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
csf
liquid formulation
disorders
formulation
neutralizing compound
Prior art date
Application number
MX2016014411A
Other languages
English (en)
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

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K47/16—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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243—Colony Stimulating Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist 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)
  • 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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Pulmonology (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (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. MX2016014411A (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 (1)

Publication Number Publication Date
MX2016014411A true MX2016014411A (es) 2017-04-06

Family

ID=50721582

Family Applications (1)

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

Country Status (14)

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)
CA (1) CA2946230A1 (es)
EA (1) EA201691883A1 (es)
MX (1) MX2016014411A (es)
PH (1) PH12016502100A1 (es)
TW (1) TWI682788B (es)
WO (1) WO2015169742A1 (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
MA53831A (fr) * 2018-10-01 2022-01-05 Amgen Inc Méthodes permettant de réduire l'agrégation d'anticorps bispécifiques
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
AU2020370372A1 (en) * 2019-10-25 2022-05-12 Amgen Inc. Compositions and methods for minimizing protein loss at low protein concentrations
AU2021392308A1 (en) * 2020-12-04 2023-06-22 CSL Innovation Pty Ltd Methods for treating inflammatory skin conditions
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
AU2022274319A1 (en) * 2021-05-12 2024-01-04 Anaptysbio, Inc. Antibody composition
WO2024114735A1 (en) * 2022-12-01 2024-06-06 I-Mab Biopharma (Hangzhou) Co., Ltd. Liquid pharmaceutical formulation of anti-gm-csf antibody and uses thereof

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Also Published As

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

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