JP2018503627A - 酢酸グラチラマーの製造方法 - Google Patents

酢酸グラチラマーの製造方法 Download PDF

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JP2018503627A
JP2018503627A JP2017534813A JP2017534813A JP2018503627A JP 2018503627 A JP2018503627 A JP 2018503627A JP 2017534813 A JP2017534813 A JP 2017534813A JP 2017534813 A JP2017534813 A JP 2017534813A JP 2018503627 A JP2018503627 A JP 2018503627A
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temperature
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aqueous pharmaceutical
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コーエン、ラケフェト
ハバ、サッソン
サファディ、ムハマド
Original Assignee
テバ ファーマシューティカル インダストリーズ リミティド
テバ ファーマシューティカル インダストリーズ リミティド
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; 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
    • A61K9/14—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/03—Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; 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
    • A61K47/06—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
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • 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
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2017534813A 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法 Withdrawn JP2018503627A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14/608,126 US9155775B1 (en) 2015-01-28 2015-01-28 Process for manufacturing glatiramer acetate product
US14/608,126 2015-01-28
PCT/US2015/051203 WO2016122722A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Related Child Applications (1)

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JP2018134124A Division JP6592150B2 (ja) 2015-01-28 2018-07-17 酢酸グラチラマーの製造方法

Publications (1)

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JP2018503627A true JP2018503627A (ja) 2018-02-08

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ID=54199060

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JP2017534813A Withdrawn JP2018503627A (ja) 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法
JP2018134124A Active JP6592150B2 (ja) 2015-01-28 2018-07-17 酢酸グラチラマーの製造方法

Family Applications After (1)

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JP2018134124A Active JP6592150B2 (ja) 2015-01-28 2018-07-17 酢酸グラチラマーの製造方法

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US (6) US9155775B1 (enExample)
EP (3) EP3113785A4 (enExample)
JP (2) JP2018503627A (enExample)
KR (2) KR101737295B1 (enExample)
CN (1) CN107530394B (enExample)
AR (1) AR102096A1 (enExample)
AU (4) AU2015380381B2 (enExample)
BR (1) BR112016023736A2 (enExample)
CA (2) CA2965890A1 (enExample)
CL (1) CL2016002607A1 (enExample)
CY (1) CY1118826T1 (enExample)
DK (1) DK3050556T3 (enExample)
EA (3) EA028484B1 (enExample)
ES (1) ES2584190T3 (enExample)
HK (1) HK1225309B (enExample)
HR (1) HRP20170625T1 (enExample)
HU (1) HUE034059T2 (enExample)
IL (3) IL247851A0 (enExample)
LT (1) LT3050556T (enExample)
ME (1) ME02721B (enExample)
MX (1) MX352734B (enExample)
PE (1) PE20170296A1 (enExample)
PL (1) PL3050556T3 (enExample)
PT (1) PT3050556T (enExample)
RS (1) RS55959B1 (enExample)
RU (1) RU2669769C2 (enExample)
SI (1) SI3050556T1 (enExample)
SM (1) SMT201700227T1 (enExample)
UA (1) UA116060C2 (enExample)
WO (1) WO2016122722A1 (enExample)
ZA (1) ZA201606903B (enExample)

Families Citing this family (14)

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Publication number Priority date Publication date Assignee Title
USRE49251E1 (en) 2010-01-04 2022-10-18 Mapi Pharma Ltd. Depot systems comprising glatiramer or pharmacologically acceptable salt thereof
EA025780B1 (ru) 2010-10-11 2017-01-30 Тева Фармасьютикал Индастриз Лтд. Цитокиновые биомаркеры в качестве биомаркеров, прогнозирующих клинический ответ на глатирамер ацетат
MX2014004309A (es) 2011-10-10 2015-07-06 Teva Pharma Polimorfismos de nucleotidos individuales utiles para predecir una respuesta clinica para el acetato de glatiramer.
WO2014058976A2 (en) 2012-10-10 2014-04-17 Teva Pharmaceutical Industries Ltd. Biomarkers predictive for clinical response for glatiramer acetate
UY35790A (es) 2013-10-21 2015-05-29 Teva Pharma Marcadores genéticos que predicen la respuesta al acetato de glatiramer
US9155775B1 (en) 2015-01-28 2015-10-13 Teva Pharmaceutical Industries, Ltd. Process for manufacturing glatiramer acetate product
CN107550853B (zh) * 2016-06-30 2020-06-12 深圳翰宇药业股份有限公司 一种醋酸格拉替雷注射液的制备方法
US12097292B2 (en) 2016-08-28 2024-09-24 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
AU2017319728B2 (en) 2016-08-31 2024-09-05 Mapi Pharma Ltd Depot systems comprising glatiramer acetate
CA3045944A1 (en) 2016-12-07 2018-06-14 Progenity, Inc. Gastrointestinal tract detection methods, devices and systems
IL316573A (en) 2017-03-26 2024-12-01 Mapi Pharma Ltd Storage systems containing glatiramer acetate for the treatment of multiple sclerosis
AU2017420758A1 (en) 2017-06-29 2020-01-02 Regeneron Pharmaceuticals Inc. Devices and methods for overfilling drug containers
WO2019036363A1 (en) 2017-08-14 2019-02-21 Progenity Inc. TREATMENT OF GASTROINTESTINAL TRACT DISEASE WITH GLATIRAMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
CN112933210A (zh) * 2019-12-11 2021-06-11 深圳翰宇药业股份有限公司 一种西曲瑞克冻干药物组合物的制备方法

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