RU2019116756A - Жидкая фармацевтическая композиция - Google Patents

Жидкая фармацевтическая композиция Download PDF

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Publication number
RU2019116756A
RU2019116756A RU2019116756A RU2019116756A RU2019116756A RU 2019116756 A RU2019116756 A RU 2019116756A RU 2019116756 A RU2019116756 A RU 2019116756A RU 2019116756 A RU2019116756 A RU 2019116756A RU 2019116756 A RU2019116756 A RU 2019116756A
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RU
Russia
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
composition according
polysorbate
lactic acid
Prior art date
Application number
RU2019116756A
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English (en)
Russian (ru)
Other versions
RU2019116756A3 (https=
Inventor
Ян ЕЗЕК
Лука БАДИАЛИ
Дэвид ДЖЕРРИНГ
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.)
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Application filed by Фрезениус Каби Дойчланд Гмбх filed Critical Фрезениус Каби Дойчланд Гмбх
Publication of RU2019116756A publication Critical patent/RU2019116756A/ru
Publication of RU2019116756A3 publication Critical patent/RU2019116756A3/ru

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Classifications

    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [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
    • 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

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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
RU2019116756A 2016-10-31 2017-10-30 Жидкая фармацевтическая композиция RU2019116756A (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16196625 2016-10-31
EP16196625.4 2016-10-31
PCT/EP2017/077793 WO2018078162A1 (en) 2016-10-31 2017-10-30 Liquid pharmaceutical composition

Publications (2)

Publication Number Publication Date
RU2019116756A true RU2019116756A (ru) 2020-11-30
RU2019116756A3 RU2019116756A3 (https=) 2021-02-26

Family

ID=57218780

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2019116756A RU2019116756A (ru) 2016-10-31 2017-10-30 Жидкая фармацевтическая композиция

Country Status (16)

Country Link
US (2) US11291725B2 (https=)
EP (2) EP3532029B1 (https=)
JP (2) JP2019536761A (https=)
KR (1) KR20190078572A (https=)
CN (1) CN110062620B (https=)
AU (1) AU2017351805A1 (https=)
BR (1) BR112019006853B1 (https=)
CA (1) CA3040342A1 (https=)
DK (1) DK3532029T3 (https=)
ES (1) ES2882181T3 (https=)
HU (1) HUE054858T2 (https=)
MY (1) MY192532A (https=)
RU (1) RU2019116756A (https=)
SG (1) SG11201902531QA (https=)
WO (1) WO2018078162A1 (https=)
ZA (1) ZA201901736B (https=)

Families Citing this family (14)

* 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
KR20190078572A (ko) * 2016-10-31 2019-07-04 프레제니우스 카비 도이치란트 게엠베하 액상의 약학 조성물
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
MA54095A (fr) * 2018-10-31 2022-02-09 Richter Gedeon Nyrt Formulations pharmaceutiques aqueuses
CA3164227A1 (en) * 2019-12-10 2021-06-17 Mitotech S.A. Polymer matrixes for different compositions of mitochondrially targeted antioxidants
IL296276A (en) * 2020-03-10 2022-11-01 Tiziana Life Sciences Plc Compositions of il-6/il-6r antibodies and methods of use thereof
EP3714902B1 (en) * 2020-03-13 2024-08-28 LEK Pharmaceuticals d.d. Stabilization of pharmaceutical compositions comprising polysorbate
WO2022006051A1 (en) * 2020-06-29 2022-01-06 Anovent Pharmaceutical (U.S.), Llc Formulation of tocilizumab and method for treating covid-19 by inhalation
KR20220028972A (ko) * 2020-08-31 2022-03-08 (주)셀트리온 안정한 약제학적 제제
WO2022234594A1 (en) * 2021-05-07 2022-11-10 Dr. Reddy’S Laboratories Limited A method of improving stability of an antibody formulation
US20230090654A1 (en) * 2021-08-24 2023-03-23 Homology Medicines, Inc. Adeno-associated virus formulations
EP4590335A1 (en) * 2022-08-26 2025-07-30 ASLAN Pharmaceuticals Pte Ltd High concentration anti-il13r antibody formulation
KR102554775B1 (ko) 2023-02-07 2023-07-12 한국코러스 주식회사 히알루로니다제의 안정화제 및 이를 포함하는 히알루로니다제 제형
WO2024257040A1 (en) * 2023-06-14 2024-12-19 Enzene Biosciences Limited Composition and stable liquid formulations comprising humanized anti-human interleukin 6 (il-6) receptor monoclonal antibodies

Family Cites Families (13)

* 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
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
GB0700523D0 (en) * 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
JP2009034095A (ja) * 2007-07-06 2009-02-19 Sanyo Chem Ind Ltd タンパク質含有水溶液安定化剤、タンパク質含有水溶液の安定化方法及びタンパク質含有水溶液
MX2010002348A (es) * 2007-08-27 2010-07-30 Biogenerix Ag Formulacion liquida de g-csf.
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
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
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
EA201590061A1 (ru) * 2012-06-21 2015-05-29 Юсб Фарма С.А. Фармацевтическая композиция
CN102961745B (zh) * 2012-09-27 2015-02-18 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
KR20190078572A (ko) * 2016-10-31 2019-07-04 프레제니우스 카비 도이치란트 게엠베하 액상의 약학 조성물

Also Published As

Publication number Publication date
US20190262450A1 (en) 2019-08-29
JP2022166006A (ja) 2022-11-01
JP7473603B2 (ja) 2024-04-23
MY192532A (en) 2022-08-26
HUE054858T2 (hu) 2021-10-28
SG11201902531QA (en) 2019-05-30
KR20190078572A (ko) 2019-07-04
RU2019116756A3 (https=) 2021-02-26
WO2018078162A1 (en) 2018-05-03
CA3040342A1 (en) 2018-05-03
BR112019006853B1 (pt) 2021-08-24
ZA201901736B (en) 2020-11-25
AU2017351805A1 (en) 2019-04-11
CN110062620A (zh) 2019-07-26
EP3532029A1 (en) 2019-09-04
EP3964197A1 (en) 2022-03-09
US11291725B2 (en) 2022-04-05
JP2019536761A (ja) 2019-12-19
CN110062620B (zh) 2023-12-05
ES2882181T3 (es) 2021-12-01
DK3532029T3 (da) 2021-06-07
BR112019006853A2 (pt) 2019-06-25
US20220175924A1 (en) 2022-06-09
EP3532029B1 (en) 2021-04-28

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