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CA3033897A1 - Pulverisation de naloxone liquide - Google Patents

Pulverisation de naloxone liquide Download PDF

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Publication number
CA3033897A1
CA3033897A1 CA3033897A CA3033897A CA3033897A1 CA 3033897 A1 CA3033897 A1 CA 3033897A1 CA 3033897 A CA3033897 A CA 3033897A CA 3033897 A CA3033897 A CA 3033897A CA 3033897 A1 CA3033897 A1 CA 3033897A1
Authority
CA
Canada
Prior art keywords
formulation
formulations
impurity
naloxone
liquid spray
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA3033897A
Other languages
English (en)
Other versions
CA3033897C (fr
Inventor
Kiran AMANCHA
Shivani CHILAMPALLI
Thrimoorthy Potta
Ningxin YAN
Venkat R. Goskonda
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hikma Pharmaceuticals USA Inc
Original Assignee
Insys Development 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
Priority claimed from US15/238,909 external-priority patent/US10722510B2/en
Priority claimed from US15/601,331 external-priority patent/US10617686B2/en
Application filed by Insys Development Co Inc filed Critical Insys Development Co Inc
Publication of CA3033897A1 publication Critical patent/CA3033897A1/fr
Application granted granted Critical
Publication of CA3033897C publication Critical patent/CA3033897C/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K31/47—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • 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
    • 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
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/0043—Nose
    • 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
    • A61K9/08—Solutions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne des formulations liquides stables contenant de la naloxone, un de ses sels pharmaceutiquement acceptables ou un de ses dérivés. L'invention concerne en outre des procédés permettant de traiter la dépendance aux opioïdes, la surdose d'opioïdes et l'insensibilité congénitale à la douleur avec anhidrose par l'administration des formulations liquides de la présente invention par voie intranasale à un patient en ayant besoin. En outre, l'invention concerne un procédé de traitement de la dépendance aux opioïdes, d'une surdose d'opioïdes et d'une insensibilité congénitale à la douleur avec anhidrose par l'administration intranasale des formulations de naloxone de la présente invention.
CA3033897A 2016-08-17 2017-08-10 Pulverisation de naloxone liquide Active CA3033897C (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US15/238,909 US10722510B2 (en) 2014-07-08 2016-08-17 Liquid naloxone spray
US15/238,909 2016-08-17
US15/601,331 2017-05-22
US15/601,331 US10617686B2 (en) 2014-07-08 2017-05-22 Liquid naloxone spray
PCT/US2017/046198 WO2018034920A1 (fr) 2016-08-17 2017-08-10 Pulvérisation de naloxone liquide

Publications (2)

Publication Number Publication Date
CA3033897A1 true CA3033897A1 (fr) 2018-02-22
CA3033897C CA3033897C (fr) 2024-03-26

Family

ID=61197156

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3033897A Active CA3033897C (fr) 2016-08-17 2017-08-10 Pulverisation de naloxone liquide

Country Status (7)

Country Link
EP (1) EP3500261A4 (fr)
JP (2) JP7114570B2 (fr)
CN (1) CN109922805A (fr)
AU (1) AU2017312811B2 (fr)
CA (1) CA3033897C (fr)
MA (1) MA45995A (fr)
WO (1) WO2018034920A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113453665A (zh) * 2019-02-21 2021-09-28 药品生产公司 用于舌下和/或经颊施用的纳洛酮制剂

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8580801B2 (en) 2008-07-23 2013-11-12 Robert I. Henkin Phosphodiesterase inhibitor treatment
WO2015126944A1 (fr) 2014-02-18 2015-08-27 Henkin Robert I Procédés et compositions permettant de diagnostiquer et de traiter une perte et/ou une distorsion du goût ou de l'odorat
JP7114570B2 (ja) * 2016-08-17 2022-08-08 ヒクマ・ファーマシューティカルズ・ユー・エス・エイ・インコーポレイテッド 液体ナロキソンスプレー
US20180193332A1 (en) * 2017-10-09 2018-07-12 Adapt Pharma Operations Limited Low-temperature stable opioid antagonist solutions
CA3122363A1 (fr) * 2018-12-19 2020-06-25 Nortic Holdings Inc. Composition therapeutique de lidocaine intranasale
CN116474218A (zh) * 2019-06-28 2023-07-25 四川普锐特药业有限公司 保持给药均一度的药物流体分配器及右美托咪定鼻喷器
WO2021158957A1 (fr) 2020-02-05 2021-08-12 Summit Biosciences Inc. Produits médicamenteux destinés à être administrés par voie intranasale et utilisations associées
AU2023205128A1 (en) * 2022-01-06 2024-07-25 Cyrano Therapeutics, Inc. Improved nasal administration of parkinson's therapeutics

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US585A (en) 1838-01-27 Apparatus for extinguishing sparks in the chimneys oe steam-boilers
US14730A (en) 1856-04-22 Improvement in corn-harvesters
CN1575795A (zh) 2003-06-25 2005-02-09 中国人民解放军军事医学科学院毒物药物研究所 盐酸纳洛酮鼻腔喷雾剂
US8627816B2 (en) * 2011-02-28 2014-01-14 Intelliject, Inc. Medicament delivery device for administration of opioid antagonists including formulations for naloxone
CN107260672A (zh) 2011-05-13 2017-10-20 欧洲凯尔特公司 包含纳洛酮的鼻内药物剂型
PT2706986E (pt) * 2011-09-19 2015-07-07 Orexo Ab Nova composição farmacêutica resistente ao abuso para o tratamento da dependência de opiáceos
WO2014018098A1 (fr) 2012-07-26 2014-01-30 DePuy Synthes Products, LLC Implant expansible
CA2795324C (fr) * 2012-11-09 2015-07-14 Purdue Pharma Compositions pharmaceutiques comprenant de l'hydromorphone et de la naloxone
JP2016529328A (ja) 2013-09-10 2016-09-23 インシス・ファーマ・インコーポレーテッド 舌下ブプレノルフィンスプレー
CN103637987B (zh) 2013-12-09 2015-12-02 韩彬 羟考酮的液体药物组合物
CA2875384A1 (fr) 2013-12-20 2015-06-20 AntiOP, Inc. Compositions de naxlone intranasales et procedes de fabrication et d'utilisation de celles-ci
US9480644B2 (en) 2014-03-14 2016-11-01 Opiant Pharmaceuticals, Inc. Nasal drug products and methods of their use
RU2016136714A (ru) 2014-03-14 2018-04-19 ОПИАНТ ФАРМАСЮТИКАЛС, Инк. Назальные готовые лекарственные формы и способы их применения
US20160199294A1 (en) * 2014-07-08 2016-07-14 Insys Development Company, Inc. Sublingual naloxone spray
CA2954370A1 (fr) 2014-07-08 2016-01-14 Insys Pharma, Inc. Aerosol sublingual de naloxone
JP7114570B2 (ja) * 2016-08-17 2022-08-08 ヒクマ・ファーマシューティカルズ・ユー・エス・エイ・インコーポレイテッド 液体ナロキソンスプレー

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113453665A (zh) * 2019-02-21 2021-09-28 药品生产公司 用于舌下和/或经颊施用的纳洛酮制剂
US12303597B2 (en) 2019-02-21 2025-05-20 Pharmaceutical Productions, Inc. Naloxone formulations for sublingual and/or buccal administration

Also Published As

Publication number Publication date
CN109922805A (zh) 2019-06-21
JP2019528278A (ja) 2019-10-10
WO2018034920A1 (fr) 2018-02-22
JP7114570B2 (ja) 2022-08-08
AU2017312811A8 (en) 2019-03-14
EP3500261A1 (fr) 2019-06-26
AU2017312811A1 (en) 2019-03-07
MA45995A (fr) 2019-06-26
JP2022119843A (ja) 2022-08-17
CA3033897C (fr) 2024-03-26
JP7455157B2 (ja) 2024-03-25
EP3500261A4 (fr) 2020-05-06
AU2017312811B2 (en) 2023-03-16

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