RU2019112680A - Жидкая фармацевтическая композиция - Google Patents
Жидкая фармацевтическая композиция Download PDFInfo
- Publication number
- RU2019112680A RU2019112680A RU2019112680A RU2019112680A RU2019112680A RU 2019112680 A RU2019112680 A RU 2019112680A RU 2019112680 A RU2019112680 A RU 2019112680A RU 2019112680 A RU2019112680 A RU 2019112680A RU 2019112680 A RU2019112680 A RU 2019112680A
- Authority
- RU
- Russia
- Prior art keywords
- pharmaceutical composition
- liquid pharmaceutical
- composition according
- polysorbate
- antibody
- Prior art date
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
- A61K9/08—Solutions
-
- 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
- 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
- A61K47/02—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
- A61K47/16—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
- A61K47/22—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
-
- 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
- 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
- A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
-
- 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
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- 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
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
-
- 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)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Rheumatology (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Physical Education & Sports Medicine (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Inorganic Chemistry (AREA)
- Endocrinology (AREA)
- Neurology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16190957 | 2016-09-27 | ||
| EP16190957.7 | 2016-09-27 | ||
| PCT/EP2017/074413 WO2018060210A1 (en) | 2016-09-27 | 2017-09-26 | Liquid pharmaceutical composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2019112680A true RU2019112680A (ru) | 2020-10-29 |
| RU2019112680A3 RU2019112680A3 (https=) | 2020-12-15 |
Family
ID=57047015
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2019112680A RU2019112680A (ru) | 2016-09-27 | 2017-09-26 | Жидкая фармацевтическая композиция |
Country Status (12)
| Country | Link |
|---|---|
| US (3) | US10961314B2 (https=) |
| EP (1) | EP3518891A1 (https=) |
| JP (3) | JP2019534863A (https=) |
| KR (1) | KR102546471B1 (https=) |
| CN (1) | CN109862880A (https=) |
| AU (1) | AU2017333367A1 (https=) |
| BR (1) | BR112019005328A2 (https=) |
| CA (1) | CA3037440A1 (https=) |
| MA (1) | MA46334A (https=) |
| RU (1) | RU2019112680A (https=) |
| WO (1) | WO2018060210A1 (https=) |
| ZA (1) | ZA201901590B (https=) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| KR20190120439A (ko) | 2010-11-08 | 2019-10-23 | 제넨테크, 인크. | 피하 투여용 항―ｉｌ―6 수용체 항체 |
| KR102546471B1 (ko) * | 2016-09-27 | 2023-06-21 | 프레제니우스 카비 도이치란트 게엠베하 | 액상의 약학 조성물 |
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| RU2020121415A (ru) * | 2017-11-30 | 2021-12-30 | Био-Тера Солюшнз, Лтд. | Жидкий препарат гуманизированного антитела для лечения заболеваний, опосредованных ил-6 |
| US11427639B2 (en) * | 2018-04-02 | 2022-08-30 | Richter Gedeon Nyrt. | Antibody-containing aqueous formulation and use thereof |
| MA54095A (fr) * | 2018-10-31 | 2022-02-09 | Richter Gedeon Nyrt | Formulations pharmaceutiques aqueuses |
| WO2020160156A2 (en) | 2019-01-30 | 2020-08-06 | Immutics, Inc. | Anti-gal3 antibodies and uses thereof |
| CN110179746A (zh) * | 2019-05-17 | 2019-08-30 | 通化东宝生物科技有限公司 | 一种稳定的苏金单抗注射剂及其制备方法 |
| EP3714902B1 (en) * | 2020-03-13 | 2024-08-28 | LEK Pharmaceuticals d.d. | Stabilization of pharmaceutical compositions comprising polysorbate |
| CN113456582B (zh) * | 2020-03-30 | 2024-06-14 | 鲁南制药集团股份有限公司 | 重组人源化抗pd-1单克隆抗体的液体制剂 |
| CN115605184A (zh) * | 2020-05-15 | 2023-01-13 | 豪夫迈·罗氏有限公司（Ch） | 防止胃肠外蛋白质溶液中的可见颗粒形成 |
| EP4157338A4 (en) * | 2020-05-26 | 2024-11-13 | TrueBinding, Inc. | METHOD FOR TREATING INFLAMMATORY DISEASES BY GALECTIN-3 BLOCKING |
| RU2745814C1 (ru) * | 2020-06-05 | 2021-04-01 | Закрытое Акционерное Общество "Биокад" | Водная фармацевтическая композиция левилимаба и ее применение |
| WO2022006051A1 (en) * | 2020-06-29 | 2022-01-06 | Anovent Pharmaceutical (U.S.), Llc | Formulation of tocilizumab and method for treating covid-19 by inhalation |
| CN116261448A (zh) * | 2020-08-19 | 2023-06-13 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
| KR20220028972A (ko) * | 2020-08-31 | 2022-03-08 | (주)셀트리온 | 안정한 약제학적 제제 |
| WO2022139457A1 (ko) * | 2020-12-24 | 2022-06-30 | 이니스트에스티 주식회사 | 봉독 추출물로부터 bvPLA2를 50~99% 함량으로 포함하는 봉독 주사제 조성물 및 이의 제조방법 |
| CN121240883A (zh) * | 2023-05-26 | 2025-12-30 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5795965A (en) | 1991-04-25 | 1998-08-18 | Chugai Seiyaku Kabushiki Kaisha | Reshaped human to human interleukin-6 receptor |
| JP5485489B2 (ja) | 2000-08-11 | 2014-05-07 | 中外製薬株式会社 | 抗体含有安定化製剤 |
| CN101721362B (zh) | 2002-02-14 | 2018-07-03 | 中外制药株式会社 | 包含抗体的溶液制剂 |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| RU2011126338A (ru) * | 2008-11-28 | 2013-01-10 | Эбботт Лэборетриз | Стабильные композиции антител и способы их стабилизации |
| EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
| CN104119438A (zh) * | 2009-01-29 | 2014-10-29 | 米迪缪尼有限公司 | 延长体内半衰期的人抗il-6抗体及其在治疗肿瘤、自身免疫性疾病和炎症性疾病中的应用 |
| WO2010106812A1 (en) * | 2009-03-19 | 2010-09-23 | Chugai Seiyaku Kabushiki Kaisha | Pharmaceutical formulation containing improved antibody molecules |
| EP2501408B1 (en) * | 2009-11-20 | 2020-05-27 | Biocon Limited | Formulations of antibody |
| BR112012013148A2 (pt) * | 2009-12-29 | 2017-03-21 | F Hoffmann - La Roche Ag | formulação farmacêutica e uso |
| JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| KR20190120439A (ko) * | 2010-11-08 | 2019-10-23 | 제넨테크, 인크. | 피하 투여용 항―ｉｌ―6 수용체 항체 |
| UY34105A (es) * | 2011-06-03 | 2012-07-31 | Lg Life Sciences Ltd | Formulación líquida estable de etanercept |
| CN108771655A (zh) | 2011-10-28 | 2018-11-09 | 诚信生物公司 | 含有氨基酸的蛋白质制剂 |
| CN104768578A (zh) | 2012-10-25 | 2015-07-08 | 米迪缪尼有限公司 | 稳定的低粘度抗体配制品 |
| KR102546471B1 (ko) * | 2016-09-27 | 2023-06-21 | 프레제니우스 카비 도이치란트 게엠베하 | 액상의 약학 조성물 |
| RU2020121415A (ru) * | 2017-11-30 | 2021-12-30 | Био-Тера Солюшнз, Лтд. | Жидкий препарат гуманизированного антитела для лечения заболеваний, опосредованных ил-6 |
| CN116261448A (zh) * | 2020-08-19 | 2023-06-13 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
| WO2023020563A1 (en) * | 2021-08-18 | 2023-02-23 | Bio-Thera Solutions, Ltd. | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
-
2017
- 2017-09-26 KR KR1020197010731A patent/KR102546471B1/ko active Active
- 2017-09-26 CA CA3037440A patent/CA3037440A1/en active Pending
- 2017-09-26 WO PCT/EP2017/074413 patent/WO2018060210A1/en not_active Ceased
- 2017-09-26 BR BR112019005328A patent/BR112019005328A2/pt not_active Application Discontinuation
- 2017-09-26 AU AU2017333367A patent/AU2017333367A1/en not_active Abandoned
- 2017-09-26 MA MA046334A patent/MA46334A/fr unknown
- 2017-09-26 EP EP17780054.7A patent/EP3518891A1/en active Pending
- 2017-09-26 CN CN201780059493.8A patent/CN109862880A/zh active Pending
- 2017-09-26 US US16/334,310 patent/US10961314B2/en active Active
- 2017-09-26 RU RU2019112680A patent/RU2019112680A/ru unknown
- 2017-09-26 JP JP2019515630A patent/JP2019534863A/ja active Pending
-
2019
- 2019-03-14 ZA ZA2019/01590A patent/ZA201901590B/en unknown
-
2021
- 2021-02-22 US US17/181,829 patent/US20210261673A1/en not_active Abandoned
-
2022
- 2022-09-15 JP JP2022146770A patent/JP2022188075A/ja active Pending
-
2023
- 2023-10-25 US US18/494,630 patent/US20240150479A1/en active Pending
-
2024
- 2024-08-30 JP JP2024148123A patent/JP2024178197A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US20240150479A1 (en) | 2024-05-09 |
| JP2019534863A (ja) | 2019-12-05 |
| BR112019005328A2 (pt) | 2019-06-18 |
| US10961314B2 (en) | 2021-03-30 |
| WO2018060210A1 (en) | 2018-04-05 |
| US20190218300A1 (en) | 2019-07-18 |
| AU2017333367A1 (en) | 2019-04-04 |
| CN109862880A (zh) | 2019-06-07 |
| JP2022188075A (ja) | 2022-12-20 |
| EP3518891A1 (en) | 2019-08-07 |
| JP2024178197A (ja) | 2024-12-24 |
| RU2019112680A3 (https=) | 2020-12-15 |
| CA3037440A1 (en) | 2018-04-05 |
| KR102546471B1 (ko) | 2023-06-21 |
| MA46334A (fr) | 2019-08-07 |
| ZA201901590B (en) | 2020-10-28 |
| KR20190062440A (ko) | 2019-06-05 |
| US20210261673A1 (en) | 2021-08-26 |
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