CN107530394B - 制备醋酸格拉替雷产品的方法 - Google Patents

制备醋酸格拉替雷产品的方法 Download PDF

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Publication number
CN107530394B
CN107530394B CN201580071551.XA CN201580071551A CN107530394B CN 107530394 B CN107530394 B CN 107530394B CN 201580071551 A CN201580071551 A CN 201580071551A CN 107530394 B CN107530394 B CN 107530394B
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temperature
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drug solution
aqueous
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CN107530394A (zh
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拉克菲特·科恩
萨松·哈巴
默罕默德·萨法迪
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Teva Pharmaceutical Industries Ltd
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    • 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
    • A61K38/02—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
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (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)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Psychology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Orthopedic Medicine & Surgery (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)
CN201580071551.XA 2015-01-28 2015-09-21 制备醋酸格拉替雷产品的方法 Active CN107530394B (zh)

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

Publications (2)

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CN107530394A CN107530394A (zh) 2018-01-02
CN107530394B true CN107530394B (zh) 2021-05-25

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

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USRE49251E1 (en) 2010-01-04 2022-10-18 Mapi Pharma Ltd. Depot systems comprising glatiramer or pharmacologically acceptable salt thereof
NZ703122A (en) 2010-10-11 2016-06-24 Teva Pharma Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate
KR20140101730A (ko) 2011-10-10 2014-08-20 테바 파마슈티컬 인더스트리즈 리미티드 글라티라머 아세테이트에 대한 임상 반응을 예측하는 데 유용한 단일 뉴클레오티드 다형성
MX2015004563A (es) 2012-10-10 2015-07-14 Teva Pharma Biomarcadores predictivos para respuesta clinica para acetato de glatiramero.
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
HUE071047T2 (hu) 2016-08-31 2025-07-28 Mapi Pharma Ltd Glatiramer-acetátot tartalmazó depórendszerek
US10610104B2 (en) 2016-12-07 2020-04-07 Progenity, Inc. Gastrointestinal tract detection methods, devices and systems
CN110382052A (zh) 2017-03-26 2019-10-25 Mapi医药公司 用于治疗进展型形式的多发性硬化症的格拉替雷储库系统
JP2020531057A (ja) 2017-06-29 2020-11-05 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 薬品容器にいっぱいに充填するためのデバイス及び方法
US20200306516A1 (en) 2017-08-14 2020-10-01 Progenity, Inc. Treatment of a disease of the gastrointestinal tract 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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