EA201691790A1 - Способ получения продукта глатирамера ацетата - Google Patents
Способ получения продукта глатирамера ацетатаInfo
- Publication number
- EA201691790A1 EA201691790A1 EA201691790A EA201691790A EA201691790A1 EA 201691790 A1 EA201691790 A1 EA 201691790A1 EA 201691790 A EA201691790 A EA 201691790A EA 201691790 A EA201691790 A EA 201691790A EA 201691790 A1 EA201691790 A1 EA 201691790A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- mannitol
- glatiramer acetate
- aqueous pharmaceutical
- pharmaceutical solution
- producting
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 title 1
- 239000011521 glass Substances 0.000 title 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 4
- 108010072051 Glatiramer Acetate Proteins 0.000 abstract 4
- 229930195725 Mannitol Natural products 0.000 abstract 4
- 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 abstract 4
- 229960003776 glatiramer acetate Drugs 0.000 abstract 4
- 235000010355 mannitol Nutrition 0.000 abstract 4
- 239000000594 mannitol Substances 0.000 abstract 4
- 239000003186 pharmaceutical solution Substances 0.000 abstract 4
- 239000000706 filtrate Substances 0.000 abstract 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 2
- 238000001914 filtration Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229940071643 prefilled syringe Drugs 0.000 abstract 1
Classifications
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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
- 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
- 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
- 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)
- 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)
Abstract
Заявка предлагает способ получения фармацевтического препарата глатирамера ацетата и маннита в подходящем контейнере, содержащий этапы: (i) получение водного фармацевтического раствора глатирамера ацетата и маннита; (ii) фильтрация данного водного фармацевтического раствора при температуре, составляющей от выше 0°С вплоть до 17,5°С, для получения фильтрата; (iii) заполнение подходящего контейнера фильтратом, полученным после осуществления этапа (ii), для того чтобы таким образом получить фармацевтический препарат глатирамера ацетата и маннита в подходящем контейнере. Данный патент дополнительно предлагает водный фармацевтический раствор, содержащий 40 мг/мл глатирамера ацетата и 40 мг/мл маннита, причем данный водный фармацевтический раствор а) имеет вязкость в диапазоне от 2,0 до 3,5 сПа; или b) имеет осмоляльность в диапазоне от 275 до 325 мосмоль/кг. Также предложены предварительно заполненный шприц, автоматический инъектор и способ лечения пациента-человека.
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 |
| PCT/US2015/051203 WO2016122722A1 (en) | 2015-01-28 | 2015-09-21 | Process for manufacturing glatiramer acetate product |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EA201691790A1 true EA201691790A1 (ru) | 2017-01-30 |
| EA028484B1 EA028484B1 (ru) | 2017-11-30 |
Family
ID=54199060
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201691790A EA028484B1 (ru) | 2015-01-28 | 2015-09-21 | Способ получения предварительно заполненного шприца, содержащего глатирамера ацетата |
| EA201791555A EA201791555A3 (ru) | 2015-01-28 | 2015-09-25 | Способ изготовления продукта, содержащего ацетат глатирамера |
| EA201500881A EA028811B1 (ru) | 2015-01-28 | 2015-09-25 | Способ изготовления фармацевтического препарата, содержащего ацетат глатирамера и маннит |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201791555A EA201791555A3 (ru) | 2015-01-28 | 2015-09-25 | Способ изготовления продукта, содержащего ацетат глатирамера |
| EA201500881A EA028811B1 (ru) | 2015-01-28 | 2015-09-25 | Способ изготовления фармацевтического препарата, содержащего ацетат глатирамера и маннит |
Country Status (30)
| Country | Link |
|---|---|
| US (6) | US9155775B1 (ru) |
| EP (3) | EP3113785A4 (ru) |
| JP (2) | JP2018503627A (ru) |
| KR (2) | KR101737295B1 (ru) |
| CN (1) | CN107530394B (ru) |
| AR (1) | AR102096A1 (ru) |
| AU (4) | AU2015380381B2 (ru) |
| BR (1) | BR112016023736A2 (ru) |
| CA (2) | CA2945537C (ru) |
| CL (1) | CL2016002607A1 (ru) |
| CY (1) | CY1118826T1 (ru) |
| DK (1) | DK3050556T3 (ru) |
| EA (3) | EA028484B1 (ru) |
| ES (1) | ES2584190T3 (ru) |
| HK (1) | HK1225309B (ru) |
| HR (1) | HRP20170625T1 (ru) |
| HU (1) | HUE034059T2 (ru) |
| IL (3) | IL247851A0 (ru) |
| LT (1) | LT3050556T (ru) |
| ME (1) | ME02721B (ru) |
| MX (1) | MX352734B (ru) |
| PE (1) | PE20170296A1 (ru) |
| PL (1) | PL3050556T3 (ru) |
| PT (1) | PT3050556T (ru) |
| RS (1) | RS55959B1 (ru) |
| RU (1) | RU2669769C2 (ru) |
| SI (1) | SI3050556T1 (ru) |
| UA (1) | UA116060C2 (ru) |
| WO (1) | WO2016122722A1 (ru) |
| ZA (1) | ZA201606903B (ru) |
Families Citing this family (11)
| 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 |
| EP2627669B1 (en) | 2010-10-11 | 2016-08-17 | Teva Pharmaceutical Industries Ltd. | Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate |
| WO2013055683A1 (en) | 2011-10-10 | 2013-04-18 | Teva Pharmaceutical Industries Ltd. | Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate |
| 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 |
| CA3044526A1 (en) | 2016-12-07 | 2018-06-14 | Progenity, Inc. | Gastrointestinal tract detection methods, devices and systems |
| EP3600553A4 (en) | 2017-03-26 | 2020-09-02 | Mapi Pharma Ltd. | GLATIRAMER DEPOT SYSTEMS FOR TREATMENT OF PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS |
| 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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| PT3199172T (pt) * | 2009-08-20 | 2018-10-18 | Yeda Res & Dev | Regime de dosagem para esclerose múltipla |
| ITMI20092069A1 (it) | 2009-11-25 | 2011-05-26 | Biofer Spa | Metodo per ottenere una miscela di fattori biologici isolati da colostro e miscela di fattori biologici attivi derivata da colostro. |
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| US9155775B1 (en) | 2015-01-28 | 2015-10-13 | Teva Pharmaceutical Industries, Ltd. | Process for manufacturing glatiramer acetate product |
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