AR077484A1 - Formulacion de acetato de glatiramer de volumen reducido y metodos para su administracion - Google Patents
Formulacion de acetato de glatiramer de volumen reducido y metodos para su administracionInfo
- Publication number
- AR077484A1 AR077484A1 ARP100102598A ARP100102598A AR077484A1 AR 077484 A1 AR077484 A1 AR 077484A1 AR P100102598 A ARP100102598 A AR P100102598A AR P100102598 A ARP100102598 A AR P100102598A AR 077484 A1 AR077484 A1 AR 077484A1
- Authority
- AR
- Argentina
- Prior art keywords
- glatiramer acetate
- mannitol
- administration
- solution
- aqueous pharmaceutical
- 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
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 208000007400 Relapsing-Remitting Multiple Sclerosis Diseases 0.000 abstract 6
- 239000003186 pharmaceutical solution Substances 0.000 abstract 5
- 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
- 239000000243 solution Substances 0.000 abstract 3
- 206010051290 Central nervous system lesion Diseases 0.000 abstract 1
- 230000005713 exacerbation Effects 0.000 abstract 1
- 239000007924 injection Substances 0.000 abstract 1
- 238000002347 injection Methods 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
Classifications
-
- 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
- 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
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
-
- 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
- A61P25/28—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
- A61P37/02—Immunomodulators
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Gastroenterology & Hepatology (AREA)
- Dermatology (AREA)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Método para reducir la frecuencia de recidivas en pacientes humanos afectados por esclerosis multiple remitente-recidivante (RRMS) que comprende administrar al paciente 0,5 ml de una solucion farmacéutica acuosa de 20 mg de acetato de glatiramer y 20 mg de manitol y dispositivo de asistencia para la inyeccion que facilita la administracion de la solucion farmacéutica. Reivindicacion 37: Una dosis individual de 0,5 ml de una solucion farmacéutica acuosa que contiene 20 mg de acetato de glatiramer y 20 mg de manitol en solucion. Reivindicacion 45: Uso de 0,5 ml de una solucion farmacéutica acuosa que contiene 20 mg de acetato de glatiramer y 20 mg de manitol en solucion para disminuir la frecuencia de exacerbaciones clínicas o para reducir la cantidad y el volumen de las lesiones cerebrales activas en el MRI de un paciente humano afectado por esclerosis multiple remitente-recidivante (RRMS). Reivindicacion 47: Una composicion farmacéutica que ha de usarse para tratar un paciente humano afectado por esclerosis multiple remitente-recidivante (RRMS), que comprende una dosis individual de 0,5 ml de una solucion farmacéutica acuosa que contiene 20 mg de acetato de glatiramer y 20 mg de manitol en solucion.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US27100909P | 2009-07-15 | 2009-07-15 | |
| US27134009P | 2009-07-20 | 2009-07-20 | |
| US33701110P | 2010-01-29 | 2010-01-29 | |
| US12/761,367 US20110060279A1 (en) | 2009-07-15 | 2010-04-15 | Reduced Volume Formulation of Glatiramer Acetate and Methods of Administration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR077484A1 true AR077484A1 (es) | 2011-08-31 |
Family
ID=42283140
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP100102598A AR077484A1 (es) | 2009-07-15 | 2010-07-15 | Formulacion de acetato de glatiramer de volumen reducido y metodos para su administracion |
Country Status (19)
| Country | Link |
|---|---|
| US (3) | US20110060279A1 (es) |
| EP (2) | EP2275086B1 (es) |
| JP (1) | JP2012533540A (es) |
| AR (1) | AR077484A1 (es) |
| AT (1) | ATE549013T1 (es) |
| AU (1) | AU2010273234A1 (es) |
| BR (1) | BR112012000878A2 (es) |
| CA (1) | CA2697570C (es) |
| DK (1) | DK2275086T3 (es) |
| EA (1) | EA201270167A1 (es) |
| ES (1) | ES2383347T3 (es) |
| HR (1) | HRP20120349T1 (es) |
| IL (1) | IL217240A0 (es) |
| MX (1) | MX2012000687A (es) |
| PL (1) | PL2275086T3 (es) |
| PT (1) | PT2275086E (es) |
| RS (1) | RS52367B (es) |
| WO (1) | WO2011008274A2 (es) |
| ZA (1) | ZA201200586B (es) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2527760T3 (es) * | 1998-07-23 | 2015-01-29 | Yeda Research And Development Co., Ltd. | Tratamiento de enfermedad de Crohn con copolímero 1 y polipéptidos |
| US12097357B2 (en) | 2008-09-15 | 2024-09-24 | West Pharma. Services IL, Ltd. | Stabilized pen injector |
| ATE549013T1 (de) | 2009-07-15 | 2012-03-15 | Teva Pharma | Formulierung von glatirameracetat mit verringertem volumen und verabreichungsverfahren |
| US8920373B2 (en) | 2009-07-15 | 2014-12-30 | Teva Pharmaceutical Industries, Ltd. | Reduced volume formulation of glatiramer acetate and methods of administration |
| UA103699C2 (ru) | 2009-08-20 | 2013-11-11 | Еда Рисёрч Энд Девелопмент Ко., Лтд. | Терапия глатирамера ацетатом с низкой частотой |
| USRE49251E1 (en) | 2010-01-04 | 2022-10-18 | Mapi Pharma Ltd. | Depot systems comprising glatiramer or pharmacologically acceptable salt thereof |
| US8759302B2 (en) | 2010-03-16 | 2014-06-24 | Teva Pharmaceutical Industries, Ltd. | Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis |
| EA025780B1 (ru) | 2010-10-11 | 2017-01-30 | Тева Фармасьютикал Индастриз Лтд. | Цитокиновые биомаркеры в качестве биомаркеров, прогнозирующих клинический ответ на глатирамер ацетат |
| CA2851510A1 (en) | 2011-10-10 | 2013-04-18 | Teva Pharmaceutical Industries Ltd. | Single nucleotide polymorphisms useful to predict clinical response for glatiramer acetate |
| JP6510408B2 (ja) * | 2012-08-20 | 2019-05-08 | ケアベイ・ヨーロッパ・リミテッドCarebay Europe Limited | 自動注射器具 |
| TW201420111A (zh) | 2012-10-10 | 2014-06-01 | Teva Pharma | 對格拉默醋酸鹽(glatiramer acetate)之臨床反應具預測性之生物標記 |
| WO2014128079A1 (en) * | 2013-02-19 | 2014-08-28 | Synthon B.V. | Glatiramer acetate multidose formulation |
| JP6073507B2 (ja) * | 2013-03-08 | 2017-02-01 | テバ ファーマシューティカル インダストリーズ リミティド | 注射器用の再使用可能な注入器装置 |
| EA028936B1 (ru) * | 2013-03-08 | 2018-01-31 | Тева Фармасьютикал Индастриз Лимитед | Инъекторное устройство многократного использования для шприца |
| US8591463B1 (en) | 2013-03-08 | 2013-11-26 | Teva Pharmaceutical Industries Ltd. | Re-useable injector device for syringe |
| UY35790A (es) | 2013-10-21 | 2015-05-29 | Teva Pharma | Marcadores genéticos que predicen la respuesta al acetato de glatiramer |
| CN112263384A (zh) | 2014-02-26 | 2021-01-26 | 阿勒根公司 | 眼内植入体递送设备及其使用方法 |
| US9415176B1 (en) | 2015-01-22 | 2016-08-16 | West Pharmaceutical Services, Inc. | Autoinjector having an end-of-dose visual indicator |
| US9155775B1 (en) * | 2015-01-28 | 2015-10-13 | Teva Pharmaceutical Industries, Ltd. | Process for manufacturing glatiramer acetate product |
| US12097292B2 (en) | 2016-08-28 | 2024-09-24 | Mapi Pharma Ltd. | Process for preparing microparticles containing glatiramer acetate |
| US12370233B2 (en) | 2016-08-31 | 2025-07-29 | Mapi Pharma Ltd. | Depot systems comprising glatiramer acetate |
| WO2018083697A1 (en) * | 2016-11-02 | 2018-05-11 | To Pharmaceuticals Llc | Combination therapy of cbd and copaxone |
| WO2018106931A1 (en) | 2016-12-07 | 2018-06-14 | Progenity Inc. | Gastrointestinal tract detection methods, devices and systems |
| WO2018178973A1 (en) | 2017-03-26 | 2018-10-04 | Mapi Pharma Ltd. | Glatiramer depot systems for treating progressive forms of multiple sclerosis |
| CN110996983A (zh) | 2017-06-26 | 2020-04-10 | 巴斯德研究所 | 清除hiv储库并降低病毒载量的治疗 |
| WO2019036363A1 (en) | 2017-08-14 | 2019-02-21 | Progenity Inc. | TREATMENT OF GASTROINTESTINAL TRACT DISEASE WITH GLATIRAMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF |
Family Cites Families (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE55260T1 (de) * | 1985-10-11 | 1990-08-15 | Duphar Int Res | Automatische spritze. |
| NL8701091A (nl) * | 1987-05-08 | 1988-12-01 | Spruyt Hillen Bv | Injectiepen. |
| US5981485A (en) * | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| GB8926825D0 (en) * | 1989-11-28 | 1990-01-17 | Glaxo Group Ltd | Device |
| IL113812A (en) * | 1994-05-24 | 2000-06-29 | Yeda Res & Dev | Copolymer-1 pharmaceutical compositions containing it and its use |
| US6454746B1 (en) * | 1997-06-04 | 2002-09-24 | Eli Lilly And Company | Medication delivery apparatus |
| US20020077278A1 (en) * | 2000-06-05 | 2002-06-20 | Yong V. Wee | Use of glatiramer acetate (copolymer 1) in the treatment of central nervous system disorders |
| SE518981C2 (sv) | 2000-12-14 | 2002-12-17 | Shl Medical Ab | Autoinjektor |
| CN100464796C (zh) * | 2002-11-25 | 2009-03-04 | 特克法马许可公司 | 包括可复位安全释放设备的自动注射器 |
| CA2540890A1 (en) * | 2003-10-03 | 2005-04-14 | Bayhill Therapeutics, Inc. | Treatment of demyelinating autoimmune disease with modified ordered peptides |
| US7655221B2 (en) * | 2004-05-07 | 2010-02-02 | Peptimmune, Inc. | Methods of treating disease with random copolymers |
| CA2579038A1 (en) * | 2004-09-02 | 2006-03-16 | Teva Pharmaceutical Industries, Ltd. | Combination therapy with glatiramer acetate and n-acetylcysteine for the treatment of multiple sclerosis |
| WO2006029411A2 (en) * | 2004-09-09 | 2006-03-16 | Yeda Research And Development Co. Ltd. | Mixtures of polypeptides, compositions containing and processes for preparing same, and uses thereof |
| ES2331015T3 (es) * | 2004-10-29 | 2009-12-18 | Sandoz Ag | Proceso para la preparacion de un glatiramero. |
| WO2007081975A2 (en) * | 2006-01-11 | 2007-07-19 | Teva Pharmaceutical Industries, Ltd. | Method of treating multiple sclerosis |
| US20070161960A1 (en) * | 2006-01-12 | 2007-07-12 | Fu-Yuan Li | Lancet device |
| WO2007146331A1 (en) * | 2006-06-12 | 2007-12-21 | Teva Pharmaceutical Industries, Ltd. | Tannate salt form of polypeptide mixtures, their preparation and use |
| CN103316402A (zh) * | 2006-06-30 | 2013-09-25 | 艾伯维生物技术有限公司 | 自动注射装置 |
| USD622374S1 (en) * | 2006-09-06 | 2010-08-24 | Abbott Biotechnology Ltd. | Automatic injection device |
| AU2008330093A1 (en) | 2007-11-28 | 2009-06-04 | Yeda Research And Development Co., Ltd. | Method of delaying the onset of clinically definite multiple sclerosis |
| USD607558S1 (en) * | 2008-09-19 | 2010-01-05 | Becton Dickinson France S.A.S. | Medicine injector |
| ATE549013T1 (de) * | 2009-07-15 | 2012-03-15 | Teva Pharma | Formulierung von glatirameracetat mit verringertem volumen und verabreichungsverfahren |
-
2010
- 2010-04-15 AT AT10160099T patent/ATE549013T1/de active
- 2010-04-15 PT PT10160099T patent/PT2275086E/pt unknown
- 2010-04-15 RS RS20120188A patent/RS52367B/sr unknown
- 2010-04-15 ES ES10160099T patent/ES2383347T3/es active Active
- 2010-04-15 US US12/761,367 patent/US20110060279A1/en not_active Abandoned
- 2010-04-15 EP EP10160099A patent/EP2275086B1/en active Active
- 2010-04-15 CA CA2697570A patent/CA2697570C/en not_active Expired - Fee Related
- 2010-04-15 PL PL10160099T patent/PL2275086T3/pl unknown
- 2010-04-15 DK DK10160099.7T patent/DK2275086T3/da active
- 2010-05-21 US US12/785,125 patent/US7855176B1/en not_active Expired - Fee Related
- 2010-07-14 BR BR112012000878A patent/BR112012000878A2/pt not_active IP Right Cessation
- 2010-07-14 MX MX2012000687A patent/MX2012000687A/es not_active Application Discontinuation
- 2010-07-14 JP JP2012520598A patent/JP2012533540A/ja active Pending
- 2010-07-14 AU AU2010273234A patent/AU2010273234A1/en not_active Abandoned
- 2010-07-14 EP EP10800156A patent/EP2453907A2/en not_active Withdrawn
- 2010-07-14 EA EA201270167A patent/EA201270167A1/ru unknown
- 2010-07-14 WO PCT/US2010/001972 patent/WO2011008274A2/en not_active Ceased
- 2010-07-15 AR ARP100102598A patent/AR077484A1/es unknown
- 2010-11-17 US US12/948,611 patent/US9018170B2/en not_active Expired - Fee Related
-
2011
- 2011-12-27 IL IL217240A patent/IL217240A0/en unknown
-
2012
- 2012-01-24 ZA ZA2012/00586A patent/ZA201200586B/en unknown
- 2012-04-18 HR HRP20120349AT patent/HRP20120349T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2011008274A2 (en) | 2011-01-20 |
| HRP20120349T1 (hr) | 2012-07-31 |
| EP2453907A2 (en) | 2012-05-23 |
| EP2275086B1 (en) | 2012-03-14 |
| US9018170B2 (en) | 2015-04-28 |
| IL217240A0 (en) | 2012-02-29 |
| DK2275086T3 (da) | 2012-07-09 |
| MX2012000687A (es) | 2012-09-07 |
| US20110066112A1 (en) | 2011-03-17 |
| HK1152249A1 (en) | 2012-02-24 |
| CA2697570A1 (en) | 2010-06-22 |
| WO2011008274A4 (en) | 2011-11-10 |
| AU2010273234A1 (en) | 2012-02-23 |
| WO2011008274A3 (en) | 2011-09-22 |
| BR112012000878A2 (pt) | 2019-09-24 |
| ATE549013T1 (de) | 2012-03-15 |
| CA2697570C (en) | 2011-11-01 |
| ZA201200586B (en) | 2013-10-30 |
| EP2275086A1 (en) | 2011-01-19 |
| JP2012533540A (ja) | 2012-12-27 |
| EA201270167A1 (ru) | 2012-08-30 |
| PL2275086T3 (pl) | 2012-09-28 |
| US20110060279A1 (en) | 2011-03-10 |
| ES2383347T3 (es) | 2012-06-20 |
| RS52367B (sr) | 2012-12-31 |
| US7855176B1 (en) | 2010-12-21 |
| PT2275086E (pt) | 2012-05-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |