CN105007896B - 包含抗体的治疗组合物 - Google Patents

包含抗体的治疗组合物 Download PDF

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Publication number
CN105007896B
CN105007896B CN201380068796.8A CN201380068796A CN105007896B CN 105007896 B CN105007896 B CN 105007896B CN 201380068796 A CN201380068796 A CN 201380068796A CN 105007896 B CN105007896 B CN 105007896B
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CN
China
Prior art keywords
hydrophilic polymer
biopharmaceuticals
preparation
peg
polymer chain
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
CN201380068796.8A
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English (en)
Chinese (zh)
Other versions
CN105007896A (zh
Inventor
M·特罗尔萨斯
J·斯坦库斯
詹姆斯·苏
赛义德·霍萨尼
约书亚·T·史密斯
沙地德·阿斯卡
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Cardiovascular Systems Inc
Original Assignee
Abbott Cardiovascular Systems Inc
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
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Publication of CN105007896A publication Critical patent/CN105007896A/zh
Application granted granted Critical
Publication of CN105007896B publication Critical patent/CN105007896B/zh
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (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)
CN201380068796.8A 2012-12-28 2013-12-27 包含抗体的治疗组合物 Expired - Fee Related CN105007896B (zh)

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 (2)

Publication Number Publication Date
CN105007896A CN105007896A (zh) 2015-10-28
CN105007896B true CN105007896B (zh) 2019-04-09

Family

ID=50000100

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380068796.8A Expired - Fee Related CN105007896B (zh) 2012-12-28 2013-12-27 包含抗体的治疗组合物

Country Status (5)

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

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JP2008543839A (ja) 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
WO2015057910A1 (en) 2013-10-16 2015-04-23 Oncobiologics, Inc. Buffer formulations for enhanced antibody stability
EP3247718B1 (en) 2015-01-21 2021-09-01 Outlook Therapeutics, 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
CN109152831A (zh) * 2015-12-29 2019-01-04 安口生物公司 贝伐珠单抗的缓冲制剂
WO2017136433A1 (en) 2016-02-03 2017-08-10 Oncobiologics, Inc. Buffer formulations for enhanced antibody stability
WO2018075818A1 (en) 2016-10-21 2018-04-26 Amgen Inc. Pharmaceutical formulations and methods of making the same
EP3558363A1 (en) 2016-12-21 2019-10-30 Amgen Inc. Anti-tnf alpha antibody formulations
JP7216006B2 (ja) 2017-03-22 2023-01-31 ジェネンテック, インコーポレイテッド ヒドロゲル架橋ヒアルロン酸プロドラッグ組成物及び方法
CN113038934A (zh) 2018-07-09 2021-06-25 里珍纳龙药品有限公司 水凝胶的释放动力学的调节
JP2021535206A (ja) * 2018-08-23 2021-12-16 バーンスタイン,エリック,エフ. 皮膚状態を治療するために抗vegf化合物を適用するためおよびこのような化合物を使用するためのシステム、デバイスおよび方法
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
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
JP2024531616A (ja) * 2021-09-09 2024-08-29 ソンバイオ・インコーポレイテッド 6-arm PEG水和ゲルの時間経過によるゾル-ゲル転換

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN101123988A (zh) * 2005-02-21 2008-02-13 株式会社Lg生命科学 蛋白药物的缓释组合物

Family Cites Families (10)

* 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
US8828433B2 (en) 2005-04-19 2014-09-09 Advanced Cardiovascular Systems, Inc. Hydrogel bioscaffoldings and biomedical device coatings
JP2009532351A (ja) * 2006-03-31 2009-09-10 バクスター・インターナショナル・インコーポレイテッド ペグ化第viii因子
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
US9492383B2 (en) * 2011-04-20 2016-11-15 Carbylan Therapeutics, Inc. Rapid in-situ gel forming compositions prepared via reaction of vinyl sulfone derivatized hyaluronic acid with thiol derivatized polyethylene glycol at alkaline pH

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN101123988A (zh) * 2005-02-21 2008-02-13 株式会社Lg生命科学 蛋白药物的缓释组合物

Also Published As

Publication number Publication date
WO2014106116A8 (en) 2015-06-18
EP2938323A2 (en) 2015-11-04
US20140186446A1 (en) 2014-07-03
WO2014106116A3 (en) 2014-07-31
JP2016504369A (ja) 2016-02-12
WO2014106116A2 (en) 2014-07-03
CN105007896A (zh) 2015-10-28
JP6533932B2 (ja) 2019-06-26
US20170042816A1 (en) 2017-02-16
US9452138B2 (en) 2016-09-27

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Granted publication date: 20190409

Termination date: 20211227