HRP20241526T1 - Stabilni višedozni pripravci, koji sadrže protutijelo i konzervans - Google Patents
Stabilni višedozni pripravci, koji sadrže protutijelo i konzervans Download PDFInfo
- Publication number
- HRP20241526T1 HRP20241526T1 HRP20241526TT HRP20241526T HRP20241526T1 HR P20241526 T1 HRP20241526 T1 HR P20241526T1 HR P20241526T T HRP20241526T T HR P20241526TT HR P20241526 T HRP20241526 T HR P20241526T HR P20241526 T1 HRP20241526 T1 HR P20241526T1
- Authority
- HR
- Croatia
- Prior art keywords
- composition according
- stable
- antibody
- salt
- chloride
- 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
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
-
- 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
- A61K47/26—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
- A61K9/0012—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
- A61K9/08—Solutions
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- 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
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10164298 | 2010-05-28 | ||
| US35152210P | 2010-06-04 | 2010-06-04 | |
| EP11721544.2A EP2575761B1 (en) | 2010-05-28 | 2011-05-26 | Stable multi-dose compositions comprising an antibody and a preservative |
| PCT/EP2011/058648 WO2011147921A1 (en) | 2010-05-28 | 2011-05-26 | Stable multi-dose compositions comprising an antibody and a preservative |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20241526T1 true HRP20241526T1 (hr) | 2025-01-03 |
Family
ID=42562357
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20241526TT HRP20241526T1 (hr) | 2010-05-28 | 2011-05-26 | Stabilni višedozni pripravci, koji sadrže protutijelo i konzervans |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US20130136733A1 (https=) |
| EP (1) | EP2575761B1 (https=) |
| JP (3) | JP6294075B2 (https=) |
| KR (1) | KR20130086144A (https=) |
| CN (2) | CN105055306B (https=) |
| AU (1) | AU2011257219B2 (https=) |
| BR (1) | BR112012030139A2 (https=) |
| CA (1) | CA2800188A1 (https=) |
| ES (1) | ES2993022T3 (https=) |
| HR (1) | HRP20241526T1 (https=) |
| MX (1) | MX2012013586A (https=) |
| RS (1) | RS66182B1 (https=) |
| RU (1) | RU2012153786A (https=) |
| WO (1) | WO2011147921A1 (https=) |
Families Citing this family (30)
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| EP2371861B1 (en) | 2002-01-25 | 2017-08-09 | Novo Nordisk A/S | Monoclonal antibodies against extracellular loops of C5aR |
| EP2254911B1 (en) | 2008-02-20 | 2015-11-25 | Novo Nordisk A/S | Humanized anti-c5ar antibodies |
| RU2011101969A (ru) | 2008-06-30 | 2012-08-10 | Ново Нордиск А/С (DK) | Антитела к человеческому интерлейкину-20 |
| US8454956B2 (en) | 2009-08-31 | 2013-06-04 | National Cheng Kung University | Methods for treating rheumatoid arthritis and osteoporosis with anti-IL-20 antibodies |
| BR112012021576A2 (pt) * | 2010-02-26 | 2016-10-25 | Novo Nordisk As | composições estáveis contendo anticorpo. |
| HUE047173T2 (hu) | 2010-03-01 | 2020-04-28 | Bayer Healthcare Llc | Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen |
| RU2012153786A (ru) * | 2010-05-28 | 2014-07-10 | Ново Нордиск А/С | Стабильные многодозовые композиции, содержащие антитело и консервант |
| PL2718322T3 (pl) | 2011-06-06 | 2019-07-31 | Novo Nordisk A/S | Lecznicze przeciwciała |
| CA2864539C (en) * | 2012-02-16 | 2022-06-07 | Santarus, Inc. | Antibody formulations |
| ES2702246T3 (es) * | 2012-03-26 | 2019-02-28 | Sanofi Sa | Formulaciones de agente de unión IgG4 estables |
| US9592289B2 (en) | 2012-03-26 | 2017-03-14 | Sanofi | Stable IgG4 based binding agent formulations |
| US20140004131A1 (en) * | 2012-05-04 | 2014-01-02 | Novartis Ag | Antibody formulation |
| US9221904B2 (en) | 2012-07-19 | 2015-12-29 | National Cheng Kung University | Treatment of osteoarthritis using IL-20 antagonists |
| US8603470B1 (en) | 2012-08-07 | 2013-12-10 | National Cheng Kung University | Use of IL-20 antagonists for treating liver diseases |
| US8852588B2 (en) | 2012-08-07 | 2014-10-07 | National Cheng Kung University | Treating allergic airway disorders using anti-IL-20 receptor antibodies |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| TWI694836B (zh) | 2014-05-16 | 2020-06-01 | 英商葛蘭素史克智慧財產管理有限公司 | 抗體調配物 |
| JP6664467B2 (ja) | 2015-08-19 | 2020-03-13 | ファイザー・インク | 組織因子経路インヒビター抗体およびその使用 |
| MX2019013142A (es) * | 2017-05-05 | 2019-12-16 | Amgen Inc | Composicion farmaceutica que comprende construcciones de anticuerpos biespecificas para mejorar el almacenamiento y la administracion. |
| US20200113912A1 (en) | 2018-09-12 | 2020-04-16 | Silverback Therapeutics, Inc. | Methods and Compositions for the Treatment of Disease with Immune Stimulatory Conjugates |
| KR102337683B1 (ko) * | 2018-09-21 | 2021-12-13 | 주식회사 녹십자 | 고효율 항-tfpi 항체 조성물 |
| MX2021015533A (es) | 2019-06-19 | 2022-02-10 | Silverback Therapeutics Inc | Anticuerpos anti-mesotelina e inmunoconjugados de los mismos. |
| BR112022007635A2 (pt) * | 2019-11-13 | 2022-07-12 | Pfizer | Formulação aquosa e estável de anticorpos |
| JP7735291B2 (ja) | 2020-02-21 | 2025-09-08 | エーアールエス ファーマシューティカルズ、インコーポレイテッド | ネクチン－４抗体コンジュゲートおよびその使用 |
| JP2023532304A (ja) | 2020-07-01 | 2023-07-27 | エーアールエス ファーマシューティカルズ オペレーションズ，インク． | 抗ａｓｇｒ１抗体コンジュゲートおよびその使用 |
| AU2021324314A1 (en) | 2020-08-12 | 2023-05-25 | Innate Pharma | Subcutaneous anti-c5ar antagonist treatment regimen with avdoralimab |
| EP4216923A1 (en) * | 2020-09-24 | 2023-08-02 | Novo Nordisk Health Care AG | Pharmaceutical formulation of concizumab and method of production thereof |
| CN112244025A (zh) * | 2020-11-27 | 2021-01-22 | 上海创宏生物科技有限公司 | 大分子蛋白和/或核酸用无菌处理剂及其制备方法和应用 |
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| EP4704808A1 (en) * | 2023-05-01 | 2026-03-11 | Regeneron Pharmaceuticals, Inc. | Multidose antibody drug products using phenol or benzyl alcohol |
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-
2011
- 2011-05-26 RU RU2012153786/10A patent/RU2012153786A/ru unknown
- 2011-05-26 BR BR112012030139A patent/BR112012030139A2/pt not_active IP Right Cessation
- 2011-05-26 JP JP2013511686A patent/JP6294075B2/ja active Active
- 2011-05-26 US US13/699,847 patent/US20130136733A1/en not_active Abandoned
- 2011-05-26 RS RS20241258A patent/RS66182B1/sr unknown
- 2011-05-26 MX MX2012013586A patent/MX2012013586A/es unknown
- 2011-05-26 CN CN201510485529.1A patent/CN105055306B/zh active Active
- 2011-05-26 WO PCT/EP2011/058648 patent/WO2011147921A1/en not_active Ceased
- 2011-05-26 HR HRP20241526TT patent/HRP20241526T1/hr unknown
- 2011-05-26 EP EP11721544.2A patent/EP2575761B1/en active Active
- 2011-05-26 AU AU2011257219A patent/AU2011257219B2/en not_active Withdrawn - After Issue
- 2011-05-26 KR KR1020127030515A patent/KR20130086144A/ko not_active Withdrawn
- 2011-05-26 CA CA2800188A patent/CA2800188A1/en not_active Withdrawn
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- 2011-05-26 ES ES11721544T patent/ES2993022T3/es active Active
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2016
- 2016-02-09 JP JP2016022657A patent/JP6239657B2/ja active Active
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- 2017-11-01 JP JP2017211614A patent/JP6568917B2/ja active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN105055306A (zh) | 2015-11-18 |
| AU2011257219B2 (en) | 2014-12-04 |
| CN102905692A (zh) | 2013-01-30 |
| MX2012013586A (es) | 2013-01-24 |
| JP2013527189A (ja) | 2013-06-27 |
| KR20130086144A (ko) | 2013-07-31 |
| JP6239657B2 (ja) | 2017-11-29 |
| JP2018030879A (ja) | 2018-03-01 |
| AU2011257219A1 (en) | 2012-11-22 |
| EP2575761A1 (en) | 2013-04-10 |
| US20130136733A1 (en) | 2013-05-30 |
| ES2993022T3 (en) | 2024-12-20 |
| BR112012030139A2 (pt) | 2017-06-13 |
| RU2012153786A (ru) | 2014-07-10 |
| CN102905692B (zh) | 2015-09-16 |
| JP6568917B2 (ja) | 2019-08-28 |
| US10835602B2 (en) | 2020-11-17 |
| WO2011147921A1 (en) | 2011-12-01 |
| US20180104335A1 (en) | 2018-04-19 |
| RS66182B1 (sr) | 2024-12-31 |
| JP2016084367A (ja) | 2016-05-19 |
| CA2800188A1 (en) | 2011-12-01 |
| EP2575761C0 (en) | 2024-08-14 |
| JP6294075B2 (ja) | 2018-03-14 |
| EP2575761B1 (en) | 2024-08-14 |
| CN105055306B (zh) | 2019-10-01 |
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