MX2019001999A - Proceso para la preparacion de microparticulas que contienen acetato de glatiramer. - Google Patents
Proceso para la preparacion de microparticulas que contienen acetato de glatiramer.Info
- Publication number
- MX2019001999A MX2019001999A MX2019001999A MX2019001999A MX2019001999A MX 2019001999 A MX2019001999 A MX 2019001999A MX 2019001999 A MX2019001999 A MX 2019001999A MX 2019001999 A MX2019001999 A MX 2019001999A MX 2019001999 A MX2019001999 A MX 2019001999A
- Authority
- MX
- Mexico
- Prior art keywords
- glatiramer acetate
- microparticles containing
- preparing microparticles
- containing glatiramer
- preparing
- Prior art date
Links
- 239000011859 microparticle Substances 0.000 title abstract 3
- 108010072051 Glatiramer Acetate Proteins 0.000 title abstract 2
- 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 2
- 229960003776 glatiramer acetate Drugs 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 abstract 3
- 238000002513 implantation Methods 0.000 abstract 1
- 238000002347 injection Methods 0.000 abstract 1
- 239000007924 injection Substances 0.000 abstract 1
- 238000007918 intramuscular administration Methods 0.000 abstract 1
- 201000006417 multiple sclerosis Diseases 0.000 abstract 1
- 239000003960 organic solvent Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 238000007920 subcutaneous administration Methods 0.000 abstract 1
Classifications
-
- 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
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5094—Microcapsules containing magnetic carrier material, e.g. ferrite for drug targeting
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/001—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof by chemical synthesis
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2/00—Peptides of undefined number of amino acids; Derivatives thereof
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G69/00—Macromolecular compounds obtained by reactions forming a carboxylic amide link in the main chain of the macromolecule
- C08G69/02—Polyamides derived from amino-carboxylic acids or from polyamines and polycarboxylic acids
- C08G69/36—Polyamides derived from amino-carboxylic acids or from polyamines and polycarboxylic acids derived from amino acids, polyamines and polycarboxylic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Gastroenterology & Hepatology (AREA)
- Polymers & Plastics (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
- Epoxy Compounds (AREA)
Abstract
La presente invención proporciona un procedimiento mejorado para la preparación de micropartículas que contienen acetato de glatiramer con bajos niveles de disolventes orgánicos residuales, en particular, diclorometano. Las micropartículas se incorporan en composiciones farmacéuticas parenterales de acción prolongada en forma depot que son adecuadas para administración o inyección subcutánea o intramuscular, y que se pueden utilizar para el tratamiento de la esclerosis múltiple.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662380426P | 2016-08-28 | 2016-08-28 | |
| PCT/IL2017/050954 WO2018042423A1 (en) | 2016-08-28 | 2017-08-28 | Process for preparing microparticles containing glatiramer acetate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2019001999A true MX2019001999A (es) | 2019-08-29 |
Family
ID=61301634
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019001999A MX2019001999A (es) | 2016-08-28 | 2017-08-28 | Proceso para la preparacion de microparticulas que contienen acetato de glatiramer. |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US11471421B2 (es) |
| EP (1) | EP3503907B1 (es) |
| JP (2) | JP7232752B2 (es) |
| CN (1) | CN109689082A (es) |
| AU (1) | AU2017319781B2 (es) |
| BR (1) | BR112019003131A2 (es) |
| ES (1) | ES2979169T3 (es) |
| IL (1) | IL264824B (es) |
| MX (1) | MX2019001999A (es) |
| WO (1) | WO2018042423A1 (es) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US12097292B2 (en) | 2016-08-28 | 2024-09-24 | Mapi Pharma Ltd. | Process for preparing microparticles containing glatiramer acetate |
| DK3506921T3 (da) * | 2016-08-31 | 2023-07-31 | Mapi Pharma Ltd | Depotsystemer, der omfatter glatirameracetat |
| JP7602322B2 (ja) * | 2017-03-26 | 2024-12-18 | マピ ファーマ リミテッド | 進行型の多発性硬化症を治療するためのグラチラマーデポシステム |
| CN111249524B (zh) * | 2020-01-18 | 2020-12-08 | 南京医科大学附属口腔医院 | 用于骨组织再生的高孔隙率聚己内酯多孔微球支架及其制备方法 |
| WO2023170493A1 (en) * | 2022-03-07 | 2023-09-14 | Hadidi Naghmeh | Drug delivery using a parenteral pharmaceutical composition |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5800808A (en) | 1994-05-24 | 1998-09-01 | Veda Research And Development Co., Ltd. | Copolymer-1 improvements in compositions of copolymers |
| US5945126A (en) * | 1997-02-13 | 1999-08-31 | Oakwood Laboratories L.L.C. | Continuous microsphere process |
| US8871241B2 (en) | 2002-05-07 | 2014-10-28 | Psivida Us, Inc. | Injectable sustained release delivery devices |
| CN1398584A (zh) | 2002-07-15 | 2003-02-26 | 裴福兴 | 一种bFGF-PLGA缓释微球及其制备方法和用途 |
| JP2007500693A (ja) | 2003-07-31 | 2007-01-18 | イエダ リサーチ アンド デベロップメント カンパニー リミテッド | 移植片拒絶反応を予防するための合成ペプチドコポリマーを含む併用療法 |
| TR201818858T4 (tr) | 2010-01-04 | 2019-01-21 | Mapi Pharma Ltd | Glati̇ramer asetat i̇çeren depo si̇stemi̇. |
| US8377885B2 (en) | 2010-01-04 | 2013-02-19 | Mapi Pharma Ltd. | Depot systems comprising glatiramer or pharmacologically acceptable salt thereof |
| ES2601892T3 (es) | 2011-04-21 | 2017-02-16 | Mapi Pharma Limited | Pentapolímero aleatorio para el tratamiento de enfermedades autoinmunes |
| 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 |
| DK3506921T3 (da) | 2016-08-31 | 2023-07-31 | Mapi Pharma Ltd | Depotsystemer, der omfatter glatirameracetat |
| JP7602322B2 (ja) | 2017-03-26 | 2024-12-18 | マピ ファーマ リミテッド | 進行型の多発性硬化症を治療するためのグラチラマーデポシステム |
-
2017
- 2017-08-28 WO PCT/IL2017/050954 patent/WO2018042423A1/en not_active Ceased
- 2017-08-28 US US16/328,572 patent/US11471421B2/en active Active
- 2017-08-28 ES ES17845665T patent/ES2979169T3/es active Active
- 2017-08-28 EP EP17845665.3A patent/EP3503907B1/en active Active
- 2017-08-28 MX MX2019001999A patent/MX2019001999A/es unknown
- 2017-08-28 JP JP2019507936A patent/JP7232752B2/ja active Active
- 2017-08-28 BR BR112019003131-6A patent/BR112019003131A2/pt unknown
- 2017-08-28 CN CN201780053557.3A patent/CN109689082A/zh active Pending
- 2017-08-28 AU AU2017319781A patent/AU2017319781B2/en active Active
-
2019
- 2019-02-13 IL IL264824A patent/IL264824B/en unknown
-
2022
- 2022-11-29 JP JP2022189936A patent/JP2023022199A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JP2019537551A (ja) | 2019-12-26 |
| CN109689082A (zh) | 2019-04-26 |
| AU2017319781B2 (en) | 2021-05-27 |
| AU2017319781A1 (en) | 2019-02-07 |
| ES2979169T3 (es) | 2024-09-24 |
| JP2023022199A (ja) | 2023-02-14 |
| EP3503907A1 (en) | 2019-07-03 |
| EP3503907C0 (en) | 2024-03-13 |
| IL264824B (en) | 2022-03-01 |
| BR112019003131A2 (pt) | 2019-05-21 |
| EP3503907B1 (en) | 2024-03-13 |
| JP7232752B2 (ja) | 2023-03-03 |
| CA3035149A1 (en) | 2018-03-08 |
| WO2018042423A1 (en) | 2018-03-08 |
| US11471421B2 (en) | 2022-10-18 |
| US20210299057A1 (en) | 2021-09-30 |
| EP3503907A4 (en) | 2020-05-20 |
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