CN101378735B - 芬太尼舌下喷雾剂 - Google Patents

芬太尼舌下喷雾剂 Download PDF

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Publication number
CN101378735B
CN101378735B CN200780003555XA CN200780003555A CN101378735B CN 101378735 B CN101378735 B CN 101378735B CN 200780003555X A CN200780003555X A CN 200780003555XA CN 200780003555 A CN200780003555 A CN 200780003555A CN 101378735 B CN101378735 B CN 101378735B
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China
Prior art keywords
fentanyl
microns
sublingual
formulation
dose
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CN200780003555XA
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English (en)
Chinese (zh)
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CN101378735A (zh
Inventor
S·G·科台尔
V·R·高斯康达
Z·朱
L·卡托卡拉安
N·N·帕里克
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Korea Biopharmaceutical Co Ltd
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Insys Therapeutics Inc
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Publication of CN101378735A publication Critical patent/CN101378735A/zh
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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
    • A61K31/44—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
    • 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
    • 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
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • 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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN200780003555XA 2006-01-25 2007-01-25 芬太尼舌下喷雾剂 Active CN101378735B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US76205706P 2006-01-25 2006-01-25
US60/762,057 2006-01-25
PCT/US2007/002163 WO2007087431A2 (en) 2006-01-25 2007-01-25 Sublingual fentanyl spray

Publications (2)

Publication Number Publication Date
CN101378735A CN101378735A (zh) 2009-03-04
CN101378735B true CN101378735B (zh) 2013-04-03

Family

ID=38309867

Family Applications (1)

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CN200780003555XA Active CN101378735B (zh) 2006-01-25 2007-01-25 芬太尼舌下喷雾剂

Country Status (16)

Country Link
US (6) US8486972B2 (enExample)
EP (2) EP2641595A1 (enExample)
JP (3) JP5241514B2 (enExample)
CN (1) CN101378735B (enExample)
AU (1) AU2007208229B2 (enExample)
BR (1) BRPI0707235B8 (enExample)
CA (1) CA2637672C (enExample)
DK (1) DK1976521T3 (enExample)
ES (1) ES2535233T3 (enExample)
MX (3) MX374396B (enExample)
NZ (1) NZ569949A (enExample)
PL (1) PL1976521T3 (enExample)
PT (1) PT1976521E (enExample)
RU (1) RU2432950C2 (enExample)
SI (1) SI1976521T1 (enExample)
WO (1) WO2007087431A2 (enExample)

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Publication number Publication date
EP1976521A4 (en) 2010-11-03
US20170202820A1 (en) 2017-07-20
CA2637672C (en) 2012-07-24
MX374396B (es) 2025-03-06
US20140343100A1 (en) 2014-11-20
BRPI0707235B8 (pt) 2021-05-25
BRPI0707235A2 (pt) 2011-04-26
RU2008130763A (ru) 2010-02-27
US20160193142A1 (en) 2016-07-07
AU2007208229A1 (en) 2007-08-02
US9289387B2 (en) 2016-03-22
CN101378735A (zh) 2009-03-04
JP2009528272A (ja) 2009-08-06
JP5241514B2 (ja) 2013-07-17
WO2007087431A3 (en) 2008-09-25
PL1976521T3 (pl) 2015-10-30
US10016403B2 (en) 2018-07-10
MX2008009522A (es) 2009-01-07
BRPI0707235B1 (pt) 2020-04-14
JP2013127003A (ja) 2013-06-27
US20130327321A1 (en) 2013-12-12
EP1976521B1 (en) 2015-03-11
RU2432950C2 (ru) 2011-11-10
CA2637672A1 (en) 2007-08-02
AU2007208229B2 (en) 2009-11-05
DK1976521T3 (en) 2015-04-27
EP1976521A2 (en) 2008-10-08
WO2007087431A2 (en) 2007-08-02
US9642797B2 (en) 2017-05-09
MX2020008616A (es) 2020-09-21
EP2641595A1 (en) 2013-09-25
JP2013056928A (ja) 2013-03-28
US8835460B2 (en) 2014-09-16
PT1976521E (pt) 2015-06-09
NZ569949A (en) 2011-10-28
US20070261695A1 (en) 2007-11-15
US20180303813A1 (en) 2018-10-25
US8486972B2 (en) 2013-07-16
SI1976521T1 (sl) 2015-06-30
ES2535233T3 (es) 2015-05-06
JP5630877B2 (ja) 2014-11-26

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