CA2417727A1 - Fentanyl composition for nasal administration - Google Patents

Fentanyl composition for nasal administration Download PDF

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Publication number
CA2417727A1
CA2417727A1 CA002417727A CA2417727A CA2417727A1 CA 2417727 A1 CA2417727 A1 CA 2417727A1 CA 002417727 A CA002417727 A CA 002417727A CA 2417727 A CA2417727 A CA 2417727A CA 2417727 A1 CA2417727 A1 CA 2417727A1
Authority
CA
Canada
Prior art keywords
fentanyl
administration
nasal administration
nasal
results
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.)
Granted
Application number
CA002417727A
Other languages
French (fr)
Other versions
CA2417727C (en
Inventor
Jesper Grarup
Hanne Wulff Nielsen
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.)
Takeda Pharma AS
Original Assignee
Nycomed Danmark A/S
Jesper Grarup
Hanne Wulff Nielsen
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=8159630&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2417727(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Nycomed Danmark A/S, Jesper Grarup, Hanne Wulff Nielsen filed Critical Nycomed Danmark A/S
Publication of CA2417727A1 publication Critical patent/CA2417727A1/en
Application granted granted Critical
Publication of CA2417727C publication Critical patent/CA2417727C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • 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
    • 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
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • 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
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Neurosurgery (AREA)
  • Anesthesiology (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Hydrogenated Pyridines (AREA)

Abstract

The treatment of acute pain with a sufficient dosage by intranasal administration of fentanyl results in a time to onset of action comparable to intravenous administration and a significantly faster onset of action than nasal titration of fentanyl. The nasal administration of a sufficient amount of fentanyl to obtain pain relief has lower maximum plasma concentrations comparable to intravenous administration and results in lower rates of adverse events like respiratory depression, nausea and vomiting. Compositions fur use in the method are also disclosed.
CA002417727A 2000-07-31 2001-07-31 Fentanyl composition for nasal administration Expired - Lifetime CA2417727C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DKPA200001154 2000-07-31
DKPA200001154 2000-07-31
PCT/DK2001/000521 WO2002009707A1 (en) 2000-07-31 2001-07-31 Fentanyl composition for nasal administration

Publications (2)

Publication Number Publication Date
CA2417727A1 true CA2417727A1 (en) 2002-02-07
CA2417727C CA2417727C (en) 2009-09-01

Family

ID=8159630

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002417727A Expired - Lifetime CA2417727C (en) 2000-07-31 2001-07-31 Fentanyl composition for nasal administration

Country Status (24)

Country Link
US (3) US8017627B2 (en)
EP (3) EP1642578B2 (en)
JP (2) JP4898073B2 (en)
KR (2) KR20080053423A (en)
CN (2) CN100346788C (en)
AT (1) ATE388705T1 (en)
AU (2) AU2001281746C1 (en)
CA (1) CA2417727C (en)
CY (2) CY1107405T1 (en)
DE (2) DE60133203T3 (en)
DK (2) DK1642578T3 (en)
EA (1) EA006384B1 (en)
EE (1) EE05420B1 (en)
ES (2) ES2427976T5 (en)
HK (1) HK1089106A1 (en)
IL (2) IL154041A0 (en)
IS (1) IS2803B (en)
NO (2) NO330565B1 (en)
NZ (1) NZ524396A (en)
PL (1) PL207845B1 (en)
PT (2) PT1642578E (en)
SI (2) SI1642578T2 (en)
UA (2) UA77398C2 (en)
WO (1) WO2002009707A1 (en)

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Also Published As

Publication number Publication date
IL154041A0 (en) 2003-07-31
KR20030034126A (en) 2003-05-01
ES2302742T5 (en) 2011-10-10
EP1642578A3 (en) 2006-09-27
DK1307194T4 (en) 2011-07-18
EA006384B1 (en) 2005-12-29
US8017627B2 (en) 2011-09-13
AU2001281746B2 (en) 2006-10-05
EP1307194A1 (en) 2003-05-07
HK1089106A1 (en) 2006-11-24
NO20110342L (en) 2003-03-31
ATE388705T1 (en) 2008-03-15
PL207845B1 (en) 2011-02-28
DK1307194T3 (en) 2008-07-14
JP4898073B2 (en) 2012-03-14
AU8174601A (en) 2002-02-13
SI1642578T2 (en) 2022-01-31
IL154041A (en) 2011-05-31
IS2803B (en) 2012-09-15
EP1642578A2 (en) 2006-04-05
US8653107B2 (en) 2014-02-18
ES2427976T3 (en) 2013-11-05
PT1307194E (en) 2008-05-27
KR100888275B1 (en) 2009-03-10
NO20030365D0 (en) 2003-01-24
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