ES2721899T3 - Composiciones farmacéuticas que comprenden fentanilo para su administración intranasal - Google Patents

Composiciones farmacéuticas que comprenden fentanilo para su administración intranasal Download PDF

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Publication number
ES2721899T3
ES2721899T3 ES11185114T ES11185114T ES2721899T3 ES 2721899 T3 ES2721899 T3 ES 2721899T3 ES 11185114 T ES11185114 T ES 11185114T ES 11185114 T ES11185114 T ES 11185114T ES 2721899 T3 ES2721899 T3 ES 2721899T3
Authority
ES
Spain
Prior art keywords
fentanyl
intranasal administration
aqueous solution
pharmaceutical compositions
composition
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.)
Expired - Lifetime
Application number
ES11185114T
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English (en)
Inventor
Jonathan David Castile
Peter James Watts
William Columbus Ian Lafferty
Alan Smith
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.)
Kyowa Kirin Services Ltd
Original Assignee
Archimedes Development Ltd
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=9950919&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2721899(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Archimedes Development Ltd filed Critical Archimedes Development Ltd
Application granted granted Critical
Publication of ES2721899T3 publication Critical patent/ES2721899T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/01Hydrocarbons
    • A61K31/015Hydrocarbons carbocyclic
    • 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
    • A61K47/26Carbohydrates, 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • 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
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/08Inhaling devices inserted into the nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • 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)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Otolaryngology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Hydrogenated Pyridines (AREA)

Abstract

Una composición para administración intranasal para su uso en el tratamiento o la prevención de dolor agudo o crónico, que comprende una solución acuosa de (i) fentanilo o de una sal farmacéuticamente aceptable del mismo y (ii) una pectina con un grado de esterificación (valor del DE) de desde el 5 al 30 %. con la condición de que la composición esté sustancialmente libre de iones metálicos divalentes; y que, en comparación con una solución acuosa simple de fentanilo administrada intranasalmente a la misma dosis, proporciona un pico de concentración plasmática de fentanilo (Cmáx) que es desde el 20 hasta el 75 % de aquel logrado usando una solución acuosa simple de fentanilo administrada intranasalmente a una dosis de fentanilo idéntica.
ES11185114T 2003-01-10 2004-01-12 Composiciones farmacéuticas que comprenden fentanilo para su administración intranasal Expired - Lifetime ES2721899T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GBGB0300531.1A GB0300531D0 (en) 2003-01-10 2003-01-10 Pharmaceutical compositions

Publications (1)

Publication Number Publication Date
ES2721899T3 true ES2721899T3 (es) 2019-08-06

Family

ID=9950919

Family Applications (2)

Application Number Title Priority Date Filing Date
ES04701381T Expired - Lifetime ES2432119T3 (es) 2003-01-10 2004-01-12 Composiciones farmacéuticas que comprenden fentanilo para su administración intranasal
ES11185114T Expired - Lifetime ES2721899T3 (es) 2003-01-10 2004-01-12 Composiciones farmacéuticas que comprenden fentanilo para su administración intranasal

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES04701381T Expired - Lifetime ES2432119T3 (es) 2003-01-10 2004-01-12 Composiciones farmacéuticas que comprenden fentanilo para su administración intranasal

Country Status (26)

Country Link
US (5) US20040166067A1 (es)
EP (2) EP2436375B1 (es)
JP (1) JP4827725B2 (es)
KR (3) KR20100118144A (es)
CN (1) CN100423709C (es)
AU (1) AU2004204381B2 (es)
BR (1) BRPI0406674B8 (es)
CA (1) CA2511974C (es)
CY (1) CY1115056T1 (es)
DK (1) DK1635783T5 (es)
EA (1) EA008500B1 (es)
ES (2) ES2432119T3 (es)
FR (1) FR14C0020I1 (es)
GB (1) GB0300531D0 (es)
GE (1) GEP20084340B (es)
HK (1) HK1088555A1 (es)
IL (1) IL169480A (es)
MX (1) MXPA05007333A (es)
NO (1) NO335127B1 (es)
NZ (1) NZ541018A (es)
PL (1) PL212950B1 (es)
PT (2) PT2436375T (es)
SI (1) SI1635783T1 (es)
UA (1) UA85050C2 (es)
WO (1) WO2004062561A2 (es)
ZA (1) ZA200505274B (es)

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PL2670674T3 (pl) 2011-02-04 2017-02-28 Archimedes Development Limited Ulepszony pojemnik
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Publication number Publication date
AU2004204381A1 (en) 2004-07-29
KR20050103275A (ko) 2005-10-28
IL169480A0 (en) 2007-07-04
SI1635783T1 (sl) 2013-11-29
PL377823A1 (pl) 2006-02-20
ES2432119T3 (es) 2013-11-29
KR101012148B1 (ko) 2011-02-07
BRPI0406674A (pt) 2005-12-20
US20080153879A1 (en) 2008-06-26
FR14C0020I1 (fr) 2014-04-18
US20120270903A1 (en) 2012-10-25
WO2004062561A2 (en) 2004-07-29
KR20090058596A (ko) 2009-06-09
US20150283123A1 (en) 2015-10-08
EA200501105A1 (ru) 2005-12-29
EA008500B1 (ru) 2007-06-29
US20120277267A1 (en) 2012-11-01
NZ541018A (en) 2008-07-31
CY1115056T1 (el) 2016-12-14
GB0300531D0 (en) 2003-02-12
PT2436375T (pt) 2019-05-24
EP1635783B1 (en) 2013-09-18
US8216604B2 (en) 2012-07-10
JP2006516272A (ja) 2006-06-29
BRPI0406674B8 (pt) 2021-05-25
NO20053119L (no) 2005-08-03
PL212950B1 (pl) 2012-12-31
AU2004204381B2 (en) 2010-11-25
NO335127B1 (no) 2014-09-22
CN1723012A (zh) 2006-01-18
PT1635783E (pt) 2013-10-29
US8889176B2 (en) 2014-11-18
WO2004062561A3 (en) 2004-10-07
US20040166067A1 (en) 2004-08-26
EP1635783A2 (en) 2006-03-22
CA2511974C (en) 2011-03-01
EP2436375B1 (en) 2019-02-27
US9814705B2 (en) 2017-11-14
DK1635783T5 (da) 2014-05-12
CA2511974A1 (en) 2004-07-29
GEP20084340B (en) 2008-03-25
CN100423709C (zh) 2008-10-08
NO20053119D0 (no) 2005-06-24
UA85050C2 (ru) 2008-12-25
ZA200505274B (en) 2014-09-25
DK1635783T3 (da) 2013-10-14
HK1088555A1 (en) 2006-11-10
EP2436375A1 (en) 2012-04-04
KR20100118144A (ko) 2010-11-04
MXPA05007333A (es) 2006-02-17
JP4827725B2 (ja) 2011-11-30
IL169480A (en) 2013-10-31
US9078814B2 (en) 2015-07-14
AU2004204381A2 (en) 2004-07-29
BRPI0406674B1 (pt) 2015-12-22

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