DK2706982T3 - Intranasale farmaceutiske dosisformer omfattende naloxon - Google Patents

Intranasale farmaceutiske dosisformer omfattende naloxon Download PDF

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Publication number
DK2706982T3
DK2706982T3 DK12721507.7T DK12721507T DK2706982T3 DK 2706982 T3 DK2706982 T3 DK 2706982T3 DK 12721507 T DK12721507 T DK 12721507T DK 2706982 T3 DK2706982 T3 DK 2706982T3
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Prior art keywords
naloxone
dosage form
administration
amount
nostril
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DK12721507.7T
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English (en)
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DK2706982T4 (da
Inventor
John Strang
Stephen Harris
Kevin Smith
Lucie Helene Jeanne Mottier
Alexander Oksche
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Euro Celtique Sa
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    • 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory 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
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36Opioid-abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • A61P39/02Antidotes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Otolaryngology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Dispersion Chemistry (AREA)
  • Addiction (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Toxicology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1. Intranasal farmaceutisk dosisform omfattende en doseringsenhed omfattende naloxon eller et farmaceutisk acceptabelt salt deraf i en mængde svarende til mellem 0,65 mg naloxon HCI og 0,8 mg naloxon HCI eller mellem 1,3 mg naloxon HCI og 1,6 mg naloxon HCI opløst i en applikationsfluid i et volumen på < 250 pi, fortrinsvis < 200 μΙ.
2. Dosisform ifølge krav 1, hvor volumenet af applikationsfluiden er inden for et område på 200 μΙ til 35 μΙ, fortrinsvis på 200 μΙ til 50 μΙ, mere fortrinsvis på 200 μΙ til 100 μΙ.
3. Dosisform ifølge krav 1 eller 2, hvor applikationsfluiden er valgt fra gruppen omfattende vand og en vandig saltopløsning, fortrinsvis en vandig NaCI-opløsning, mere fortrinsvis en vandig 0,9 % (vægt/volumen) NaCI-opløsning.
4. Dosisform ifølge et hvilket som helst af de foregående krav, hvor dosisformen er valgt fra gruppen af dosisformer omfattende en næsespray, en nasal slimhindeklæbende dosisform og en slimhinde-forstøvningsindretning (Mucosal Atomizer Device).
5. Intranasal farmaceutisk dosisform omfattende naloxon eller et farmaceutisk acceptabelt salt deraf opløst i en applikationsfluid til anvendelse i behandlingen af mindst et af opioid overdoserings-associerede symptomer af åndenød, ændret bevidsthedsniveau, miotiske pupiller, hypoxæmi, akut lungeskade og aspirationslungebetændelse, hvor en mængde svarende til mellem 1,3 mg naloxon HCI og 1,6 mg naloxon HCI administreres intranasalt, hvor mængden tilvejebringes ved administration til et næsebor eller hvor mængden er tilvejebragt ved administration til to næsebor, og hvor volumenet af applikationsfluiden per næsebor er < 250 μΙ, fortrinsvis < 200 μΙ.
6. Dosisform til anvendelse ifølge krav 5, hvor en mængde af naloxon eller et farmaceutisk acceptabelt salt deraf svarende til 1,3 mg naloxon HCI eller 1,4 mg naloxon HCI eller 1,5 mg naloxon HCI eller 1,6 mg naloxon HCI administreres intranasalt.
7. Dosisform til anvendelse ifølge krav 5 eller 6, hvor volumenet af applikationsfluiden per næsebor er inden for et område på 200 pi til 35 μΙ, fortrinsvis på 200 μΙ til 50 μΙ, mere fortrinsvis på 200 μΙ til 100 μΙ.
8. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 7, hvor volumenet af applikationsfluiden per næsebor er inden for et område på 150 μΙ til 100 μΙ.
9. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 8, hvor mængden tilvejebringes ved administration til et næsebor.
10. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 9, hvor applikationsfluiden er valgt fra gruppen omfattende vand og en vandig saltopløsning, fortrinsvis en vandig NaCI-opløsning, mere fortrinsvis en vandig 0,9 % (vægt/volumen) NaCI-opløsning.
11. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 10, hvor dosisformen omfatter mængden eller halvdelen af mængden opløst i en applikationsfluid i en doseringsenhed, hvor mængden er afhængig af hvorvidt mængden tilvejebringes ved administration til et næsebor eller ved administration til to næsebor.
12. Dosisform til anvendelse ifølge krav 11, hvor dosisformen omfatter en enkelt doseringsenhed eller to doseringsenheder, afhængigt af hvorvidt mængden tilvejebringes ved administration til et næsebor eller ved administration til to næsebor, og er til enkelt anvendelse eller hvor dosisformen omfatter mindst to doseringsenheder, fortrinsvis mindst tre doseringsenheder, mere fortrinsvis mindst fire doseringsenheder og most fortrinsvis mindst fem doseringsenheder og er til multiple anvendelser.
13. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 12, hvor dosisformen er valgt fra gruppen af dosisformer omfattende en næsespray, en nasal slimhindeklæbende dosisform og en slimhinde-forstøvningsindretning (Mucosal Atomizer Device).
14. Dosisform til anvendelse ifølge krav 5, hvor åndenøden er postoperativ opioid åndenød.
DK12721507.7T 2011-05-13 2012-05-11 Intranasale farmaceutiske dosisformer omfattende naloxon DK2706982T4 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP11166076 2011-05-13
PCT/EP2012/058792 WO2012156317A2 (en) 2011-05-13 2012-05-11 Intranasal pharmaceutical dosage forms comprising naloxone

Publications (2)

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DK2706982T3 true DK2706982T3 (da) 2018-03-12
DK2706982T4 DK2706982T4 (da) 2021-05-10

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DK12721507.7T DK2706982T4 (da) 2011-05-13 2012-05-11 Intranasale farmaceutiske dosisformer omfattende naloxon
DKBA201800034U DK201800034U1 (da) 2011-05-13 2018-04-19 Intranasale farmaceutiske doseringsformer, der omfatter naloxon

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DKBA201800034U DK201800034U1 (da) 2011-05-13 2018-04-19 Intranasale farmaceutiske doseringsformer, der omfatter naloxon

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US (7) US20150018379A1 (da)
EP (2) EP3320893A1 (da)
JP (3) JP6110367B2 (da)
KR (2) KR101698182B1 (da)
CN (2) CN107260672A (da)
AR (1) AR086391A1 (da)
AT (1) AT16553U1 (da)
AU (2) AU2012257785B2 (da)
BR (1) BR112013029126A2 (da)
CA (1) CA2835940C (da)
CO (1) CO6821959A2 (da)
CY (1) CY1120399T1 (da)
DE (1) DE202012013606U1 (da)
DK (2) DK2706982T4 (da)
ES (1) ES2661838T5 (da)
HK (1) HK1255428A1 (da)
HR (1) HRP20180233T1 (da)
HU (1) HUE036465T2 (da)
IL (1) IL229409B (da)
LT (1) LT2706982T (da)
ME (1) ME02958B (da)
MX (1) MX354249B (da)
MY (1) MY194947A (da)
NO (1) NO2706982T3 (da)
PH (1) PH12016501342B1 (da)
PL (1) PL2706982T3 (da)
PT (1) PT2706982T (da)
RS (1) RS57054B1 (da)
RU (2) RU2657441C1 (da)
SG (1) SG194927A1 (da)
SI (1) SI2706982T1 (da)
TR (1) TR201802716T4 (da)
TW (1) TWI486161B (da)
UA (1) UA110974C2 (da)
WO (1) WO2012156317A2 (da)
ZA (1) ZA201308280B (da)

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DK2706982T4 (da) 2021-05-10
SI2706982T1 (en) 2018-05-31
AT16553U1 (de) 2020-01-15
RU2013155479A (ru) 2015-06-20
HRP20180233T1 (hr) 2018-06-01
CA2835940A1 (en) 2012-11-22
US11020343B2 (en) 2021-06-01
ES2661838T5 (es) 2021-11-18
LT2706982T (lt) 2018-05-25
AU2016204880A1 (en) 2016-07-28
NO2706982T3 (da) 2018-06-02
RU2657441C1 (ru) 2018-06-13
US20170231904A1 (en) 2017-08-17
BR112013029126A2 (pt) 2017-02-07
AU2016204880B2 (en) 2017-11-23
PH12016501342A1 (en) 2018-06-11
CN103764119A (zh) 2014-04-30
HK1255428A1 (zh) 2019-08-16
WO2012156317A2 (en) 2012-11-22
CA2835940C (en) 2020-08-04
JP2018150336A (ja) 2018-09-27
IL229409A0 (en) 2014-01-30
KR101698182B1 (ko) 2017-01-19
RU2587051C2 (ru) 2016-06-10
JP6110367B2 (ja) 2017-04-05
EP3320893A1 (en) 2018-05-16
HUE036465T2 (hu) 2018-07-30
MX354249B (es) 2018-02-20
EP2706982A2 (en) 2014-03-19
US20170304192A1 (en) 2017-10-26
JP2014513683A (ja) 2014-06-05
JP2016128453A (ja) 2016-07-14
ME02958B (me) 2018-07-20
MX2013013276A (es) 2014-08-07
IL229409B (en) 2020-10-29
PH12016501342B1 (en) 2018-06-11
CY1120399T1 (el) 2019-07-10
PT2706982T (pt) 2018-03-08
TW201311244A (zh) 2013-03-16
KR20170010078A (ko) 2017-01-25
ZA201308280B (en) 2014-07-30
US11806428B2 (en) 2023-11-07
MY194947A (en) 2022-12-27
DK201800034U1 (da) 2018-05-25
CO6821959A2 (es) 2013-12-31
SG194927A1 (en) 2013-12-30
WO2012156317A3 (en) 2013-05-10
AU2012257785B2 (en) 2016-04-14
US20190374464A1 (en) 2019-12-12
US20240082149A1 (en) 2024-03-14
NZ617442A (en) 2015-03-27
UA110974C2 (uk) 2016-03-10
ES2661838T3 (es) 2018-04-04
NZ705933A (en) 2016-07-29
AR086391A1 (es) 2013-12-11
AU2012257785A1 (en) 2013-11-28
RS57054B1 (sr) 2018-05-31
KR101873174B1 (ko) 2018-06-29
US20210338574A1 (en) 2021-11-04
US20150018379A1 (en) 2015-01-15
KR20140007482A (ko) 2014-01-17
EP2706982B2 (en) 2021-03-10
PL2706982T3 (pl) 2018-07-31
EP2706982B1 (en) 2018-01-03
US20150126540A1 (en) 2015-05-07
DE202012013606U1 (de) 2018-04-18
CN107260672A (zh) 2017-10-20
TWI486161B (zh) 2015-06-01
TR201802716T4 (tr) 2018-03-21

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