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WO2001068140A3 - Opioid formulations - Google Patents

Opioid formulations Download PDF

Info

Publication number
WO2001068140A3
WO2001068140A3 PCT/US2001/006955 US0106955W WO0168140A3 WO 2001068140 A3 WO2001068140 A3 WO 2001068140A3 US 0106955 W US0106955 W US 0106955W WO 0168140 A3 WO0168140 A3 WO 0168140A3
Authority
WO
WIPO (PCT)
Prior art keywords
formulations
fentanyl
concentration
subject
further provides
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.)
Ceased
Application number
PCT/US2001/006955
Other languages
French (fr)
Other versions
WO2001068140A2 (en
Inventor
Dana Litmanovitz
Barbara J F Laidlaw
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Durect Corp
Original Assignee
Durect Corp
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 to AU2001243414A priority Critical patent/AU2001243414B2/en
Priority to CA002402865A priority patent/CA2402865A1/en
Priority to JP2001566703A priority patent/JP4969009B2/en
Priority to US10/220,525 priority patent/US7074803B2/en
Priority to AU4341401A priority patent/AU4341401A/en
Application filed by Durect Corp filed Critical Durect Corp
Publication of WO2001068140A2 publication Critical patent/WO2001068140A2/en
Publication of WO2001068140A3 publication Critical patent/WO2001068140A3/en
Priority to US10/188,325 priority patent/US6835194B2/en
Anticipated expiration legal-status Critical
Priority to US10/922,239 priority patent/US20050106205A1/en
Priority to US13/355,217 priority patent/US20120239007A1/en
Priority to US14/260,181 priority patent/US20140350053A1/en
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4468Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00Anaesthetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • 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]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Rheumatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Hydrogenated Pyridines (AREA)

Abstract

The present invention provides high-concentration formulations of opioids such as fentanyl or fentanyl congeners. The formulation of the invention comprises fentanyl or a fentanyl congener in concentrations significantly in excess of conventional formulations, e.g., on the order about 2-fold to about 10,000-fold greater than conventional formulations, e.g., currently commercially available formulations. These formulations are particularly useful for long-term delivery to a subject suffering from pain. The invention further provides drug delivery devices comprising the high-concentration opioid formulations, and further provides methods of alleviating pain in a subject, comprising administering the high-concentration formulations to a subject in need thereof.
PCT/US2001/006955 1999-03-18 2001-03-02 Opioid formulations Ceased WO2001068140A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
AU2001243414A AU2001243414B2 (en) 2000-03-10 2001-03-02 Opioid formulations
CA002402865A CA2402865A1 (en) 2000-03-10 2001-03-02 Opioid formulations
JP2001566703A JP4969009B2 (en) 2000-03-10 2001-03-02 Opioid formulation
US10/220,525 US7074803B2 (en) 2001-03-02 2001-03-02 Opioid formulations
AU4341401A AU4341401A (en) 2000-03-10 2001-03-02 Opioid formulations
US10/188,325 US6835194B2 (en) 1999-03-18 2002-06-27 Implantable devices and methods for treatment of pain by delivery of fentanyl and fentanyl congeners
US10/922,239 US20050106205A1 (en) 1999-03-18 2004-08-18 Implantable devices and methods for treatment of pain by delivery of fentanyl and fentanyl congeners
US13/355,217 US20120239007A1 (en) 1999-03-18 2012-01-20 Implantable Devices and Methods for Treatment of Pain by Delivery of Fentanyl and Fentanyl Congeners
US14/260,181 US20140350053A1 (en) 2000-03-10 2014-04-23 Opioid formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18826300P 2000-03-10 2000-03-10
US60/188,263 2000-03-10

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US09/522,535 Continuation-In-Part US6541021B1 (en) 1999-03-18 2000-03-10 Devices and methods for pain management

Related Child Applications (4)

Application Number Title Priority Date Filing Date
US10/220,525 A-371-Of-International US7074803B2 (en) 2000-03-10 2001-03-02 Opioid formulations
PCT/US2001/043143 Continuation-In-Part WO2002043800A2 (en) 1999-03-18 2001-11-21 Devices and methods for controlled delivery from a drug delivery device
US10/188,325 Continuation-In-Part US6835194B2 (en) 1999-03-18 2002-06-27 Implantable devices and methods for treatment of pain by delivery of fentanyl and fentanyl congeners
US11/477,140 Continuation US20070014820A1 (en) 2000-03-10 2006-06-27 Opioid formulations

Publications (2)

Publication Number Publication Date
WO2001068140A2 WO2001068140A2 (en) 2001-09-20
WO2001068140A3 true WO2001068140A3 (en) 2001-12-13

Family

ID=22692427

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/006955 Ceased WO2001068140A2 (en) 1999-03-18 2001-03-02 Opioid formulations

Country Status (4)

Country Link
JP (1) JP4969009B2 (en)
AU (2) AU4341401A (en)
CA (1) CA2402865A1 (en)
WO (1) WO2001068140A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0300531D0 (en) 2003-01-10 2003-02-12 West Pharm Serv Drug Res Ltd Pharmaceutical compositions
KR100912307B1 (en) * 2004-10-21 2009-08-14 유니버시티 오브 아이오와 리써치 파운데이션 In situ controlled release drug delivery system
US20140179740A1 (en) * 2012-12-21 2014-06-26 Mylan Inc. Stable liquid remifentanil formulations
JP6081240B2 (en) * 2013-03-13 2017-02-15 テルモ株式会社 Remifentanil injection
WO2016038734A1 (en) 2014-09-12 2016-03-17 テルモ株式会社 Remifentanil injection
US20180117012A1 (en) * 2016-10-31 2018-05-03 Teikoku Pharma Usa, Inc. Methods of Managing Pain Using Dexmedetomidine Transdermal Delivery Devices

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4588580A (en) * 1984-07-23 1986-05-13 Alza Corporation Transdermal administration of fentanyl and device therefor
WO1990007333A1 (en) * 1989-01-06 1990-07-12 Riker Laboratories, Inc. Fentanyl containing aerosol compositions
WO1997049402A1 (en) * 1996-06-27 1997-12-31 Janssen Pharmaceutica N.V. Sustained release sufentanil compositions
US5910301A (en) * 1994-05-13 1999-06-08 Aradigm Corporation Method of intrapulmonary administration of a narcotic drug
WO2000054745A2 (en) * 1999-03-18 2000-09-21 Durect Corporation Devices and methods for pain management

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ZA856002B (en) * 1984-08-10 1987-04-29 Du Pont Transdermal delivery of opioids
JPH05331064A (en) * 1992-05-26 1993-12-14 Sekisui Chem Co Ltd Anti-inflammatory analgesic plaster
JPH07206903A (en) * 1994-01-24 1995-08-08 Takeda Chem Ind Ltd Aggregate of super molecule structure type
JPH09176000A (en) * 1995-12-28 1997-07-08 Teijin Ltd Plaster for medical use

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4588580A (en) * 1984-07-23 1986-05-13 Alza Corporation Transdermal administration of fentanyl and device therefor
US4588580B1 (en) * 1984-07-23 1989-01-03
US4588580B2 (en) * 1984-07-23 1999-02-16 Alaz Corp Transdermal administration of fentanyl and device therefor
WO1990007333A1 (en) * 1989-01-06 1990-07-12 Riker Laboratories, Inc. Fentanyl containing aerosol compositions
US5910301A (en) * 1994-05-13 1999-06-08 Aradigm Corporation Method of intrapulmonary administration of a narcotic drug
WO1997049402A1 (en) * 1996-06-27 1997-12-31 Janssen Pharmaceutica N.V. Sustained release sufentanil compositions
WO2000054745A2 (en) * 1999-03-18 2000-09-21 Durect Corporation Devices and methods for pain management

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; 1995, RAMSAY E C ET AL: "Immobilization of black bears (Ursus americanus) with orally administered carfentanil citrate.", XP002175618, Database accession no. PREV199598404995 *
JOURNAL OF WILDLIFE DISEASES, vol. 31, no. 3, 1995, pages 391 - 393, ISSN: 0090-3558 *

Also Published As

Publication number Publication date
JP2003526680A (en) 2003-09-09
WO2001068140A2 (en) 2001-09-20
JP4969009B2 (en) 2012-07-04
AU2001243414B2 (en) 2005-05-19
AU4341401A (en) 2001-09-24
CA2402865A1 (en) 2001-09-20

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