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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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (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
KR20150132332A (ko) 2013-03-15 2015-11-25 글락소스미스클라인 인털렉츄얼 프로퍼티 (넘버 2) 리미티드 저농도 항체 제형
US10525137B2 (en) * 2015-12-30 2020-01-07 Genentech, Inc. Formulations with reduced degradation of polysorbate
CN109716127B (zh) * 2016-08-15 2022-06-14 豪夫迈·罗氏有限公司 定量包含非离子表面活性剂和多肽的组合物中非离子表面活性剂的层析方法
JP2020512830A (ja) * 2017-03-17 2020-04-30 ロングボート アムニオティクス アーベーＬｏｎｇｂｏａｔ Ａｍｎｉｏｔｉｃｓ Ａｂ 細胞ストレス及び活性酸素を低減するための方法、システム、因子、および培地
WO2019002295A1 (en) 2017-06-27 2019-01-03 Coriolis Pharma Research GmbH QUANTITATIVE DETERMINATION OF POLYSORBATE
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
MY209127A (en) * 2018-10-18 2025-06-23 Merck Sharp & Dohme Llc Formulations of anti-rsv antibodies and methods of use thereof
EP3876990A4 (en) 2018-11-07 2023-09-06 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
CN114040754A (zh) * 2019-06-28 2022-02-11 基因泰克公司 用于稳定液体蛋白质制剂的组合物及方法
CN114206381A (zh) * 2019-07-10 2022-03-18 瑞泽恩制药公司 宿主细胞蛋白水平降低的合成物及其制备方法
EP4096802A4 (en) * 2020-01-29 2024-07-03 Merck Sharp & Dohme LLC METHOD FOR SEPARATION OF HOST CELL LIPASES FROM ANTI-LAG3 ANTIBODY PRODUCTION
EP4153130A1 (en) * 2020-05-19 2023-03-29 F. Hoffmann-La Roche AG The use of chelators for the prevention of visible particle formation in parenteral protein solutions
WO2021242908A1 (en) * 2020-05-26 2021-12-02 Lonza Ltd Method of determining surfactant concentration in a protein sample
KR20220126654A (ko) * 2021-03-09 2022-09-16 (주)지아이이노베이션 IgE Fc 수용체의 알파 서브유닛의 세포외 도메인을 포함하는 융합단백질의 제형
JP2025503755A (ja) * 2022-01-19 2025-02-04 ロンザ リミテッド 少量のクエン酸によるタンパク質製剤におけるポリソルベート分解の低減

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5202238A (en) 1987-10-27 1993-04-13 Oncogen Production of chimeric antibodies by homologous recombination
US5204244A (en) 1987-10-27 1993-04-20 Oncogen Production of chimeric antibodies by homologous recombination
US20030138417A1 (en) * 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
DE10355251A1 (de) * 2003-11-26 2005-06-23 Merck Patent Gmbh Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor
US20070184050A1 (en) * 2003-12-25 2007-08-09 Kirin Beer Kabushiki Kaisha Stable water-based medicinal preparation containing antibody
EP1740946B1 (en) * 2004-04-20 2013-11-06 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
CN104887620A (zh) * 2007-05-02 2015-09-09 诺沃—诺迪斯克保健股份有限公司 包括芳香族防腐剂和抗氧化剂的高浓度因子vii多肽制剂
US20100189721A1 (en) * 2007-07-06 2010-07-29 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
CN102711833A (zh) 2012-10-03
RU2012133473A (ru) 2014-02-27
BR112012012969A2 (pt) 2017-03-01
WO2011089062A3 (en) 2012-03-15
KR20120103702A (ko) 2012-09-19
CA2786952A1 (en) 2011-07-28
EP2525826A2 (en) 2012-11-28
US20120294866A1 (en) 2012-11-22
WO2011089062A2 (en) 2011-07-28
JP2013517309A (ja) 2013-05-16

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Legal Events

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