KR20210087490A - 경구 투여용 에다라본 현탁액 - Google Patents

경구 투여용 에다라본 현탁액 Download PDF

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Publication number
KR20210087490A
KR20210087490A KR1020217016462A KR20217016462A KR20210087490A KR 20210087490 A KR20210087490 A KR 20210087490A KR 1020217016462 A KR1020217016462 A KR 1020217016462A KR 20217016462 A KR20217016462 A KR 20217016462A KR 20210087490 A KR20210087490 A KR 20210087490A
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Prior art keywords
edaravone
suspension
particles
oral administration
edarabone
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Pending
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KR1020217016462A
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English (en)
Korean (ko)
Inventor
데츠오 하야마
도모히로 다카하시
도모유키 오무라
고우지 하야시
무네토모 마츠다
다다시 미야자와
Original Assignee
미쓰비시 타나베 파마 코퍼레이션
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=70463399&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR20210087490(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 미쓰비시 타나베 파마 코퍼레이션 filed Critical 미쓰비시 타나베 파마 코퍼레이션
Publication of KR20210087490A publication Critical patent/KR20210087490A/ko
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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A61K31/4152—1,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Dispersion Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
KR1020217016462A 2018-11-02 2019-11-01 경구 투여용 에다라본 현탁액 Pending KR20210087490A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2018207646 2018-11-02
JPJP-P-2018-207646 2018-11-02
PCT/JP2019/043013 WO2020091036A1 (ja) 2018-11-02 2019-11-01 経口投与用エダラボン懸濁剤

Publications (1)

Publication Number Publication Date
KR20210087490A true KR20210087490A (ko) 2021-07-12

Family

ID=70463399

Family Applications (1)

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KR1020217016462A Pending KR20210087490A (ko) 2018-11-02 2019-11-01 경구 투여용 에다라본 현탁액

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Country Link
US (5) US10987341B2 (enExample)
EP (2) EP3875085B1 (enExample)
JP (3) JP7274502B2 (enExample)
KR (1) KR20210087490A (enExample)
CN (4) CN117398346A (enExample)
AR (1) AR116967A1 (enExample)
AU (2) AU2019369843A1 (enExample)
BR (1) BR112021008197A2 (enExample)
DK (1) DK3875085T3 (enExample)
ES (1) ES2991523T3 (enExample)
FI (1) FI3875085T3 (enExample)
HU (1) HUE068117T2 (enExample)
IL (2) IL319280A (enExample)
MX (3) MX2021005144A (enExample)
PH (1) PH12021550988A1 (enExample)
PL (1) PL3875085T3 (enExample)
PT (1) PT3875085T (enExample)
SG (1) SG11202104365QA (enExample)
WO (1) WO2020091036A1 (enExample)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019167178A1 (ja) 2018-02-28 2019-09-06 田辺三菱製薬株式会社 ３－メチル－１－フェニル－２－ピラゾリン－５－オン原薬の分析方法、筋萎縮性側索硬化症の治療および筋萎縮性側索硬化症の進行抑制、ならびに、３－メチル－１－フェニル－２－ピラゾリン－５－オン原薬を含む薬剤の製造方法
MX2021005144A (es) 2018-11-02 2021-07-15 Mitsubishi Tanabe Pharma Corp Suspension de edaravona para administracion oral.
US11826352B2 (en) 2018-11-02 2023-11-28 Mitsubishi Tanabe Pharma Corporation Edaravone suspension for oral administration
EP3989968A4 (en) * 2019-07-18 2023-07-12 BDR Pharmaceuticals International Private Limited ORAL FORMULATIONS OF EDARAVON AND PROCESSES FOR THEIR PREPARATION
US12194025B2 (en) 2020-11-12 2025-01-14 Mitsubishi Tanabe Pharma Corporation Pharmaceutical composition for oral administration of edaravone and method of administering same
CA3198014A1 (en) 2020-11-12 2022-05-19 Hidetoshi Shimizu Pharmaceutical composition for oral administration of edaravone and method of administering same
GB202103807D0 (en) 2021-03-18 2021-05-05 Johnson Matthey Plc A crystalline salt of edaravone, processes for the preparation and use thereof
JPWO2023149539A1 (enExample) 2022-02-03 2023-08-10
WO2024005187A1 (ja) 2022-07-01 2024-01-04 田辺三菱製薬株式会社 組成物、およびエダラボンの応答可能性の評価方法
US12343330B2 (en) 2023-02-16 2025-07-01 Slayback Pharma Llc Stable pharmaceutical compositions of edaravone
CN118178328A (zh) * 2024-03-21 2024-06-14 药云(西安)医药技术有限公司 依达拉奉包埋物制备方法与其口服制剂

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0531523A (ja) 1991-07-26 1993-02-09 Aichi Steel Works Ltd ロ−ラ回転数・間隙測定可能な圧延機用ロ−ラガイド装置
JP2004091441A (ja) 2002-09-04 2004-03-25 Mitsubishi Pharma Corp ピラゾロン誘導体を含有する経口投与製剤
JP3758164B2 (ja) 2000-10-24 2006-03-22 三菱ウェルファーマ株式会社 筋萎縮性側索硬化症（ａｌｓ）治療剤
WO2014134243A1 (en) 2013-02-27 2014-09-04 Regents Of The University Of Michigan Pharmaceutical compounds and use of same in cancer and tauopathies

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61263917A (ja) 1985-05-20 1986-11-21 Mitsubishi Yuka Yakuhin Kk 脳機能正常化剤
JPH07121861B2 (ja) 1986-11-25 1995-12-25 三菱化学株式会社 ３−メチル−１−フエニル−２−ピラゾロン−５−オンを含有する安定な注射剤
JP3402195B2 (ja) * 1997-05-14 2003-04-28 千寿製薬株式会社 再分散性の良い水性懸濁液剤
JPH1120463A (ja) 1997-06-30 1999-01-26 Zexel Corp 車両用デュアルエアコン
US20080161378A1 (en) 2004-02-09 2008-07-03 Hiide Yoshino Novel Therapeutic Agent For Amyotrophic Lateral Sclerosis (Als) or Diseases Caused by Als
JP5836004B2 (ja) 2010-08-12 2015-12-24 日新化成株式会社 可溶化剤
CN102824356A (zh) 2012-09-25 2012-12-19 江西中医学院 一种黄芩苷纳晶混悬剂、纳晶干粉及其制备方法
JP6336246B2 (ja) 2013-03-13 2018-06-06 大同化成工業株式会社 ナノ粒子化製剤及びその製造方法
CN105878171A (zh) * 2014-12-22 2016-08-24 南京海恒医药科技有限公司 一种依达拉奉新制剂及其制备方法
EP3247334A1 (en) 2015-01-20 2017-11-29 Merck Patent GmbH Solid dispersions of compounds using polyvinyl alcohol as a carrier polymer
JP7026609B2 (ja) * 2016-03-10 2022-02-28 大日本住友製薬株式会社 微細粒子含有組成物およびその製法
CN113768879A (zh) * 2016-03-16 2021-12-10 苏州澳宗生物科技有限公司 依达拉奉剂型
PL3551181T3 (pl) 2017-01-17 2021-05-31 Treeway Tw001 B.V. Leczenie obejmujące doustne lub dożołądkowe podawanie edarawonu
AU2017394478B2 (en) * 2017-01-17 2023-07-20 Treeway Tw001 B.V. Medical treatment comprising enteral administration of edaravone
CA3069048A1 (en) * 2017-07-06 2019-01-10 Treeway Tw001 B.V. Use of edaravone in oral treatment of oxidative-stress mediated neurodegenerative disorders
MX2021005144A (es) * 2018-11-02 2021-07-15 Mitsubishi Tanabe Pharma Corp Suspension de edaravona para administracion oral.
EP3989968A4 (en) * 2019-07-18 2023-07-12 BDR Pharmaceuticals International Private Limited ORAL FORMULATIONS OF EDARAVON AND PROCESSES FOR THEIR PREPARATION

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0531523A (ja) 1991-07-26 1993-02-09 Aichi Steel Works Ltd ロ−ラ回転数・間隙測定可能な圧延機用ロ−ラガイド装置
JP3758164B2 (ja) 2000-10-24 2006-03-22 三菱ウェルファーマ株式会社 筋萎縮性側索硬化症（ａｌｓ）治療剤
JP2004091441A (ja) 2002-09-04 2004-03-25 Mitsubishi Pharma Corp ピラゾロン誘導体を含有する経口投与製剤
WO2014134243A1 (en) 2013-02-27 2014-09-04 Regents Of The University Of Michigan Pharmaceutical compounds and use of same in cancer and tauopathies

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Drug Delivery, 24:1, 962-978.
International Journal of Pharmaceutics 515 (2016) 490-500
Journal of Pharmaceutical Sciences 103:730-742, 2014.

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EP3875085B1 (en) 2024-06-19
CN117379369A (zh) 2024-01-12
US10987341B2 (en) 2021-04-27
PL3875085T3 (pl) 2024-10-21
AU2025205635A1 (en) 2025-08-07
US20220110915A1 (en) 2022-04-14
JP7828317B2 (ja) 2026-03-11
EP3875085A1 (en) 2021-09-08
MX2023009973A (es) 2023-09-06
HUE068117T2 (hu) 2024-12-28
AU2019369843A2 (en) 2023-02-02
DK3875085T3 (da) 2024-07-08
BR112021008197A2 (pt) 2021-08-03
PH12021550988A1 (en) 2021-10-04
CN112969459B (zh) 2023-12-05
IL282773A (en) 2021-06-30
CN117379370A (zh) 2024-01-12
US11957660B2 (en) 2024-04-16
AU2019369843A1 (en) 2021-05-27
WO2020091036A1 (ja) 2020-05-07
TW202031256A (zh) 2020-09-01
US11241416B2 (en) 2022-02-08
JP7274502B2 (ja) 2023-05-16
CN117398346A (zh) 2024-01-16
JP2026010001A (ja) 2026-01-21
JPWO2020091036A1 (ja) 2021-09-24
ES2991523T3 (es) 2024-12-03
FI3875085T3 (fi) 2024-08-06
US20240226064A1 (en) 2024-07-11
US12599586B2 (en) 2026-04-14
EP4420724A2 (en) 2024-08-28
US11478450B2 (en) 2022-10-25
US20230030285A1 (en) 2023-02-02
US20210212990A1 (en) 2021-07-15
EP3875085A4 (en) 2022-07-27
EP4420724A3 (en) 2024-11-27
MX2021005144A (es) 2021-07-15
US20200268712A1 (en) 2020-08-27
JP2023087011A (ja) 2023-06-22
CN112969459A (zh) 2021-06-15
IL282773B2 (en) 2025-08-01
PT3875085T (pt) 2024-08-09
IL319280A (en) 2025-04-01
IL282773B1 (en) 2025-04-01
MX2024000663A (es) 2024-01-31
AR116967A1 (es) 2021-06-30
SG11202104365QA (en) 2021-05-28

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