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MX387451B - 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
MX387451B
MX387451B MX2016014411A MX2016014411A MX387451B MX 387451 B MX387451 B MX 387451B MX 2016014411 A MX2016014411 A MX 2016014411A MX 2016014411 A MX2016014411 A MX 2016014411A MX 387451 B MX387451 B MX 387451B
Authority
MX
Mexico
Prior art keywords
liquid formulation
present
neutralizing compound
csf neutralizing
concentration
Prior art date
Application number
MX2016014411A
Other languages
English (en)
Other versions
MX2016014411A (es
Inventor
Phuong Nguyen
Willow Diluzio
Original Assignee
Takeda Pharmaceuticals Co
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 Pharmaceuticals Co filed Critical Takeda Pharmaceuticals Co
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
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • A61K47/08Organic 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (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)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (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 una composición acuosa que comprende i) un anticuerpo monoclonal humano o un fragmento funcional del mismo que se enlaza a GM-CSF, ii) un modificador de tonicidad, que está presente en una concentración de 3% a 7%(p/v), en done dicho modificador de tonicidad es sorbitol; iii) un amortiguador, que está presente en una concentración de mM a 40 mM, en done dicho amortiguador es un buffer de histidina; y iv) un tensoactivo, que está presente en una concentración de 0.01% a 0.08%(p/v), en donde el tensoactivo es polisorbato 80, en donde el pH está entre 5 y 7.
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 MX2016014411A (es) 2017-04-06
MX387451B true 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)

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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
MX2021003628A (es) * 2018-10-01 2021-05-27 Amgen Inc Metodos para reducir la agregacion de anticuerpos biespecificos.
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
US11267858B2 (en) 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment 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
CA3198765A1 (en) * 2020-12-04 2022-06-09 Catherine Mary Owczarek Methods for treating inflammatory skin conditions
KR20230123477A (ko) * 2020-12-21 2023-08-23 씨에스엘 이노베이션 피티와이 엘티디 급성 호흡곤란 증후군의 치료 또는 예방 방법
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
CN117615788A (zh) * 2021-05-12 2024-02-27 安奈普泰斯生物有限公司 抗体组合物
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

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Also Published As

Publication number Publication date
KR102385802B1 (ko) 2022-04-13
WO2015169742A1 (en) 2015-11-12
TW201622702A (zh) 2016-07-01
CN106659785B (zh) 2021-04-30
EP3139960A1 (en) 2017-03-15
PH12016502100A1 (en) 2017-02-06
EA201691883A1 (ru) 2017-05-31
AU2015257798B2 (en) 2020-04-23
BR112016025126A2 (pt) 2018-02-20
US20170252436A1 (en) 2017-09-07
CN106659785A (zh) 2017-05-10
EP3139960B1 (en) 2024-01-17
US11173208B2 (en) 2021-11-16
CA2946230A1 (en) 2015-11-12
ZA201607097B (en) 2024-11-27
TWI682788B (zh) 2020-01-21
JP6769879B2 (ja) 2020-10-14
AU2015257798C1 (en) 2020-10-22
BR112016025126B1 (pt) 2024-02-15
AR100268A1 (es) 2016-09-21
MX2016014411A (es) 2017-04-06
JP2017514868A (ja) 2017-06-08
KR20160149210A (ko) 2016-12-27
ES2974895T3 (es) 2024-07-02
BR112016025126A8 (pt) 2022-08-09
AU2015257798A1 (en) 2016-11-17

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