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
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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 [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], 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)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (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)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Physical Education & Sports Medicine (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)
Claims (26)
1. Жидкая фармацевтическая композиция, содержащая:
(а) антитело к рецептору IL-6 (анти-IL-6R антитело);
(b) гистидиновый буфер;
(c) полиол;
(d) свободную аминокислоту;
(е) поверхностно-активное вещество;
(f) воду для инъекций; и
(g) необязательно соль,
причем композиция имеет рН от 5,5 до 7,5.
2. Жидкая фармацевтическая композиция по п.1, имеющая рН от 6,0 до 6,5.
3. Жидкая фармацевтическая композиция по любому из предшествующих пунктов, в которой полиол представляет собой маннит.
4. Жидкая фармацевтическая композиция по любому из предшествующих пунктов, в которой свободная аминокислота представляет собой метионин.
5. Жидкая фармацевтическая композиция по любому из предшествующих пунктов, в которой поверхностно-активное вещество представляет собой полисорбат.
6. Жидкая фармацевтическая композиция по п.5, в которой полисорбат представляет собой полисорбат 80.
7. Жидкая фармацевтическая композиция по любому из предшествующих пунктов, в которой необязательная соль представляет собой хлорид натрия.
8. Жидкая фармацевтическая композиция по любому из предшествующих пунктов, в которой анти-IL-6R антитело выбирают из группы, состоящей из тоцилизумаба, сапелизумаба, вобарилизумаба или сарилумаба.
9. Жидкая фармацевтическая композиция по любому из предшествующих пунктов, включающая:
от 15 до 200 мг/мл анти-IL-6R;
10 и 25 мМ гистидина (или системы гистидинового буфера);
от 190 до 210 мМ маннита;
от 0,4 до 0,6 мМ метионина;
от 0,4 до 0,9 мМ полисорбата 80;
воду (для инъекций);
от 75 до 125 мМ хлорида натрия.
10. Устройство для доставки лекарственного вещества, содержащее жидкую фармацевтическую композицию по любому из предшествующих пунктов.
11. Жидкая фармацевтическая композиция по любому из пп.1-9, предназначенная для лечения ревматоидного артрита, ювенильного идиопатического артрита, гигантоклеточного артериита или системного склероза.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16190957.7 | 2016-09-27 | ||
| EP16190957 | 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 (ru) | 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 (ru) |
| EP (1) | EP3518891A1 (ru) |
| JP (2) | JP2019534863A (ru) |
| KR (1) | KR102546471B1 (ru) |
| CN (1) | CN109862880A (ru) |
| AU (1) | AU2017333367A1 (ru) |
| BR (1) | BR112019005328A2 (ru) |
| CA (1) | CA3037440A1 (ru) |
| MA (1) | MA46334A (ru) |
| RU (1) | RU2019112680A (ru) |
| WO (1) | WO2018060210A1 (ru) |
| ZA (1) | ZA201901590B (ru) |
Families Citing this family (13)
| 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 |
| EP3351559A3 (en) | 2010-11-08 | 2018-10-31 | F. Hoffmann-La Roche AG | Subcutaneously administered anti-il-6 receptor antibody |
| 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 |
| US11427639B2 (en) * | 2018-04-02 | 2022-08-30 | Richter Gedeon Nyrt. | Antibody-containing aqueous formulation and use thereof |
| US20210393783A1 (en) * | 2018-10-31 | 2021-12-23 | Richter Gedeon Nyrt | Aqueous pharmaceutical formulations |
| 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 |
| US11365248B2 (en) * | 2020-06-29 | 2022-06-21 | 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 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK0628639T3 (da) | 1991-04-25 | 2000-01-24 | Chugai Pharmaceutical Co Ltd | Rekonstitueret humant antistof mod 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 |
| RU2335299C2 (ru) | 2002-02-14 | 2008-10-10 | Чугаи Сейяку Кабусики Кайся | Препараты в форме растворов, содержащие антитела |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| CN102301235B (zh) * | 2008-11-28 | 2014-11-19 | Abbvie公司 | 稳定的抗体组合物和用于稳定其的方法 |
| EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
| KR101468271B1 (ko) * | 2009-03-19 | 2014-12-03 | 추가이 세이야쿠 가부시키가이샤 | 개량된 항체분자를 함유하는 의약 제제 |
| AU2010320515B2 (en) * | 2009-11-20 | 2013-05-02 | Biocon Limited | Formulations of antibody |
| EP2519262A2 (en) * | 2009-12-29 | 2012-11-07 | F. Hoffmann-La Roche AG | Antibody formulation |
| JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| EP3351559A3 (en) * | 2010-11-08 | 2018-10-31 | F. Hoffmann-La Roche AG | Subcutaneously administered anti-il-6 receptor antibody |
| UY34105A (es) * | 2011-06-03 | 2012-07-31 | Lg Life Sciences Ltd | Formulación líquida estable de etanercept |
| KR101759694B1 (ko) | 2011-10-28 | 2017-07-19 | 인테그리티 바이오, 아이엔씨. | 아미노산을 함유하는 단백질 제제 |
| MX2015004668A (es) | 2012-10-25 | 2015-07-23 | Medimmune Llc | Formulacion estable de anticuerpos de baja viscosidad. |
| 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 |
| 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 |
| CN117858722A (zh) * | 2021-08-18 | 2024-04-09 | 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 |
-
2017
- 2017-09-26 MA MA046334A patent/MA46334A/fr unknown
- 2017-09-26 BR BR112019005328A patent/BR112019005328A2/pt not_active Application Discontinuation
- 2017-09-26 RU RU2019112680A patent/RU2019112680A/ru unknown
- 2017-09-26 CN CN201780059493.8A patent/CN109862880A/zh active Pending
- 2017-09-26 EP EP17780054.7A patent/EP3518891A1/en active Pending
- 2017-09-26 WO PCT/EP2017/074413 patent/WO2018060210A1/en unknown
- 2017-09-26 AU AU2017333367A patent/AU2017333367A1/en not_active Abandoned
- 2017-09-26 CA CA3037440A patent/CA3037440A1/en active Pending
- 2017-09-26 JP JP2019515630A patent/JP2019534863A/ja active Pending
- 2017-09-26 US US16/334,310 patent/US10961314B2/en active Active
- 2017-09-26 KR KR1020197010731A patent/KR102546471B1/ko active IP Right Grant
-
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
Also Published As
| Publication number | Publication date |
|---|---|
| CA3037440A1 (en) | 2018-04-05 |
| JP2022188075A (ja) | 2022-12-20 |
| US20210261673A1 (en) | 2021-08-26 |
| KR102546471B1 (ko) | 2023-06-21 |
| ZA201901590B (en) | 2020-10-28 |
| RU2019112680A3 (ru) | 2020-12-15 |
| MA46334A (fr) | 2019-08-07 |
| US20190218300A1 (en) | 2019-07-18 |
| US10961314B2 (en) | 2021-03-30 |
| AU2017333367A1 (en) | 2019-04-04 |
| US20240150479A1 (en) | 2024-05-09 |
| KR20190062440A (ko) | 2019-06-05 |
| WO2018060210A1 (en) | 2018-04-05 |
| BR112019005328A2 (pt) | 2019-06-18 |
| CN109862880A (zh) | 2019-06-07 |
| EP3518891A1 (en) | 2019-08-07 |
| JP2019534863A (ja) | 2019-12-05 |
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