SG11201804961UA - Formulations with reduced degradation of polysorbate - Google Patents

Formulations with reduced degradation of polysorbate

Info

Publication number
SG11201804961UA
SG11201804961UA SG11201804961UA SG11201804961UA SG11201804961UA SG 11201804961U A SG11201804961U A SG 11201804961UA SG 11201804961U A SG11201804961U A SG 11201804961UA SG 11201804961U A SG11201804961U A SG 11201804961UA SG 11201804961U A SG11201804961U A SG 11201804961UA
Authority
SG
Singapore
Prior art keywords
polysorbate
international
formulations
san francisco
methods
Prior art date
Application number
SG11201804961UA
Other languages
English (en)
Inventor
Brian Connolly
Lydia Hamburg
Emily HOLZ
Original Assignee
Genentech Inc
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 Genentech Inc filed Critical Genentech Inc
Publication of SG11201804961UA publication Critical patent/SG11201804961UA/en

Links

Classifications

    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • 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
    • A61K47/06—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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/10—Dispersions; Emulsions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dispersion Chemistry (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
SG11201804961UA 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate SG11201804961UA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562272965P 2015-12-30 2015-12-30
PCT/US2016/069046 WO2017117311A1 (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate

Publications (1)

Publication Number Publication Date
SG11201804961UA true SG11201804961UA (en) 2018-07-30

Family

ID=57868354

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201804961UA SG11201804961UA (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate

Country Status (11)

Country Link
US (3) US10525137B2 (de)
EP (1) EP3397287A1 (de)
JP (2) JP7008023B2 (de)
KR (1) KR20180098625A (de)
CN (2) CN108472379B (de)
AU (2) AU2016380988B2 (de)
BR (1) BR112018010945A2 (de)
CA (1) CA3007419A1 (de)
IL (2) IL299759A (de)
SG (1) SG11201804961UA (de)
WO (1) WO2017117311A1 (de)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20180098625A (ko) 2015-12-30 2018-09-04 제넨테크, 인크. 분해가 감소된 폴리소르베이트를 갖는 제형
EP3560945A1 (de) 2018-04-27 2019-10-30 F. Hoffmann-La Roche AG Verfahren zur reinigung von polypeptiden mit polysorbaten
EP3934620A1 (de) 2019-03-05 2022-01-12 Regeneron Pharmaceuticals, Inc. Humanserumalbumin in formulierungen
CA3143663A1 (en) 2019-06-17 2020-12-24 Intas Pharmaceuticals Ltd. A stable formulation of cetrorelix
BR112021026492A2 (pt) * 2019-06-28 2022-02-08 Genentech Inc Formulações líquidas, formulação liofilizada, artigos de fabricação e método para preparar uma formulação líquida
IL296330A (en) * 2020-03-20 2022-11-01 Glaxosmithkline Ip Dev Ltd A method for the detection of polysorbates
AU2022420630A1 (en) 2021-12-20 2024-05-02 Boehringer Ingelheim International Gmbh Method for determining the degree of oxidative degradation of polysorbate 20 in aqueous formulations

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US20170189536A1 (en) 2017-07-06
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US20200215195A1 (en) 2020-07-09
CN108472379B (zh) 2022-06-21
AU2022256163A1 (en) 2022-11-24
US20220040312A1 (en) 2022-02-10
BR112018010945A2 (pt) 2018-12-04
IL259646A (en) 2018-07-31
IL259646B2 (en) 2023-06-01
EP3397287A1 (de) 2018-11-07
IL299759A (en) 2023-03-01
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CA3007419A1 (en) 2017-07-06
WO2017117311A1 (en) 2017-07-06
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