BRPI0707235B8 - formulação de fentanil sublingual sem propelente, e, dispositivo de dose unitária para administração sublingual de uma formulação de fentanil sublingual - Google Patents

formulação de fentanil sublingual sem propelente, e, dispositivo de dose unitária para administração sublingual de uma formulação de fentanil sublingual

Info

Publication number
BRPI0707235B8
BRPI0707235B8 BRPI0707235A BRPI0707235A BRPI0707235B8 BR PI0707235 B8 BRPI0707235 B8 BR PI0707235B8 BR PI0707235 A BRPI0707235 A BR PI0707235A BR PI0707235 A BRPI0707235 A BR PI0707235A BR PI0707235 B8 BRPI0707235 B8 BR PI0707235B8
Authority
BR
Brazil
Prior art keywords
sublingual
fentanyl formulation
administration
propellant
unit dose
Prior art date
Application number
BRPI0707235A
Other languages
English (en)
Inventor
Kattookaran Linet
N Parikh Neha
George Kottayil S
R Goskonda Venkat
Zhu Zhongyuan
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=BRPI0707235(B8) "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
Publication of BRPI0707235A2 publication Critical patent/BRPI0707235A2/pt
Publication of BRPI0707235B1 publication Critical patent/BRPI0707235B1/pt
Publication of BRPI0707235B8 publication Critical patent/BRPI0707235B8/pt

Links

Classifications

    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4468Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00Anaesthetics
    • 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
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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

Abstract

formulação de fentanil sublingual, e, dispositivo para a administração sublingual de uma droga a presente invenção está direcionada às formulações sublinguais contendo fentanil, um sal farmaceuticamente aceitável do mesmo ou derivado do mesmo, adequados para a administração a um paciente, e métodos para tratamento com as formulações.
BRPI0707235A 2006-01-25 2007-01-25 formulação de fentanil sublingual sem propelente, e, dispositivo de dose unitária para administração sublingual de uma formulação de fentanil sublingual BRPI0707235B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US76205706P 2006-01-25 2006-01-25
US60/762057 2006-01-25
PCT/US2007/002163 WO2007087431A2 (en) 2006-01-25 2007-01-25 Sublingual fentanyl spray

Publications (3)

Publication Number Publication Date
BRPI0707235A2 BRPI0707235A2 (pt) 2011-04-26
BRPI0707235B1 BRPI0707235B1 (pt) 2020-04-14
BRPI0707235B8 true BRPI0707235B8 (pt) 2021-05-25

Family

ID=38309867

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0707235A BRPI0707235B8 (pt) 2006-01-25 2007-01-25 formulação de fentanil sublingual sem propelente, e, dispositivo de dose unitária para administração sublingual de uma formulação de fentanil sublingual

Country Status (16)

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

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Also Published As

Publication number Publication date
JP2013056928A (ja) 2013-03-28
JP5630877B2 (ja) 2014-11-26
CA2637672A1 (en) 2007-08-02
MX2008009522A (es) 2009-01-07
WO2007087431A2 (en) 2007-08-02
US9642797B2 (en) 2017-05-09
US8835460B2 (en) 2014-09-16
SI1976521T1 (sl) 2015-06-30
JP2013127003A (ja) 2013-06-27
JP2009528272A (ja) 2009-08-06
AU2007208229A1 (en) 2007-08-02
US9289387B2 (en) 2016-03-22
CN101378735B (zh) 2013-04-03
CA2637672C (en) 2012-07-24
WO2007087431A3 (en) 2008-09-25
US20070261695A1 (en) 2007-11-15
BRPI0707235A2 (pt) 2011-04-26
JP5241514B2 (ja) 2013-07-17
RU2008130763A (ru) 2010-02-27
NZ569949A (en) 2011-10-28
US20160193142A1 (en) 2016-07-07
DK1976521T3 (en) 2015-04-27
EP1976521B1 (en) 2015-03-11
RU2432950C2 (ru) 2011-11-10
EP1976521A2 (en) 2008-10-08
CN101378735A (zh) 2009-03-04
US20140343100A1 (en) 2014-11-20
PL1976521T3 (pl) 2015-10-30
PT1976521E (pt) 2015-06-09
BRPI0707235B1 (pt) 2020-04-14
EP1976521A4 (en) 2010-11-03
MX2020008616A (es) 2020-09-21
US8486972B2 (en) 2013-07-16
EP2641595A1 (en) 2013-09-25
AU2007208229B2 (en) 2009-11-05
US10016403B2 (en) 2018-07-10
ES2535233T3 (es) 2015-05-06
US20170202820A1 (en) 2017-07-20
US20180303813A1 (en) 2018-10-25
US20130327321A1 (en) 2013-12-12

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