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MX2020012893A - Formulaciones de proteinas. - Google Patents

Formulaciones de proteinas.

Info

Publication number
MX2020012893A
MX2020012893A MX2020012893A MX2020012893A MX2020012893A MX 2020012893 A MX2020012893 A MX 2020012893A MX 2020012893 A MX2020012893 A MX 2020012893A MX 2020012893 A MX2020012893 A MX 2020012893A MX 2020012893 A MX2020012893 A MX 2020012893A
Authority
MX
Mexico
Prior art keywords
protein formulations
formulations
present disclosure
temperatures
variety
Prior art date
Application number
MX2020012893A
Other languages
English (en)
Inventor
Sungae Park
Arnold J Mcauley
Original Assignee
Amgen 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 Amgen Inc filed Critical Amgen Inc
Publication of MX2020012893A publication Critical patent/MX2020012893A/es

Links

Classifications

    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/20Organic 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • 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
    • C07K16/22Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Hematology (AREA)
  • Diabetes (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)

Abstract

La presente descripción proporciona formulaciones sólidas de proteínas que son estables sobre una variedad de temperaturas durante períodos prolongados de tiempo. La presente descripción también proporciona los métodos para preparar y utilizar estas formulaciones.
MX2020012893A 2014-06-26 2016-12-19 Formulaciones de proteinas. MX2020012893A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201462017560P 2014-06-26 2014-06-26

Publications (1)

Publication Number Publication Date
MX2020012893A true MX2020012893A (es) 2021-02-26

Family

ID=53610976

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2016017025A MX377774B (es) 2014-06-26 2015-06-15 Formulaciones de proteinas.
MX2020012893A MX2020012893A (es) 2014-06-26 2016-12-19 Formulaciones de proteinas.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2016017025A MX377774B (es) 2014-06-26 2015-06-15 Formulaciones de proteinas.

Country Status (8)

Country Link
US (1) US20170209582A1 (es)
EP (2) EP4285930A3 (es)
JP (4) JP6634394B2 (es)
AU (3) AU2015280480A1 (es)
CA (1) CA2952609A1 (es)
ES (1) ES2960599T3 (es)
MX (2) MX377774B (es)
WO (1) WO2015200027A1 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101994456B1 (ko) * 2017-03-15 2019-06-28 이건무 당 수액제 조성물
JP2021503441A (ja) * 2017-11-16 2021-02-12 アムジエン・インコーポレーテツド Peg化されたカルフィルゾミブ化合物の安定組成物
CN112739323A (zh) 2018-05-10 2021-04-30 瑞泽恩制药公司 含有高浓度vegf受体融合蛋白的制剂
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
IL294461A (en) * 2020-01-13 2022-09-01 Aptevo Res & Development Llc Methods and compositions for preventing adsorption of therapeutic proteins to drug delivery system components
JP7278503B2 (ja) * 2020-09-24 2023-05-19 ノヴォ・ノルディスク・ヘルス・ケア・アーゲー コンシズマブの医薬製剤およびその生産方法
AU2021404495A1 (en) * 2020-12-17 2023-07-27 Astrazeneca Ab Anti-il5r antibody formulations
WO2024141645A1 (en) 2022-12-30 2024-07-04 Biotalys N.V. Agglomerate
WO2025013783A1 (ja) * 2023-07-07 2025-01-16 ナガセヴィータ株式会社 タンパク質の変性抑制用組成物

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4703008A (en) 1983-12-13 1987-10-27 Kiren-Amgen, Inc. DNA sequences encoding erythropoietin
US4667016A (en) 1985-06-20 1987-05-19 Kirin-Amgen, Inc. Erythropoietin purification
US7217689B1 (en) 1989-10-13 2007-05-15 Amgen Inc. Glycosylation analogs of erythropoietin
JPH11510170A (ja) * 1995-07-27 1999-09-07 ジェネンテック インコーポレーテッド タンパク質の処方
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6673901B2 (en) 1997-06-12 2004-01-06 Research Corporation Technologies, Inc. Artificial antibody polypeptides
US20030133939A1 (en) 2001-01-17 2003-07-17 Genecraft, Inc. Binding domain-immunoglobulin fusion proteins
EP1409018B1 (en) * 2001-07-25 2010-01-06 Facet Biotech Corporation Stable lyophilized pharmaceutical formulation the igg antibody daclizumab
WO2007014073A2 (en) * 2005-07-22 2007-02-01 Amgen Inc. Concentrated protein lyophilates, methods, and uses
CN101541345A (zh) * 2006-09-25 2009-09-23 米迪缪尼有限公司 稳定化的抗体制剂和其应用
CA2666492C (en) * 2006-10-20 2012-07-17 Douglas Rehder Stable polypeptide formulations
US20120114646A1 (en) * 2009-06-18 2012-05-10 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
HUE028688T2 (en) * 2009-09-21 2017-01-30 Baxalta GmbH Stabilized liquid and lyophilized adamts13 formulations
US9072668B2 (en) * 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
US9441039B2 (en) 2012-05-07 2016-09-13 Amgen Inc. Anti-erythropoietin antibodies

Also Published As

Publication number Publication date
JP2021178862A (ja) 2021-11-18
JP2019203018A (ja) 2019-11-28
AU2023200296A1 (en) 2023-02-23
EP3160511B1 (en) 2023-07-26
WO2015200027A1 (en) 2015-12-30
EP4285930A2 (en) 2023-12-06
MX377774B (es) 2025-03-11
JP6634394B2 (ja) 2020-01-22
AU2015280480A1 (en) 2017-01-05
JP2017519777A (ja) 2017-07-20
CA2952609A1 (en) 2015-12-30
ES2960599T3 (es) 2024-03-05
EP4285930A3 (en) 2024-02-28
AU2020250182A1 (en) 2020-11-05
JP2023162442A (ja) 2023-11-08
EP3160511A1 (en) 2017-05-03
AU2023200296B2 (en) 2024-09-19
US20170209582A1 (en) 2017-07-27
MX2016017025A (es) 2017-08-08

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