CN107427458A - 静脉内加奈索酮制剂及其在治疗癫痫持续状态和其他癫痫发作病症中的用途 - Google Patents

静脉内加奈索酮制剂及其在治疗癫痫持续状态和其他癫痫发作病症中的用途 Download PDF

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Publication number
CN107427458A
CN107427458A CN201680008938.5A CN201680008938A CN107427458A CN 107427458 A CN107427458 A CN 107427458A CN 201680008938 A CN201680008938 A CN 201680008938A CN 107427458 A CN107427458 A CN 107427458A
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Prior art keywords
ganaxolone
formulation
cyclodextrin
patient
sulfobutyl ether
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Pending
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CN201680008938.5A
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English (en)
Chinese (zh)
Inventor
张明宝
雷蒙德·C·格洛瓦基
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Immedica Pharma US Inc
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Marinus Pharmaceuticals Inc
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Publication date
Application filed by Marinus Pharmaceuticals Inc filed Critical Marinus Pharmaceuticals Inc
Priority to CN202211152228.3A priority Critical patent/CN115487313A/zh
Priority to CN202211150855.3A priority patent/CN115381772A/zh
Publication of CN107427458A publication Critical patent/CN107427458A/zh
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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (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)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (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)
CN201680008938.5A 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其在治疗癫痫持续状态和其他癫痫发作病症中的用途 Pending CN107427458A (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202211152228.3A CN115487313A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途
CN202211150855.3A CN115381772A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途

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

Related Child Applications (2)

Application Number Title Priority Date Filing Date
CN202211152228.3A Division CN115487313A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途
CN202211150855.3A Division CN115381772A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途

Publications (1)

Publication Number Publication Date
CN107427458A true CN107427458A (zh) 2017-12-01

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Family Applications (3)

Application Number Title Priority Date Filing Date
CN201680008938.5A Pending CN107427458A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其在治疗癫痫持续状态和其他癫痫发作病症中的用途
CN202211152228.3A Pending CN115487313A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途
CN202211150855.3A Pending CN115381772A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途

Family Applications After (2)

Application Number Title Priority Date Filing Date
CN202211152228.3A Pending CN115487313A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途
CN202211150855.3A Pending CN115381772A (zh) 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途

Country Status (8)

Country Link
US (4) US20160228454A1 (https=)
EP (2) EP4059522A1 (https=)
JP (4) JP2018504420A (https=)
CN (3) CN107427458A (https=)
AU (1) AU2016214996B2 (https=)
CA (2) CA3254865A1 (https=)
IL (2) IL302203A (https=)
WO (1) WO2016127170A1 (https=)

Cited By (6)

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CN108535398A (zh) * 2018-04-04 2018-09-14 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
CN113226286A (zh) * 2018-12-14 2021-08-06 卫材R&D管理有限公司 1,2-二氢吡啶化合物的水基药物制剂
CN113395958A (zh) * 2019-02-01 2021-09-14 H.隆德贝克有限公司 基本上无10-溴-卡马西平的可注射卡马西平组合物
CN114272216A (zh) * 2021-10-11 2022-04-05 浙江歌文达生物医药科技有限公司 一种2-氧代-1-吡咯烷衍生物的冻干制剂及其制备
CN114728012A (zh) * 2019-08-05 2022-07-08 马瑞纳斯制药公司 用于治疗癫痫持续状态的加奈索酮
CN116769070A (zh) * 2023-06-07 2023-09-19 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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US9549909B2 (en) 2013-05-03 2017-01-24 The Katholieke Universiteit Leuven Method for the treatment of dravet syndrome
JOP20200195A1 (ar) 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
EP4059522A1 (en) * 2015-02-06 2022-09-21 Marinus Pharmaceuticals, Inc. Intravenous ganaxolone formulations and their use in treating status epilepticus and other seizure disorders
AR105044A1 (es) * 2015-06-18 2017-08-30 Sage Therapeutics Inc Soluciones de esteroides neuroactivos y sus métodos de uso, recipiente
EA036155B1 (ru) 2015-10-16 2020-10-06 Маринус Фармасьютикалс, Инк. Инъекционные составы нейростероида, содержащие наночастицы
PT4293009T (pt) 2015-12-22 2025-09-08 Zogenix International Ltd Composições de fenfluramina e métodos de preparação das mesmas
WO2017112701A1 (en) 2015-12-22 2017-06-29 Zogenix International Limited Metabolism resistant fenfluramine analogs and methods of using the same
HK1258616A1 (zh) 2016-03-08 2019-11-15 Sage Therapeutics, Inc. 神经活性类固醇、组合物、及其用途
EP4233861A3 (en) 2016-08-11 2023-10-11 Ovid Therapeutics, Inc. Compositions for treatment of essential tremor
AU2017315273B2 (en) 2016-08-24 2021-04-29 Zogenix International Limited Formulation for inhibiting formation of 5-HT 2B agonists and methods of using same
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CN109890392A (zh) * 2016-10-14 2019-06-14 马瑞纳斯制药公司 施用神经类固醇以实现脑电图（eeg）爆发抑制的方法
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EP3790537A1 (en) 2018-05-11 2021-03-17 Zogenix International Limited Compositions and methods for treating seizure-induced sudden death
EP3806835A1 (en) 2018-06-14 2021-04-21 Zogenix International Limited Compositions and methods for treating respiratory depression with fenfluramine
KR20210087952A (ko) * 2018-11-05 2021-07-13 오비드 테라퓨틱스 인크. 운동 장애들을 치료하기 위한 가복사돌, 가낙솔론 및 알로프레그나놀론의 사용
AU2019384963B2 (en) 2018-11-19 2022-05-26 Zogenix International Limited Methods of treating Rett syndrome using fenfluramine
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CA3129648A1 (en) * 2019-02-15 2020-08-20 Saol International Limited Injectable formulations comprising phenol and cyclodextrin and uses thereof________________________________
EP3930841A4 (en) * 2019-02-25 2022-11-30 Zogenix International Limited FORMULATION TO IMPROVE SEIZURE CONTROL
US20200338090A1 (en) * 2019-04-29 2020-10-29 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
US20210260074A1 (en) * 2019-04-29 2021-08-26 Marsh and Wang Medical Systems, LLC Seizure control compositions and methods of using same
SG11202112111WA (en) 2019-05-10 2021-11-29 Brii Biosciences Inc Pharmaceutical composition containing brexanolone, ganaxolone, or zuranolone, and use thereof
JP7780431B2 (ja) 2019-12-06 2025-12-04 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 結節性硬化症の治療での使用のためのガナキソロン
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108535398A (zh) * 2018-04-04 2018-09-14 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
CN113226286A (zh) * 2018-12-14 2021-08-06 卫材R&D管理有限公司 1,2-二氢吡啶化合物的水基药物制剂
US12303499B2 (en) 2018-12-14 2025-05-20 Eisai R&D Management Co., Ltd. Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds
CN113395958A (zh) * 2019-02-01 2021-09-14 H.隆德贝克有限公司 基本上无10-溴-卡马西平的可注射卡马西平组合物
CN114728012A (zh) * 2019-08-05 2022-07-08 马瑞纳斯制药公司 用于治疗癫痫持续状态的加奈索酮
CN114272216A (zh) * 2021-10-11 2022-04-05 浙江歌文达生物医药科技有限公司 一种2-氧代-1-吡咯烷衍生物的冻干制剂及其制备
CN116769070A (zh) * 2023-06-07 2023-09-19 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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AU2016214996B2 (en) 2021-03-04
IL302203A (en) 2023-06-01
US20250325562A1 (en) 2025-10-23
JP2021155457A (ja) 2021-10-07
JP2023078301A (ja) 2023-06-06
CN115381772A (zh) 2022-11-25
CA3254865A1 (en) 2025-05-28
IL252848B2 (en) 2024-07-01
EP3253418A1 (en) 2017-12-13
JP7566961B2 (ja) 2024-10-15
US20240016817A1 (en) 2024-01-18
CA2973140A1 (en) 2016-08-11
JP2018504420A (ja) 2018-02-15
CA2973140C (en) 2025-09-16
US20230293549A1 (en) 2023-09-21
IL252848B1 (en) 2024-03-01
CN115487313A (zh) 2022-12-20
IL252848A0 (en) 2017-08-31
US20160228454A1 (en) 2016-08-11
AU2016214996A1 (en) 2017-06-29
JP7273897B2 (ja) 2023-05-15
WO2016127170A1 (en) 2016-08-11
JP2024178469A (ja) 2024-12-24
EP4059522A1 (en) 2022-09-21

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Application publication date: 20171201