WO2001085257A3 - Opioid antagonist compositions and dosage forms - Google Patents

Opioid antagonist compositions and dosage forms Download PDF

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Publication number
WO2001085257A3
WO2001085257A3 PCT/US2001/014377 US0114377W WO0185257A3 WO 2001085257 A3 WO2001085257 A3 WO 2001085257A3 US 0114377 W US0114377 W US 0114377W WO 0185257 A3 WO0185257 A3 WO 0185257A3
Authority
WO
WIPO (PCT)
Prior art keywords
opioid antagonist
dosage forms
active ingredient
disclosed
release
Prior art date
Application number
PCT/US2001/014377
Other languages
French (fr)
Other versions
WO2001085257A2 (en
Inventor
Barry Sherman
Mary Remien
Remi Barbier
James W Mcginity
Original Assignee
Pain Therapeutics Inc
Einstein Coll Med
Barry Sherman
Mary Remien
Remi Barbier
James W Mcginity
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, James W Mcginity filed Critical Pain Therapeutics Inc
Priority to AU2001259458A priority Critical patent/AU2001259458B2/en
Priority to EP01932983A priority patent/EP1284736A2/en
Priority to CA002408106A priority patent/CA2408106A1/en
Priority to JP2001581910A priority patent/JP2004515455A/en
Priority to AU5945801A priority patent/AU5945801A/en
Priority to PCT/US2001/014377 priority patent/WO2001085257A2/en
Publication of WO2001085257A2 publication Critical patent/WO2001085257A2/en
Publication of WO2001085257A3 publication Critical patent/WO2001085257A3/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
    • 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
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • 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
    • 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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • 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

The present invention is directed to novel dosage forms, pharmaceutical compositions, kits, and methods of administration of an opioid antagonist in an amount of at least about 0.0001 mg to about or less than about 1.0 mg, including from about 0.0001 mg to less than about 0.5 mg. Solid oral dosage forms are disclosed consisting essentially of an opioid antagonist or alternatively comprising an opioid antagonist and another active ingredient, such as an opioid agonist. Immediate release oral dosage forms are disclosed that release all or a substantial percentage of opioid antagonist, and another active ingredient when present, in a desired time. Concurrent release dosage forms are disclosed that provide concurrent release of an opioid antagonist and another active ingredient.
PCT/US2001/014377 2000-05-05 2001-05-04 Opioid antagonist compositions and dosage forms WO2001085257A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
AU2001259458A AU2001259458B2 (en) 2000-05-05 2001-05-04 Opioid antagonist compositions and dosage forms
EP01932983A EP1284736A2 (en) 2000-05-05 2001-05-04 Opioid antagonist compositions and dosage forms
CA002408106A CA2408106A1 (en) 2000-05-05 2001-05-04 Opioid antagonist compositions and dosage forms
JP2001581910A JP2004515455A (en) 2000-05-05 2001-05-04 Opioid antagonist compositions and dosage forms
AU5945801A AU5945801A (en) 2000-05-05 2001-05-04 Opoid antagonist compositions and dosage forms
PCT/US2001/014377 WO2001085257A2 (en) 2000-05-05 2001-05-04 Opioid antagonist compositions and dosage forms

Applications Claiming Priority (17)

Application Number Priority Date Filing Date Title
US20222700P 2000-05-05 2000-05-05
US20226800P 2000-05-05 2000-05-05
US56607100A 2000-05-05 2000-05-05
US09/566,071 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
USPCT/US00/12493WO 2000-05-05
US60/202,268 2000-05-05
US60/202,227 2000-05-05
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
PCT/US2001/014377 WO2001085257A2 (en) 2000-05-05 2001-05-04 Opioid antagonist compositions and dosage forms

Publications (2)

Publication Number Publication Date
WO2001085257A2 WO2001085257A2 (en) 2001-11-15
WO2001085257A3 true WO2001085257A3 (en) 2002-06-13

Family

ID=38051036

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/014377 WO2001085257A2 (en) 2000-05-05 2001-05-04 Opioid antagonist compositions and dosage forms

Country Status (5)

Country Link
EP (1) EP1284736A2 (en)
JP (1) JP2004515455A (en)
AU (1) AU5945801A (en)
CA (1) CA2408106A1 (en)
WO (1) WO2001085257A2 (en)

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US8846090B2 (en) 2002-04-05 2014-09-30 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
US8916195B2 (en) 2006-06-05 2014-12-23 Orexigen Therapeutics, Inc. Sustained release formulation of naltrexone
US8932630B1 (en) 1997-12-22 2015-01-13 Purdue Pharma L.P Opioid agonist/antagonist combinations
US8936812B2 (en) 2000-02-08 2015-01-20 Purdue Pharma L.P. Tamper-resistant oral opioid agonist formulations
US8969369B2 (en) 2001-05-11 2015-03-03 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9125868B2 (en) 2006-11-09 2015-09-08 Orexigen Therapeutics, Inc. Methods for administering weight loss medications
US9180125B2 (en) 2008-09-30 2015-11-10 Wyeth, Llc Peripheral opioid receptor antagonists and uses thereof
US9248123B2 (en) 2010-01-11 2016-02-02 Orexigen Therapeutics, Inc. Methods of providing weight loss therapy in patients with major depression
US9271940B2 (en) 2009-03-10 2016-03-01 Purdue Pharma L.P. Immediate release pharmaceutical compositions comprising oxycodone and naloxone
US9457005B2 (en) 2005-11-22 2016-10-04 Orexigen Therapeutics, Inc. Compositions and methods for increasing insulin sensitivity
US9526723B2 (en) 2008-03-21 2016-12-27 The University Of Chicago Treatment with opioid antagonists and mTOR inhibitors

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US6274591B1 (en) 1997-11-03 2001-08-14 Joseph F. Foss Use of methylnaltrexone and related compounds
AU2002239427A1 (en) * 2000-10-30 2002-06-03 Pain Therapeutics, Inc. Inhibitors of ABC drug transporters at the blood-brain barrier
US7968119B2 (en) 2001-06-26 2011-06-28 Farrell John J Tamper-proof narcotic delivery system
SI1416842T1 (en) 2001-07-18 2009-06-30 Euro Celtique Sa Pharmaceutical combinations of oxycodone and naloxone
ES2326794T3 (en) 2001-08-06 2009-10-20 Euro-Celtique S.A. FORMULATIONS OF OPIOID AGONISTS WITH LIBERABLE AND SEQUESTED ANTAGONISTS.
US20030157168A1 (en) 2001-08-06 2003-08-21 Christopher Breder Sequestered antagonist formulations
US8128957B1 (en) 2002-02-21 2012-03-06 Valeant International (Barbados) Srl Modified release compositions of at least one form of tramadol
WO2003077867A2 (en) * 2002-03-14 2003-09-25 Euro-Celtique, S.A. Naltrexone hydrochloride compositions
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US8518962B2 (en) 2005-03-07 2013-08-27 The University Of Chicago Use of opioid antagonists
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Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US9278073B2 (en) 2000-02-08 2016-03-08 Purdue Pharma L.P. Tamper-resistant oral opioid agonist formulations
US9456989B2 (en) 2000-02-08 2016-10-04 Purdue Pharma L.P. Tamper-resistant oral opioid agonist formulations
US8936812B2 (en) 2000-02-08 2015-01-20 Purdue Pharma L.P. Tamper-resistant oral opioid agonist formulations
US9161937B2 (en) 2001-05-11 2015-10-20 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
US9358230B1 (en) 2001-05-11 2016-06-07 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
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
US9283221B2 (en) 2001-05-11 2016-03-15 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
US8846090B2 (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
US8846091B2 (en) 2002-04-05 2014-09-30 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
US9457005B2 (en) 2005-11-22 2016-10-04 Orexigen Therapeutics, Inc. Compositions and methods for increasing insulin sensitivity
US9107837B2 (en) 2006-06-05 2015-08-18 Orexigen Therapeutics, Inc. Sustained release formulation of naltrexone
US8916195B2 (en) 2006-06-05 2014-12-23 Orexigen Therapeutics, Inc. Sustained release formulation of naltrexone
US9125868B2 (en) 2006-11-09 2015-09-08 Orexigen Therapeutics, Inc. Methods for administering weight loss medications
US9526723B2 (en) 2008-03-21 2016-12-27 The University Of Chicago Treatment with opioid antagonists and mTOR inhibitors
US9180125B2 (en) 2008-09-30 2015-11-10 Wyeth, Llc Peripheral opioid receptor antagonists and uses thereof
US9271940B2 (en) 2009-03-10 2016-03-01 Purdue Pharma L.P. Immediate release pharmaceutical compositions comprising oxycodone and naloxone
US9248123B2 (en) 2010-01-11 2016-02-02 Orexigen Therapeutics, Inc. Methods of providing weight loss therapy in patients with major depression

Also Published As

Publication number Publication date
CA2408106A1 (en) 2001-11-15
EP1284736A2 (en) 2003-02-26
WO2001085257A2 (en) 2001-11-15
AU5945801A (en) 2001-11-20
JP2004515455A (en) 2004-05-27

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