JP7220664B2 - 液体医薬組成物 - Google Patents
液体医薬組成物 Download PDFInfo
- Publication number
- JP7220664B2 JP7220664B2 JP2019548458A JP2019548458A JP7220664B2 JP 7220664 B2 JP7220664 B2 JP 7220664B2 JP 2019548458 A JP2019548458 A JP 2019548458A JP 2019548458 A JP2019548458 A JP 2019548458A JP 7220664 B2 JP7220664 B2 JP 7220664B2
- Authority
- JP
- Japan
- Prior art keywords
- liquid pharmaceutical
- adalimumab
- pharmaceutical composition
- arginine
- composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K9/08—Solutions
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- 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
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17159458.3 | 2017-03-06 | ||
| EP17159458.3A EP3372241A1 (en) | 2017-03-06 | 2017-03-06 | Liquid pharmaceutical composition |
| PCT/EP2018/055509 WO2018162503A1 (en) | 2017-03-06 | 2018-03-06 | Liquid pharmaceutical composition |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020511443A JP2020511443A (ja) | 2020-04-16 |
| JP2020511443A5 JP2020511443A5 (https=) | 2021-04-08 |
| JP7220664B2 true JP7220664B2 (ja) | 2023-02-10 |
Family
ID=58261542
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019548458A Active JP7220664B2 (ja) | 2017-03-06 | 2018-03-06 | 液体医薬組成物 |
Country Status (4)
| Country | Link |
|---|---|
| US (2) | US11534403B2 (https=) |
| EP (2) | EP3372241A1 (https=) |
| JP (1) | JP7220664B2 (https=) |
| WO (1) | WO2018162503A1 (https=) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| GB201703063D0 (en) * | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| US11608357B2 (en) | 2018-08-28 | 2023-03-21 | Arecor Limited | 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 |
| CN113727730A (zh) * | 2019-03-18 | 2021-11-30 | 阿尔沃科技Hf公司 | 高浓度TNFα抗体的含水制剂 |
| US11596669B2 (en) | 2021-03-11 | 2023-03-07 | 89Bio, Inc. | Liquid formulations comprising mutant FGF-21 peptide pegylated conjugates |
| CN117120070B (zh) * | 2021-03-11 | 2024-11-15 | 89生物公司 | 包含突变型fgf-21肽peg化缀合物的液体制剂 |
| WO2023043232A1 (ko) * | 2021-09-16 | 2023-03-23 | 주식회사 에이프로젠 | 항-TNFα 항체를 포함하는 약제학적 조성물 |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2010505852A (ja) | 2006-10-06 | 2010-02-25 | アムジエン・インコーポレーテツド | 安定な抗体製剤 |
| 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 |
| JP2014524748A (ja) | 2011-07-19 | 2014-09-25 | グラクソ グループ リミテッド | FcRn結合の増加したTNF−α抗原結合タンパク質 |
| JP2015509526A (ja) | 2012-03-07 | 2015-03-30 | カディラ ヘルスケア リミティド | 医薬製剤 |
| 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 |
| JP2016505633A (ja) | 2013-01-24 | 2016-02-25 | グラクソスミスクライン、インテレクチュアル、プロパティー、ディベロップメント、リミテッドGlaxosmithkline Intellectual Property Development Limited | TNFα抗原結合性タンパク質 |
| 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 |
Family Cites Families (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK0929578T3 (da) | 1996-02-09 | 2003-08-25 | Abbott Lab Bermuda Ltd | Humane antistoffer, der binder human TNFalfa |
| PL219131B1 (pl) | 2000-05-15 | 2015-03-31 | Hoffmann La Roche | Ciekła kompozycja farmaceutyczna, sposób jej wytwarzania oraz jej zastosowanie |
| JP5290489B2 (ja) | 2001-11-08 | 2013-09-18 | アッヴィ・バイオセラピューティクス・インコーポレイテッド | Igg抗体の安定な液体医薬製剤 |
| PT1946776T (pt) | 2002-02-27 | 2017-03-17 | Immunex Corp | Composição de tnfr-fc estabilizada compreendendo arginina |
| CA2492143A1 (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 |
| BRPI0606867A2 (pt) | 2005-01-28 | 2009-07-21 | Wyeth Corp | formulação lìquida; forma de dosagem unitária farmacêutica; kit; recipiente; método para aumentar a estabilidade de um polipeptìdeo de ligação a antìgeno numa formulação; método para preparar uma forma de dosagem unitária farmacêutica; formulação estável; formulação; e produto terapêutico |
| EP1871806A2 (en) | 2005-03-08 | 2008-01-02 | Pharmacia & Upjohn Company LLC | ANTI-MAdCAM ANTIBODY COMPOSITIONS |
| TW200806317A (en) | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| US7705132B2 (en) | 2006-10-20 | 2010-04-27 | Amgen Inc. | Stable polypeptide formulations |
| GB0700523D0 (en) | 2007-01-11 | 2007-02-21 | Insense Ltd | The Stabilisation Of Proteins |
| 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 |
| MX2011011772A (es) * | 2009-05-04 | 2012-02-08 | Abbott Biotech Ltd | Formulaicones estables de anticuerpos humanos anti-tnf-alfa con alta concentracion de proteina. |
| EP2598167B1 (en) | 2010-07-30 | 2015-04-01 | Arecor Limited | Stabilized aqueous antibody compositions |
| TWI603738B (zh) | 2010-11-08 | 2017-11-01 | 建南德克公司 | 皮下投予抗-il-6受體抗體 |
| CN104203282A (zh) | 2012-01-30 | 2014-12-10 | 艾瑞克有限公司 | 稳定的水性抗体组合物 |
| HUP1400510A1 (hu) * | 2014-10-28 | 2016-05-30 | Richter Gedeon Nyrt | Gyógyászati TNFalfa ellenes antitest készítmény |
| JP2018500380A (ja) | 2014-12-31 | 2018-01-11 | ノベルメド セラピューティクス,インコーポレーテッド | アグリコシル化治療用抗体の製剤 |
| 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 |
| WO2016162819A1 (en) | 2015-04-07 | 2016-10-13 | Lupin Limited | Stable aqueous pharmaceutical composition of anti-tnf alpha antibody |
| GB201612317D0 (en) | 2016-07-15 | 2016-08-31 | Philogen Spa | Antibody compositions |
| GB201703062D0 (en) | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| US11608357B2 (en) | 2018-08-28 | 2023-03-21 | Arecor Limited | Stabilized antibody protein solutions |
| GB201703063D0 (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 |
| 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 |
| WO2018184693A1 (en) | 2017-04-07 | 2018-10-11 | Ares Trading S.A. | Liquid pharmaceutical composition |
| WO2018184692A1 (en) | 2017-04-07 | 2018-10-11 | Ares Trading S.A. | Liquid pharmaceutical composition |
-
2017
- 2017-03-06 EP EP17159458.3A patent/EP3372241A1/en not_active Withdrawn
-
2018
- 2018-03-06 US US16/491,506 patent/US11534403B2/en active Active
- 2018-03-06 JP JP2019548458A patent/JP7220664B2/ja active Active
- 2018-03-06 WO PCT/EP2018/055509 patent/WO2018162503A1/en not_active Ceased
- 2018-03-06 EP EP18714446.4A patent/EP3592385B1/en active Active
-
2022
- 2022-12-01 US US18/072,852 patent/US20230233463A1/en not_active Abandoned
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2010505852A (ja) | 2006-10-06 | 2010-02-25 | アムジエン・インコーポレーテツド | 安定な抗体製剤 |
| 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 |
| JP2014524748A (ja) | 2011-07-19 | 2014-09-25 | グラクソ グループ リミテッド | FcRn結合の増加したTNF−α抗原結合タンパク質 |
| JP2015509526A (ja) | 2012-03-07 | 2015-03-30 | カディラ ヘルスケア リミティド | 医薬製剤 |
| 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 |
| JP2016505633A (ja) | 2013-01-24 | 2016-02-25 | グラクソスミスクライン、インテレクチュアル、プロパティー、ディベロップメント、リミテッドGlaxosmithkline Intellectual Property Development Limited | TNFα抗原結合性タンパク質 |
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| US11534403B2 (en) | 2022-12-27 |
| JP2020511443A (ja) | 2020-04-16 |
| US20200016075A1 (en) | 2020-01-16 |
| EP3372241A1 (en) | 2018-09-12 |
| US20230233463A1 (en) | 2023-07-27 |
| EP3592385B1 (en) | 2022-05-04 |
| EP3592385A1 (en) | 2020-01-15 |
| WO2018162503A1 (en) | 2018-09-13 |
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