DK1906961T3 - Fast doserede formuleringer af fentanyl med forbedret bukkal adsorption - Google Patents

Fast doserede formuleringer af fentanyl med forbedret bukkal adsorption Download PDF

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Publication number
DK1906961T3
DK1906961T3 DK06776336.7T DK06776336T DK1906961T3 DK 1906961 T3 DK1906961 T3 DK 1906961T3 DK 06776336 T DK06776336 T DK 06776336T DK 1906961 T3 DK1906961 T3 DK 1906961T3
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DK
Denmark
Prior art keywords
fentanyl
amine
active ingredient
adsorption
buchal
Prior art date
Application number
DK06776336.7T
Other languages
English (en)
Inventor
Federico Stroppolo
Shahbaz Ardalan
Original Assignee
Alpex Pharma Sa
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
Application filed by Alpex Pharma Sa filed Critical Alpex Pharma Sa
Application granted granted Critical
Publication of DK1906961T3 publication Critical patent/DK1906961T3/da

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    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

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

Claims (4)

1. Farmaceutisk sammensætning i form af en tablet der er egnet til opløsning i mundhulen, hvilken sammensætning omfatter i) en effektiv mængde afen narkotisk aktiv bestanddel valgt fra gruppen bestående af Fentanyl og farmaceutisk acceptable salte deraf, og ii) en farmaceutisk acceptabel amin med en pK på 8 eller derover, hvor aminen er arginin, hvor molforholdet af amin:aktiv bestanddel er mindst 5:1.
2. Sammensætningen ifølge krav 1, hvor molforholdet af amin:aktiv bestanddel er fra 5:1 til 1000:1.
3. Sammensætningen ifølge krav 2, hvor molforholdet af amin: aktiv bestanddel ligger i området fra 10:1 til 500:1.
4. Sammensætningen ifølge krav 3, hvor molforholdet af amin:aktiv bestanddel ligger i området fra 20:1 til 250:1.
DK06776336.7T 2005-07-22 2006-07-21 Fast doserede formuleringer af fentanyl med forbedret bukkal adsorption DK1906961T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/186,925 US20070020186A1 (en) 2005-07-22 2005-07-22 Solid dosage formulations of narcotic drugs having improved buccal adsorption
PCT/EP2006/007189 WO2007009806A2 (en) 2005-07-22 2006-07-21 Solid dosage formulations of narcotic drugs having improved buccal adsorption

Publications (1)

Publication Number Publication Date
DK1906961T3 true DK1906961T3 (da) 2016-05-02

Family

ID=37440618

Family Applications (1)

Application Number Title Priority Date Filing Date
DK06776336.7T DK1906961T3 (da) 2005-07-22 2006-07-21 Fast doserede formuleringer af fentanyl med forbedret bukkal adsorption

Country Status (26)

Country Link
US (3) US20070020186A1 (da)
EP (1) EP1906961B1 (da)
JP (1) JP5714797B2 (da)
KR (1) KR101326206B1 (da)
CN (1) CN101208091A (da)
AU (1) AU2006271870B2 (da)
BR (1) BRPI0613769A2 (da)
CA (1) CA2607360C (da)
CY (1) CY1117470T1 (da)
DK (1) DK1906961T3 (da)
ES (1) ES2569228T3 (da)
HR (1) HRP20160327T1 (da)
HU (1) HUE027354T2 (da)
IL (1) IL187387A (da)
MA (1) MA29744B1 (da)
MX (1) MX2007015480A (da)
NO (1) NO20080827L (da)
NZ (1) NZ563511A (da)
PL (1) PL1906961T3 (da)
RS (1) RS54670B1 (da)
RU (1) RU2408373C2 (da)
SI (1) SI1906961T1 (da)
TW (1) TW200727922A (da)
UA (1) UA90518C2 (da)
WO (1) WO2007009806A2 (da)
ZA (1) ZA200710406B (da)

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Also Published As

Publication number Publication date
ES2569228T3 (es) 2016-05-09
EP1906961B1 (en) 2016-03-23
WO2007009806A3 (en) 2007-04-05
NZ563511A (en) 2011-03-31
MA29744B1 (fr) 2008-09-01
TW200727922A (en) 2007-08-01
IL187387A0 (en) 2008-02-09
IL187387A (en) 2016-10-31
CY1117470T1 (el) 2017-04-26
US8574552B2 (en) 2013-11-05
US20070020186A1 (en) 2007-01-25
US20140018392A1 (en) 2014-01-16
HRP20160327T1 (hr) 2016-05-20
WO2007009806A2 (en) 2007-01-25
AU2006271870A1 (en) 2007-01-25
CA2607360C (en) 2014-02-18
JP5714797B2 (ja) 2015-05-07
RU2408373C2 (ru) 2011-01-10
HUE027354T2 (en) 2016-09-28
US10258693B2 (en) 2019-04-16
JP2009502761A (ja) 2009-01-29
CA2607360A1 (en) 2007-01-25
KR20080030608A (ko) 2008-04-04
AU2006271870B2 (en) 2011-11-24
EP1906961A2 (en) 2008-04-09
UA90518C2 (ru) 2010-05-11
BRPI0613769A2 (pt) 2011-02-01
KR101326206B1 (ko) 2013-11-08
US20070020187A1 (en) 2007-01-25
RS54670B1 (en) 2016-08-31
SI1906961T1 (sl) 2016-09-30
PL1906961T3 (pl) 2016-07-29
CN101208091A (zh) 2008-06-25
NO20080827L (no) 2008-02-15
RU2007149044A (ru) 2009-06-27
MX2007015480A (es) 2008-04-29
ZA200710406B (en) 2008-11-26

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