WO2024254522A3 - Epinephrine liquid formulations - Google Patents

Epinephrine liquid formulations Download PDF

Info

Publication number
WO2024254522A3
WO2024254522A3 PCT/US2024/033103 US2024033103W WO2024254522A3 WO 2024254522 A3 WO2024254522 A3 WO 2024254522A3 US 2024033103 W US2024033103 W US 2024033103W WO 2024254522 A3 WO2024254522 A3 WO 2024254522A3
Authority
WO
WIPO (PCT)
Prior art keywords
epinephrine
liquid formulations
pharmaceutically acceptable
acceptable salt
liquid formulation
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.)
Ceased
Application number
PCT/US2024/033103
Other languages
French (fr)
Other versions
WO2024254522A2 (en
Inventor
Arunya Usayapant
Chaoju Xiao
Christopher Kegan CALA
Jennifer GEHLE-NOVAK
Jessica ROZEMBERG
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.)
Fresenius Kabi USA LLC
Original Assignee
Fresenius Kabi USA LLC
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
Application filed by Fresenius Kabi USA LLC filed Critical Fresenius Kabi USA LLC
Priority to EP24820178.2A priority Critical patent/EP4724056A2/en
Publication of WO2024254522A2 publication Critical patent/WO2024254522A2/en
Publication of WO2024254522A3 publication Critical patent/WO2024254522A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

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)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention provides a liquid formulation comprising epinephrine or a pharmaceutically acceptable salt thereof. The formulation invention includes ascorbic acid and/or a pharmaceutically acceptable salt thereof, an isotonicity agent, and has a pH of about 3.0-5.0. The liquid formulation according to the invention is stable and ready-to-administer.
PCT/US2024/033103 2023-06-07 2024-06-07 Epinephrine liquid formulations Ceased WO2024254522A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24820178.2A EP4724056A2 (en) 2023-06-07 2024-06-07 Epinephrine liquid formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363506780P 2023-06-07 2023-06-07
US63/506,780 2023-06-07

Publications (2)

Publication Number Publication Date
WO2024254522A2 WO2024254522A2 (en) 2024-12-12
WO2024254522A3 true WO2024254522A3 (en) 2025-05-15

Family

ID=93796410

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/033103 Ceased WO2024254522A2 (en) 2023-06-07 2024-06-07 Epinephrine liquid formulations

Country Status (2)

Country Link
EP (1) EP4724056A2 (en)
WO (1) WO2024254522A2 (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170189352A1 (en) * 2015-03-13 2017-07-06 Par Pharmaceutical, Inc. Epinephrine formulations
US20190269782A1 (en) * 2018-02-06 2019-09-05 Ars Pharmaceuticals Inc. Intranasal epinephrine formulations and methods for the treatment of disease
US20200230079A1 (en) * 2017-01-30 2020-07-23 Nevakar Inc. Norepinephrine compositions and methods therefor
US20200268689A1 (en) * 2017-09-26 2020-08-27 Ys Pharmtech Stabilization of epinephrine formulations

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170189352A1 (en) * 2015-03-13 2017-07-06 Par Pharmaceutical, Inc. Epinephrine formulations
US20200230079A1 (en) * 2017-01-30 2020-07-23 Nevakar Inc. Norepinephrine compositions and methods therefor
US20200268689A1 (en) * 2017-09-26 2020-08-27 Ys Pharmtech Stabilization of epinephrine formulations
US20190269782A1 (en) * 2018-02-06 2019-09-05 Ars Pharmaceuticals Inc. Intranasal epinephrine formulations and methods for the treatment of disease

Also Published As

Publication number Publication date
EP4724056A2 (en) 2026-04-15
WO2024254522A2 (en) 2024-12-12

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