HUE054858T2 - Folyékony gyógyszerészeti készítmény - Google Patents

Folyékony gyógyszerészeti készítmény

Info

Publication number
HUE054858T2
HUE054858T2 HUE17797579A HUE17797579A HUE054858T2 HU E054858 T2 HUE054858 T2 HU E054858T2 HU E17797579 A HUE17797579 A HU E17797579A HU E17797579 A HUE17797579 A HU E17797579A HU E054858 T2 HUE054858 T2 HU E054858T2
Authority
HU
Hungary
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
liquid
composition
pharmaceutical
Prior art date
Application number
HUE17797579A
Other languages
English (en)
Hungarian (hu)
Inventor
Jan Jezek
Luca Badiali
David Gerring
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 HUE054858T2 publication Critical patent/HUE054858T2/hu

Links

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)
HUE17797579A 2016-10-31 2017-10-30 Folyékony gyógyszerészeti készítmény HUE054858T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP16196625 2016-10-31

Publications (1)

Publication Number Publication Date
HUE054858T2 true HUE054858T2 (hu) 2021-10-28

Family

ID=57218780

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE17797579A HUE054858T2 (hu) 2016-10-31 2017-10-30 Folyékony gyógyszerészeti készítmény

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
RU2019116756A (ru) 2020-11-30
JP2022166006A (ja) 2022-11-01
JP7473603B2 (ja) 2024-04-23
MY192532A (en) 2022-08-26
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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