CN109862880A - 液体药物组合物 - Google Patents

液体药物组合物 Download PDF

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Publication number
CN109862880A
CN109862880A CN201780059493.8A CN201780059493A CN109862880A CN 109862880 A CN109862880 A CN 109862880A CN 201780059493 A CN201780059493 A CN 201780059493A CN 109862880 A CN109862880 A CN 109862880A
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CN
China
Prior art keywords
composition
liquid medicine
antibody
monoclonal antibody
ser
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.)
Pending
Application number
CN201780059493.8A
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English (en)
Chinese (zh)
Inventor
阿莱桑德拉·德尔·里奥
卡梅拉·萨比娜
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of CN109862880A publication Critical patent/CN109862880A/zh
Pending legal-status Critical Current

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    • 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
    • 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
    • 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
    • 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
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (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)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
CN201780059493.8A 2016-09-27 2017-09-26 液体药物组合物 Pending CN109862880A (zh)

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 (1)

Publication Number Publication Date
CN109862880A true CN109862880A (zh) 2019-06-07

Family

ID=57047015

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201780059493.8A Pending CN109862880A (zh) 2016-09-27 2017-09-26 液体药物组合物

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=)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN116157115A (zh) * 2020-08-31 2023-05-23 赛特瑞恩股份有限公司 稳定的药物制剂
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

Families Citing this family (16)

* Cited by examiner, † Cited by third party
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PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
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
US10961314B2 (en) * 2016-09-27 2021-03-30 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
BR112020010761A2 (pt) * 2017-11-30 2020-11-24 Bio-Thera Solutions, Ltd. formulação líquida de anticorpo humanizado para o tratamento de doenças relacionadas à il-6
US11427639B2 (en) * 2018-04-02 2022-08-30 Richter Gedeon Nyrt. Antibody-containing aqueous formulation and use thereof
KR102917813B1 (ko) * 2018-10-31 2026-01-26 리히터 게데온 닐트. 수성 약학 제제
AU2020214796A1 (en) 2019-01-30 2021-07-29 Truebinding, 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
WO2021242776A2 (en) * 2020-05-26 2021-12-02 Truebinding, Inc. Methods of treating inflammatory diseases by blocking galectin-3
RU2745814C1 (ru) * 2020-06-05 2021-04-01 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция левилимаба и ее применение
US11365248B2 (en) * 2020-06-29 2022-06-21 Anovent Pharmaceutical (U.S.), Llc Formulation of tocilizumab and method for treating COVID-19 by inhalation
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

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010062896A1 (en) * 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
WO2012064627A2 (en) * 2010-11-08 2012-05-18 Genentech, Inc. Subcutaneously administered anti-il-6 receptor antibody
CN102869346A (zh) * 2010-01-08 2013-01-09 瑞泽恩制药公司 含有抗白介素-6受体(il-6r)的抗体的稳定制剂

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EP0628639B1 (en) 1991-04-25 1999-06-23 Chugai Seiyaku Kabushiki Kaisha Reconstituted human antibody against human interleukin 6 receptor
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
AU2003211990A1 (en) 2002-02-14 2003-09-04 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution pharmaceuticals
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
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
JP4885308B2 (ja) * 2009-03-19 2012-02-29 中外製薬株式会社 改良された抗体分子を含有する製剤
AU2010320515B2 (en) * 2009-11-20 2013-05-02 Biocon Limited Formulations of antibody
MX2012007676A (es) * 2009-12-29 2012-08-03 Hoffmann La Roche Nueva formulacion de anticuerpo.
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
US20150239970A1 (en) 2012-10-25 2015-08-27 Medimmune, Llc Stable, Low Viscosity Antibody Formulation
US10961314B2 (en) * 2016-09-27 2021-03-30 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody
BR112020010761A2 (pt) * 2017-11-30 2020-11-24 Bio-Thera Solutions, Ltd. formulação líquida de anticorpo humanizado para o tratamento de doenças relacionadas à il-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
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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010062896A1 (en) * 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
CN102869346A (zh) * 2010-01-08 2013-01-09 瑞泽恩制药公司 含有抗白介素-6受体(il-6r)的抗体的稳定制剂
WO2012064627A2 (en) * 2010-11-08 2012-05-18 Genentech, Inc. Subcutaneously administered anti-il-6 receptor antibody
US20120301460A1 (en) * 2010-11-08 2012-11-29 Hoffmann-La Roche, Inc. Subcutaneously administered anti-il-6 receptor antibody

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
CN116157115A (zh) * 2020-08-31 2023-05-23 赛特瑞恩股份有限公司 稳定的药物制剂

Also Published As

Publication number Publication date
JP2024178197A (ja) 2024-12-24
US20240150479A1 (en) 2024-05-09
MA46334A (fr) 2019-08-07
EP3518891A1 (en) 2019-08-07
CA3037440A1 (en) 2018-04-05
WO2018060210A1 (en) 2018-04-05
ZA201901590B (en) 2020-10-28
RU2019112680A3 (https=) 2020-12-15
KR20190062440A (ko) 2019-06-05
US20210261673A1 (en) 2021-08-26
BR112019005328A2 (pt) 2019-06-18
AU2017333367A1 (en) 2019-04-04
JP2022188075A (ja) 2022-12-20
RU2019112680A (ru) 2020-10-29
JP2019534863A (ja) 2019-12-05
KR102546471B1 (ko) 2023-06-21
US20190218300A1 (en) 2019-07-18
US10961314B2 (en) 2021-03-30

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