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CO2018011733A2 - Composición farmacéutica - Google Patents

Composición farmacéutica

Info

Publication number
CO2018011733A2
CO2018011733A2 CONC2018/0011733A CO2018011733A CO2018011733A2 CO 2018011733 A2 CO2018011733 A2 CO 2018011733A2 CO 2018011733 A CO2018011733 A CO 2018011733A CO 2018011733 A2 CO2018011733 A2 CO 2018011733A2
Authority
CO
Colombia
Prior art keywords
pharmaceutical compositions
freeze
antibody
pharmaceutical composition
drying
Prior art date
Application number
CONC2018/0011733A
Other languages
English (en)
Inventor
Andrew Jeffrey Yates
Jan Ivo Massant
Original Assignee
Ucb Biopharma Sprl
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=56320265&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO2018011733(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ucb Biopharma Sprl filed Critical Ucb Biopharma Sprl
Publication of CO2018011733A2 publication Critical patent/CO2018011733A2/es

Links

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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • 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
    • A61K39/39566—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
    • 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
    • A61K47/22—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

RESUMEN La presente invención se refiere a composiciones farmacéuticas que comprenden un anticuerpo o un fragmento del mismo, adecuadas para el secado por congelación (es decir liofilización). Las composiciones farmacéuticas, que comprenden un anticuerpo o un fragmento de unión al antígeno del mismo; de 1 % a 20 % p/v de sucrosa; un aminoácido o una mezcla de aminoácidos; y un agente tensioactivo, son provistas como composiciones farmacéuticas para el secado por congelación; como composiciones secadas por congelación (es decir liofilizadas) que se pueden reconstituir en un disolvente en el momento del uso o como formulaciones líquidas reconstituidas listas para su administración.
CONC2018/0011733A 2016-05-12 2018-10-30 Composición farmacéutica CO2018011733A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1608323.0A GB201608323D0 (en) 2016-05-12 2016-05-12 Pharmaceutical compositions
PCT/EP2017/061261 WO2017194646A1 (en) 2016-05-12 2017-05-11 Pharmaceutical composition

Publications (1)

Publication Number Publication Date
CO2018011733A2 true CO2018011733A2 (es) 2019-02-08

Family

ID=56320265

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2018/0011733A CO2018011733A2 (es) 2016-05-12 2018-10-30 Composición farmacéutica

Country Status (18)

Country Link
US (1) US11407835B2 (es)
EP (1) EP3454899B1 (es)
JP (1) JP7126454B2 (es)
KR (1) KR102436694B1 (es)
CN (1) CN109069643A (es)
AR (1) AR108449A1 (es)
AU (1) AU2017264553A1 (es)
BR (1) BR112018072264A2 (es)
CA (1) CA3022124A1 (es)
CL (1) CL2018003178A1 (es)
CO (1) CO2018011733A2 (es)
EA (1) EA201892446A1 (es)
ES (1) ES2977545T3 (es)
GB (1) GB201608323D0 (es)
IL (1) IL262654A (es)
MX (1) MX2018013215A (es)
SG (1) SG11201809229VA (es)
WO (1) WO2017194646A1 (es)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI703158B (zh) 2015-09-18 2020-09-01 美商希佛隆公司 特異性結合tl1a之抗體
MX2019010757A (es) 2017-03-11 2020-01-20 Selecta Biosciences Inc Métodos y composiciones relacionados con el tratamiento combinado con antiinflamatorios y nanoportadores sintéticos que comprenden un inmunosupresor.
GB201708655D0 (en) * 2017-05-31 2017-07-12 Ucb Biopharma Sprl Cell culture methods
EP3768706A1 (en) * 2018-03-23 2021-01-27 AbbVie Deutschland GmbH & Co. KG Stable aqueous anti-tau antibody formulations
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
KR20220152263A (ko) * 2020-03-11 2022-11-15 셀렉타 바이오사이언시즈, 인크. 합성 나노담체와 관련된 방법 및 조성물
KR20220001482A (ko) * 2020-06-29 2022-01-05 한올바이오파마주식회사 항-FcRn 항체에 대한 제형
CA3218343A1 (en) * 2021-05-12 2022-11-17 Anaptysbio, Inc. Antibody composition
AU2022402319A1 (en) 2021-12-01 2024-05-02 Biogen Ma Inc Formulations comprising fab-peg
JPWO2023224112A1 (es) * 2022-05-20 2023-11-23
CN119013043A (zh) 2022-05-30 2024-11-22 韩兀生物制药股份有限公司 具有改善的稳定性的抗FcRn抗体或其抗原结合片段
WO2024184444A1 (en) * 2023-03-08 2024-09-12 Immunovant Sciences Gmbh High concentration protein formulations with polysorbate excipients and methods of making the same

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ATE454137T1 (de) * 2001-07-25 2010-01-15 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
CA2545603A1 (en) 2003-11-12 2005-05-26 Biogen Idec Ma Inc. Neonatal fc receptor (fcrn)-binding polypeptide variants, dimeric fc binding proteins and methods related thereto
CN101124245A (zh) * 2003-11-12 2008-02-13 比奥根艾迪克Ma公司 新生儿Fc受体(FcRn)-结合多肽变体、二聚体Fc结合蛋白及其相关方法
US9283260B2 (en) 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
BRPI0711608B8 (pt) * 2006-05-12 2021-05-25 Bharat Biotech Int Ltd composição liofilizada, uso de antígeno viral, método de tratamento ou prevenção de vírus associado, método de adaptação de um vírus de uma linhagem celular adequada
AR070315A1 (es) 2008-02-07 2010-03-31 Merck & Co Inc Anticuerpos 1b20 antagonistas de pcsk9
AR070316A1 (es) * 2008-02-07 2010-03-31 Merck & Co Inc Antagonistas de pcsk9 (proproteina subtilisina-kexina tipo 9)
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KR20170065662A (ko) 2014-10-18 2017-06-13 화이자 인코포레이티드 항-il-7r 항체 조성물
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Also Published As

Publication number Publication date
EP3454899C0 (en) 2024-03-20
RU2018141591A3 (es) 2021-01-13
EP3454899B1 (en) 2024-03-20
KR102436694B1 (ko) 2022-08-25
US20200048346A1 (en) 2020-02-13
IL262654A (en) 2018-12-31
GB201608323D0 (en) 2016-06-29
CA3022124A1 (en) 2017-11-16
ES2977545T3 (es) 2024-08-26
WO2017194646A1 (en) 2017-11-16
JP7126454B2 (ja) 2022-08-26
US11407835B2 (en) 2022-08-09
CL2018003178A1 (es) 2019-02-01
JP2019514998A (ja) 2019-06-06
MX2018013215A (es) 2019-02-21
EA201892446A1 (ru) 2019-04-30
KR20190008320A (ko) 2019-01-23
SG11201809229VA (en) 2018-11-29
CN109069643A (zh) 2018-12-21
RU2018141591A (ru) 2020-06-15
AU2017264553A1 (en) 2018-12-13
BR112018072264A2 (pt) 2019-02-12
EP3454899A1 (en) 2019-03-20
AR108449A1 (es) 2018-08-22

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