DK1976521T3 - Sublingual fentanyl-spray - Google Patents

Sublingual fentanyl-spray Download PDF

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Publication number
DK1976521T3
DK1976521T3 DK07762549T DK07762549T DK1976521T3 DK 1976521 T3 DK1976521 T3 DK 1976521T3 DK 07762549 T DK07762549 T DK 07762549T DK 07762549 T DK07762549 T DK 07762549T DK 1976521 T3 DK1976521 T3 DK 1976521T3
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DK
Denmark
Prior art keywords
fentanyl
formulation
microns
sublingual
dose
Prior art date
Application number
DK07762549T
Other languages
English (en)
Inventor
S George Kottayil
Venkat R Goskonda
Zhongyuan Zhu
Linet Kattookaran
Neha N Parikh
Original Assignee
Insys Therapeutics Inc
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=38309867&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1976521(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Insys Therapeutics Inc filed Critical Insys Therapeutics Inc
Application granted granted Critical
Publication of DK1976521T3 publication Critical patent/DK1976521T3/da

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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
    • 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)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (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)

Claims (11)

1. Sublingual fentanylformulering uden drivmiddel omfattende diskrete væskedråber af en effektiv mængde fentanyl i en farmaceutisk acceptabel væskebærer, hvilke dråber har en middeldiameter på mindst ca. 10 mikron, hvor fentanylformuleringen er konfigureret til sublingual levering og hvor den sublinguale formulering omfatter fra ca. 0,1 til ca. 0,8 vægtprocent fentanyl eller et farmaceutisk acceptabelt salt deraf; fra ca. 20 til ca. 60 vægtprocent ethanol; og fra ca. 4 til ca. 6 vægtprocent propylenglycol.
2. Sublingual fentanylformulering ifølge krav 1, hvor de diskrete væskedråber har en størrelsesfordeling på fra ca. 10 til ca. 200 pm.
3. Sublingual fentanylformulering ifølge krav 1, hvor væskedråberne haren middeldiameter på mindst ca. 20 mikron.
4. Sublingual fentanylformulering ifølge krav 1, yderligere omfattende en absorptionsforstærker, idet formuleringen omfatter fra ca. 0,001 til ca. 10 vægtprocent af en absorptionsforstærker.
5. Sublingual fentanylformulering ifølge krav 4, hvor absorptionsforstærkeren er triacetin.
6. Enhedsdosisindretning til sublingual administration afen sublingual fentanylformulering ifølge et hvilket som helst af de foregående krav omfattende: en beholder indeholdende en enhedsdosis af den sublinguale fentanylformulering; og en aktuator der når den aktiveres udleverer en terapeutisk effektiv dosis af den flydende formulering i form af væskedråber med en middeldiameter på mindst ca. 10 mikron, og hvor den leverede enhedsdosis omfatter fra ca. 10 pg til ca. 10 mg fentanyl eller et farmaceutisk acceptabelt salt deraf.
7. Enhedsdosisindretning ifølge krav 6, yderligere omfattende en lukker omfattende et materiale der udelukker eller i det væsentlige udelukker absorptionen af fentanyl eller et farmaceutisk acceptabelt salt deraf, hvor lukkeren er en komponent af en primær indpakning af indretningen der påvirker væskeformuleringens spraykarakteristika.
8. Indretningen ifølge krav 7, hvor indretningen yderligere omfatter en tætning omfattende et materiale der udelukker eller i det væsentlige udelukker absorptionen af fentanyl eller et farmaceutisk acceptabelt salt deraf.
9. Indretningen ifølge krav 7 eller 8, hvor væskedråberne har en middeldiameter på mindst ca. 20 mikron.
10. Indretningen ifølge et hvilket som helst af kravene 7 til 9, hvor væskedråberne har en størrelsesfordeling på fra ca. 5 mikron til ca. 500 mikron.
11. Indretningen ifølge krav 6, yderligere omfattende en spærremekanisme der tillader administrationen af en dosis og spærrer for yderligere administration i en vis tidsperiode.
DK07762549T 2006-01-25 2007-01-25 Sublingual fentanyl-spray DK1976521T3 (da)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
DK1976521T3 true DK1976521T3 (da) 2015-04-27

Family

ID=38309867

Family Applications (1)

Application Number Title Priority Date Filing Date
DK07762549T DK1976521T3 (da) 2006-01-25 2007-01-25 Sublingual fentanyl-spray

Country Status (16)

Country Link
US (6) US8486972B2 (da)
EP (2) EP2641595A1 (da)
JP (3) JP5241514B2 (da)
CN (1) CN101378735B (da)
AU (1) AU2007208229B2 (da)
BR (1) BRPI0707235B8 (da)
CA (1) CA2637672C (da)
DK (1) DK1976521T3 (da)
ES (1) ES2535233T3 (da)
MX (2) MX2008009522A (da)
NZ (1) NZ569949A (da)
PL (1) PL1976521T3 (da)
PT (1) PT1976521E (da)
RU (1) RU2432950C2 (da)
SI (1) SI1976521T1 (da)
WO (1) WO2007087431A2 (da)

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Also Published As

Publication number Publication date
EP1976521A2 (en) 2008-10-08
BRPI0707235B1 (pt) 2020-04-14
EP1976521A4 (en) 2010-11-03
US9289387B2 (en) 2016-03-22
MX2008009522A (es) 2009-01-07
PT1976521E (pt) 2015-06-09
AU2007208229A1 (en) 2007-08-02
BRPI0707235B8 (pt) 2021-05-25
US20170202820A1 (en) 2017-07-20
JP2013127003A (ja) 2013-06-27
US20070261695A1 (en) 2007-11-15
US20140343100A1 (en) 2014-11-20
JP2013056928A (ja) 2013-03-28
US9642797B2 (en) 2017-05-09
US20160193142A1 (en) 2016-07-07
JP5241514B2 (ja) 2013-07-17
CN101378735B (zh) 2013-04-03
ES2535233T3 (es) 2015-05-06
BRPI0707235A2 (pt) 2011-04-26
CA2637672A1 (en) 2007-08-02
RU2008130763A (ru) 2010-02-27
CA2637672C (en) 2012-07-24
PL1976521T3 (pl) 2015-10-30
JP5630877B2 (ja) 2014-11-26
US8835460B2 (en) 2014-09-16
EP2641595A1 (en) 2013-09-25
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NZ569949A (en) 2011-10-28
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US8486972B2 (en) 2013-07-16
US20130327321A1 (en) 2013-12-12
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