DK3532029T3 - Flydende farmaceutisk sammensætning - Google Patents

Flydende farmaceutisk sammensætning Download PDF

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Publication number
DK3532029T3
DK3532029T3 DK17797579.4T DK17797579T DK3532029T3 DK 3532029 T3 DK3532029 T3 DK 3532029T3 DK 17797579 T DK17797579 T DK 17797579T DK 3532029 T3 DK3532029 T3 DK 3532029T3
Authority
DK
Denmark
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
liquid
composition
pharmaceutical
Prior art date
Application number
DK17797579.4T
Other languages
Danish (da)
English (en)
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
Application granted granted Critical
Publication of DK3532029T3 publication Critical patent/DK3532029T3/da

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Classifications

    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • 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

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)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (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)
DK17797579.4T 2016-10-31 2017-10-30 Flydende farmaceutisk sammensætning DK3532029T3 (da)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
DK3532029T3 true DK3532029T3 (da) 2021-06-07

Family

ID=57218780

Family Applications (1)

Application Number Title Priority Date Filing Date
DK17797579.4T DK3532029T3 (da) 2016-10-31 2017-10-30 Flydende farmaceutisk sammensætning

Country Status (16)

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

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
BR112019006853B1 (pt) * 2016-10-31 2021-08-24 Fresenius Kabi Deutschland Gmbh Composição farmacêutica líquida, seu método de fabricação, seu uso, kit e dispositivo de liberação de fármaco que a compreendem e método de fabricação do dito dispositivo
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
WO2020088346A1 (en) * 2018-10-31 2020-05-07 Mycenax Biotech Inc. Aqueous pharmaceutical formulations
EP4072512A4 (en) * 2019-12-10 2024-01-10 Mitotech S.A. POLYMER MATRICES FOR VARIOUS COMPOSITIONS OF MITOCHONDRIALLY DIRECTED ANTIOXIDANTS
JP2023517611A (ja) * 2020-03-10 2023-04-26 ティジアーナ ライフ サイエンシズ パブリック リミティド カンパニー Il-6/il-6r抗体の組成物及びその使用方法
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
JP2024516293A (ja) * 2021-05-07 2024-04-12 ドクター レディズ ラボラトリーズ リミテッド 抗体製剤の安定性を向上させる方法
US20230090654A1 (en) * 2021-08-24 2023-03-23 Homology Medicines, Inc. Adeno-associated virus formulations
KR20250075749A (ko) * 2022-08-26 2025-05-28 아슬란 파마슈티컬스 피티이 엘티디 항-il13r 항체의 고농도 제형
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
AU668349B2 (en) 1991-04-25 1996-05-02 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
WO2003068260A1 (fr) 2002-02-14 2003-08-21 Chugai Seiyaku Kabushiki Kaisha Produits pharmaceutiques en solution contenant des anticorps
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
UA100245C2 (uk) * 2007-08-27 2012-12-10 Біогенерікс Аг Рідка форма г-ксф
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
KR101933197B1 (ko) * 2010-11-08 2018-12-27 제넨테크, 인크. 피하 투여용 항―il―6 수용체 항체
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
CN104520326A (zh) * 2012-06-21 2015-04-15 Ucb医药有限公司 药物制剂
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
BR112019006853B1 (pt) * 2016-10-31 2021-08-24 Fresenius Kabi Deutschland Gmbh Composição farmacêutica líquida, seu método de fabricação, seu uso, kit e dispositivo de liberação de fármaco que a compreendem e método de fabricação do dito dispositivo

Also Published As

Publication number Publication date
JP2019536761A (ja) 2019-12-19
US20190262450A1 (en) 2019-08-29
BR112019006853A2 (pt) 2019-06-25
RU2019116756A (ru) 2020-11-30
WO2018078162A1 (en) 2018-05-03
CA3040342A1 (en) 2018-05-03
US20220175924A1 (en) 2022-06-09
EP3532029B1 (en) 2021-04-28
AU2017351805A1 (en) 2019-04-11
CN110062620A (zh) 2019-07-26
EP3964197A1 (en) 2022-03-09
RU2019116756A3 (enExample) 2021-02-26
US11291725B2 (en) 2022-04-05
KR20190078572A (ko) 2019-07-04
ES2882181T3 (es) 2021-12-01
MY192532A (en) 2022-08-26
EP3532029A1 (en) 2019-09-04
SG11201902531QA (en) 2019-05-30
CN110062620B (zh) 2023-12-05
JP7473603B2 (ja) 2024-04-23
JP2022166006A (ja) 2022-11-01
ZA201901736B (en) 2020-11-25
BR112019006853B1 (pt) 2021-08-24
HUE054858T2 (hu) 2021-10-28

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