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MX2016014411A - Formulacion liquida que comprende un compuesto neutralizante de gm-csf. - Google Patents

Formulacion liquida que comprende un compuesto neutralizante de gm-csf.

Info

Publication number
MX2016014411A
MX2016014411A MX2016014411A MX2016014411A MX2016014411A MX 2016014411 A MX2016014411 A MX 2016014411A MX 2016014411 A MX2016014411 A MX 2016014411A MX 2016014411 A MX2016014411 A MX 2016014411A MX 2016014411 A MX2016014411 A MX 2016014411A
Authority
MX
Mexico
Prior art keywords
neutralizing compound
csf neutralizing
formulation
disorders
liquid formulation
Prior art date
Application number
MX2016014411A
Other languages
English (en)
Other versions
MX387451B (es
Inventor
Diluzio Willow
Nguyen Phuong
Original Assignee
Takeda Gmbh
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 Takeda Gmbh filed Critical Takeda Gmbh
Publication of MX2016014411A publication Critical patent/MX2016014411A/es
Publication of MX387451B publication Critical patent/MX387451B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • 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
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243Colony Stimulating Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención se refiere a formulaciones acuosas que comprenden un compuesto neutralizante de GM-CSF en concentraciones de al menos aproximadamente 20 mg/ml, un modificador de la tonicidad, un buffer y uno o más de surfactantes, aminoácidos, antioxidantes y/o agentes quelantes, en donde la composición es estable. Los ingredientes de la formulación preferiblemente proveen estabilidad al compuesto neutralizante GM-CSF en vista del almacenamiento a largo plazo. En un aspecto preferido, la formulación es para uso en terapia, preferiblemente para su uso en el tratamiento de trastornos inflamatorios y autoinmunes, incluyendo preferiblemente trastornos alérgicos y psoriáticos, así como también trastornos artríticos y asmáticos. Adicionalmente, se provee un kit que comprende la formulación de la invención.
MX2016014411A 2014-05-07 2015-05-04 Formulacion liquida que comprende un compuesto neutralizante de gm-csf. MX387451B (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP14167405 2014-05-07
US201461994319P 2014-05-16 2014-05-16
US201462043636P 2014-08-29 2014-08-29
PCT/EP2015/059709 WO2015169742A1 (en) 2014-05-07 2015-05-04 Liquid formulation comprising gm-csf neutralizing compound

Publications (2)

Publication Number Publication Date
MX2016014411A true MX2016014411A (es) 2017-04-06
MX387451B MX387451B (es) 2025-03-18

Family

ID=50721582

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016014411A MX387451B (es) 2014-05-07 2015-05-04 Formulacion liquida que comprende un compuesto neutralizante de gm-csf.

Country Status (15)

Country Link
US (1) US11173208B2 (es)
EP (1) EP3139960B1 (es)
JP (1) JP6769879B2 (es)
KR (1) KR102385802B1 (es)
CN (1) CN106659785B (es)
AR (1) AR100268A1 (es)
AU (1) AU2015257798C1 (es)
BR (1) BR112016025126B1 (es)
EA (1) EA201691883A1 (es)
ES (1) ES2974895T3 (es)
MX (1) MX387451B (es)
PH (1) PH12016502100A1 (es)
TW (1) TWI682788B (es)
WO (1) WO2015169742A1 (es)
ZA (1) ZA201607097B (es)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20190255A1 (ar) 2017-04-28 2019-10-27 Amgen Inc صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها
CN107167613B (zh) * 2017-06-22 2018-10-02 深圳清华大学研究院 用于等离子体金芯片的蛋白点样缓冲液
EA202190955A1 (ru) * 2018-10-01 2021-08-17 Эмджен Инк. Способы снижения агрегации биспецифических антител
US11267858B2 (en) 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment using G-CSF protein complex
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
WO2021081326A1 (en) * 2019-10-25 2021-04-29 Amgen Inc. Compositions and methods for minimizing protein loss at low protein concentrations
BR112022024296A2 (pt) * 2020-05-29 2023-04-25 Amgen Inc Formulações de anticorpos e seus usos
KR20230124910A (ko) * 2020-12-04 2023-08-28 씨에스엘 이노베이션 피티와이 엘티디 염증성 피부 상태 치료 방법
WO2022133519A1 (en) * 2020-12-21 2022-06-30 CSL Innovation Pty Ltd Methods for treating or preventing acute respiratory distress syndrome
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
JP2024518536A (ja) * 2021-05-12 2024-05-01 アナプティスバイオ インコーポレイティッド 抗体組成物
JP2025539457A (ja) * 2022-12-01 2025-12-05 アイ-エムエービー バイオファーマ (ハンジョウ) カンパニー リミテッド 抗gm-csf抗体の液体医薬品製剤及びその用途

Family Cites Families (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2916711A1 (de) 1979-04-25 1980-11-06 Behringwerke Ag Blutgerinnungsfaktoren und verfahren zu ihrer herstellung
US4783441A (en) 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
DE3583880D1 (de) 1984-04-09 1991-10-02 Takeda Chemical Industries Ltd Stabile interleukin-2-zusammensetzung.
DE3883899T3 (de) 1987-03-18 1999-04-22 Sb2, Inc., Danville, Calif. Geänderte antikörper.
GB8903593D0 (en) 1989-02-16 1989-04-05 Pafra Ltd Storage of materials
WO1994009149A1 (en) 1990-08-10 1994-04-28 Amrad Corporation Limited Monoclonal antibody
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
PT1516628E (pt) 1995-07-27 2013-09-24 Genentech Inc Formulação de proteína liofilizada isotónica estável
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
DE69909459T2 (de) 1998-04-21 2004-05-27 Micromet Ag Cd19xcd3 spezifische polypeptide und deren verwendung
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
PT1478394E (pt) 2002-02-27 2008-10-08 Immunex Corp Composição estabilizada compreendendo tnfr - fc e arginina
US7511476B2 (en) * 2005-01-04 2009-03-31 Digisensors, Inc. Electromagnetic sensor systems and methods of use thereof
SI1874819T1 (sl) 2005-04-18 2015-09-30 Amgen Research (Munich) Gmbh Protitelesni nevtralizatorji humanega faktorja stimulacije kolonij granulocitov makrofagov
CA2608498C (en) 2005-05-18 2017-04-04 Morphosys Ag Anti-gm-csf antibodies and uses therefor
JP4736037B2 (ja) * 2005-10-26 2011-07-27 株式会社イーベック ヒトgm−csfに結合するヒトのモノクローナル抗体並びにその抗原結合部分
ES2609088T3 (es) 2006-02-08 2017-04-18 Morphotek, Inc. Péptidos GM-CSF antigénicos y anticuerpos anti-GM-CSF
DK1999152T3 (da) 2006-03-27 2013-01-14 Medimmune Ltd Bindende element til gm-csf-receptor
EP1970384A1 (en) 2007-03-14 2008-09-17 Ganymed Pharmaceuticals AG Monoclonal antibodies for treatment of cancer
MX2009013886A (es) * 2007-06-25 2010-01-27 Amgen Inc Composiciones de agentes de aglutinacion especifica al factor de crecimiento de los hepatocitos.
TW200918553A (en) * 2007-09-18 2009-05-01 Amgen Inc Human GM-CSF antigen binding proteins
PT2215119E (pt) 2007-11-13 2013-02-11 Boehringer Ingelheim Int Anticorpos monoclonais que se ligam a hgm-csf e composições médicas que os compreendem
KR101852915B1 (ko) 2008-04-28 2018-04-27 휴머니건, 아이엔씨. 과립구-대식세포 콜로니 자극 인자에 대한 항체
EP2362767B1 (en) * 2008-10-29 2017-12-06 Ablynx N.V. Formulations of single domain antigen binding molecules
CN102686241A (zh) * 2009-12-29 2012-09-19 霍夫曼-拉罗奇有限公司 抗体配制剂
CN104995210A (zh) * 2012-09-20 2015-10-21 莫弗系统股份公司 类风湿关节炎的治疗
AR093297A1 (es) * 2012-10-31 2015-05-27 Amgen Res Munich Gmbh Formulacion liquida que comprende un compuesto neutralizante de gm-csf

Also Published As

Publication number Publication date
TW201622702A (zh) 2016-07-01
BR112016025126A8 (pt) 2022-08-09
JP2017514868A (ja) 2017-06-08
EA201691883A1 (ru) 2017-05-31
US11173208B2 (en) 2021-11-16
CN106659785A (zh) 2017-05-10
AU2015257798A1 (en) 2016-11-17
KR102385802B1 (ko) 2022-04-13
AR100268A1 (es) 2016-09-21
WO2015169742A1 (en) 2015-11-12
EP3139960A1 (en) 2017-03-15
AU2015257798B2 (en) 2020-04-23
US20170252436A1 (en) 2017-09-07
ES2974895T3 (es) 2024-07-02
CN106659785B (zh) 2021-04-30
JP6769879B2 (ja) 2020-10-14
EP3139960B1 (en) 2024-01-17
AU2015257798C1 (en) 2020-10-22
MX387451B (es) 2025-03-18
TWI682788B (zh) 2020-01-21
BR112016025126A2 (pt) 2018-02-20
ZA201607097B (en) 2024-11-27
CA2946230A1 (en) 2015-11-12
BR112016025126B1 (pt) 2024-02-15
PH12016502100A1 (en) 2017-02-06
KR20160149210A (ko) 2016-12-27

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