JP6884858B2 - 医薬製剤及びその製造方法 - Google Patents

医薬製剤及びその製造方法 Download PDF

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JP6884858B2
JP6884858B2 JP2019520794A JP2019520794A JP6884858B2 JP 6884858 B2 JP6884858 B2 JP 6884858B2 JP 2019520794 A JP2019520794 A JP 2019520794A JP 2019520794 A JP2019520794 A JP 2019520794A JP 6884858 B2 JP6884858 B2 JP 6884858B2
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pharmaceutical composition
etanercept
composition according
arginine
weeks
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Japanese (ja)
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JP2019533679A5 (enExample
JP2019533679A (ja
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ゴス，モニカ
ボール，ニコール
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アムジエン・インコーポレーテツド
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Priority to JP2023180119A priority patent/JP7754903B2/ja
Priority to JP2025165212A priority patent/JP2026004430A/ja
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    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • 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
    • A61K47/16—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
    • A61K47/26—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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • 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
    • 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]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/32—Fusion polypeptide fusions with soluble part of a cell surface receptor, "decoy receptors"

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Toxicology (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)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2019520794A 2016-10-21 2017-10-19 医薬製剤及びその製造方法 Active JP6884858B2 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2021080160A JP7402195B2 (ja) 2016-10-21 2021-05-11 医薬製剤及びその製造方法
JP2023180119A JP7754903B2 (ja) 2016-10-21 2023-10-19 医薬製剤及びその製造方法
JP2025165212A JP2026004430A (ja) 2016-10-21 2025-10-01 医薬製剤及びその製造方法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662411458P 2016-10-21 2016-10-21
US62/411,458 2016-10-21
PCT/US2017/057472 WO2018075818A1 (en) 2016-10-21 2017-10-19 Pharmaceutical formulations and methods of making the same

Related Child Applications (1)

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JP2021080160A Division JP7402195B2 (ja) 2016-10-21 2021-05-11 医薬製剤及びその製造方法

Publications (3)

Publication Number Publication Date
JP2019533679A JP2019533679A (ja) 2019-11-21
JP2019533679A5 JP2019533679A5 (enExample) 2020-12-10
JP6884858B2 true JP6884858B2 (ja) 2021-06-09

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JP2019520794A Active JP6884858B2 (ja) 2016-10-21 2017-10-19 医薬製剤及びその製造方法
JP2021080160A Active JP7402195B2 (ja) 2016-10-21 2021-05-11 医薬製剤及びその製造方法
JP2023180119A Active JP7754903B2 (ja) 2016-10-21 2023-10-19 医薬製剤及びその製造方法
JP2025165212A Pending JP2026004430A (ja) 2016-10-21 2025-10-01 医薬製剤及びその製造方法

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JP2021080160A Active JP7402195B2 (ja) 2016-10-21 2021-05-11 医薬製剤及びその製造方法
JP2023180119A Active JP7754903B2 (ja) 2016-10-21 2023-10-19 医薬製剤及びその製造方法
JP2025165212A Pending JP2026004430A (ja) 2016-10-21 2025-10-01 医薬製剤及びその製造方法

Country Status (20)

Country Link
US (5) US20180110856A1 (enExample)
EP (2) EP3528787B1 (enExample)
JP (4) JP6884858B2 (enExample)
KR (2) KR102413592B1 (enExample)
CN (2) CN114917185B (enExample)
AU (1) AU2017345490B2 (enExample)
CA (1) CA3040899A1 (enExample)
CL (1) CL2019001053A1 (enExample)
DK (1) DK3528787T3 (enExample)
EA (1) EA201990998A1 (enExample)
ES (1) ES3064802T3 (enExample)
FI (1) FI3528787T3 (enExample)
IL (1) IL266132B (enExample)
LT (1) LT3528787T (enExample)
MX (1) MX2019004580A (enExample)
PL (1) PL3528787T3 (enExample)
PT (1) PT3528787T (enExample)
SG (1) SG11201903521XA (enExample)
SI (1) SI3528787T1 (enExample)
WO (1) WO2018075818A1 (enExample)

Cited By (1)

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Publication number Priority date Publication date Assignee Title
JP2021120393A (ja) * 2016-10-21 2021-08-19 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法

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GB201911461D0 (en) * 2019-08-09 2019-09-25 Arecor Ltd Novel composition
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US20230081265A1 (en) * 2020-04-06 2023-03-16 The Board Of Trustees Of The Leland Stanford Junior University Antibody formulation
US11777543B2 (en) 2020-05-12 2023-10-03 Nec Corporation Distortion compensation apparatus and distortion compensation method

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Publication number Priority date Publication date Assignee Title
JP2021120393A (ja) * 2016-10-21 2021-08-19 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法
JP7402195B2 (ja) 2016-10-21 2023-12-20 アムジエン・インコーポレーテツド 医薬製剤及びその製造方法

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