JP6533932B2 - 抗体を含む治療用組成物 - Google Patents

抗体を含む治療用組成物 Download PDF

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JP6533932B2
JP6533932B2 JP2015550818A JP2015550818A JP6533932B2 JP 6533932 B2 JP6533932 B2 JP 6533932B2 JP 2015550818 A JP2015550818 A JP 2015550818A JP 2015550818 A JP2015550818 A JP 2015550818A JP 6533932 B2 JP6533932 B2 JP 6533932B2
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peg
hydrophilic polymer
formulation
polymer chains
biological therapeutic
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Japanese (ja)
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JP2016504369A5 (enExample
JP2016504369A (ja
Inventor
トロールサス,ミカエル
スタンクス,ジョン
スー,ジェイムス
ホッサイニー,シード
スミス,ジョシュア,タケシ
アスカー,シャディド
Original Assignee
アボット カーディオバスキュラー システムズ インコーポレイテッド
アボット カーディオバスキュラー システムズ インコーポレイテッド
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • 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
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • 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
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • 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
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • A61K38/215IFN-beta
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
JP2015550818A 2012-12-28 2013-12-27 抗体を含む治療用組成物 Active JP6533932B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261747176P 2012-12-28 2012-12-28
US61/747,176 2012-12-28
PCT/US2013/078102 WO2014106116A2 (en) 2012-12-28 2013-12-27 Delivery of biologic therapeutics

Publications (3)

Publication Number Publication Date
JP2016504369A JP2016504369A (ja) 2016-02-12
JP2016504369A5 JP2016504369A5 (enExample) 2017-02-09
JP6533932B2 true JP6533932B2 (ja) 2019-06-26

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Application Number Title Priority Date Filing Date
JP2015550818A Active JP6533932B2 (ja) 2012-12-28 2013-12-27 抗体を含む治療用組成物

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Country Link
US (2) US9452138B2 (enExample)
EP (1) EP2938323A2 (enExample)
JP (1) JP6533932B2 (enExample)
CN (1) CN105007896B (enExample)
WO (1) WO2014106116A2 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1909831A4 (en) 2005-06-14 2013-02-20 Amgen Inc SELF-BUFFING PROTEIN FORMULATIONS
US10376582B2 (en) 2013-10-16 2019-08-13 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
WO2016118707A1 (en) 2015-01-21 2016-07-28 Oncobiologics, Inc. Modulation of charge variants in a monoclonal antibody composition
EP3078675A1 (en) 2015-04-10 2016-10-12 Ares Trading S.A. Induction dosing regimen for the treatment of tnf alpha mediated disorders
AU2016382786A1 (en) * 2015-12-29 2018-07-19 Outlook Therapeutics, Inc. Buffered formulations of bevacizumab
AU2017213775A1 (en) 2016-02-03 2018-08-16 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
AU2017345490B2 (en) 2016-10-21 2022-07-07 Amgen Inc. Pharmaceutical formulations and methods of making the same
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
CA3055985A1 (en) 2017-03-22 2018-09-27 Genentech, Inc. Hydrogel cross-linked hyaluronic acid prodrug compositions and methods
JP2021530480A (ja) * 2018-07-09 2021-11-11 リジェネロン・ファーマシューティカルズ・インコーポレイテッドRegeneron Pharmaceuticals, Inc. ハイドロゲルにおける放出速度の調整
CN113286579A (zh) * 2018-08-23 2021-08-20 埃里克·F·伯恩斯坦 应用抗vegf化合物和使用这类化合物治疗皮肤病的系统、装置和方法
CN112569358B (zh) * 2019-09-30 2022-06-28 上海生物制品研究所有限责任公司 培干扰素和原癌基因产物靶向抑制剂在协同抑制肿瘤中的应用
CN112569359A (zh) * 2019-09-30 2021-03-30 上海生物制品研究所有限责任公司 培干扰素和原癌基因产物靶向抑制剂在协同治疗肾癌中的应用
US20240269349A1 (en) * 2021-09-09 2024-08-15 Sunbio Inc. Sol-gel conversion over time of 6-arm peg hydrogel

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL7908799A (nl) * 1978-12-22 1980-06-24 Tno Werkwijze voor de bereiding van een polymeermengsel, gevormde produkten, verkregen daaruit en polymeer- legering.
US5971953A (en) * 1998-01-09 1999-10-26 Bachynsky; Nicholas Dual chamber syringe apparatus
US6605273B2 (en) * 1999-04-08 2003-08-12 Schering Corporation Renal cell carcinoma treatment
CN1569892A (zh) * 2004-04-30 2005-01-26 新峰生物科技(上海)有限公司 多臂树杈型聚乙二醇与蛋白质或多肽的结合物及其制备方法
MY139088A (en) * 2005-02-21 2009-08-28 Lg Life Sciences Ltd Sustained release composition of protein drug
US8828433B2 (en) * 2005-04-19 2014-09-09 Advanced Cardiovascular Systems, Inc. Hydrogel bioscaffoldings and biomedical device coatings
NZ572050A (en) * 2006-03-31 2011-09-30 Baxter Int Factor VIII conjugated to polyethylene glycol
US7732190B2 (en) 2006-07-31 2010-06-08 Advanced Cardiovascular Systems, Inc. Modified two-component gelation systems, methods of use and methods of manufacture
EP2014256A1 (en) * 2007-07-12 2009-01-14 Straumann Holding AG Composite bone repair material
US8642737B2 (en) * 2010-07-26 2014-02-04 Baxter International Inc. Nucleophilic catalysts for oxime linkage
US8524215B2 (en) * 2010-08-02 2013-09-03 Janssen Biotech, Inc. Absorbable PEG-based hydrogels
ES2537411T3 (es) * 2011-04-20 2015-06-08 Carbylan Therapeutics, Inc. Composiciones formadoras de gel in situ

Also Published As

Publication number Publication date
US20140186446A1 (en) 2014-07-03
WO2014106116A8 (en) 2015-06-18
US20170042816A1 (en) 2017-02-16
CN105007896B (zh) 2019-04-09
CN105007896A (zh) 2015-10-28
WO2014106116A3 (en) 2014-07-31
US9452138B2 (en) 2016-09-27
EP2938323A2 (en) 2015-11-04
WO2014106116A2 (en) 2014-07-03
JP2016504369A (ja) 2016-02-12

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