AR074357A1 - Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas. metodo de dialisis in vitro - Google Patents
Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas. metodo de dialisis in vitroInfo
- Publication number
- AR074357A1 AR074357A1 ARP090104434A ARP090104434A AR074357A1 AR 074357 A1 AR074357 A1 AR 074357A1 AR P090104434 A ARP090104434 A AR P090104434A AR P090104434 A ARP090104434 A AR P090104434A AR 074357 A1 AR074357 A1 AR 074357A1
- Authority
- AR
- Argentina
- Prior art keywords
- cyclodextrin
- antibody
- formulation
- macromolecule
- macromolecula
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; 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
- A61K9/0012—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/04—Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
-
- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- 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
-
- 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
-
- 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
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/08—Vasodilators for multiple indications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
Abstract
Reivindicación 1: Un método para reducir al mínimo la inflamación en el sitio de inyección durante la administración subcutánea de una macromolécula, que comprende agregar a una formulación que contiene la macromolécula de 2% a 30% de ciclodextrina. Reivindicación 8: El método de acuerdo con la reivindicación 1 donde la macromolécula es una proteína. Reivindicación 9: El método de acuerdo con la reivindicación 8 donde la proteína es un anticuerpo. Reivindicación 12: El método de acuerdo con la reivindicación 9 donde el anticuerpo es un anticuerpo anti-CD20. Reivindicación 14: El método de acuerdo con la reivindicación 12 donde el anticuerpo comprende una secuencia de aminoácidos seleccionada del grupo formado por SEC ID Ns:1-15. Reivindicación 25: Una formulación farmacéutica para la administración subcutánea de un anticuerpo, que comprende un anticuerpo en un rango de concentración de 10 mg/ml a 200 mg/mI, y de 2% a 30% de ciclodextrina. Reivindicación 30: La formulación de acuerdo con la reivindicación 29 donde la formulación comprende además 50 mM a 200 mM de succinato de arginina. Reivindicación 42: Un método para tratar un cáncer de células B CD20 positivo, que comprende administrar a un paciente que tiene el cáncer una cantidad terapéuticamente eficaz de un anticuerpo 2H7 humanizado de la Tabla 1 en una formulación farmacéutica que comprende de 2% a 30% de ciclodextrina, donde la ciclodextrina se selecciona del grupo formado por HP-Beta ciclodextrina, HP-Gamma ciclodextrina, y SBE-ciclodextrina. Reivindicación 46: Un método para tratar una enfermedad autoinmune, que comprende administrar a un paciente que tiene la enfermedad autoinmune una cantidad terapéuticamente eficaz de un anticuerpo 2H7 humanizado de la Tabla 1 en una formulación farmacéutica que comprende de 2% a 30% de ciclodextrina, donde la ciclodextrina se selecciona del grupo formado por HP-Beta ciclodextrina, HP-Gamma ciclodextrina, y SBE-ciclodextrina.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11544108P | 2008-11-17 | 2008-11-17 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR074357A1 true AR074357A1 (es) | 2011-01-12 |
Family
ID=42170392
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP090104434A AR074357A1 (es) | 2008-11-17 | 2009-11-16 | Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas. metodo de dialisis in vitro |
Country Status (17)
| Country | Link |
|---|---|
| US (2) | US20110305639A1 (es) |
| EP (1) | EP2358395A4 (es) |
| JP (2) | JP2012509269A (es) |
| KR (1) | KR20110086705A (es) |
| CN (1) | CN102281903B (es) |
| AR (1) | AR074357A1 (es) |
| AU (1) | AU2009313754A1 (es) |
| BR (1) | BRPI0916072A2 (es) |
| CA (1) | CA2742988A1 (es) |
| CL (1) | CL2011001132A1 (es) |
| IL (1) | IL212533A0 (es) |
| MX (1) | MX2011005051A (es) |
| PE (1) | PE20120169A1 (es) |
| RU (1) | RU2563823C2 (es) |
| TW (1) | TW201032826A (es) |
| WO (1) | WO2010057107A1 (es) |
| ZA (1) | ZA201103006B (es) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EA036531B1 (ru) | 2003-11-05 | 2020-11-19 | Роше Гликарт Аг | Гуманизированное антитело типа ii к cd20 (варианты), фармацевтическая композиция, содержащая эти варианты антитела, и их применение |
| TW201014605A (en) | 2008-09-16 | 2010-04-16 | Genentech Inc | Methods for treating progressive multiple sclerosis |
| JP5341059B2 (ja) * | 2010-11-09 | 2013-11-13 | 株式会社大塚製薬工場 | 幹細胞懸濁液 |
| EP3412310B1 (en) * | 2012-03-07 | 2022-09-07 | Cadila Healthcare Limited | Pharmaceutical formulations of tnf-alpha antibodies |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| SG11201506372RA (en) | 2013-03-13 | 2015-09-29 | Seattle Genetics Inc | Cyclodextrin and antibody-drug conjugate formulations |
| EP3397287A1 (en) | 2015-12-30 | 2018-11-07 | Genentech, Inc. | Formulations with reduced degradation of polysorbate |
| GB201604124D0 (en) * | 2016-03-10 | 2016-04-27 | Ucb Biopharma Sprl | Pharmaceutical formulation |
| KR102039709B1 (ko) | 2017-11-03 | 2019-11-01 | 삼성전자주식회사 | 유기 인터포저를 포함하는 반도체 패키지 |
| MA55033A (fr) | 2019-02-18 | 2021-12-29 | Lilly Co Eli | Formulation d'anticorps thérapeutique |
| RU2754509C1 (ru) * | 2020-12-21 | 2021-09-02 | федеральное государственное бюджетное образовательное учреждение высшего образования "Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова" Министерства здравоохранения Российской Федерации | Способ лечения первичной мембранозной нефропатии с нефротическим синдромом и повышенным уровнем анти-plar2 |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5997856A (en) * | 1988-10-05 | 1999-12-07 | Chiron Corporation | Method and compositions for solubilization and stabilization of polypeptides, especially proteins |
| WO1994023697A1 (en) * | 1993-04-22 | 1994-10-27 | Depotech Corporation | Cyclodextrin liposomes encapsulating pharmacologic compounds and methods for their use |
| JP2000226336A (ja) * | 1998-11-30 | 2000-08-15 | Sankyo Co Ltd | 免疫グロブリン製剤 |
| BR0014486A (pt) * | 1999-10-04 | 2002-09-17 | Chiron Corp | Composições farmacêuticas contendo polipeptìdeo lìquido estabilizado |
| JP2004522803A (ja) * | 2001-06-29 | 2004-07-29 | マキシゲン・エイピーエス | インターフェロン製剤 |
| DE10228049A1 (de) * | 2002-06-24 | 2004-01-15 | Merck Patent Gmbh | Flüssige Zubereitung enthaltend Oligopeptide |
| US7960512B2 (en) * | 2003-01-09 | 2011-06-14 | Macrogenics, Inc. | Identification and engineering of antibodies with variant Fc regions and methods of using same |
| EA009123B1 (ru) * | 2003-01-14 | 2007-10-26 | Тева Фармасьютикал Индастриз, Лтд. | Парентеральные композиции пептидов для лечения системной красной волчанки |
| BRPI0403964B8 (pt) * | 2003-04-04 | 2021-05-25 | Genentech Inc | formulações líquidas estáveis, artigo manufaturado e uso dessas formulações para o tratamento de disfunção mediada por ige |
| US20050158303A1 (en) * | 2003-04-04 | 2005-07-21 | Genentech, Inc. | Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations |
| ES2322267T3 (es) * | 2003-04-09 | 2009-06-18 | Genentech, Inc. | Terapia de una enfermedad autoinmunologica en un paciente que presenta una respuesta inadecuada a un inhibidor de tnf-alfa. |
| DE10361599A1 (de) * | 2003-12-24 | 2005-07-28 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Flüssigformulierung von Antikörperkonjugaten |
| CN101115769A (zh) * | 2004-05-19 | 2008-01-30 | 马克西根公司 | 干扰素-α多肽和偶联物 |
| US20060128654A1 (en) * | 2004-12-10 | 2006-06-15 | Chunlin Tang | Pharmaceutical formulation of cytidine analogs and derivatives |
| DOP2006000029A (es) * | 2005-02-07 | 2006-08-15 | Genentech Inc | Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas) |
| NZ623901A (en) * | 2005-08-03 | 2015-10-30 | Immunogen Inc | Immunoconjugate formulations |
| MX2009006199A (es) * | 2006-12-11 | 2009-06-22 | Hoffmann La Roche | Formulacion parenteral de anticuerpos abeta. |
| CN101204374A (zh) * | 2006-12-18 | 2008-06-25 | 宜兴市天石饲料有限公司 | 一种包被复合型多价高效蛋黄抗体 |
| EP2205280B1 (en) * | 2007-09-27 | 2019-09-04 | Amgen Inc. | Pharmaceutical formulations |
-
2009
- 2009-11-16 PE PE2011001040A patent/PE20120169A1/es not_active Application Discontinuation
- 2009-11-16 RU RU2011124550/15A patent/RU2563823C2/ru not_active IP Right Cessation
- 2009-11-16 MX MX2011005051A patent/MX2011005051A/es not_active Application Discontinuation
- 2009-11-16 WO PCT/US2009/064610 patent/WO2010057107A1/en active Application Filing
- 2009-11-16 CA CA2742988A patent/CA2742988A1/en not_active Abandoned
- 2009-11-16 AR ARP090104434A patent/AR074357A1/es unknown
- 2009-11-16 BR BRPI0916072A patent/BRPI0916072A2/pt not_active IP Right Cessation
- 2009-11-16 TW TW098138926A patent/TW201032826A/zh unknown
- 2009-11-16 EP EP09826919.4A patent/EP2358395A4/en not_active Withdrawn
- 2009-11-16 JP JP2011536560A patent/JP2012509269A/ja active Pending
- 2009-11-16 AU AU2009313754A patent/AU2009313754A1/en not_active Abandoned
- 2009-11-16 CN CN2009801546640A patent/CN102281903B/zh not_active Expired - Fee Related
- 2009-11-16 KR KR1020117011124A patent/KR20110086705A/ko not_active Application Discontinuation
-
2011
- 2011-04-20 ZA ZA2011/03006A patent/ZA201103006B/en unknown
- 2011-04-28 IL IL212533A patent/IL212533A0/en unknown
- 2011-05-13 US US13/107,137 patent/US20110305639A1/en not_active Abandoned
- 2011-05-16 CL CL2011001132A patent/CL2011001132A1/es unknown
-
2013
- 2013-06-10 US US13/914,094 patent/US20140093493A1/en not_active Abandoned
-
2015
- 2015-07-30 JP JP2015150264A patent/JP2016020350A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP2358395A4 (en) | 2013-11-20 |
| RU2563823C2 (ru) | 2015-09-20 |
| CA2742988A1 (en) | 2010-05-20 |
| IL212533A0 (en) | 2011-06-30 |
| BRPI0916072A2 (pt) | 2015-11-10 |
| KR20110086705A (ko) | 2011-07-29 |
| CL2011001132A1 (es) | 2012-07-20 |
| US20140093493A1 (en) | 2014-04-03 |
| TW201032826A (en) | 2010-09-16 |
| CN102281903A (zh) | 2011-12-14 |
| MX2011005051A (es) | 2011-06-01 |
| WO2010057107A1 (en) | 2010-05-20 |
| ZA201103006B (en) | 2012-07-25 |
| RU2011124550A (ru) | 2012-12-27 |
| JP2016020350A (ja) | 2016-02-04 |
| JP2012509269A (ja) | 2012-04-19 |
| US20110305639A1 (en) | 2011-12-15 |
| AU2009313754A1 (en) | 2010-05-20 |
| CN102281903B (zh) | 2013-11-13 |
| EP2358395A1 (en) | 2011-08-24 |
| PE20120169A1 (es) | 2012-02-29 |
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