HRP20170625T1 - Postupak za proizvodnju farmaceutskog pripravka koji sadrži glatiramer acetat - Google Patents

Postupak za proizvodnju farmaceutskog pripravka koji sadrži glatiramer acetat Download PDF

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Publication number
HRP20170625T1
HRP20170625T1 HRP20170625TT HRP20170625T HRP20170625T1 HR P20170625 T1 HRP20170625 T1 HR P20170625T1 HR P20170625T T HRP20170625T T HR P20170625TT HR P20170625 T HRP20170625 T HR P20170625T HR P20170625 T1 HRP20170625 T1 HR P20170625T1
Authority
HR
Croatia
Prior art keywords
temperature
aqueous pharmaceutical
filter
pharmaceutical solution
filtering
Prior art date
Application number
HRP20170625TT
Other languages
English (en)
Croatian (hr)
Inventor
Rakefet Cohen
Sasson Habbah
Muhammad Safadi
Original Assignee
Teva Pharmaceutical Industries, Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54199060&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20170625(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceutical Industries, Ltd. filed Critical Teva Pharmaceutical Industries, Ltd.
Publication of HRP20170625T1 publication Critical patent/HRP20170625T1/hr

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Classifications

    • 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

Landscapes

  • 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)
HRP20170625TT 2015-01-28 2017-04-21 Postupak za proizvodnju farmaceutskog pripravka koji sadrži glatiramer acetat HRP20170625T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/608,126 US9155775B1 (en) 2015-01-28 2015-01-28 Process for manufacturing glatiramer acetate product
EP15186721.5A EP3050556B1 (en) 2015-01-28 2015-09-24 Process for manufacturing a pharmaceutical preparation containing glatiramer acetate

Publications (1)

Publication Number Publication Date
HRP20170625T1 true HRP20170625T1 (hr) 2017-06-30

Family

ID=54199060

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20170625TT HRP20170625T1 (hr) 2015-01-28 2017-04-21 Postupak za proizvodnju farmaceutskog pripravka koji sadrži glatiramer acetat

Country Status (31)

Country Link
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)

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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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Publication number Publication date
WO2016122722A1 (en) 2016-08-04
CA2945537A1 (en) 2016-08-04
CA2965890A1 (en) 2016-08-04
DK3050556T3 (en) 2017-04-24
AR102096A1 (es) 2017-02-01
KR102268210B1 (ko) 2021-06-23
MX352734B (es) 2017-12-06
US20160213734A1 (en) 2016-07-28
AU2016273881A1 (en) 2017-01-05
IL267152A (en) 2019-08-29
KR20170101891A (ko) 2017-09-06
KR101737295B1 (ko) 2017-05-29
EA028811B1 (ru) 2018-01-31
EA028484B1 (ru) 2017-11-30
EP3050556A1 (en) 2016-08-03
AU2016101453B4 (en) 2016-11-03
US9155775B1 (en) 2015-10-13
EA201791555A2 (ru) 2017-12-29
IL277601A (en) 2020-11-30
KR20160136348A (ko) 2016-11-29
EP3238706A1 (en) 2017-11-01
US20170196930A1 (en) 2017-07-13
CA2945537C (en) 2017-08-22
RS55959B1 (sr) 2017-09-29
EA201791555A3 (ru) 2018-05-31
HUE034059T2 (en) 2018-01-29
NZ724875A (en) 2023-10-27
US9763993B2 (en) 2017-09-19
ES2584190T1 (es) 2016-09-26
IL247851A0 (en) 2016-11-30
AU2015380381A1 (en) 2016-09-01
US20170312331A1 (en) 2017-11-02
JP2018184433A (ja) 2018-11-22
PT3050556T (pt) 2017-05-17
SI3050556T1 (sl) 2017-06-30
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UA116060C2 (uk) 2018-01-25
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ME02721B (me) 2017-10-20
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AU2018200518A1 (en) 2018-02-15
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