US20040214849A1 - Parenteral administration of 6-hydroxy-oxymorphone for use as an analgesic - Google Patents

Parenteral administration of 6-hydroxy-oxymorphone for use as an analgesic Download PDF

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Publication number
US20040214849A1
US20040214849A1 US10/189,653 US18965302A US2004214849A1 US 20040214849 A1 US20040214849 A1 US 20040214849A1 US 18965302 A US18965302 A US 18965302A US 2004214849 A1 US2004214849 A1 US 2004214849A1
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United States
Prior art keywords
oxymorphone
hydroxy
hydroxy oxymorphone
pharmaceutical composition
blood plasma
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US10/189,653
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English (en)
Inventor
Huai-Hung Kao
Richard Smith-Carliss
Troy McCall
David Lee
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Endo Pharmaceuticals Inc
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Endo Pharmaceuticals Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27501826&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20040214849(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Endo Pharmaceuticals Inc filed Critical Endo Pharmaceuticals Inc
Priority to US10/189,653 priority Critical patent/US20040214849A1/en
Assigned to ENDO PHARMACEUTICALS, INC. reassignment ENDO PHARMACEUTICALS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LEE, DAVID, SMITH-CARLISS, RICHARD, KAO, HUAI-HUNG, MCCALL, TROY
Publication of US20040214849A1 publication Critical patent/US20040214849A1/en
Abandoned legal-status Critical Current

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    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2009—Inorganic 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
    • A61K9/20—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
    • 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
    • A61K9/20—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
    • 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]

Definitions

  • the invention relates to methods for alleviating pain. More particularly, the invention relates to methods for alleviating pain by administering 6-hydroxy oxymorphone. Most particularly, the invention relates to methods of inducing analgesia by increasing blood plasma levels of 6-hydroxy oxymorphone.
  • the present invention provides methods for treating pain by administration of a pharmaceutical composition comprising 6-hydroxy oxymorphone in an amount sufficient to induce analgesia.
  • the pharmaceutical composition is administered parenterally, preferably by injection and intravenous drip.
  • blood plasma levels of 6-hydroxy oxymorphone are raised to at least approximately 0.05 ng/mL.
  • Methods for administering compositions comprising 6-hydroxy oxymorphone, and one or more carriers, diluents, and excipients in an amount sufficient to induce analgesia are also provided.
  • FIG. 1 is a phannacokinetic profile for 6-hydroxy oxymorphone with PID scores.
  • FIG. 2 is a pharmacokinetic profile for oxymorphone with PID scores.
  • FIG. 3 is a pharmacokinetic profile for 6-hydroxy oxymorphone with categorical pain scores.
  • FIG. 4 is a pharmacokinetic profile for oxymorphone with categorical pain scores.
  • compositions containing 6-hydroxy oxymorphone as an active ingredient.
  • the composition comprising 6-hydroxy oxymorphone alone (excepting, of course, carriers, diluents, and other excipients),
  • 6-hydorxy oxymorphone may be combined with other opioids or other pharmaceutical agents.
  • compositions comprising both 6-hydroxy oxymorphone and its parent, oxymorphone.
  • FIGS. 1-4 show graphical representation of the data combining the two studies such that the effect of blood plasma levels on pain can be evaluated.
  • Oxymorphone levels peak within 2 hours, fall slightly, and plateau. Interestingly, the level spikes again at 4-6 hours from administration. After this time, oxymorphone levels again drop and eventually fall to levels near the earlier plateau.
  • 6-hydroxy oxymorphone blood plasma levels peak within 2 hours after administration. After the initial peak, however, a more or less steady decline in the 6-hydroxy oxymorphone's plasma levels is observed.
  • 6-hydroxy oxymorphone ensures immediate release into the blood stream and the quickest route to pain relief. Administration of a composition containing 6-hydroxy oxymorphone by injection, IV drip, or other means is most effective. Regardless of the actual route of administration, an amount of 6-hydroxy oxymorphone sufficient to induce analgesia will be supplied. Blood plasma levels of 6-hydroxy oxymorphone must be raised to levels sufficient to induce the desired level of analgesia.
  • the amount administered will be dependent upon normal criteria such as patient weight, intensity of pain, and other factors. Based on the pharmacokinetic studies blood plasma levels around at least 0.05 ng/mL will provide some analgesia. The upper plasma level limit will be ultimately established by safety concerns. Over-dosing of any opioid, including 6-hydroxy oxymorphone, can lead to respiratory failure and other undesirable side effects, and can even result in death. Preferably, the blood plasma level of 6-hydroxy oxymorphone will be raised to at least 0.075 ng/mL. Subsequent doses may be required to maintain these blood levels.
  • the preferred administration is of 6-hydroxy oxymorphone with appropriate carriers and excipients as will be readily apparent to those skilled in the art.
  • the resulting blood plasma in these preferred administrations will therefore be substantially free of oxymorphone.

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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)
US10/189,653 2001-07-06 2002-07-03 Parenteral administration of 6-hydroxy-oxymorphone for use as an analgesic Abandoned US20040214849A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US10/189,653 US20040214849A1 (en) 2001-07-06 2002-07-03 Parenteral administration of 6-hydroxy-oxymorphone for use as an analgesic

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
US10/189,653 US20040214849A1 (en) 2001-07-06 2002-07-03 Parenteral administration of 6-hydroxy-oxymorphone for use as an analgesic

Publications (1)

Publication Number Publication Date
US20040214849A1 true US20040214849A1 (en) 2004-10-28

Family

ID=27501826

Family Applications (13)

Application Number Title Priority Date Filing Date
US10/189,653 Abandoned US20040214849A1 (en) 2001-07-06 2002-07-03 Parenteral administration of 6-hydroxy-oxymorphone for use as an analgesic
US10/190,192 Expired - Fee Related US9820982B2 (en) 2001-07-06 2002-07-03 Oxymorphone controlled release formulations
US10/189,897 Abandoned US20030130297A1 (en) 2001-07-06 2002-07-03 Oral administration of 6-hydroxy-oxymorphone for use as an analgesic
US11/425,966 Abandoned US20070098792A1 (en) 2001-07-06 2006-06-22 Oxymorphone controlled release formulations
US11/426,170 Abandoned US20070098793A1 (en) 2001-07-06 2006-06-23 Oxymorphone controlled release formulations
US11/680,432 Expired - Lifetime US8309122B2 (en) 2001-07-06 2007-02-28 Oxymorphone controlled release formulations
US12/167,859 Abandoned US20080262013A1 (en) 2001-07-06 2008-07-03 Oxymorphone controlled release formulations
US12/426,112 Abandoned US20090192183A1 (en) 2001-07-06 2009-04-17 Oxymorphone Controlled Release Formulations
US13/908,328 Abandoned US20140134250A1 (en) 2001-07-06 2013-06-03 Oxymorphone controlled release formulations
US14/492,701 Abandoned US20150011577A1 (en) 2001-07-06 2014-09-22 Oxymorphone controlled release formulations
US14/798,619 Abandoned US20160136152A1 (en) 2001-07-06 2015-07-14 Oxymorphone controlled release compositions
US16/049,390 Abandoned US20180338967A1 (en) 2001-07-06 2018-07-30 Oxymorphone controlled release compositions
US17/035,453 Abandoned US20210008063A1 (en) 2001-07-06 2020-09-28 Oxymorphone controlled release compositions

Family Applications After (12)

Application Number Title Priority Date Filing Date
US10/190,192 Expired - Fee Related US9820982B2 (en) 2001-07-06 2002-07-03 Oxymorphone controlled release formulations
US10/189,897 Abandoned US20030130297A1 (en) 2001-07-06 2002-07-03 Oral administration of 6-hydroxy-oxymorphone for use as an analgesic
US11/425,966 Abandoned US20070098792A1 (en) 2001-07-06 2006-06-22 Oxymorphone controlled release formulations
US11/426,170 Abandoned US20070098793A1 (en) 2001-07-06 2006-06-23 Oxymorphone controlled release formulations
US11/680,432 Expired - Lifetime US8309122B2 (en) 2001-07-06 2007-02-28 Oxymorphone controlled release formulations
US12/167,859 Abandoned US20080262013A1 (en) 2001-07-06 2008-07-03 Oxymorphone controlled release formulations
US12/426,112 Abandoned US20090192183A1 (en) 2001-07-06 2009-04-17 Oxymorphone Controlled Release Formulations
US13/908,328 Abandoned US20140134250A1 (en) 2001-07-06 2013-06-03 Oxymorphone controlled release formulations
US14/492,701 Abandoned US20150011577A1 (en) 2001-07-06 2014-09-22 Oxymorphone controlled release formulations
US14/798,619 Abandoned US20160136152A1 (en) 2001-07-06 2015-07-14 Oxymorphone controlled release compositions
US16/049,390 Abandoned US20180338967A1 (en) 2001-07-06 2018-07-30 Oxymorphone controlled release compositions
US17/035,453 Abandoned US20210008063A1 (en) 2001-07-06 2020-09-28 Oxymorphone controlled release compositions

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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