JP7885121B2 - 経口利尿薬に不応性の浮腫を処置するための方法及び組成物 - Google Patents

経口利尿薬に不応性の浮腫を処置するための方法及び組成物

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Publication number
JP7885121B2
JP7885121B2 JP2022533344A JP2022533344A JP7885121B2 JP 7885121 B2 JP7885121 B2 JP 7885121B2 JP 2022533344 A JP2022533344 A JP 2022533344A JP 2022533344 A JP2022533344 A JP 2022533344A JP 7885121 B2 JP7885121 B2 JP 7885121B2
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pharmaceutical composition
bumetanide
use according
administration
subject
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JP2023505189A5 (cg-RX-API-DMAC10.html
JP2023505189A (ja
Inventor
ラダクリシュナン,バラシンガム
エスケ,ベン
リン,ウェイ
チェン,アンドリュー,シャン
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レスク ファーマシューティカルズ エルエルシー
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Physiology (AREA)
  • Otolaryngology (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Diabetes (AREA)
  • Hospice & Palliative Care (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
JP2022533344A 2019-12-04 2020-12-04 経口利尿薬に不応性の浮腫を処置するための方法及び組成物 Active JP7885121B2 (ja)

Priority Applications (1)

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JP2025281644A JP2026076167A (ja) 2019-12-04 2025-12-25 経口利尿薬に不応性の浮腫を処置するための方法及び組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962943638P 2019-12-04 2019-12-04
US62/943,638 2019-12-04
PCT/US2020/063491 WO2021113775A1 (en) 2019-12-04 2020-12-04 Methods and compositions for treating edema refractory to oral diuretics

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JP2025281644A Division JP2026076167A (ja) 2019-12-04 2025-12-25 経口利尿薬に不応性の浮腫を処置するための方法及び組成物

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JP2023505189A JP2023505189A (ja) 2023-02-08
JP2023505189A5 JP2023505189A5 (cg-RX-API-DMAC10.html) 2023-12-12
JP7885121B2 true JP7885121B2 (ja) 2026-07-06

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JP2022533344A Active JP7885121B2 (ja) 2019-12-04 2020-12-04 経口利尿薬に不応性の浮腫を処置するための方法及び組成物
JP2025281644A Pending JP2026076167A (ja) 2019-12-04 2025-12-25 経口利尿薬に不応性の浮腫を処置するための方法及び組成物

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Country Status (10)

Country Link
US (5) US11123319B2 (cg-RX-API-DMAC10.html)
EP (1) EP4069222A4 (cg-RX-API-DMAC10.html)
JP (2) JP7885121B2 (cg-RX-API-DMAC10.html)
KR (1) KR20220113436A (cg-RX-API-DMAC10.html)
CN (1) CN115023223A (cg-RX-API-DMAC10.html)
AU (1) AU2020397176A1 (cg-RX-API-DMAC10.html)
BR (1) BR112022010879A2 (cg-RX-API-DMAC10.html)
CA (1) CA3160278A1 (cg-RX-API-DMAC10.html)
IL (1) IL293429A (cg-RX-API-DMAC10.html)
WO (1) WO2021113775A1 (cg-RX-API-DMAC10.html)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3160278A1 (en) 2019-12-04 2021-06-10 Balasingam Radhakrishnan Methods and compositions for treating edema refractory to oral diuretics
JP2024520788A (ja) * 2021-06-09 2024-05-24 レスク ファーマシューティカルズ エルエルシー 経口利尿薬に不応性の浮腫を処置するための皮下製剤及び方法
JP2024526357A (ja) * 2021-07-16 2024-07-17 ドリペル ビー.ブイ. 水性ブメタニド含有液体
IL313921A (en) * 2021-12-30 2024-08-01 Neuropro Therapeutics Inc Pharmaceutical composition
CN115645363B (zh) * 2022-10-31 2025-06-10 浙江普利药业有限公司 一种布美他尼注射液及其制备方法
WO2026017600A1 (en) 2024-07-15 2026-01-22 Dripel B.V. Aqueous bumetanide-containing liquid
WO2026043819A1 (en) * 2024-08-19 2026-02-26 Strategic Drug Solutions, Inc. Formulations and methods for convenient and rapid diuresis for the treatment of edema

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140128469A1 (en) 2011-05-10 2014-05-08 Concert Pharmaceuticals Inc. Deuterated n-butyl bumetanide
WO2019193161A1 (en) 2018-04-06 2019-10-10 Universität Wien Bumetanide derivatives for the therapy of stroke and other neurological diseases/disorders involving nkccs

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040105818A1 (en) 2002-11-26 2004-06-03 Alexza Molecular Delivery Corporation Diuretic aerosols and methods of making and using them
EP2389371A4 (en) * 2009-01-22 2012-09-12 Neurotherapeutics Pharma Inc ANALOGUES OF BUMETANIDE, FUROSEMIDE, PIRETANIDE, AZOSEMIDE AND TORSEMID, AND RELATED COMPOSITIONS AND METHODS OF USE
JP5914357B2 (ja) * 2010-01-15 2016-05-11 インセルム(インスティチュート ナショナル デ ラ サンテ エ デ ラ リシェルシェ メディカル) 自閉症の治療のための化合物
AU2012250050B2 (en) * 2011-04-28 2017-04-06 Platform Brightworks Two, Ltd. Improved parenteral formulations of lipophilic pharmaceutical agents and methods for preparing and using the same
US20150239832A1 (en) * 2012-09-04 2015-08-27 Neuro Pro Therapeutics, Inc. Analogs and prodrugs of loop diuretics, including bumetanide, furosemide and piretanide; compositions and methods of use
KR20160091348A (ko) * 2014-06-08 2016-08-02 오토텔릭 엘엘씨 부종없이 통증을 완화시키기 위한 고정된 용량의 복합제
CA3160278A1 (en) 2019-12-04 2021-06-10 Balasingam Radhakrishnan Methods and compositions for treating edema refractory to oral diuretics
JP2024520788A (ja) 2021-06-09 2024-05-24 レスク ファーマシューティカルズ エルエルシー 経口利尿薬に不応性の浮腫を処置するための皮下製剤及び方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140128469A1 (en) 2011-05-10 2014-05-08 Concert Pharmaceuticals Inc. Deuterated n-butyl bumetanide
WO2019193161A1 (en) 2018-04-06 2019-10-10 Universität Wien Bumetanide derivatives for the therapy of stroke and other neurological diseases/disorders involving nkccs

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CrystEngComm,2012年,14,2428-2434

Also Published As

Publication number Publication date
US12150923B2 (en) 2024-11-26
WO2021113775A1 (en) 2021-06-10
AU2020397176A1 (en) 2022-06-30
CA3160278A1 (en) 2021-06-10
CN115023223A (zh) 2022-09-06
US20210169833A1 (en) 2021-06-10
US11260038B1 (en) 2022-03-01
US20220287996A1 (en) 2022-09-15
US20250268853A1 (en) 2025-08-28
KR20220113436A (ko) 2022-08-12
BR112022010879A2 (pt) 2022-10-18
US20250032436A1 (en) 2025-01-30
IL293429A (en) 2022-07-01
US12329731B2 (en) 2025-06-17
WO2021113775A8 (en) 2021-07-22
US11123319B2 (en) 2021-09-21
EP4069222A1 (en) 2022-10-12
EP4069222A4 (en) 2023-12-27
JP2026076167A (ja) 2026-05-11
US12558330B2 (en) 2026-02-24
JP2023505189A (ja) 2023-02-08

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