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MX2012008039A - Formulacion farmaceutica para proteinas. - Google Patents

Formulacion farmaceutica para proteinas.

Info

Publication number
MX2012008039A
MX2012008039A MX2012008039A MX2012008039A MX2012008039A MX 2012008039 A MX2012008039 A MX 2012008039A MX 2012008039 A MX2012008039 A MX 2012008039A MX 2012008039 A MX2012008039 A MX 2012008039A MX 2012008039 A MX2012008039 A MX 2012008039A
Authority
MX
Mexico
Prior art keywords
pharmaceutical formulation
proteins
surfactant
group
provides
Prior art date
Application number
MX2012008039A
Other languages
English (en)
Inventor
Hanns-Christian Mahler
Satya Krishna Kishore Ravuri
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of MX2012008039A publication Critical patent/MX2012008039A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/20—Organic 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente invención proporciona una formulación farmacéutica líquida que comprende una proteína terapéutica, un tensioactivo y por lo menos un antioxidante que se selecciona del grupo de eliminadores de radicales, agentes quelantes y terminadores de cadena.
MX2012008039A 2010-01-19 2011-01-14 Formulacion farmaceutica para proteinas. MX2012008039A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP10151021 2010-01-19
PCT/EP2011/050427 WO2011089062A2 (en) 2010-01-19 2011-01-14 Pharmaceutical formulation for proteins

Publications (1)

Publication Number Publication Date
MX2012008039A true MX2012008039A (es) 2012-08-01

Family

ID=43799484

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2012008039A MX2012008039A (es) 2010-01-19 2011-01-14 Formulacion farmaceutica para proteinas.

Country Status (10)

Country Link
US (1) US20120294866A1 (es)
EP (1) EP2525826A2 (es)
JP (1) JP2013517309A (es)
KR (1) KR20120103702A (es)
CN (1) CN102711833A (es)
BR (1) BR112012012969A2 (es)
CA (1) CA2786952A1 (es)
MX (1) MX2012008039A (es)
RU (1) RU2012133473A (es)
WO (1) WO2011089062A2 (es)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2968535A2 (en) * 2013-03-15 2016-01-20 Glaxosmithkline Intellectual Property (No. 2) Limited Low concentration antibody formulations
IL299759A (en) * 2015-12-30 2023-03-01 Genentech Inc Formulations with reduced polysorbate dissolution
SG11201901228QA (en) * 2016-08-15 2019-03-28 Genentech Inc Chromatography method for quantifying a non-ionic surfactant in a composition comprising the non-ionic surfactant and a polypeptide
WO2018169554A1 (en) * 2017-03-17 2018-09-20 Longboat Explorers Ab Methods, systems, factors, and media for reduction of cellular stress and reactive oxygen species
CA3067110A1 (en) 2017-06-27 2019-01-03 Coriolis Pharma Research GmbH Polysorbate quantification assay
JP7183268B2 (ja) * 2017-11-20 2022-12-05 ジャスト－エヴォテック バイオロジックス、インコーポレイテッド 等張化剤としてリジン塩を含有するアフリベルセプト製剤及びその使用
EP3586875A1 (en) * 2018-06-21 2020-01-01 Lonza Limited Stabilization of polysorbate
FR3082729A1 (fr) * 2018-06-26 2019-12-27 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Conditions de stockage d'une composition de proteines comprenant du tensioactif et evolution de la teneur en tensioactif
SG11202103907PA (en) * 2018-10-18 2021-05-28 Merck Sharp & Dohme Formulations of anti-rsv antibodies and methods of use thereof
AU2019377456A1 (en) 2018-11-07 2021-05-27 Merck Sharp & Dohme Llc Co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
CN111346225A (zh) * 2018-12-21 2020-06-30 上海张江生物技术有限公司 含有蛋白质的药物制剂
MX2021015694A (es) * 2019-06-28 2022-03-11 Genentech Inc Composición y métodos para estabilizar formulaciones líquidas de proteínas.
BR112022000026A2 (pt) * 2019-07-10 2022-06-07 Regeneron Pharma Métodos e composições compreendendo nível reduzido de proteínas de células hospedeiras
EP4096802A4 (en) * 2020-01-29 2024-07-03 Merck Sharp & Dohme LLC METHOD FOR SEPARATION OF HOST CELL LIPASES FROM ANTI-LAG3 ANTIBODY PRODUCTION
CN115605185A (zh) * 2020-05-19 2023-01-13 豪夫迈·罗氏有限公司（Ch） 螯合剂用于防止胃肠外蛋白质溶液中形成可见颗粒的用途
WO2021242908A1 (en) * 2020-05-26 2021-12-02 Lonza Ltd Method of determining surfactant concentration in a protein sample
JP2024509937A (ja) * 2021-03-09 2024-03-05 ジーアイ・イノベイション・インコーポレイテッド Ｉｇｅ ｆｃ受容体のアルファサブユニットの細胞外ドメインを含む融合タンパク質の製剤
AU2023208344A1 (en) * 2022-01-19 2024-08-29 Lonza Biologics Plc. Reducing polysorbate degradation in protein formulations by low amounts of citric acid

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5204244A (en) 1987-10-27 1993-04-20 Oncogen Production of chimeric antibodies by homologous recombination
US5202238A (en) 1987-10-27 1993-04-13 Oncogen Production of chimeric antibodies by homologous recombination
CN1292655C (zh) * 2001-11-08 2007-01-03 蛋白质设计实验室股份有限公司 IgG抗体稳定的液态药物制剂
DE10355251A1 (de) * 2003-11-26 2005-06-23 Merck Patent Gmbh Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor
EP1712240B1 (en) * 2003-12-25 2015-09-09 Kyowa Hakko Kirin Co., Ltd. Stable water-based medicinal preparation containing antibody
US7850962B2 (en) * 2004-04-20 2010-12-14 Genmab A/S Human monoclonal antibodies against CD20
JP5364382B2 (ja) * 2006-02-07 2013-12-11 シャイアー ヒューマン ジェネティック セラピーズ インコーポレイテッド 遊離チオール部分を有するタンパク質の安定化された組成物
US9186323B2 (en) * 2007-05-02 2015-11-17 Novo Nordisk Healthcare Ag High concentration factor VII polypeptide formulations comprising an aromatic preservative and an antioxidant
WO2009009406A1 (en) * 2007-07-06 2009-01-15 Smithkline Beecham Corporation Antibody formulations
US20110152188A1 (en) * 2009-12-23 2011-06-23 Hanns-Christian Mahler Pharmaceutical compositions of igf/i proteins

Also Published As

Publication number Publication date
CA2786952A1 (en) 2011-07-28
EP2525826A2 (en) 2012-11-28
WO2011089062A2 (en) 2011-07-28
BR112012012969A2 (pt) 2017-03-01
CN102711833A (zh) 2012-10-03
RU2012133473A (ru) 2014-02-27
KR20120103702A (ko) 2012-09-19
JP2013517309A (ja) 2013-05-16
US20120294866A1 (en) 2012-11-22
WO2011089062A3 (en) 2012-03-15

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