CA3033897C - Liquid naloxone spray - Google Patents

Liquid naloxone spray Download PDF

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Publication number
CA3033897C
CA3033897C CA3033897A CA3033897A CA3033897C CA 3033897 C CA3033897 C CA 3033897C CA 3033897 A CA3033897 A CA 3033897A CA 3033897 A CA3033897 A CA 3033897A CA 3033897 C CA3033897 C CA 3033897C
Authority
CA
Canada
Prior art keywords
formulation
formulations
impurity
naloxone
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.)
Active
Application number
CA3033897A
Other languages
English (en)
French (fr)
Other versions
CA3033897A1 (en
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
Hikma Pharmaceuticals USA 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 Hikma Pharmaceuticals USA Inc filed Critical Hikma Pharmaceuticals USA Inc
Publication of CA3033897A1 publication Critical patent/CA3033897A1/en
Application granted granted Critical
Publication of CA3033897C publication Critical patent/CA3033897C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • 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
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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

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)
CA3033897A 2016-08-17 2017-08-10 Liquid naloxone spray Active CA3033897C (en)

Applications Claiming Priority (5)

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

Publications (2)

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

Family

ID=61197156

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3033897A Active CA3033897C (en) 2016-08-17 2017-08-10 Liquid naloxone spray

Country Status (7)

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

Families Citing this family (10)

* 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
US10598672B2 (en) 2014-02-18 2020-03-24 Cyrano Therapeutics, Inc. Methods and compositions for diagnosing and treating loss and/or distortion of taste or smell
WO2018034920A1 (en) * 2016-08-17 2018-02-22 Insys Development Company, Inc. Liquid naloxone spray
US20180193332A1 (en) * 2017-10-09 2018-07-12 Adapt Pharma Operations Limited Low-temperature stable opioid antagonist solutions
EP3897603A4 (en) * 2018-12-19 2022-09-14 Grace Therapeutics Inc. THERAPEUTIC COMPOSITION OF INTRANASAL LIDOCAINE
ES3011582T3 (en) 2019-02-21 2025-04-07 Pharmaceutical Productions Inc Naloxone formulations for sublingual and/or buccal administration
CN116474219A (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
CA3166250A1 (en) 2020-02-05 2021-08-12 Gregory G. Plucinski Drug products for intranasal administration and uses thereof
JP7606530B2 (ja) 2020-03-24 2024-12-25 シラノ セラピューティクス, インコーポレイテッド コロナウイルス感染症による化学感覚機能障害の治療
JP2025502075A (ja) * 2022-01-06 2025-01-24 シラノ セラピューティクス, インコーポレイテッド パーキンソン病治療剤の改善された鼻投与

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
MY194947A (en) 2011-05-13 2022-12-27 Euro Celtique Sa Intranasal pharmaceutical dosage forms comprising naloxone
JP6210988B2 (ja) * 2011-09-19 2017-10-11 オレクソ・アクチエボラゲット オピオイド依存を治療するための新規乱用耐性医薬組成物
US8940052B2 (en) 2012-07-26 2015-01-27 DePuy Synthes Products, LLC Expandable implant
CA2881144A1 (en) * 2012-11-09 2014-05-09 Purdue Pharma Pharmaceutical compositions comprising hydromorphone and naloxone
DK3043777T3 (da) 2013-09-10 2020-07-20 Fresh Cut Dev Llc Sublingual buprenorphinspray
CN103637987B (zh) 2013-12-09 2015-12-02 韩彬 羟考酮的液体药物组合物
CA2875384A1 (en) 2013-12-20 2015-06-20 AntiOP, Inc. Intranasal naloxone compositions and methods of making and using same
MX365383B (es) 2014-03-14 2019-05-31 Opiant Pharmaceuticals Inc Medicamentos de administracion nasal y metodos para su uso.
US9480644B2 (en) 2014-03-14 2016-11-01 Opiant Pharmaceuticals, Inc. Nasal drug products and methods of their use
WO2016007245A1 (en) * 2014-07-08 2016-01-14 Insys Pharma, Inc. Sublingual naloxone spray
US20160199294A1 (en) * 2014-07-08 2016-07-14 Insys Development Company, Inc. Sublingual naloxone spray
WO2018034920A1 (en) * 2016-08-17 2018-02-22 Insys Development Company, Inc. Liquid naloxone spray

Also Published As

Publication number Publication date
AU2017312811B2 (en) 2023-03-16
CA3033897A1 (en) 2018-02-22
JP2019528278A (ja) 2019-10-10
AU2017312811A8 (en) 2019-03-14
WO2018034920A1 (en) 2018-02-22
JP2022119843A (ja) 2022-08-17
AU2017312811A1 (en) 2019-03-07
JP7114570B2 (ja) 2022-08-08
MA45995A (fr) 2019-06-26
EP3500261A4 (en) 2020-05-06
EP3500261A1 (en) 2019-06-26
CN109922805A (zh) 2019-06-21
JP7455157B2 (ja) 2024-03-25

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