JP7539761B2 - 医薬製剤 - Google Patents

医薬製剤 Download PDF

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Publication number
JP7539761B2
JP7539761B2 JP2018566642A JP2018566642A JP7539761B2 JP 7539761 B2 JP7539761 B2 JP 7539761B2 JP 2018566642 A JP2018566642 A JP 2018566642A JP 2018566642 A JP2018566642 A JP 2018566642A JP 7539761 B2 JP7539761 B2 JP 7539761B2
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Japan
Prior art keywords
cyclodextrin
antibody
hydroxypropyl
bone
liquid formulation
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JP2018566642A
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Japanese (ja)
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JP2019512540A5 (cg-RX-API-DMAC10.html
JP2019512540A (ja
Inventor
ジェフリー イェイツ，アンドリュー
グレゴリー クリップストーン，ジェームズ
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ユーシービー バイオファーマ エスアールエル
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    • 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
    • A61K47/06—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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
    • 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2018566642A 2016-03-10 2017-03-09 医薬製剤 Active JP7539761B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022001395A JP2022062014A (ja) 2016-03-10 2022-01-07 医薬製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1604124.6 2016-03-10
GBGB1604124.6A GB201604124D0 (en) 2016-03-10 2016-03-10 Pharmaceutical formulation
PCT/EP2017/055594 WO2017153541A1 (en) 2016-03-10 2017-03-09 Pharmaceutical formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022001395A Division JP2022062014A (ja) 2016-03-10 2022-01-07 医薬製剤

Publications (3)

Publication Number Publication Date
JP2019512540A JP2019512540A (ja) 2019-05-16
JP2019512540A5 JP2019512540A5 (cg-RX-API-DMAC10.html) 2020-04-09
JP7539761B2 true JP7539761B2 (ja) 2024-08-26

Family

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Family Applications (2)

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JP2018566642A Active JP7539761B2 (ja) 2016-03-10 2017-03-09 医薬製剤
JP2022001395A Pending JP2022062014A (ja) 2016-03-10 2022-01-07 医薬製剤

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JP2022001395A Pending JP2022062014A (ja) 2016-03-10 2022-01-07 医薬製剤

Country Status (19)

Country Link
US (2) US11576970B2 (cg-RX-API-DMAC10.html)
EP (2) EP3426294B1 (cg-RX-API-DMAC10.html)
JP (2) JP7539761B2 (cg-RX-API-DMAC10.html)
CN (2) CN114767849A (cg-RX-API-DMAC10.html)
CA (1) CA3016117A1 (cg-RX-API-DMAC10.html)
DK (1) DK3426294T3 (cg-RX-API-DMAC10.html)
ES (1) ES2946259T3 (cg-RX-API-DMAC10.html)
FI (1) FI3426294T3 (cg-RX-API-DMAC10.html)
GB (1) GB201604124D0 (cg-RX-API-DMAC10.html)
HR (1) HRP20230733T1 (cg-RX-API-DMAC10.html)
HU (1) HUE062429T2 (cg-RX-API-DMAC10.html)
LT (1) LT3426294T (cg-RX-API-DMAC10.html)
MA (1) MA43705A (cg-RX-API-DMAC10.html)
PL (1) PL3426294T3 (cg-RX-API-DMAC10.html)
PT (1) PT3426294T (cg-RX-API-DMAC10.html)
RS (1) RS64337B1 (cg-RX-API-DMAC10.html)
SI (1) SI3426294T1 (cg-RX-API-DMAC10.html)
SM (1) SMT202300183T1 (cg-RX-API-DMAC10.html)
WO (1) WO2017153541A1 (cg-RX-API-DMAC10.html)

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US10961305B2 (en) 2016-12-21 2021-03-30 Mereo Biopharma 3 Limited Use of anti-sclerostin antibodies in the treatment of osteogenesis imperfecta
KR20200034748A (ko) * 2017-07-27 2020-03-31 지앙수 헨그루이 메디슨 컴퍼니 리미티드 Sost 항체 약학적 조성물 및 그의 용도
EP3774879B1 (en) * 2018-03-30 2026-01-28 Amgen Inc. C-terminal antibody variants
CA3108693A1 (en) * 2018-08-10 2020-02-13 Ashutosh Sharma Method of preparing an antibody pharmaceutical formulation
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
WO2021030179A1 (en) * 2019-08-12 2021-02-18 Amgen Inc. Anti-sclerostin antibody formulations
EP4434517A4 (en) * 2021-11-30 2025-06-25 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Anti-sost antibody pharmaceutical composition and use thereof
WO2023224112A1 (ja) * 2022-05-20 2023-11-23 株式会社ダイセル 液状医薬組成物
CN118236484B (zh) * 2022-12-23 2025-11-04 信立泰(苏州)药业有限公司 一种Romosozumab抗体稳定制剂及其制备方法和用途
WO2024259656A1 (en) * 2023-06-21 2024-12-26 Shanghai Mabgeek Biotech Co., Ltd. Formulation of an anti-il-4 receptor alpha mab or an antigen-binding fragment thereof comprising 2hpbetacd and leucine
KR20260040623A (ko) * 2023-07-19 2026-03-25 암젠 인크 치료 단백질 제형용 완충제 제조 방법
CN118384184A (zh) * 2024-04-25 2024-07-26 北京圣美细胞生命科学工程研究院有限公司 一种经修饰的免疫细胞外泌体组合物及其制备方法

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