CN115487313A - 静脉内加奈索酮制剂及其用途 - Google Patents

静脉内加奈索酮制剂及其用途 Download PDF

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Publication number
CN115487313A
CN115487313A CN202211152228.3A CN202211152228A CN115487313A CN 115487313 A CN115487313 A CN 115487313A CN 202211152228 A CN202211152228 A CN 202211152228A CN 115487313 A CN115487313 A CN 115487313A
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Prior art keywords
ganaxolone
formulation
cyclodextrin
patient
sulfobutyl ether
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Pending
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CN202211152228.3A
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English (en)
Chinese (zh)
Inventor
张明宝
雷蒙德·C·格洛瓦基
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Marinus Pharmaceuticals Inc
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Marinus Pharmaceuticals Inc
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Publication of CN115487313A publication Critical patent/CN115487313A/zh
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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)
CN202211152228.3A 2015-02-06 2016-02-08 静脉内加奈索酮制剂及其用途 Pending CN115487313A (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562112943P 2015-02-06 2015-02-06
US62/112,943 2015-02-06
CN201680008938.5A 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
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 Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201680008938.5A Division 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

Publications (1)

Publication Number Publication Date
CN115487313A true CN115487313A (zh) 2022-12-20

Family

ID=56564813

Family Applications (3)

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
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

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

Country Status (8)

Country Link
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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CN115487313A (zh) * 2015-02-06 2022-12-20 马瑞纳斯制药公司 静脉内加奈索酮制剂及其用途
MA45276A (fr) * 2015-06-18 2018-04-25 Sage Therapeutics Inc Solutions de stéroïdes neuroactifs et leurs méthodes d'utilisation
CA3001722A1 (en) 2015-10-16 2017-04-20 Marinus Pharmaceuticals, Inc. Injectable neurosteroid formulations containing nanoparticles
JP2019507111A (ja) 2015-12-22 2019-03-14 ゾゲニクス インターナショナル リミテッド 代謝抵抗性フェンフルラミン類縁体およびその使用法
KR102688278B1 (ko) 2015-12-22 2024-07-26 조게닉스 인터내셔널 리미티드 펜플루라민 조성물 및 그 제조 방법
CN113616661A (zh) 2016-03-08 2021-11-09 萨奇治疗股份有限公司 神经活性类固醇、其组合物及用途
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US10391105B2 (en) 2016-09-09 2019-08-27 Marinus Pharmaceuticals Inc. Methods of treating certain depressive disorders and delirium tremens
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
CA3097335A1 (en) 2018-05-11 2019-11-14 Zogenix International Limited Compositions and methods for treating seizure-induced sudden death
WO2019241005A1 (en) 2018-06-14 2019-12-19 Zogenix International Limited Compositions and methods for treating respiratory depression with fenfluramine
WO2020097045A1 (en) * 2018-11-05 2020-05-14 Ovid Therapeutics Inc. Use of gaboxadol, ganaxolone and allopregnanolone to treat movement disorders
AU2019384963B2 (en) 2018-11-19 2022-05-26 Zogenix International Limited Methods of treating Rett syndrome using fenfluramine
WO2020118142A1 (en) 2018-12-07 2020-06-11 Marinus Pharmaceuticals, Inc. Ganaxolone for use in prophylaxis and treatment of pospartum depression
MX2021006317A (es) * 2018-12-14 2021-08-11 Eisai R&D Man Co Ltd Formulaciones farmaceuticas de base acuosa de compuestos de 1,2-dihidropiridina.
WO2020157257A1 (en) * 2019-02-01 2020-08-06 H. Lundbeck A/S Injectable carbamazepine composition essentially free of 10-br-carbamazepine
MX2021009777A (es) * 2019-02-15 2021-12-15 Saol Int Development Ltd Formulaciones inyectables de fenol y metodos de su uso.
EP3930841A4 (en) * 2019-02-25 2022-11-30 Zogenix International Limited A formulation for improving 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
CA3145923A1 (en) * 2019-08-05 2021-02-11 David Czekai Ganaxolone for use in treatment of status epilepticus
IL293525A (en) 2019-12-06 2022-08-01 Marinus Pharmaceuticals Inc Ganaxolone for use in the treatment of multiple sclerosis complex
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
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WO2023060020A1 (en) * 2021-10-04 2023-04-13 Marinus Pharmaceuticals, Inc. Ganaxolone for use in treatment of established status epilepticus
CN114272216B (zh) * 2021-10-11 2023-07-04 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
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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JP7566961B2 (ja) 2024-10-15
IL252848A0 (en) 2017-08-31
CN115381772A (zh) 2022-11-25
CA2973140C (en) 2025-09-16
CN107427458A (zh) 2017-12-01
AU2016214996A1 (en) 2017-06-29
IL252848B1 (en) 2024-03-01
US20240016817A1 (en) 2024-01-18
EP4059522A1 (en) 2022-09-21
CA2973140A1 (en) 2016-08-11
EP3253418A1 (en) 2017-12-13
IL252848B2 (en) 2024-07-01
AU2016214996B2 (en) 2021-03-04
JP2024178469A (ja) 2024-12-24
JP2018504420A (ja) 2018-02-15
JP2021155457A (ja) 2021-10-07
WO2016127170A1 (en) 2016-08-11
JP2023078301A (ja) 2023-06-06
IL302203A (en) 2023-06-01
US20160228454A1 (en) 2016-08-11
JP7273897B2 (ja) 2023-05-15
US20230293549A1 (en) 2023-09-21
CA3254865A1 (en) 2025-05-28
US20250325562A1 (en) 2025-10-23

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