AR107708A1 - Formulaciones de antagonista de il-6 y sus usos - Google Patents
Formulaciones de antagonista de il-6 y sus usosInfo
- Publication number
- AR107708A1 AR107708A1 ARP170100456A ARP170100456A AR107708A1 AR 107708 A1 AR107708 A1 AR 107708A1 AR P170100456 A ARP170100456 A AR P170100456A AR P170100456 A ARP170100456 A AR P170100456A AR 107708 A1 AR107708 A1 AR 107708A1
- Authority
- AR
- Argentina
- Prior art keywords
- seq
- sequence
- formulation
- antibody
- container
- Prior art date
Links
Classifications
-
- 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
- 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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
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- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
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- 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
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- 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
- A61K9/0048—Eye, e.g. artificial tears
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/14—Decongestants or antiallergics
-
- 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- 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
- C07K16/244—Interleukins [IL]
- C07K16/248—IL-6
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Ophthalmology & Optometry (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Dermatology (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
Abstract
Se caracterizan en la presente composiciones farmacéuticas y formulaciones que contienen un antagonista de interleuquina 6 (IL-6), por ejemplo, una molécula de anticuerpo de IL-6, diseñado para administrar a un sujeto. Las composiciones farmacéuticas y formulaciones proporcionadas en la presente son apropiadas para usar en la fabricación de medicamentos o métodos de tratamiento de sujetos con enfermedades asociadas con IL-6, por ejemplo, enfermedades oculares asociadas con niveles elevados de IL-6. Reivindicación 1: Una formulación farmacéutica que comprende 1 - 100 mg/mL de un anticuerpo anti-IL-6 o su fragmento; 10 - 50 mM de histidina; 0,01% - 0,1% de polisorbato-20 (Tween-20), polisorbato-80 (Tween-80) o poloxámero 188; 1 - 150 mM de cloruro de sodio; y 1 - 10% de sorbitol; y en donde el pH de la formulación esta entre 5,5 y 7,5. Reivindicación 5: La formulación de acuerdo con cualquiera de las reivindicaciones 1 - 4, en donde el anticuerpo de IL-6 o su fragmento comprende una VH CDR1 que comprende la secuencia de SEQ ID Nº 19, una VH CDR2 que comprende la secuencia de SEQ ID Nº 20 y una VH CDR3 que comprende la secuencia de SEQ ID Nº 21. Reivindicación 6: La formulación de acuerdo con cualquiera de las reivindicaciones 1 - 5, en donde el anticuerpo de IL-6 o su fragmento también comprende una VL CDR1 que comprende la secuencia de SEQ ID Nº 22, una VL CDR2 que comprende la secuencia de SEQ ID Nº 23 y una VL CDR3 que comprende la secuencia de SEQ ID Nº 21. Reivindicación 42: La formulación de acuerdo con cualquiera de las reivindicaciones 1 - 41, en donde la formulación es apropiada para administración por vía intravítrea, intraocular o subconjuntival. Reivindicación 44: La formulación de acuerdo con cualquiera de las reivindicaciones 1 - 42, en donde la formulación es estable a una temperatura entre 2 a 8ºC durante al menos 6 meses. Reivindicación 47: El recipiente de acuerdo con cualquier reivindicación 45 ó 46, en donde el recipiente es un recipiente multidosis. Reivindicación 49: Un kit que comprende un recipiente o dispositivo que comprende la formulación de acuerdo con cualquiera de las reivindicaciones 1 a 44 y opcionalmente instrucciones para el uso.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662298774P | 2016-02-23 | 2016-02-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR107708A1 true AR107708A1 (es) | 2018-05-23 |
Family
ID=59685584
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP170100456A AR107708A1 (es) | 2016-02-23 | 2017-02-23 | Formulaciones de antagonista de il-6 y sus usos |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20190046642A1 (es) |
| EP (1) | EP3419599A4 (es) |
| JP (2) | JP2019510078A (es) |
| KR (1) | KR20180116359A (es) |
| CN (1) | CN108718522A (es) |
| AR (1) | AR107708A1 (es) |
| AU (1) | AU2017223687A1 (es) |
| BR (1) | BR112018017031A2 (es) |
| CA (1) | CA3012350A1 (es) |
| MX (1) | MX2018010032A (es) |
| WO (1) | WO2017147293A1 (es) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109350740B (zh) * | 2017-11-30 | 2023-06-20 | 百奥泰生物制药股份有限公司 | 一种治疗il-6相关疾病的人源化抗体的液体制剂 |
| CN112739378A (zh) * | 2018-09-14 | 2021-04-30 | 田边三菱制药株式会社 | 含有人抗il-33单克隆抗体的医药用组合物 |
| MA54095A (fr) * | 2018-10-31 | 2022-02-09 | Richter Gedeon Nyrt | Formulations pharmaceutiques aqueuses |
| EP4188544A1 (en) * | 2020-07-31 | 2023-06-07 | Alamab Therapeutics, Inc. | Anti-connexin antibody formulations |
| WO2022037606A1 (en) * | 2020-08-19 | 2022-02-24 | Bio-Thera Solutions, Ltd. | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
| KR20220028972A (ko) * | 2020-08-31 | 2022-03-08 | (주)셀트리온 | 안정한 약제학적 제제 |
| US20230073821A1 (en) * | 2021-08-27 | 2023-03-09 | International Business Machines Corporation | Antigen-binding proteins targeting coronavirus (cov) variants |
| CN116355825A (zh) * | 2022-02-25 | 2023-06-30 | 南京工业大学 | 一种强化纤维素合成来提高人表皮生长因子分泌生产效率的方法 |
| WO2024073718A1 (en) * | 2022-09-30 | 2024-04-04 | Sonnet BioTherapeutics, Inc. | Low dose il-6 formulations and methods of use thereof |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| AU2003293543A1 (en) * | 2002-12-13 | 2004-07-09 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| ES2657485T3 (es) * | 2007-09-14 | 2018-03-05 | Sanofi Pasteur Biologics, Llc | Composiciones farmacéuticas que contienen toxoides A y B de Clostridium difficile |
| WO2010039750A2 (en) * | 2008-10-01 | 2010-04-08 | Monsanto Technology Llc | Transgenic plants with enhanced agronomic traits |
| US8992920B2 (en) * | 2008-11-25 | 2015-03-31 | Alderbio Holdings Llc | Anti-IL-6 antibodies for the treatment of arthritis |
| RU2650594C1 (ru) * | 2009-01-29 | 2018-04-17 | Медиммун, Ллк | Человеческие анти-il-6 антитела с пролонгированным периодом выведения in vivo и их применение при лечении онкологических, аутоиммунных заболеваний и воспалительных заболеваний |
| JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| JP5913307B2 (ja) * | 2010-07-12 | 2016-04-27 | コヴェックス・テクノロジーズ・アイルランド・リミテッド | 多機能性抗体複合体 |
| US20140371427A1 (en) * | 2011-12-07 | 2014-12-18 | Amgen Inc. | IgG2 DISULFIDE ISOFORM SEPARATION |
| EA201492289A1 (ru) * | 2012-06-01 | 2015-05-29 | Офтотек Корпорейшн | Композиции, содержащие аптамер против pdgf и антагонист vegf |
| JP6463268B2 (ja) * | 2012-09-07 | 2019-01-30 | 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 |
| BR112015008186A2 (pt) * | 2012-10-25 | 2017-09-19 | Medimmune Llc | formulação de um anticorpo estável e de baixa viscosidade |
| EP3489258A1 (en) * | 2012-11-08 | 2019-05-29 | Eleven Biotherapeutics, Inc. | Il-6 antagonists and uses thereof |
| EP3628373A1 (en) * | 2013-07-12 | 2020-04-01 | IVERIC bio, Inc. | Methods for treating or preventing opthalmological conditions |
| EP2898896A1 (en) * | 2014-01-22 | 2015-07-29 | Université Pierre et Marie Curie (Paris 6) | Agents for use in the treatment of retinal inflammation |
-
2017
- 2017-02-23 EP EP17757207.0A patent/EP3419599A4/en active Pending
- 2017-02-23 MX MX2018010032A patent/MX2018010032A/es unknown
- 2017-02-23 BR BR112018017031A patent/BR112018017031A2/pt not_active IP Right Cessation
- 2017-02-23 JP JP2018563405A patent/JP2019510078A/ja active Pending
- 2017-02-23 AU AU2017223687A patent/AU2017223687A1/en not_active Abandoned
- 2017-02-23 WO PCT/US2017/019131 patent/WO2017147293A1/en active Application Filing
- 2017-02-23 AR ARP170100456A patent/AR107708A1/es unknown
- 2017-02-23 CA CA3012350A patent/CA3012350A1/en not_active Abandoned
- 2017-02-23 KR KR1020187027338A patent/KR20180116359A/ko unknown
- 2017-02-23 CN CN201780013039.9A patent/CN108718522A/zh active Pending
- 2017-02-23 US US16/078,671 patent/US20190046642A1/en not_active Abandoned
-
2022
- 2022-03-31 JP JP2022058898A patent/JP2022084922A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| WO2017147293A1 (en) | 2017-08-31 |
| KR20180116359A (ko) | 2018-10-24 |
| JP2019510078A (ja) | 2019-04-11 |
| CA3012350A1 (en) | 2017-08-31 |
| US20220241414A1 (en) | 2022-08-04 |
| CN108718522A (zh) | 2018-10-30 |
| US20190046642A1 (en) | 2019-02-14 |
| BR112018017031A2 (pt) | 2019-01-22 |
| JP2022084922A (ja) | 2022-06-07 |
| AU2017223687A1 (en) | 2018-08-09 |
| EP3419599A4 (en) | 2019-09-11 |
| MX2018010032A (es) | 2019-03-11 |
| EP3419599A1 (en) | 2019-01-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |