HRP20191053T1 - Nova stabilna formulacija - Google Patents

Nova stabilna formulacija Download PDF

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Publication number
HRP20191053T1
HRP20191053T1 HRP20191053TT HRP20191053T HRP20191053T1 HR P20191053 T1 HRP20191053 T1 HR P20191053T1 HR P20191053T T HRP20191053T T HR P20191053TT HR P20191053 T HRP20191053 T HR P20191053T HR P20191053 T1 HRP20191053 T1 HR P20191053T1
Authority
HR
Croatia
Prior art keywords
immunoconjugate
lyophilized preparation
formulation
spdb
reconstitution
Prior art date
Application number
HRP20191053TT
Other languages
English (en)
Croatian (hr)
Inventor
Carsten Olbrich
Thomas Trill
Original Assignee
Bayer Pharma Aktiengesellschaft
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 Bayer Pharma Aktiengesellschaft filed Critical Bayer Pharma Aktiengesellschaft
Publication of HRP20191053T1 publication Critical patent/HRP20191053T1/hr

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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/537Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
    • 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
    • A61K47/26Carbohydrates, 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
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68033Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
HRP20191053TT 2013-10-25 2014-10-21 Nova stabilna formulacija HRP20191053T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13190276 2013-10-25
EP14786915.0A EP3060256B1 (en) 2013-10-25 2014-10-21 A novel stable formulation
PCT/EP2014/072558 WO2015059147A1 (en) 2013-10-25 2014-10-21 A novel stable formulation

Publications (1)

Publication Number Publication Date
HRP20191053T1 true HRP20191053T1 (hr) 2019-09-20

Family

ID=49552164

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20191053TT HRP20191053T1 (hr) 2013-10-25 2014-10-21 Nova stabilna formulacija

Country Status (15)

Country Link
US (2) US20160250349A1 (enExample)
EP (1) EP3060256B1 (enExample)
JP (1) JP6813355B2 (enExample)
CY (1) CY1121791T1 (enExample)
DK (1) DK3060256T3 (enExample)
ES (1) ES2735645T3 (enExample)
HR (1) HRP20191053T1 (enExample)
HU (1) HUE045020T2 (enExample)
LT (1) LT3060256T (enExample)
PL (1) PL3060256T3 (enExample)
PT (1) PT3060256T (enExample)
RS (1) RS58856B1 (enExample)
SI (1) SI3060256T1 (enExample)
TR (1) TR201909034T4 (enExample)
WO (1) WO2015059147A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UY32560A (es) 2009-04-29 2010-11-30 Bayer Schering Pharma Ag Inmunoconjugados de antimesotelina y usos de los mismos
BR112019014785A2 (pt) * 2017-01-19 2020-05-12 Bayer Pharma Aktiengesellschaft Nova formulação estável para anticorpos fxia
WO2019039483A1 (ja) 2017-08-23 2019-02-28 第一三共株式会社 抗体-薬物コンジュゲートの製剤及びその凍結乾燥方法
WO2020234114A1 (en) 2019-05-21 2020-11-26 Bayer Aktiengesellschaft A novel stable high concentration formulation for anetumab ravtansine
CN119630433A (zh) 2022-05-23 2025-03-14 逻辑生物治疗公司 基因疗法组合物及其使用方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2281577B1 (en) * 2003-05-14 2016-11-16 ImmunoGen, Inc. Drug conjugate composition
WO2007019232A2 (en) * 2005-08-03 2007-02-15 Immunogen, Inc. Immunoconjugate formulations
TW200806315A (en) * 2006-04-26 2008-02-01 Wyeth Corp Novel formulations which stabilize and inhibit precipitation of immunogenic compositions
EP1854478A1 (en) * 2006-05-12 2007-11-14 Cytos Biotechnology AG Nicotine-carrier vaccine formulation
UY32560A (es) * 2009-04-29 2010-11-30 Bayer Schering Pharma Ag Inmunoconjugados de antimesotelina y usos de los mismos
TWI582112B (zh) * 2011-04-21 2017-05-11 西雅圖遺傳學公司 新穎結合劑-藥物接合物(ADCs)及其用途(二)
JP6024025B2 (ja) * 2011-05-02 2016-11-09 イミューノメディクス、インコーポレイテッドImmunomedics, Inc. 少容量投与用のアロタイプ選択抗体の限外濾過濃縮
AU2012275233A1 (en) * 2011-06-30 2013-11-28 Genentech, Inc. Anti-c-met antibody formulations

Also Published As

Publication number Publication date
CY1121791T1 (el) 2020-07-31
TR201909034T4 (tr) 2019-07-22
EP3060256B1 (en) 2019-05-08
LT3060256T (lt) 2019-07-10
SI3060256T1 (sl) 2019-08-30
WO2015059147A1 (en) 2015-04-30
RS58856B1 (sr) 2019-07-31
JP2016534062A (ja) 2016-11-04
US20190240345A1 (en) 2019-08-08
PL3060256T3 (pl) 2019-10-31
HUE045020T2 (hu) 2019-12-30
JP6813355B2 (ja) 2021-01-13
PT3060256T (pt) 2019-07-19
EP3060256A1 (en) 2016-08-31
DK3060256T3 (da) 2019-07-29
ES2735645T3 (es) 2019-12-19
US20160250349A1 (en) 2016-09-01

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