DK2706982T3 - Intranasale farmaceutiske dosisformer omfattende naloxon - Google Patents
Intranasale farmaceutiske dosisformer omfattende naloxon Download PDFInfo
- 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
- Authority
- DK
- Denmark
- Prior art keywords
- naloxone
- dosage form
- administration
- amount
- nostril
- Prior art date
Links
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Classifications
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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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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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.
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EP11166076 | 2011-05-13 | ||
PCT/EP2012/058792 WO2012156317A2 (en) | 2011-05-13 | 2012-05-11 | Intranasal pharmaceutical dosage forms comprising naloxone |
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DK2706982T4 DK2706982T4 (da) | 2021-05-10 |
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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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2012
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2017
- 2017-01-27 US US15/418,138 patent/US20170231904A1/en not_active Abandoned
- 2017-05-09 US US15/590,466 patent/US20170304192A1/en not_active Abandoned
-
2018
- 2018-02-07 HR HRP20180233TT patent/HRP20180233T1/hr unknown
- 2018-02-26 CY CY20181100228T patent/CY1120399T1/el unknown
- 2018-04-19 DK DKBA201800034U patent/DK201800034U1/da not_active Application Discontinuation
- 2018-05-09 JP JP2018090275A patent/JP2018150336A/ja active Pending
- 2018-11-15 HK HK18114591.4A patent/HK1255428A1/zh unknown
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2019
- 2019-08-23 US US16/549,838 patent/US11020343B2/en active Active
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2021
- 2021-04-23 US US17/238,509 patent/US11806428B2/en active Active
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2023
- 2023-09-19 US US18/370,116 patent/US20240082149A1/en active Pending
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