JP2018504420A - 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用 - Google Patents

静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用 Download PDF

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JP2018504420A
JP2018504420A JP2017540743A JP2017540743A JP2018504420A JP 2018504420 A JP2018504420 A JP 2018504420A JP 2017540743 A JP2017540743 A JP 2017540743A JP 2017540743 A JP2017540743 A JP 2017540743A JP 2018504420 A JP2018504420 A JP 2018504420A
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ganaxolone
formulation
cyclodextrin
patient
preparation
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JP2018504420A5 (enExample
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ミングバオ チャン
ミングバオ チャン
レイモンド シー グロワキー
レイモンド シー グロワキー
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マリナス ファーマシューティカルズ インコーポレイテッド
マリナス ファーマシューティカルズ インコーポレイテッド
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Publication of JP2018504420A publication Critical patent/JP2018504420A/ja
Publication of JP2018504420A5 publication Critical patent/JP2018504420A5/ja
Priority to JP2021110619A priority Critical patent/JP7273897B2/ja
Priority to JP2023042531A priority patent/JP7566961B2/ja
Priority to JP2024173821A priority patent/JP2024178469A/ja
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    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/26—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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • 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
    • A61K47/40—Cyclodextrins; Derivatives 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2017540743A 2015-02-06 2016-02-08 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用 Pending JP2018504420A (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2021110619A JP7273897B2 (ja) 2015-02-06 2021-07-02 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2023042531A JP7566961B2 (ja) 2015-02-06 2023-03-17 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2024173821A JP2024178469A (ja) 2015-02-06 2024-10-02 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562112943P 2015-02-06 2015-02-06
US62/112,943 2015-02-06
PCT/US2016/016977 WO2016127170A1 (en) 2015-02-06 2016-02-08 Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders

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JP2021110619A Division JP7273897B2 (ja) 2015-02-06 2021-07-02 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2023042531A Division JP7566961B2 (ja) 2015-02-06 2023-03-17 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用

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JP2018504420A5 JP2018504420A5 (enExample) 2019-03-14

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JP2017540743A Pending JP2018504420A (ja) 2015-02-06 2016-02-08 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2021110619A Active JP7273897B2 (ja) 2015-02-06 2021-07-02 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2023042531A Active JP7566961B2 (ja) 2015-02-06 2023-03-17 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2024173821A Withdrawn JP2024178469A (ja) 2015-02-06 2024-10-02 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用

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JP2023042531A Active JP7566961B2 (ja) 2015-02-06 2023-03-17 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2024173821A Withdrawn JP2024178469A (ja) 2015-02-06 2024-10-02 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用

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US (4) US20160228454A1 (enExample)
EP (2) EP4059522A1 (enExample)
JP (4) JP2018504420A (enExample)
CN (3) CN115487313A (enExample)
AU (1) AU2016214996B2 (enExample)
CA (2) CA3254865A1 (enExample)
IL (2) IL252848B2 (enExample)
WO (1) WO2016127170A1 (enExample)

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JP2021155457A (ja) * 2015-02-06 2021-10-07 マリナス ファーマシューティカルズ インコーポレイテッド 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2022510947A (ja) * 2018-12-14 2022-01-28 エーザイ・アール・アンド・ディー・マネジメント株式会社 １，２－ジヒドロピリジン化合物の水性医薬製剤
JP2022521446A (ja) * 2019-02-25 2022-04-07 ゾゲニクス インターナショナル リミテッド 発作制御を改善するための製剤
JP2022530793A (ja) * 2019-04-29 2022-07-01 マーシュ・アンド・ワン・メディカル・システムズ，エルエルシー 発作制御組成物およびその使用方法
JP2022543837A (ja) * 2019-08-05 2022-10-14 マリナス ファーマシューティカルズ， インコーポレイテッド てんかん重積状態の治療に使用するためのガナキソロン

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KR102688278B1 (ko) 2015-12-22 2024-07-26 조게닉스 인터내셔널 리미티드 펜플루라민 조성물 및 그 제조 방법
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EP3525797A4 (en) * 2016-10-14 2020-06-24 Marinus Pharmaceuticals, Inc. Method of administering a neurosteroid to effect electroencephalographic (eeg) burst suppression
CN110225754A (zh) * 2016-11-22 2019-09-10 奥维德医疗公司 用氟吡汀治疗发育障碍和/或癫痫发作紊乱的方法
US10682317B2 (en) 2017-09-26 2020-06-16 Zogenix International Limited Ketogenic diet compatible fenfluramine formulation
WO2019094724A1 (en) * 2017-11-10 2019-05-16 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treating genetic epileptic disoders
CN108535398B (zh) * 2018-04-04 2020-03-27 福州海王福药制药有限公司 一种采用反相高效液相色谱法分离盐酸噻加宾手性对映体的方法
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WO2020097045A1 (en) * 2018-11-05 2020-05-14 Ovid Therapeutics Inc. Use of gaboxadol, ganaxolone and allopregnanolone to treat movement disorders
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US11612574B2 (en) 2020-07-17 2023-03-28 Zogenix International Limited Method of treating patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
WO2022109440A1 (en) * 2020-11-23 2022-05-27 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treatment of super refractory status epilepticus
EP4255438A4 (en) * 2020-12-07 2024-10-16 Marinus Pharmaceuticals, Inc. USE OF GANAXOLONE IN THE TREATMENT OF AN EPILEPTIC DISORDER
WO2023060020A1 (en) * 2021-10-04 2023-04-13 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treatment of established status epilepticus
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CN116769070B (zh) * 2023-06-07 2025-07-01 浙江工业大学 一种功能化磁性纳米颗粒及作为手性萃取剂在液-液萃取拆分手性化合物中的应用

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JP2021155457A (ja) * 2015-02-06 2021-10-07 マリナス ファーマシューティカルズ インコーポレイテッド 静注用ガナキソロン製剤ならびにてんかん重積状態および他の発作性障害の治療におけるその使用
JP2022510947A (ja) * 2018-12-14 2022-01-28 エーザイ・アール・アンド・ディー・マネジメント株式会社 １，２－ジヒドロピリジン化合物の水性医薬製剤
JP7177937B2 (ja) 2018-12-14 2022-11-24 エーザイ・アール・アンド・ディー・マネジメント株式会社 １，２－ジヒドロピリジン化合物の水性医薬製剤
JP2022521446A (ja) * 2019-02-25 2022-04-07 ゾゲニクス インターナショナル リミテッド 発作制御を改善するための製剤
JP2022530793A (ja) * 2019-04-29 2022-07-01 マーシュ・アンド・ワン・メディカル・システムズ，エルエルシー 発作制御組成物およびその使用方法
JP7661238B2 (ja) 2019-04-29 2025-04-14 マーシュ・アンド・ワン・メディカル・システムズ，エルエルシー 発作制御組成物およびその使用方法
JP2022543837A (ja) * 2019-08-05 2022-10-14 マリナス ファーマシューティカルズ， インコーポレイテッド てんかん重積状態の治療に使用するためのガナキソロン
JP7754799B2 (ja) 2019-08-05 2025-10-15 マリナス ファーマシューティカルズ， インコーポレイテッド てんかん重積状態の治療に使用するためのガナキソロン

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CN107427458A (zh) 2017-12-01
AU2016214996A1 (en) 2017-06-29
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US20160228454A1 (en) 2016-08-11
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