MX2016007878A - Composicion farmaceutica que comprende adalimumab. - Google Patents

Composicion farmaceutica que comprende adalimumab.

Info

Publication number
MX2016007878A
MX2016007878A MX2016007878A MX2016007878A MX2016007878A MX 2016007878 A MX2016007878 A MX 2016007878A MX 2016007878 A MX2016007878 A MX 2016007878A MX 2016007878 A MX2016007878 A MX 2016007878A MX 2016007878 A MX2016007878 A MX 2016007878A
Authority
MX
Mexico
Prior art keywords
pharmaceutical composition
adalimumab
protective agent
structural protective
trehalose
Prior art date
Application number
MX2016007878A
Other languages
English (en)
Inventor
Bai Hua
Fang Weijie
Wang Haibin
QIU Minhong
Zheng Hongjian
Ying Yuebin
Original Assignee
Zhejiang Hisun Pharm Co Ltd
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 Zhejiang Hisun Pharm Co Ltd filed Critical Zhejiang Hisun Pharm Co Ltd
Publication of MX2016007878A publication Critical patent/MX2016007878A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • 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
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders

Landscapes

  • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Epidemiology (AREA)
  • Rheumatology (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Se divulga una composición farmacéutica que comprende adalimumab y un estabilizador de estructura, en donde el estabilizador de estructura selecciona de sacarosa o trehalosa y la composición farmacéutica tiene una alta estabilidad.
MX2016007878A 2013-12-16 2014-12-12 Composicion farmaceutica que comprende adalimumab. MX2016007878A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201310693338.5A CN104707146B (zh) 2013-12-16 2013-12-16 一种含有阿达木单抗的药物组合物
PCT/CN2014/093722 WO2015090162A1 (zh) 2013-12-16 2014-12-12 一种含有阿达木单抗的药物组合物

Publications (1)

Publication Number Publication Date
MX2016007878A true MX2016007878A (es) 2016-10-21

Family

ID=53402094

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016007878A MX2016007878A (es) 2013-12-16 2014-12-12 Composicion farmaceutica que comprende adalimumab.

Country Status (5)

Country Link
EP (1) EP3085385B1 (es)
CN (1) CN104707146B (es)
MX (1) MX2016007878A (es)
RU (1) RU2664736C2 (es)
WO (1) WO2015090162A1 (es)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
ES2607489T3 (es) 2014-05-23 2017-03-31 Ares Trading S.A. Composición farmacéutica líquida
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
CN106620691B (zh) * 2015-11-04 2020-08-21 信达生物制药(苏州)有限公司 一种重组全人源抗ctla-4单克隆抗体制剂及其应用
CN106955361B (zh) * 2016-01-08 2020-10-27 浙江海正药业股份有限公司 一种含有结核病***反应原ce的药物组合物
EP3402470A4 (en) * 2016-01-12 2019-11-13 Dr. Reddy's Laboratories Limited STABLE PHARMACEUTICAL COMPOSITION
US11951207B2 (en) * 2016-06-30 2024-04-09 Celltrion Inc. Stable liquid pharmaceutical preparation
WO2018119142A1 (en) * 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
JP7177777B2 (ja) * 2017-01-11 2022-11-24 セルトリオン, インク. 安定した液体製剤
CN106913869B (zh) * 2017-03-17 2020-07-28 信达生物制药(苏州)有限公司 一种抗ctla-4单克隆抗体制剂及其应用
CN108686205B (zh) * 2017-04-07 2021-12-10 海正生物制药有限公司 英夫利西单抗冻干制剂
CN108686204A (zh) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 包含组氨酸缓冲体系的英夫利西单抗组合物
EA201900360A1 (ru) * 2017-12-29 2019-12-30 Закрытое Акционерное Общество "Биокад" ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα
CN111665352B (zh) * 2020-06-23 2024-05-17 广州市丹蓝生物科技有限公司 一种储存剂及由其制备的抗体溶液制剂及其应用

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1516628B1 (en) * 1995-07-27 2013-08-21 Genentech, Inc. Stable isotonic lyophilized protein formulation
ZA966075B (en) * 1995-07-27 1998-01-19 Genentech Inc Protein formulation.
US20040033228A1 (en) * 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
EP1998806A1 (en) * 2006-03-28 2008-12-10 F. Hoffmann-Roche AG Anti-igf-1r human monoclonal antibody formulation
CA2904458C (en) * 2007-11-30 2017-07-25 Wolfgang Fraunhofer Protein formulations and methods of making same
SG187473A1 (en) * 2008-01-15 2013-02-28 Abbott Gmbh & Co Kg Powdered protein compositions and methods of making same
NZ595694A (en) * 2009-05-04 2013-09-27 Abbvie Biotechnology Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
WO2011104381A2 (en) * 2010-02-26 2011-09-01 Novo Nordisk A/S Stable antibody containing compositions
MY161390A (en) * 2010-06-24 2017-04-14 Genentech Inc Compositions and methods containing alkylglycosides for stabilizing protein-containing formulations
MX363700B (es) * 2012-03-07 2019-03-29 Cadila Healthcare Ltd Formulaciones farmaceuticas de anticuerpos tnf-alfa.

Also Published As

Publication number Publication date
EP3085385B1 (en) 2021-08-25
WO2015090162A1 (zh) 2015-06-25
CN104707146A (zh) 2015-06-17
CN104707146B (zh) 2019-04-16
RU2016125159A (ru) 2018-01-23
EP3085385A1 (en) 2016-10-26
EP3085385A4 (en) 2017-06-28
RU2664736C2 (ru) 2018-08-22

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