MX339666B - Composiciones y metodos para estabilizar formulaciones que contienen proteinas. - Google Patents

Composiciones y metodos para estabilizar formulaciones que contienen proteinas.

Info

Publication number
MX339666B
MX339666B MX2012014862A MX2012014862A MX339666B MX 339666 B MX339666 B MX 339666B MX 2012014862 A MX2012014862 A MX 2012014862A MX 2012014862 A MX2012014862 A MX 2012014862A MX 339666 B MX339666 B MX 339666B
Authority
MX
Mexico
Prior art keywords
compositions
alkylgycosides
stabilizing protein
methods
formulations
Prior art date
Application number
MX2012014862A
Other languages
English (en)
Other versions
MX2012014862A (es
Inventor
Osigwe Esue
Vikas K Sharma
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 MX2012014862A publication Critical patent/MX2012014862A/es
Publication of MX339666B publication Critical patent/MX339666B/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
    • A61K39/39591—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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/14—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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K16/2803—Immunoglobulins [IG], 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
    • 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
    • C07K16/2839—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2845—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta2-subunit-containing molecules, e.g. CD11, CD18
    • 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
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3076—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties
    • C07K16/3092—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties against tumour-associated mucins
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Saccharide Compounds (AREA)
  • Anti-Oxidant Or Stabilizer Compositions (AREA)
  • Preventing Corrosion Or Incrustation Of Metals (AREA)

Abstract

La presente invención se refiere a una composición acuosa de materia que comprende un anticuerpo y un alquilglicósido que tiene un valor CMC de aproximadamente 1.0 mM o mayor en agua a 25°C, en donde el alquilglicósido está presente a una concentración que es menor que el valor CMC del alquilglicósido en agua a 25°C.
MX2012014862A 2010-06-24 2011-06-23 Composiciones y metodos para estabilizar formulaciones que contienen proteinas. MX339666B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US35810510P 2010-06-24 2010-06-24
PCT/US2011/041598 WO2011163458A2 (en) 2010-06-24 2011-06-23 Compositions and methods for stabilizing protein-containing formulations

Publications (2)

Publication Number Publication Date
MX2012014862A MX2012014862A (es) 2013-03-25
MX339666B true MX339666B (es) 2016-06-03

Family

ID=44628056

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2012014862A MX339666B (es) 2010-06-24 2011-06-23 Composiciones y metodos para estabilizar formulaciones que contienen proteinas.

Country Status (19)

Country Link
US (4) US9254321B2 (es)
EP (3) EP3586826B1 (es)
JP (1) JP5894154B2 (es)
KR (2) KR102058307B1 (es)
CN (1) CN103068367B (es)
AU (1) AU2011270828B2 (es)
BR (1) BR112012033002B1 (es)
CA (2) CA2802756C (es)
ES (2) ES2751381T3 (es)
HR (2) HRP20191878T1 (es)
IL (2) IL223651A (es)
MX (1) MX339666B (es)
MY (2) MY184736A (es)
NZ (1) NZ605147A (es)
PL (2) PL3586826T3 (es)
SG (1) SG186783A1 (es)
SI (2) SI2585045T1 (es)
WO (1) WO2011163458A2 (es)
ZA (1) ZA201209539B (es)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
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MY184736A (en) 2010-06-24 2021-04-20 Genentech Inc Compositions and methods containing alkylglycosides for stabilizing protein-containing formulations
MY199135A (en) * 2013-03-13 2023-10-17 Genentech Inc Formulations with reduced oxidation
AR095398A1 (es) 2013-03-13 2015-10-14 Genentech Inc Formulaciones con oxidación reducida
WO2015032972A1 (en) * 2013-09-09 2015-03-12 Lek Pharmaceuticals D.D. Nanoformulation of g-csf for non-parenteral delivery
WO2015032981A1 (en) * 2013-09-09 2015-03-12 Lek Pharmaceuticals D.D. Erythropoietin conjugates having oral bioavailability
KR102228443B1 (ko) * 2013-09-30 2021-03-16 엔자 바이오테크 에이비 계면활성제 조성물
CN104707146B (zh) * 2013-12-16 2019-04-16 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
CA3030422C (en) 2016-07-13 2021-10-26 Reform Biologics, Llc Stabilizing excipients for therapeutic protein formulations
WO2019036619A1 (en) * 2017-08-18 2019-02-21 Reform Biologics, Llc STABILIZING EXCIPIENTS FOR FORMULATIONS OF THERAPEUTIC PROTEIN
AR118536A1 (es) 2019-04-01 2021-10-20 Genentech Inc Composiciones y métodos para estabilizar formulaciones que contienen proteína
CN114761022B (zh) * 2019-11-29 2024-02-13 千寿制药株式会社 药物组合物
CN116531514A (zh) * 2023-05-29 2023-08-04 大连理工大学 一种烷基糖苷表面活性剂在铝佐剂冻干中的应用
CN117599193A (zh) * 2023-11-24 2024-02-27 皓阳生物科技(上海)有限公司 包含抗原和表面活性剂的物质组合物及其制备方法与应用

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Also Published As

Publication number Publication date
AU2011270828A1 (en) 2013-01-17
US20210353756A1 (en) 2021-11-18
US10188735B2 (en) 2019-01-29
EP3586826A1 (en) 2020-01-01
US11103584B2 (en) 2021-08-31
KR20130098283A (ko) 2013-09-04
PL2585045T3 (pl) 2020-01-31
SI2585045T1 (sl) 2019-11-29
ZA201209539B (en) 2015-03-25
PL3586826T3 (pl) 2021-10-25
BR112012033002B1 (pt) 2021-10-13
KR20180130590A (ko) 2018-12-07
AU2011270828A2 (en) 2013-02-07
EP2585045B1 (en) 2019-08-21
EP2585045A2 (en) 2013-05-01
US11938189B2 (en) 2024-03-26
CA3111727A1 (en) 2011-12-29
JP2013533244A (ja) 2013-08-22
CA2802756C (en) 2021-05-04
EP4008313A1 (en) 2022-06-08
US20130224213A1 (en) 2013-08-29
KR102058307B1 (ko) 2019-12-20
ES2751381T3 (es) 2020-03-31
IL223651A (en) 2017-09-28
IL254354A0 (en) 2017-11-30
CA2802756A1 (en) 2011-12-29
MX2012014862A (es) 2013-03-25
KR101924653B1 (ko) 2018-12-03
WO2011163458A3 (en) 2012-06-07
AU2011270828B2 (en) 2015-09-24
CA3111727C (en) 2022-07-26
MY184736A (en) 2021-04-20
JP5894154B2 (ja) 2016-03-23
MY161390A (en) 2017-04-14
RU2013103025A (ru) 2014-07-27
ES2880802T3 (es) 2021-11-25
NZ605147A (en) 2014-12-24
SG186783A1 (en) 2013-02-28
IL254354B (en) 2021-05-31
CN103068367A (zh) 2013-04-24
US20160199494A1 (en) 2016-07-14
US9254321B2 (en) 2016-02-09
EP3586826B1 (en) 2021-05-12
WO2011163458A2 (en) 2011-12-29
HRP20211056T1 (hr) 2021-10-01
CN103068367B (zh) 2016-09-07
BR112012033002A2 (pt) 2016-12-20
SI3586826T1 (sl) 2021-09-30
US20190216929A1 (en) 2019-07-18
HRP20191878T1 (hr) 2019-12-27

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