CY1118826T1 - Διαδικασια για την κατασκευη ενος φαρμακευτικου σκευασματος που περιεχει glatiramer acetate - Google Patents
Διαδικασια για την κατασκευη ενος φαρμακευτικου σκευασματος που περιεχει glatiramer acetateInfo
- Publication number
- CY1118826T1 CY1118826T1 CY20171100442T CY171100442T CY1118826T1 CY 1118826 T1 CY1118826 T1 CY 1118826T1 CY 20171100442 T CY20171100442 T CY 20171100442T CY 171100442 T CY171100442 T CY 171100442T CY 1118826 T1 CY1118826 T1 CY 1118826T1
- Authority
- CY
- Cyprus
- Prior art keywords
- glatiramer acetate
- mannitol
- provides
- pharmaceutical
- aqueous
- Prior art date
Links
- 108010072051 Glatiramer Acetate Proteins 0.000 title abstract 5
- 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 5
- 229960003776 glatiramer acetate Drugs 0.000 title abstract 5
- 238000000034 method Methods 0.000 title abstract 2
- 238000010276 construction Methods 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
- 229930195725 Mannitol Natural products 0.000 abstract 4
- 235000010355 mannitol Nutrition 0.000 abstract 4
- 239000000594 mannitol Substances 0.000 abstract 4
- 239000007864 aqueous solution Substances 0.000 abstract 2
- 239000003814 drug Substances 0.000 abstract 2
- 229940079593 drug Drugs 0.000 abstract 1
- 238000001914 filtration Methods 0.000 abstract 1
- 239000007924 injection Substances 0.000 abstract 1
- 238000002347 injection Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 239000003186 pharmaceutical solution Substances 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
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- 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
Η ευρεσιτεχνία παρέχει μία διαδικασία παρασκευής ενός φαρμακευτικού σκευάσματος από glatiramer acetate και mannitol μέσα σε ένα κατάλληλο δοχείο που περιλαμβάνει τα εξής βήματα: (i) λήψη ενός υδατικού φαρμακευτικού διαλύματος από glatiramer acetate και mannitol, (ii) φιλτράρισμα του υδατικού φαρμακευτικού διαλύματος σε θερμοκρασία πάνω από 0°C μέχρι 17,5°C ώστε να παραχθεί ένα προϊόν φιλτραρίσματος, και (iii) γέμισμα του κατάλληλου δοχείου με το προϊόν φιλτραρίσματος που λαμβάνεται μετά την πραγματοποίηση του βήματος (ii), έτσι ώστε να παρασκευαστεί το φαρμακευτικό σκεύασμα από glatiramer acetate και mannitol μέσα στο κατάλληλο δοχείο. Αυτή η ευρεσιτεχνία παρέχει περαιτέρω ένα φαρμακευτικό υδατικό διάλυμα που περιέχει 40mg/ml glatiramer acetate και 40mg/ml mannitol, όπου το υδατικό διάλυμα που περιέχει a) έχει ιξώδες που κυμαίνεται μεταξύ 2,0-3,5 cPa, ή b) έχει μία ωσμωγραμμομοριακότητα που κυμαίνεται μεταξύ 275-325 mosmol/Kg. Αυτή η ευρεσιτεχνία παρέχει επίσης μία προ-γεμισμένη σύριγγα, μία αυτόματη συσκευή ενέσεων και μία μέθοδο για την θεραπεία ενός ανθρώπου ασθενούς.
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 |
|---|---|
| CY1118826T1 true CY1118826T1 (el) | 2018-01-10 |
Family
ID=54199060
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CY20171100442T CY1118826T1 (el) | 2015-01-28 | 2017-04-13 | Διαδικασια για την κατασκευη ενος φαρμακευτικου σκευασματος που περιεχει glatiramer acetate |
Country Status (30)
| Country | Link |
|---|---|
| US (6) | US9155775B1 (el) |
| EP (3) | EP3113785A4 (el) |
| JP (2) | JP2018503627A (el) |
| KR (2) | KR101737295B1 (el) |
| CN (1) | CN107530394B (el) |
| AR (1) | AR102096A1 (el) |
| AU (4) | AU2015380381B2 (el) |
| BR (1) | BR112016023736A2 (el) |
| CA (2) | CA2945537C (el) |
| CL (1) | CL2016002607A1 (el) |
| CY (1) | CY1118826T1 (el) |
| DK (1) | DK3050556T3 (el) |
| EA (3) | EA028484B1 (el) |
| ES (1) | ES2584190T3 (el) |
| HK (1) | HK1225309B (el) |
| HR (1) | HRP20170625T1 (el) |
| HU (1) | HUE034059T2 (el) |
| IL (3) | IL247851A0 (el) |
| LT (1) | LT3050556T (el) |
| ME (1) | ME02721B (el) |
| MX (1) | MX352734B (el) |
| PE (1) | PE20170296A1 (el) |
| PL (1) | PL3050556T3 (el) |
| PT (1) | PT3050556T (el) |
| RS (1) | RS55959B1 (el) |
| RU (1) | RU2669769C2 (el) |
| SI (1) | SI3050556T1 (el) |
| UA (1) | UA116060C2 (el) |
| WO (1) | WO2016122722A1 (el) |
| ZA (1) | ZA201606903B (el) |
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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| WO2013055683A1 (en) | 2011-10-10 | 2013-04-18 | Teva Pharmaceutical Industries Ltd. | Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate |
| JP6389170B2 (ja) * | 2012-07-06 | 2018-09-12 | スリーディー マトリックス， エルティーディー３−Ｄ Ｍａｔｒｉｘ， Ｌｔｄ． | ペプチド溶液のためのフィル−フィニッシュ過程 |
| WO2014058976A2 (en) | 2012-10-10 | 2014-04-17 | Teva Pharmaceutical Industries Ltd. | Biomarkers predictive for clinical response for glatiramer acetate |
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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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