LT3050556T - Farmacinio preparato, turinčio glatiramero acetatą, gavimo būdas - Google Patents
Farmacinio preparato, turinčio glatiramero acetatą, gavimo būdasInfo
- Publication number
- LT3050556T LT3050556T LTEP15186721.5T LT15186721T LT3050556T LT 3050556 T LT3050556 T LT 3050556T LT 15186721 T LT15186721 T LT 15186721T LT 3050556 T LT3050556 T LT 3050556T
- Authority
- LT
- Lithuania
- Prior art keywords
- manufacturing
- pharmaceutical preparation
- preparation containing
- glatiramer acetate
- containing glatiramer
- Prior art date
Links
- 108010072051 Glatiramer Acetate Proteins 0.000 title 1
- FHEAIOHRHQGZPC-KIWGSFCNSA-N acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid Chemical compound CC(O)=O.C[C@H](N)C(O)=O.NCCCC[C@H](N)C(O)=O.OC(=O)[C@@H](N)CCC(O)=O.OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 FHEAIOHRHQGZPC-KIWGSFCNSA-N 0.000 title 1
- 229960003776 glatiramer acetate Drugs 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 title 1
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)
- 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)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Hospice & Palliative Care (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Psychology (AREA)
- Physical Education & Sports Medicine (AREA)
- Psychiatry (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)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US14/608,126 US9155775B1 (en) | 2015-01-28 | 2015-01-28 | Process for manufacturing glatiramer acetate product |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| LT3050556T true LT3050556T (lt) | 2017-05-10 |
Family
ID=54199060
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| LTEP15186721.5T LT3050556T (lt) | 2015-01-28 | 2015-09-24 | Farmacinio preparato, turinčio glatiramero acetatą, gavimo būdas |
Country Status (30)
| Country | Link |
|---|---|
| US (6) | US9155775B1 (enExample) |
| EP (3) | EP3113785A4 (enExample) |
| JP (2) | JP2018503627A (enExample) |
| KR (2) | KR102268210B1 (enExample) |
| CN (1) | CN107530394B (enExample) |
| AR (1) | AR102096A1 (enExample) |
| AU (4) | AU2015380381B2 (enExample) |
| BR (1) | BR112016023736A2 (enExample) |
| CA (2) | CA2945537C (enExample) |
| CL (1) | CL2016002607A1 (enExample) |
| CY (1) | CY1118826T1 (enExample) |
| DK (1) | DK3050556T3 (enExample) |
| EA (3) | EA028484B1 (enExample) |
| ES (1) | ES2584190T3 (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)
| 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 |
| ES2602977T3 (es) | 2010-10-11 | 2017-02-23 | Teva Pharmaceutical Industries Ltd. | Biomarcadores de citocinas como biomarcadores predictivos de la respuesta clínica para acetato de glatirámero |
| AU2012323345A1 (en) | 2011-10-10 | 2014-05-22 | Teva Pharmaceutical Industries Ltd. | Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate |
| 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 |
| CN109982712A (zh) | 2016-08-31 | 2019-07-05 | Mapi医药公司 | 包含醋酸格拉替雷的储库系统 |
| EP3551034A1 (en) | 2016-12-07 | 2019-10-16 | Progenity, Inc. | Gastrointestinal tract detection methods, devices and systems |
| BR112019017724A2 (pt) | 2017-03-26 | 2020-03-31 | Mapi Pharma Ltd. | Sistemas depot de glatiramer para tratar formas progressivas de esclerose múltipla |
| IL271434B2 (en) | 2017-06-29 | 2025-11-01 | Regeneron Pharma | Devices and methods for overfilling drug containers |
| 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 |
Family Cites Families (71)
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| FR2459619B1 (fr) | 1979-06-26 | 1983-07-29 | Agronomique Inst Nat Rech | Procede pour l'obtention a partir de lactoserum, d'un produit enrichi en alpha-lactalbumine et applications dudit procede |
| US4350156A (en) | 1980-05-29 | 1982-09-21 | Japan Foundation For Artificial Organs | Method and apparatus for on-line filtration removal of macromolecules from a physiological fluid |
| US4455256A (en) | 1981-05-05 | 1984-06-19 | The Regents Of The University Of California | Bone morphogenetic protein |
| DE69427226T2 (de) | 1993-03-24 | 2001-08-30 | Owen Mumford Ltd., Woodstock | Vorrichtung zur injektion |
| IL113812A (en) | 1994-05-24 | 2000-06-29 | Yeda Res & Dev | Copolymer-1 pharmaceutical compositions containing it and its use |
| US5631347A (en) | 1995-06-07 | 1997-05-20 | Eli Lilly And Company | Reducing gelation of a fatty acid-acylated protein |
| DE19543737A1 (de) | 1995-11-24 | 1997-05-28 | Hoechst Ag | Verfahren zur Ultrafiltration von Peptide oder Proteine enthaltender biologischer Matrices |
| IL119989A0 (en) | 1997-01-10 | 1997-04-15 | Yeda Res & Dev | Pharmaceutical compositions for oral treatment of multiple sclerosis |
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| JP2003521448A (ja) | 1998-07-23 | 2003-07-15 | ザ・プレジデント・アンド・フェローズ・オブ・ハーバード・カレッジ | 合成ペプチドおよび自己免疫疾患治療のための使用方法 |
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| HRP20140524T1 (hr) | 2003-05-14 | 2014-12-19 | Teva Pharmaceutical Industries Ltd. | Kombinacijska terapija glatiramer acetatom i mitoksantronom za lijeäśenje multiple skleroze |
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| TW201521757A (zh) | 2013-03-12 | 2015-06-16 | Teva Pharma | 先後通過利妥昔單抗（ｒｉｔｕｘｉｍａｂ）誘導治療及格拉默醋酸鹽（ｇｌａｔｉｒａｍｅｒ ａｃｅｔａｔｅ）治療 |
| CN103169670B (zh) * | 2013-03-22 | 2016-07-06 | 深圳翰宇药业股份有限公司 | 一种醋酸格拉替雷微球及其制备方法 |
| 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 |
-
2015
- 2015-01-28 US US14/608,126 patent/US9155775B1/en active Active
- 2015-09-21 KR KR1020177012458A patent/KR102268210B1/ko active Active
- 2015-09-21 CN CN201580071551.XA patent/CN107530394B/zh active Active
- 2015-09-21 CA CA2945537A patent/CA2945537C/en active Active
- 2015-09-21 PE PE2016001955A patent/PE20170296A1/es unknown
- 2015-09-21 EA EA201691790A patent/EA028484B1/ru unknown
- 2015-09-21 KR KR1020167028604A patent/KR101737295B1/ko active Active
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