RU2669769C2 - Способ получения продукта глатирамера ацетата - Google Patents
Способ получения продукта глатирамера ацетата Download PDFInfo
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- RU2669769C2 RU2669769C2 RU2017104222A RU2017104222A RU2669769C2 RU 2669769 C2 RU2669769 C2 RU 2669769C2 RU 2017104222 A RU2017104222 A RU 2017104222A RU 2017104222 A RU2017104222 A RU 2017104222A RU 2669769 C2 RU2669769 C2 RU 2669769C2
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- temperature
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- aqueous pharmaceutical
- pharmaceutical solution
- solution
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- 108010072051 Glatiramer Acetate Proteins 0.000 title claims abstract description 180
- 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 claims abstract description 114
- 229960003776 glatiramer acetate Drugs 0.000 title claims abstract description 114
- 238000000034 method Methods 0.000 title claims abstract description 78
- 238000001914 filtration Methods 0.000 claims abstract description 141
- 239000003186 pharmaceutical solution Substances 0.000 claims abstract description 114
- 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 claims abstract description 56
- 229930195725 Mannitol Natural products 0.000 claims abstract description 56
- 239000000594 mannitol Substances 0.000 claims abstract description 56
- 235000010355 mannitol Nutrition 0.000 claims abstract description 56
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 41
- 238000011049 filling Methods 0.000 claims abstract description 28
- 239000000706 filtrate Substances 0.000 claims abstract description 22
- 239000000126 substance Substances 0.000 claims abstract description 8
- 238000002360 preparation method Methods 0.000 claims abstract description 3
- 238000002156 mixing Methods 0.000 claims description 40
- 239000000203 mixture Substances 0.000 claims description 23
- 230000001954 sterilising effect Effects 0.000 claims description 21
- 239000011148 porous material Substances 0.000 claims description 6
- 239000008176 lyophilized powder Substances 0.000 claims description 4
- 239000007864 aqueous solution Substances 0.000 claims description 3
- 230000005855 radiation Effects 0.000 claims description 3
- 239000003708 ampul Substances 0.000 claims description 2
- 238000001802 infusion Methods 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 24
- 229940126534 drug product Drugs 0.000 abstract description 11
- 239000003814 drug Substances 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 3
- 229940038717 copaxone Drugs 0.000 description 66
- 239000008364 bulk solution Substances 0.000 description 57
- 239000000243 solution Substances 0.000 description 54
- 238000002474 experimental method Methods 0.000 description 34
- 229940071643 prefilled syringe Drugs 0.000 description 24
- 238000001816 cooling Methods 0.000 description 18
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 description 11
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 10
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 description 10
- 239000000047 product Substances 0.000 description 9
- 239000007924 injection Substances 0.000 description 8
- 238000002347 injection Methods 0.000 description 8
- 238000012360 testing method Methods 0.000 description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 8
- 238000013461 design Methods 0.000 description 7
- 238000003860 storage Methods 0.000 description 7
- 230000006866 deterioration Effects 0.000 description 6
- 239000011521 glass Substances 0.000 description 6
- 229940126601 medicinal product Drugs 0.000 description 6
- 201000006417 multiple sclerosis Diseases 0.000 description 6
- 239000008215 water for injection Substances 0.000 description 6
- 239000004480 active ingredient Substances 0.000 description 5
- 238000004806 packaging method and process Methods 0.000 description 5
- QNAYBMKLOCPYGJ-UHFFFAOYSA-N D-alpha-Ala Natural products CC([NH3+])C([O-])=O QNAYBMKLOCPYGJ-UHFFFAOYSA-N 0.000 description 4
- QNAYBMKLOCPYGJ-UWTATZPHSA-N L-Alanine Natural products C[C@@H](N)C(O)=O QNAYBMKLOCPYGJ-UWTATZPHSA-N 0.000 description 4
- 235000019766 L-Lysine Nutrition 0.000 description 4
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 description 4
- 239000004472 Lysine Substances 0.000 description 4
- 229960003767 alanine Drugs 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 229960002989 glutamic acid Drugs 0.000 description 4
- 230000007774 longterm Effects 0.000 description 4
- 229960003646 lysine Drugs 0.000 description 4
- 238000004659 sterilization and disinfection Methods 0.000 description 4
- 238000010254 subcutaneous injection Methods 0.000 description 4
- 239000007929 subcutaneous injection Substances 0.000 description 4
- 229960004441 tyrosine Drugs 0.000 description 4
- 238000012371 Aseptic Filling Methods 0.000 description 3
- 101000942680 Sus scrofa Clusterin Proteins 0.000 description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- 239000011888 foil Substances 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- 230000002906 microbiologic effect Effects 0.000 description 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 2
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 description 2
- 125000000998 L-alanino group Chemical group [H]N([*])[C@](C([H])([H])[H])([H])C(=O)O[H] 0.000 description 2
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 2
- 229940022663 acetate Drugs 0.000 description 2
- 159000000021 acetate salts Chemical class 0.000 description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 2
- 229940024606 amino acid Drugs 0.000 description 2
- 235000001014 amino acid Nutrition 0.000 description 2
- 150000001413 amino acids Chemical class 0.000 description 2
- 238000012790 confirmation Methods 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 229940088679 drug related substance Drugs 0.000 description 2
- 238000013401 experimental design Methods 0.000 description 2
- 239000000644 isotonic solution Substances 0.000 description 2
- 238000002372 labelling Methods 0.000 description 2
- 244000005700 microbiome Species 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 229920001184 polypeptide Polymers 0.000 description 2
- 108090000765 processed proteins & peptides Proteins 0.000 description 2
- 102000004196 processed proteins & peptides Human genes 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000001179 sorption measurement Methods 0.000 description 2
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 235000011054 acetic acid Nutrition 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000002238 attenuated effect Effects 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 239000004067 bulking agent Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 239000003054 catalyst Substances 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 239000002158 endotoxin Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000005429 filling process Methods 0.000 description 1
- 235000013922 glutamic acid Nutrition 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000011016 integrity testing Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000012907 medicinal substance Substances 0.000 description 1
- YDWPOGYTJVQQIL-UHFFFAOYSA-N methyl 2-(4-aminophenoxy)acetate Chemical compound COC(=O)COC1=CC=C(N)C=C1 YDWPOGYTJVQQIL-UHFFFAOYSA-N 0.000 description 1
- 125000000896 monocarboxylic acid group Chemical group 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 239000006201 parenteral dosage form Substances 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 238000012503 pharmacopoeial method Methods 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 229940068196 placebo Drugs 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000000955 prescription drug Substances 0.000 description 1
- 238000009516 primary packaging Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 238000013094 purity test Methods 0.000 description 1
- 238000009517 secondary packaging Methods 0.000 description 1
- 238000011146 sterile filtration Methods 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 230000001256 tonic effect Effects 0.000 description 1
- 238000010200 validation analysis Methods 0.000 description 1
Images
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
- 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)
- 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)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- Psychology (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)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US14/608,126 | 2015-01-28 | ||
| 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 (1)
| Publication Number | Publication Date |
|---|---|
| RU2669769C2 true RU2669769C2 (ru) | 2018-10-16 |
Family
ID=54199060
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017104222A RU2669769C2 (ru) | 2015-01-28 | 2015-09-21 | Способ получения продукта глатирамера ацетата |
Country Status (30)
| Country | Link |
|---|---|
| US (6) | US9155775B1 (OSRAM) |
| EP (3) | EP3113785A4 (OSRAM) |
| JP (2) | JP2018503627A (OSRAM) |
| KR (2) | KR102268210B1 (OSRAM) |
| CN (1) | CN107530394B (OSRAM) |
| AR (1) | AR102096A1 (OSRAM) |
| AU (4) | AU2015380381B2 (OSRAM) |
| BR (1) | BR112016023736A2 (OSRAM) |
| CA (2) | CA2945537C (OSRAM) |
| CL (1) | CL2016002607A1 (OSRAM) |
| CY (1) | CY1118826T1 (OSRAM) |
| DK (1) | DK3050556T3 (OSRAM) |
| EA (3) | EA028484B1 (OSRAM) |
| ES (1) | ES2584190T3 (OSRAM) |
| HR (1) | HRP20170625T1 (OSRAM) |
| HU (1) | HUE034059T2 (OSRAM) |
| IL (3) | IL247851A0 (OSRAM) |
| LT (1) | LT3050556T (OSRAM) |
| ME (1) | ME02721B (OSRAM) |
| MX (1) | MX352734B (OSRAM) |
| PE (1) | PE20170296A1 (OSRAM) |
| PL (1) | PL3050556T3 (OSRAM) |
| PT (1) | PT3050556T (OSRAM) |
| RS (1) | RS55959B1 (OSRAM) |
| RU (1) | RU2669769C2 (OSRAM) |
| SI (1) | SI3050556T1 (OSRAM) |
| SM (1) | SMT201700227T1 (OSRAM) |
| UA (1) | UA116060C2 (OSRAM) |
| WO (1) | WO2016122722A1 (OSRAM) |
| ZA (1) | ZA201606903B (OSRAM) |
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 |
| TW201326399A (zh) | 2011-10-10 | 2013-07-01 | Teva Pharma | 用於預測對格拉替雷（ｇｌａｔｉｒａｍｅｒ）醋酸鹽之臨床反應之單核苷酸多型性之判定 |
| EP2906719A4 (en) | 2012-10-10 | 2016-11-09 | Teva Pharma | PREDICTIVE BIOMARKER FOR CLINICAL REACTION FOR GLATIRAMERACETATE |
| 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 |
| HRP20250396T1 (hr) | 2016-08-31 | 2025-05-23 | Mapi Pharma Ltd. | Depo sustavi koji sadrže glatiramer acetat |
| EP3551047A1 (en) | 2016-12-07 | 2019-10-16 | Progenity, Inc. | Gastrointestinal tract detection methods, devices and systems |
| AU2018242998B2 (en) | 2017-03-26 | 2023-11-02 | Mapi Pharma Ltd. | Glatiramer depot systems for treating progressive forms of multiple sclerosis |
| US11577025B2 (en) | 2017-06-29 | 2023-02-14 | Regeneron Pharmaceuticals, Inc. | 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 |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050013912A1 (en) * | 2001-11-21 | 2005-01-20 | Gunther Geiger | Method for reducing the total bacteria count in aqueous dispersions of non-homogeneous two-phase or multi-phase mixtures |
| US20070161566A1 (en) * | 2006-01-11 | 2007-07-12 | Teva Pharmaceutical Industries, Ltd. | Method of treating multiple sclerosis |
| WO2011008274A2 (en) * | 2009-07-15 | 2011-01-20 | Teva Pharmaceutical Industries Ltd. | Reduced volume formulation of glatiramer acetate and methods of administration |
| WO2011022063A1 (en) * | 2009-08-20 | 2011-02-24 | Teva Pharmaceutical Industries Ltd. | Low frequency glatiramer acetate therapy |
| WO2014128079A1 (en) * | 2013-02-19 | 2014-08-28 | Synthon B.V. | Glatiramer acetate multidose formulation |
Family Cites Families (66)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL36670A (en) | 1971-04-21 | 1974-09-10 | Sela M | Therapeutic basic copolymers of amino acids |
| 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 |
| EP0693946B1 (en) | 1993-03-24 | 2001-05-16 | Owen Mumford Limited | Improvements relating to injection devices |
| US5800808A (en) | 1994-05-24 | 1998-09-01 | Veda Research And Development Co., Ltd. | Copolymer-1 improvements in compositions of copolymers |
| 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 |
| US6214791B1 (en) | 1997-01-10 | 2001-04-10 | Yeda Research And Development Co. Ltd. | Treatment of multiple sclerosis through ingestion or inhalation of copolymer-1 |
| IL119989A0 (en) | 1997-01-10 | 1997-04-15 | Yeda Res & Dev | Pharmaceutical compositions for oral treatment of multiple sclerosis |
| 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 |
| WO2000005250A1 (en) | 1998-07-23 | 2000-02-03 | Yeda Research And Development Co., Ltd | Treatment of autoimmune conditions with copolymer 1 and related copolymers and peptides |
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