CL2016002607A1 - Procedimiento para preparar una preparación farmacéutica de acetato de glatiramer y manitol en un contenedor adecuado que comprende las etapas de obtener una solución acuosa de acetato de glatiramer y manitol, filtración de la solución entre 0 y 17,5 grado celsius y llenado del contenedor. pct - Google Patents
Procedimiento para preparar una preparación farmacéutica de acetato de glatiramer y manitol en un contenedor adecuado que comprende las etapas de obtener una solución acuosa de acetato de glatiramer y manitol, filtración de la solución entre 0 y 17,5 grado celsius y llenado del contenedor. pctInfo
- Publication number
- CL2016002607A1 CL2016002607A1 CL2016002607A CL2016002607A CL2016002607A1 CL 2016002607 A1 CL2016002607 A1 CL 2016002607A1 CL 2016002607 A CL2016002607 A CL 2016002607A CL 2016002607 A CL2016002607 A CL 2016002607A CL 2016002607 A1 CL2016002607 A1 CL 2016002607A1
- Authority
- CL
- Chile
- Prior art keywords
- mannitol
- glatiramer acetate
- container
- solution
- procedure
- Prior art date
Links
- 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 title abstract 4
- 108010072051 Glatiramer Acetate Proteins 0.000 title 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 title abstract 4
- 229960003776 glatiramer acetate Drugs 0.000 title abstract 4
- 238000001914 filtration Methods 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 239000000825 pharmaceutical preparation Substances 0.000 title abstract 2
- 229930195725 Mannitol Natural products 0.000 title 2
- 235000010355 mannitol Nutrition 0.000 title 2
- 239000000594 mannitol Substances 0.000 title 2
- 239000007864 aqueous solution Substances 0.000 title 1
- 239000000243 solution Substances 0.000 title 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
- 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)
- 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)
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 |
|---|---|
| CL2016002607A1 true CL2016002607A1 (es) | 2017-05-26 |
Family
ID=54199060
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CL2016002607A CL2016002607A1 (es) | 2015-01-28 | 2016-10-13 | Procedimiento para preparar una preparación farmacéutica de acetato de glatiramer y manitol en un contenedor adecuado que comprende las etapas de obtener una solución acuosa de acetato de glatiramer y manitol, filtración de la solución entre 0 y 17,5 grado celsius y llenado del contenedor. pct |
Country Status (30)
| Country | Link |
|---|---|
| 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=) |
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 |
| 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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| KR20140101730A (ko) | 2011-10-10 | 2014-08-20 | 테바 파마슈티컬 인더스트리즈 리미티드 | 글라티라머 아세테이트에 대한 임상 반응을 예측하는 데 유용한 단일 뉴클레오티드 다형성 |
| EP2869903B1 (en) * | 2012-07-06 | 2018-11-28 | 3-D Matrix Ltd. | Fill-finish process for peptide solutions |
| MX2015004563A (es) | 2012-10-10 | 2015-07-14 | Teva Pharma | Biomarcadores predictivos para respuesta clinica para acetato de glatiramero. |
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| 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 |
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2015
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