 2001-11-20
AU2001259560B2 (en) 2007-02-15
JP2004501094A (en) 2004-01-15
CA2408098A1 (en) 2001-11-15
EP1280529A2 (en) 2003-02-05
WO2001085150A2 (en) 2001-11-15
AU2001259458B2 (en) 2006-09-14

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