JP7357540B2 - 液体医薬組成物 - Google Patents
液体医薬組成物 Download PDFInfo
- Publication number
- JP7357540B2 JP7357540B2 JP2019548380A JP2019548380A JP7357540B2 JP 7357540 B2 JP7357540 B2 JP 7357540B2 JP 2019548380 A JP2019548380 A JP 2019548380A JP 2019548380 A JP2019548380 A JP 2019548380A JP 7357540 B2 JP7357540 B2 JP 7357540B2
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- liquid pharmaceutical
- pharmaceutical composition
- adalimumab
- polyol
- edta
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- 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
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- 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
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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
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- C07—ORGANIC CHEMISTRY
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
Landscapes
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| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| EP4467565A3 (en) | 2016-12-21 | 2025-03-12 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| US11608357B2 (en) | 2018-08-28 | 2023-03-21 | Arecor Limited | Stabilized antibody protein solutions |
| EP3372241A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
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| MA55033A (fr) * | 2019-02-18 | 2021-12-29 | Lilly Co Eli | Formulation d'anticorps thérapeutique |
| US20230203147A1 (en) * | 2019-03-18 | 2023-06-29 | Alvotech Hf | Aqueous formulations of tnf-alpha antibodies in high concentrations |
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| JP2015506369A (ja) | 2012-01-30 | 2015-03-02 | アレコー リミテッド | 安定化された水性抗体組成物 |
| JP2015527402A (ja) | 2012-09-07 | 2015-09-17 | コヒラス・バイオサイエンシズ・インコーポレイテッド | 安定水性アダリムマブ製剤 |
| WO2016066688A1 (en) | 2014-10-28 | 2016-05-06 | Richter Gedeon Nyrt. | Pharmaceutical anti-tnf-alpha antibody formulation |
| JP2016117732A (ja) | 2014-12-23 | 2016-06-30 | ファイザー・インク | 安定な水性抗体製剤 |
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| ATE291436T2 (de) | 2000-05-15 | 2005-04-15 | Hoffmann La Roche | Flüssige arzneizubereitung enthaltend ein erythropoietin derivat |
| CA2466034C (en) | 2001-11-08 | 2012-12-18 | Protein Design Labs, Inc. | Stable aqueous pharmaceutical formulations of daclizumab antibodies |
| PT1946776T (pt) | 2002-02-27 | 2017-03-17 | Immunex Corp | Composição de tnfr-fc estabilizada compreendendo arginina |
| WO2004007520A2 (en) | 2002-07-12 | 2004-01-22 | Medarex, Inc. | Methods and compositions for preventing oxidative degradation of proteins |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| PA8661401A1 (es) | 2005-01-28 | 2006-09-08 | Wyeth Corp | Formulaciones del liquido polipeptido estabilizado |
| AR054233A1 (es) | 2005-03-08 | 2007-06-13 | Pharmacia & Upjohn Co Llc | Composiciones de anticuerpos igg2 |
| TW200806317A (en) | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| JP5631591B2 (ja) | 2006-10-06 | 2014-11-26 | アムジエン・インコーポレーテツド | 安定な抗体製剤 |
| MX2009003982A (es) | 2006-10-20 | 2009-04-27 | Amgen Inc | Formulaciones de polipeptido estables. |
| GB0700523D0 (en) | 2007-01-11 | 2007-02-21 | Insense Ltd | The Stabilisation Of Proteins |
| JP2010529999A (ja) | 2007-06-14 | 2010-09-02 | バイオジェン・アイデック・エムエイ・インコーポレイテッド | 抗体製剤 |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| WO2010062896A1 (en) | 2008-11-28 | 2010-06-03 | Abbott Laboratories | Stable antibody compositions and methods for stabilizing same |
| CN104490767A (zh) * | 2009-05-04 | 2015-04-08 | 艾伯维生物技术有限公司 | 人抗TNF-α抗体的稳定高蛋白质浓度制剂 |
| EP2598167B1 (en) | 2010-07-30 | 2015-04-01 | Arecor Limited | Stabilized aqueous antibody compositions |
| WO2012064627A2 (en) | 2010-11-08 | 2012-05-18 | Genentech, Inc. | Subcutaneously administered anti-il-6 receptor antibody |
| GB201112429D0 (en) * | 2011-07-19 | 2011-08-31 | Glaxo Group Ltd | Antigen-binding proteins with increased FcRn binding |
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| TW201636047A (zh) | 2015-01-28 | 2016-10-16 | 麥博賽恩斯有限公司 | 抗-TNF-α抗體之醫藥調配物 |
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| GB201703062D0 (en) | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| US20200069799A1 (en) | 2018-08-28 | 2020-03-05 | Arecor Limited | Stabilized antibody protein solutions |
| GB201703063D0 (en) | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| EP3372242A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
| EP3372241A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
| WO2018184692A1 (en) | 2017-04-07 | 2018-10-11 | Ares Trading S.A. | Liquid pharmaceutical composition |
| WO2018184693A1 (en) | 2017-04-07 | 2018-10-11 | Ares Trading S.A. | Liquid pharmaceutical composition |
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2017
- 2017-03-06 EP EP17159460.9A patent/EP3372242A1/en not_active Withdrawn
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2018
- 2018-03-06 EP EP18710815.4A patent/EP3592383B1/en active Active
- 2018-03-06 US US16/491,500 patent/US11534402B2/en active Active
- 2018-03-06 WO PCT/EP2018/055505 patent/WO2018162500A1/en not_active Ceased
- 2018-03-06 JP JP2019548380A patent/JP7357540B2/ja active Active
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2022
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2023
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| JP2015506369A (ja) | 2012-01-30 | 2015-03-02 | アレコー リミテッド | 安定化された水性抗体組成物 |
| JP2015527402A (ja) | 2012-09-07 | 2015-09-17 | コヒラス・バイオサイエンシズ・インコーポレイテッド | 安定水性アダリムマブ製剤 |
| WO2016066688A1 (en) | 2014-10-28 | 2016-05-06 | Richter Gedeon Nyrt. | Pharmaceutical anti-tnf-alpha antibody formulation |
| JP2016117732A (ja) | 2014-12-23 | 2016-06-30 | ファイザー・インク | 安定な水性抗体製剤 |
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| Pharm.Res.,2010年,Vol.27,No.4,544-575 |
Also Published As
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| WO2018162500A1 (en) | 2018-09-13 |
| JP2020511440A (ja) | 2020-04-16 |
| US20230330014A1 (en) | 2023-10-19 |
| JP2023058632A (ja) | 2023-04-25 |
| EP3372242A1 (en) | 2018-09-12 |
| EP3592383A1 (en) | 2020-01-15 |
| US11534402B2 (en) | 2022-12-27 |
| EP3592383B1 (en) | 2022-05-04 |
| US20200016074A1 (en) | 2020-01-16 |
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