FI3875085T3 - Edaravonisuspensio annettavaksi oraalisesti - Google Patents
Edaravonisuspensio annettavaksi oraalisesti Download PDFInfo
- Publication number
- FI3875085T3 FI3875085T3 FIEP19880770.3T FI19880770T FI3875085T3 FI 3875085 T3 FI3875085 T3 FI 3875085T3 FI 19880770 T FI19880770 T FI 19880770T FI 3875085 T3 FI3875085 T3 FI 3875085T3
- Authority
- FI
- Finland
- Prior art keywords
- suspension according
- suspension
- dispersant
- mass concentration
- edaravone
- Prior art date
Links
- 239000000725 suspension Substances 0.000 title claims 20
- QELUYTUMUWHWMC-UHFFFAOYSA-N edaravone Chemical compound O=C1CC(C)=NN1C1=CC=CC=C1 QELUYTUMUWHWMC-UHFFFAOYSA-N 0.000 title claims 9
- 229950009041 edaravone Drugs 0.000 title claims 9
- 239000002270 dispersing agent Substances 0.000 claims 10
- 239000002245 particle Substances 0.000 claims 8
- 239000002562 thickening agent Substances 0.000 claims 4
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 3
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 3
- 238000000034 method Methods 0.000 claims 2
- 229920000609 methyl cellulose Polymers 0.000 claims 2
- 239000001923 methylcellulose Substances 0.000 claims 2
- 235000010981 methylcellulose Nutrition 0.000 claims 2
- 239000000230 xanthan gum Substances 0.000 claims 2
- 229920001285 xanthan gum Polymers 0.000 claims 2
- 235000010493 xanthan gum Nutrition 0.000 claims 2
- 229940082509 xanthan gum Drugs 0.000 claims 2
- 241000416162 Astragalus gummifer Species 0.000 claims 1
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 229920001615 Tragacanth Polymers 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 230000005540 biological transmission Effects 0.000 claims 1
- 235000014113 dietary fatty acids Nutrition 0.000 claims 1
- 238000004090 dissolution Methods 0.000 claims 1
- 238000007922 dissolution test Methods 0.000 claims 1
- 239000000194 fatty acid Substances 0.000 claims 1
- 229930195729 fatty acid Natural products 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 229960003943 hypromellose Drugs 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 239000008247 solid mixture Substances 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- -1 sucrose fatty acid ester Chemical class 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- 239000012085 test solution Substances 0.000 claims 1
- 239000000196 tragacanth Substances 0.000 claims 1
- 235000010487 tragacanth Nutrition 0.000 claims 1
- 229940116362 tragacanth Drugs 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
Landscapes
- 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)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2018207646 | 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 |
|---|---|
| FI3875085T3 true FI3875085T3 (fi) | 2024-08-06 |
Family
ID=70463399
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FIEP19880770.3T FI3875085T3 (fi) | 2018-11-02 | 2019-11-01 | Edaravonisuspensio annettavaksi oraalisesti |
Country Status (19)
| 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)
| 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 |
Family Cites Families (21)
| 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 |
| 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 |
| 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 |
| WO2002034264A1 (en) | 2000-10-24 | 2002-05-02 | Mitsubishi Pharma Corporation | Remedies for amyotrophic lateral sclerosis (als) |
| 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 |
| 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 |
| WO2014134243A1 (en) | 2013-02-27 | 2014-09-04 | Regents Of The University Of Michigan | Pharmaceutical compounds and use of same in cancer and tauopathies |
| 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 |
-
2019
- 2019-11-01 MX MX2021005144A patent/MX2021005144A/es unknown
- 2019-11-01 BR BR112021008197-6A patent/BR112021008197A2/pt unknown
- 2019-11-01 PT PT198807703T patent/PT3875085T/pt unknown
- 2019-11-01 CN CN202311552337.9A patent/CN117398346A/zh active Pending
- 2019-11-01 DK DK19880770.3T patent/DK3875085T3/da active
- 2019-11-01 AR ARP190103206A patent/AR116967A1/es unknown
- 2019-11-01 EP EP19880770.3A patent/EP3875085B1/en active Active
- 2019-11-01 CN CN201980072370.7A patent/CN112969459B/zh active Active
- 2019-11-01 WO PCT/JP2019/043013 patent/WO2020091036A1/ja not_active Ceased
- 2019-11-01 EP EP24181935.8A patent/EP4420724A3/en active Pending
- 2019-11-01 ES ES19880770T patent/ES2991523T3/es active Active
- 2019-11-01 PL PL19880770.3T patent/PL3875085T3/pl unknown
- 2019-11-01 JP JP2020554977A patent/JP7274502B2/ja active Active
- 2019-11-01 CN CN202311552338.3A patent/CN117379369A/zh active Pending
- 2019-11-01 IL IL319280A patent/IL319280A/en unknown
- 2019-11-01 FI FIEP19880770.3T patent/FI3875085T3/fi active
- 2019-11-01 AU AU2019369843A patent/AU2019369843A1/en not_active Abandoned
- 2019-11-01 IL IL282773A patent/IL282773B2/en unknown
- 2019-11-01 HU HUE19880770A patent/HUE068117T2/hu unknown
- 2019-11-01 SG SG11202104365QA patent/SG11202104365QA/en unknown
- 2019-11-01 KR KR1020217016462A patent/KR20210087490A/ko active Pending
- 2019-11-01 CN CN202311552339.8A patent/CN117379370A/zh active Pending
-
2020
- 2020-05-12 US US16/872,741 patent/US10987341B2/en active Active
-
2021
- 2021-03-26 US US17/213,501 patent/US11241416B2/en active Active
- 2021-04-30 MX MX2023009973A patent/MX2023009973A/es unknown
- 2021-04-30 PH PH12021550988A patent/PH12021550988A1/en unknown
- 2021-04-30 MX MX2024000663A patent/MX2024000663A/es unknown
- 2021-12-23 US US17/560,493 patent/US11478450B2/en active Active
-
2022
- 2022-09-22 US US17/934,234 patent/US11957660B2/en active Active
-
2023
- 2023-05-01 JP JP2023075654A patent/JP7828317B2/ja active Active
-
2024
- 2024-03-26 US US18/616,227 patent/US12599586B2/en active Active
-
2025
- 2025-07-21 AU AU2025205635A patent/AU2025205635A1/en active Pending
- 2025-10-06 JP JP2025168147A patent/JP2026010001A/ja active Pending
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