DK2180844T3 - Sublingual fentanylspray - Google Patents

Sublingual fentanylspray Download PDF

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Publication number
DK2180844T3
DK2180844T3 DK08795007.7T DK08795007T DK2180844T3 DK 2180844 T3 DK2180844 T3 DK 2180844T3 DK 08795007 T DK08795007 T DK 08795007T DK 2180844 T3 DK2180844 T3 DK 2180844T3
Authority
DK
Denmark
Prior art keywords
fentanyl
dose
formulation
approx
sublingual
Prior art date
Application number
DK08795007.7T
Other languages
English (en)
Inventor
S George Kottayil
Zhongyuan Zhu
Venkat R Goskonda
Linet Kattookaran
Neha Parikh
Original Assignee
Insys Dev Co 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=40305148&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2180844(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Insys Dev Co Inc filed Critical Insys Dev Co Inc
Application granted granted Critical
Publication of DK2180844T3 publication Critical patent/DK2180844T3/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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids

Claims (17)

1. Drivmiddel-fri sublingual sprayformulering omfattende en effektiv mængde fentanyl eller et farmaceutisk acceptabelt salt deraf; og mindst én farmaceutisk acceptabel excipiens, hvor formuleringen omfatter fra 0,1 til 0,8 vægtprocent fentanyl eller et farmaceutisk acceptabelt salt deraf; fra 50 til 60 vægtprocent ethanol og fra 4 til 6 vægtprocent propylenglycol; hvilken sprayformulering administreres som diskrete væskesmådråber med en gennemsnitsdiameter på mindst ca. 10 mikrometer.
2. Sublingual formulering ifølge krav 1, hvor koncentrationen af fentanyl er fra 1 mg/ml til 8 mg/ml.
3. Sublingual formulering ifølge krav 1, hvor koncentrationen af fentanyl vælges fra gruppen bestående af ca. 1 mg/ml, ca. 2 mg/ml, ca. 4 mg/ml, ca. 6 mg/ml og ca. 8 mg/ml.
4. Sublingual formulering ifølge krav 1, omfattende 4 mg/ml fentanyl; ca. 55% vægt/vægt ethanol; og ca. 5% vægt/vægt propylenglycol.
5. Sublingual formulering ifølge krav 4, der udviser en gennemsnitsmaksimumplasmakoncentration (Cmax) på ca. 0,813 ng/ml +/- 0,252 baseret på en sublingual dosis på ca. 400 mikrogram fentanyl når det administreres til mennesker.
6. Sublingual formulering ifølge krav 4, der tilvejebringer en dosismængde fentanyl valgt fra gruppen bestående af ca. 100 mikrogram, ca. 200 mikrogram, ca. 600 mikrogram og ca. 800 mikrogram, og tilvejebringer en gennemsnitlig Cmax der i det væsentlige er dosisproportionel med den sublinguale formulering indeholdende 400 mikrogram fentanyl dosismængde, når det administreres til mennesker.
7. Sublingual formulering ifølge krav 4, der tilvejebringer en i det væsentlige dosis proportionalgennemsnitlig Cmax baseret på en gennemsnitlig Cmax på ca. 0,813 ng/ml +/- 0,252 for en 400 mikrogram fentanyldosis når det administreres til mennesker.
8. Sublingual formulering ifølge krav 4, der tilvejebringer en gennemsnitlig Tmax når det administreres til mennesker valgt fra gruppen bestående af: ca. 1,12 timer når formuleringen tilvejebringer en 100 mikrogram dosis, ca. 1,04 timer når formuleringen tilvejebringer en 200 mikrogram dosis, ca. 0,97 timer når formuleringen tilvejebringer en 400 mikrogram dosis, ca. .987 timer når formuleringen tilvejebringer en 600 mikrogram dosis, og ca. 1,06 timer når formuleringen tilvejebringer en 800 mikrogram dosis.
9. Sublingual formulering ifølge krav 4, der tilvejebringer en plasmakoncentration efter administration til mennesker valgt fra gruppen bestående af: ca. 60% af den gennemsnitlige Cmax i ca. 10 minutter, ca. 86% af den gennemsnitlige Cmax ved ca. 20 minutter og en kombination deraf.
10. Sublingual formulering ifølge krav 4, der når den administreres til mennesker tilvejebringer en plasmakoncentration der er større end ca. 80% af den gennemsnitlige C max i ca. 2 timer.
11. Sublingual formulering ifølge krav 4, omfattende 400 mikrogram fentanyl, tilvejebringende én eller flere gennemsnitlige farmakokinetiske værdier valgt fra gruppen bestående af AUCiast 4.863 +/-1.70821 t*ng/ml, AUCmf 5.761 +/- 1.916 t*ng/ml, og AUCextrap 10,26 +/- 5.66%, når det administreres til mennesker.
12. Sublingual formulering ifølge krav 4, der tilvejebringer en dosismængde af fentanyl når det administreres til mennesker der i det væsentlige er dosisproportionel med doseringen der indeholder ca. 400 mikrogram fentanyl valgt fra gruppen bestående af ca. 100 mikrogram, ca. 200 mikrogram, ca. 600 mikrogram, ca. 800 mikrogram, og tilvejebringer én eller flere farmakokinetiske værdier valgt fra gruppen bestående af: gennemsnitlig AUCiast, gennemsnitlig AUCint, og gennemsnitlig AUCextrap.
13. Sublingual formulering ifølge krav 4, der tilvejebringer en i det væsentlige dosis proportionalgennemsnitlig AUCiast baseret på en gennemsnitlig AUCiast på ca. 4,863 +/-1,70821 t*ng/ml for en 400 mikrogram fentanyldosis når det administreres til mennesker.
14. Sublingual formulering ifølge krav 4, omfattende en 400 mikrogram dosis af fentanyl, tilvejebringer en geometrik gennemsnitlig In(Cmax) på ca. 0,7865 ng/ml når en dosis administreres til mennesker.
15. Sublingual formulering ifølge krav 4, omfattende en 400 mikrogram dosis af fentanyl, tilvejebringeren gennemsnitlig F(AUCiast) på ca. 0,721 +/- 0,199 ng/ml når en dosis administreres til mennesker.
16. Sublingual formulering ifølge krav 4, omfattende en 400 mikrogram dosis af fentanyl når en dosis administreres til mennesker, tilvejebringer en gennemsnitlig F (biotilgængelighed) valgt fra gruppen bestående af: ca. 71 % +/- 16%, 0,721 +/- 0,199 baseret på AUCiast og ca. 0,756 +/- 0,212 baseret på AUGnf, eller kombinationer deraf.
17. Sublingual sprayformulering ifølge krav 1, yderligere omfattende vand.
DK08795007.7T 2007-08-02 2008-08-01 Sublingual fentanylspray DK2180844T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US96307607P 2007-08-02 2007-08-02
US96325307P 2007-08-03 2007-08-03
PCT/US2008/009359 WO2009017837A2 (en) 2007-08-02 2008-08-01 Sublingual fentanyl spray

Publications (1)

Publication Number Publication Date
DK2180844T3 true DK2180844T3 (da) 2018-04-23

Family

ID=40305148

Family Applications (1)

Application Number Title Priority Date Filing Date
DK08795007.7T DK2180844T3 (da) 2007-08-02 2008-08-01 Sublingual fentanylspray

Country Status (10)

Country Link
US (5) US8486973B2 (da)
EP (1) EP2180844B1 (da)
AU (1) AU2008282743B2 (da)
CA (1) CA2698749C (da)
DK (1) DK2180844T3 (da)
ES (1) ES2668366T3 (da)
NO (1) NO2180844T3 (da)
PL (1) PL2180844T3 (da)
PT (1) PT2180844T (da)
WO (1) WO2009017837A2 (da)

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Also Published As

Publication number Publication date
US9642844B2 (en) 2017-05-09
US20160095846A1 (en) 2016-04-07
EP2180844A2 (en) 2010-05-05
NO2180844T3 (da) 2018-07-21
US9241935B2 (en) 2016-01-26
EP2180844A4 (en) 2013-09-11
US8486973B2 (en) 2013-07-16
PT2180844T (pt) 2018-04-06
US20170239230A1 (en) 2017-08-24
WO2009017837A3 (en) 2009-04-30
WO2009017837A2 (en) 2009-02-05
WO2009017837A9 (en) 2009-06-25
US20140343288A1 (en) 2014-11-20
US10610523B2 (en) 2020-04-07
CA2698749A1 (en) 2009-02-05
AU2008282743B2 (en) 2012-11-29
PL2180844T3 (pl) 2018-07-31
EP2180844B1 (en) 2018-02-21
ES2668366T3 (es) 2018-05-17
US8835459B2 (en) 2014-09-16
US20130296368A1 (en) 2013-11-07
US20090176834A1 (en) 2009-07-09
AU2008282743A1 (en) 2009-02-05
CA2698749C (en) 2017-05-23

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