RU2019112680A - Жидкая фармацевтическая композиция - Google Patents

Жидкая фармацевтическая композиция Download PDF

Info

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
Application number
RU2019112680A
Other languages
English (en)
Russian (ru)
Other versions
RU2019112680A3 (enExample
Inventor
Алессандра Дель Рио
Кармела САБИНА
Original Assignee
Фрезениус Каби Дойчланд Гмбх
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 Фрезениус Каби Дойчланд Гмбх filed Critical Фрезениус Каби Дойчланд Гмбх
Publication of RU2019112680A publication Critical patent/RU2019112680A/ru
Publication of RU2019112680A3 publication Critical patent/RU2019112680A3/ru

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02Muscle relaxants, e.g. for tetanus or cramps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (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)
RU2019112680A 2016-09-27 2017-09-26 Жидкая фармацевтическая композиция RU2019112680A (ru)

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 (enExample) 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 (enExample)
EP (1) EP3518891A1 (enExample)
JP (3) JP2019534863A (enExample)
KR (1) KR102546471B1 (enExample)
CN (1) CN109862880A (enExample)
AU (1) AU2017333367A1 (enExample)
BR (1) BR112019005328A2 (enExample)
CA (1) CA3037440A1 (enExample)
MA (1) MA46334A (enExample)
RU (1) RU2019112680A (enExample)
WO (1) WO2018060210A1 (enExample)
ZA (1) ZA201901590B (enExample)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
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
EP4029881A1 (en) 2010-11-08 2022-07-20 F. Hoffmann-La Roche AG Subcutaneously administered anti-il-6 receptor antibody
EP3518891A1 (en) * 2016-09-27 2019-08-07 Fresenius Kabi Deutschland GmbH Liquid pharmaceutical composition
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
CA3083971A1 (en) * 2017-11-30 2019-06-06 Bio-Thera Solutions, Ltd. Liquid formulation of humanized antibody for treating il-6 related diseases
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
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
ES2987347T3 (es) * 2020-03-13 2024-11-14 Lek Pharmaceuticals Estabilización de composiciones farmacéuticas que comprenden polisorbato
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
WO2021228917A1 (en) * 2020-05-15 2021-11-18 F. Hoffmann-La Roche Ag Prevention of visible particle formation in parenteral protein solutions
US12281166B2 (en) 2020-05-26 2025-04-22 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
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
WO2024245170A1 (en) * 2023-05-26 2024-12-05 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases

Family Cites Families (18)

* Cited by examiner, † Cited by third party
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
WO2002013860A1 (en) 2000-08-11 2002-02-21 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing preparations
WO2003068259A1 (fr) 2002-02-14 2003-08-21 Chugai Seiyaku Kabushiki Kaisha Produits pharmaceutiques en solution contenant des anticorps
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
CN104398471A (zh) * 2008-11-28 2015-03-11 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
WO2011061712A1 (en) * 2009-11-20 2011-05-26 Biocon Limited Formulations of antibody
CA2783715A1 (en) * 2009-12-29 2011-07-07 F. Hoffmann-La Roche Ag Novel 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
EP4029881A1 (en) * 2010-11-08 2022-07-20 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
CA2951856A1 (en) 2011-10-28 2013-05-02 Integritybio Inc. Protein formulations containing amino acids
BR112015008186A2 (pt) * 2012-10-25 2017-09-19 Medimmune Llc formulação de um anticorpo estável e de baixa viscosidade
EP3518891A1 (en) * 2016-09-27 2019-08-07 Fresenius Kabi Deutschland GmbH Liquid pharmaceutical composition
CA3083971A1 (en) * 2017-11-30 2019-06-06 Bio-Thera Solutions, Ltd. Liquid formulation of humanized antibody for treating il-6 related diseases
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

Also Published As

Publication number Publication date
BR112019005328A2 (pt) 2019-06-18
AU2017333367A1 (en) 2019-04-04
US20210261673A1 (en) 2021-08-26
EP3518891A1 (en) 2019-08-07
KR20190062440A (ko) 2019-06-05
US10961314B2 (en) 2021-03-30
RU2019112680A3 (enExample) 2020-12-15
WO2018060210A1 (en) 2018-04-05
JP2024178197A (ja) 2024-12-24
KR102546471B1 (ko) 2023-06-21
CA3037440A1 (en) 2018-04-05
US20190218300A1 (en) 2019-07-18
JP2022188075A (ja) 2022-12-20
JP2019534863A (ja) 2019-12-05
US20240150479A1 (en) 2024-05-09
CN109862880A (zh) 2019-06-07
MA46334A (fr) 2019-08-07
ZA201901590B (en) 2020-10-28

Similar Documents

Publication Publication Date Title
RU2019112680A (ru) Жидкая фармацевтическая композиция
RU2019116756A (ru) Жидкая фармацевтическая композиция
JP2019534863A5 (enExample)
HRP20120903T4 (hr) Tekuća formulacija koja sadrži visoku koncentraciju protutijela
JP2019536761A5 (enExample)
PH12017500844A1 (en) Stable protein solution formulation containing high concentration of an anti-vegf antibody
CY1123657T1 (el) Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1
NZ719036A (en) Anti-pdl1 antibody formulations
RU2017101667A (ru) Фармацевтические композиции
HRP20201573T1 (hr) Vodena farmaceutska formulacija koja sadrži anti-pd-1 protutijelo avelumab
HRP20191299T1 (hr) Formulacije protutijela
JO3417B1 (ar) الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
RU2016150640A (ru) Жидкая фармацевтическая композиция
EA201992570A1 (ru) Составы на основе человеческих антител к rankl, а также способы их применения
AR107708A1 (es) Formulaciones de antagonista de il-6 y sus usos
HRP20220011T1 (hr) Nova stabilna formulacija za fxia protutijela
RU2018129077A (ru) Стабильная фармацевтическая композиция
PH12021551307A1 (en) Protein solution formulation containing high concentration of an anti-vegf antibody
AR117607A1 (es) Formulaciones de anticuerpo líquidas de alta concentración
HRP20171016T1 (hr) VISOKOKONCENTRIRANE FORMULACIJE TOPLJIVIH RECEPTORA Fcγ
RU2016119565A (ru) Полипептиды длительного действия и способы их получения и введения
RU2018124983A (ru) Пептидная композиция
EP3793520C0 (en) ORAL TABLET FOR THE ADMINISTRATION OF ACTIVE INGREDIENTS TO THE THROAT COMPRISING NON-DIRECTLY COMPRESSIBLE SUGAR ALCOHOL PARTICLES
RU2743681C3 (ru) Состав антитела
RU2020136721A (ru) Стабильные композиции терапевтического антитела