JP4440635B2 - オキシモルホン放出制御性処方物 - Google Patents

オキシモルホン放出制御性処方物 Download PDF

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Publication number
JP4440635B2
JP4440635B2 JP2003510041A JP2003510041A JP4440635B2 JP 4440635 B2 JP4440635 B2 JP 4440635B2 JP 2003510041 A JP2003510041 A JP 2003510041A JP 2003510041 A JP2003510041 A JP 2003510041A JP 4440635 B2 JP4440635 B2 JP 4440635B2
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Prior art keywords
oxymorphone
hours
controlled release
treatment
release
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Expired - Fee Related
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JP2003510041A
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Japanese (ja)
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JP2004536832A (ja
Inventor
フアイ−フン カオ,
アナンド アール. バイクワル,
トロイ マコール,
デイビッド リー,
Original Assignee
エンドー ファーマシューティカルズ, インコーポレイティド
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Application filed by エンドー ファーマシューティカルズ, インコーポレイティド filed Critical エンドー ファーマシューティカルズ, インコーポレイティド
Publication of JP2004536832A publication Critical patent/JP2004536832A/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Dental Preparations (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2003510041A 2001-07-06 2002-07-03 オキシモルホン放出制御性処方物 Expired - Fee Related JP4440635B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US30335701P 2001-07-06 2001-07-06
US32943201P 2001-10-15 2001-10-15
US32944401P 2001-10-15 2001-10-15
US32944501P 2001-10-15 2001-10-15
PCT/US2002/021396 WO2003004030A1 (en) 2001-07-06 2002-07-03 Oxymorphone controlled release formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2009044920A Division JP2009114209A (ja) 2001-07-06 2009-02-26 オキシモルホン放出制御性処方物

Publications (2)

Publication Number Publication Date
JP2004536832A JP2004536832A (ja) 2004-12-09
JP4440635B2 true JP4440635B2 (ja) 2010-03-24

Family

ID=27501826

Family Applications (4)

Application Number Title Priority Date Filing Date
JP2003510043A Pending JP2005515966A (ja) 2001-07-06 2002-07-03 鎮痛薬としての使用のための6−ヒドロキシ−オキシモルホンの経口投与
JP2003510042A Pending JP2005520778A (ja) 2001-07-06 2002-07-03 鎮痛薬として使用するための6−ヒドロキシ−オキシモルホンの非経口投与
JP2003510041A Expired - Fee Related JP4440635B2 (ja) 2001-07-06 2002-07-03 オキシモルホン放出制御性処方物
JP2009044920A Pending JP2009114209A (ja) 2001-07-06 2009-02-26 オキシモルホン放出制御性処方物

Family Applications Before (2)

Application Number Title Priority Date Filing Date
JP2003510043A Pending JP2005515966A (ja) 2001-07-06 2002-07-03 鎮痛薬としての使用のための6−ヒドロキシ−オキシモルホンの経口投与
JP2003510042A Pending JP2005520778A (ja) 2001-07-06 2002-07-03 鎮痛薬として使用するための6−ヒドロキシ−オキシモルホンの非経口投与

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2009044920A Pending JP2009114209A (ja) 2001-07-06 2009-02-26 オキシモルホン放出制御性処方物

Country Status (13)

Country Link
US (13) US20040214849A1 (https=)
EP (4) EP2311460A1 (https=)
JP (4) JP2005515966A (https=)
KR (1) KR20030034171A (https=)
CN (3) CN1268338C (https=)
AT (1) ATE359077T1 (https=)
AU (3) AU2002318211B2 (https=)
BR (1) BR0205721A (https=)
CA (3) CA2452871C (https=)
DE (1) DE60219478T2 (https=)
ES (1) ES2284888T3 (https=)
NO (1) NO20031018L (https=)
WO (3) WO2003004032A1 (https=)

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US20080318993A1 (en) 2007-06-21 2008-12-25 Endo Pharmaceuticals, Inc. Method of Treating Pain Utilizing Controlled Release Oxymorphone Pharmaceutical Compositions and Instruction on Dosing for Hepatic Impairment

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US20070098793A1 (en) 2007-05-03
US20080262013A1 (en) 2008-10-23
US20160136152A1 (en) 2016-05-19
DE60219478T2 (de) 2008-01-03
US20090192183A1 (en) 2009-07-30
AU2002320309B2 (en) 2007-07-12
EP2311460A1 (en) 2011-04-20
JP2005520778A (ja) 2005-07-14
EP1414458B1 (en) 2007-04-11
WO2003004031A1 (en) 2003-01-16
DE60219478D1 (en) 2007-05-24
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NO20031018D0 (no) 2003-03-05
EP1406630A1 (en) 2004-04-14
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US20030130297A1 (en) 2003-07-10
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US20140134250A1 (en) 2014-05-15
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CN1610551A (zh) 2005-04-27
ES2284888T3 (es) 2007-11-16
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US20030157167A1 (en) 2003-08-21
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