JP2021518385A - エピネフリンのスプレー製剤 - Google Patents

エピネフリンのスプレー製剤 Download PDF

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Publication number
JP2021518385A
JP2021518385A JP2020550178A JP2020550178A JP2021518385A JP 2021518385 A JP2021518385 A JP 2021518385A JP 2020550178 A JP2020550178 A JP 2020550178A JP 2020550178 A JP2020550178 A JP 2020550178A JP 2021518385 A JP2021518385 A JP 2021518385A
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JP
Japan
Prior art keywords
pharmaceutical spray
spray formulation
microns
pharmaceutical
epinephrine
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.)
Pending
Application number
JP2020550178A
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English (en)
Japanese (ja)
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JPWO2019182908A5 (https=
JP2021518385A5 (https=
Inventor
スティーブン ハートマン，
スティーブン ハートマン，
ミシェル ローベル，
ミシェル ローベル，
マシュー ピー． ロベン，
マシュー ピー． ロベン，
ケネス エル． ドレチェン，
ケネス エル． ドレチェン，
マイケル メサ，
マイケル メサ，
Original Assignee
ブリン ファーマ， エルエルシー
ブリン ファーマ， エルエルシー
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 ブリン ファーマ， エルエルシー, ブリン ファーマ， エルエルシー filed Critical ブリン ファーマ， エルエルシー
Publication of JP2021518385A publication Critical patent/JP2021518385A/ja
Publication of JPWO2019182908A5 publication Critical patent/JPWO2019182908A5/ja
Publication of JP2021518385A5 publication Critical patent/JP2021518385A5/ja
Priority to JP2023065124A priority Critical patent/JP2023085545A/ja
Pending legal-status Critical Current

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    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • 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
    • 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
    • A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/007—Syringe-type or piston-type sprayers or atomisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • 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
    • A61M15/00—Inhalators
    • A61M15/08—Inhaling devices inserted into the nose
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2020550178A 2018-03-19 2019-03-15 エピネフリンのスプレー製剤 Pending JP2021518385A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023065124A JP2023085545A (ja) 2018-03-19 2023-04-12 エピネフリンのスプレー製剤

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US201862644834P 2018-03-19 2018-03-19
US62/644,834 2018-03-19
US201862663100P 2018-04-26 2018-04-26
US62/663,100 2018-04-26
US201862712678P 2018-07-31 2018-07-31
US62/712,678 2018-07-31
US201862747048P 2018-10-17 2018-10-17
US62/747,048 2018-10-17
US201962810261P 2019-02-25 2019-02-25
US62/810,261 2019-02-25
PCT/US2019/022557 WO2019182908A1 (en) 2018-03-19 2019-03-15 Epinephrine spray formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023065124A Division JP2023085545A (ja) 2018-03-19 2023-04-12 エピネフリンのスプレー製剤

Publications (3)

Publication Number Publication Date
JP2021518385A true JP2021518385A (ja) 2021-08-02
JPWO2019182908A5 JPWO2019182908A5 (https=) 2022-03-24
JP2021518385A5 JP2021518385A5 (https=) 2022-03-24

Family

ID=67903732

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2020550178A Pending JP2021518385A (ja) 2018-03-19 2019-03-15 エピネフリンのスプレー製剤
JP2023065124A Pending JP2023085545A (ja) 2018-03-19 2023-04-12 エピネフリンのスプレー製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023065124A Pending JP2023085545A (ja) 2018-03-19 2023-04-12 エピネフリンのスプレー製剤

Country Status (13)

Country Link
US (12) US20190282496A1 (https=)
EP (2) EP4338804A3 (https=)
JP (2) JP2021518385A (https=)
KR (1) KR20200140830A (https=)
CN (1) CN112153966A (https=)
AU (2) AU2019239640B2 (https=)
BR (1) BR112020018913A2 (https=)
CA (1) CA3094147A1 (https=)
IL (2) IL316152A (https=)
MX (2) MX2020009602A (https=)
PH (1) PH12020551427A1 (https=)
SG (1) SG11202008811WA (https=)
WO (2) WO2019182745A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024515159A (ja) * 2021-03-09 2024-04-05 アプター フランス エスアーエス 経鼻流体投与装置

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WO2021026330A1 (en) * 2019-08-06 2021-02-11 Bryn Pharma, LLC Methods, devices, and systems for administered epinephrine
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WO2022046976A1 (en) * 2020-08-26 2022-03-03 Amphastar Pharmaceuticals, Inc. An epinephrine injection formulation with very low epinephrine concentration and low impurities during its shelf-life
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