MX2021012672A - Inyeccion estable de secukinumab y procedimiento de preparacion del mismo. - Google Patents

Inyeccion estable de secukinumab y procedimiento de preparacion del mismo.

Info

Publication number
MX2021012672A
MX2021012672A MX2021012672A MX2021012672A MX2021012672A MX 2021012672 A MX2021012672 A MX 2021012672A MX 2021012672 A MX2021012672 A MX 2021012672A MX 2021012672 A MX2021012672 A MX 2021012672A MX 2021012672 A MX2021012672 A MX 2021012672A
Authority
MX
Mexico
Prior art keywords
stable
mmol
secukinumab
injection
preparation
Prior art date
Application number
MX2021012672A
Other languages
English (en)
Inventor
Nan Zhang
Depeng Wang
Shanshan Wei
Xindan Fan
Zhongyu Zhang
Chunsheng Leng
Xiaohui Chang
Original Assignee
Tonghua Dongbao Pharmaceutical 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 Tonghua Dongbao Pharmaceutical Co Ltd filed Critical Tonghua Dongbao Pharmaceutical Co Ltd
Publication of MX2021012672A publication Critical patent/MX2021012672A/es

Links

Classifications

    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule

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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Se proporciona una inyección estable de secukinumab y un procedimiento de preparación del mismo. La inyección estable de secukinumab se compone de los siguientes ingredientes: 50 mg/ml - 300 mg/ml de secukinumab, 5 mmol/l - 50 mmol/l de histidina y un clorhidrato de histidina, 5 mmol/l - 50 mmol/l de metionina, 150 mmol/l - 400 mmol/l de un alcohol bajo en azúcar, y polisorbato 80 al 0.01% - 0.02%, en la que el resto es agua para inyección y el pH es 5.0 - 7.0. Las pruebas de estabilidad demuestran que la calidad de la inyección estable de secukinumab es estable, en la que la estabilidad de la misma es superior a la de las variedades comerciales en el mercado, y la misma tiene varios indicadores que cumplen con la normativa relevante de la Farmacopea China, y tiene buenas perspectivas de aplicación.
MX2021012672A 2019-05-17 2020-05-18 Inyeccion estable de secukinumab y procedimiento de preparacion del mismo. MX2021012672A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910412754.0A CN110179746A (zh) 2019-05-17 2019-05-17 一种稳定的苏金单抗注射剂及其制备方法
PCT/CN2020/090776 WO2020233540A1 (zh) 2019-05-17 2020-05-18 一种稳定的苏金单抗注射剂及其制备方法

Publications (1)

Publication Number Publication Date
MX2021012672A true MX2021012672A (es) 2021-11-12

Family

ID=67716762

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021012672A MX2021012672A (es) 2019-05-17 2020-05-18 Inyeccion estable de secukinumab y procedimiento de preparacion del mismo.

Country Status (7)

Country Link
US (1) US20220177563A1 (es)
EP (1) EP3970744A4 (es)
JP (1) JP7196333B2 (es)
CN (2) CN110179746A (es)
BR (1) BR112021021359A2 (es)
MX (1) MX2021012672A (es)
WO (1) WO2020233540A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3129901A1 (en) 2019-02-18 2020-08-27 Eli Lilly And Company Therapeutic antibody formulation
CN110179746A (zh) * 2019-05-17 2019-08-30 通化东宝生物科技有限公司 一种稳定的苏金单抗注射剂及其制备方法
CN110124030A (zh) * 2019-06-10 2019-08-16 通化东宝生物科技有限公司 一种苏金单抗注射液及其制备方法
EP4251197A1 (en) * 2020-11-25 2023-10-04 Dr. Reddy's Laboratories Ltd. Stable therapeutic protein formulation and methods of making the same

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000186046A (ja) * 1998-10-14 2000-07-04 Snow Brand Milk Prod Co Ltd 慢性関節リウマチ治療剤及び診断方法
GB0417487D0 (en) * 2004-08-05 2004-09-08 Novartis Ag Organic compound
US9345661B2 (en) * 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
CA2813849C (en) * 2010-11-05 2021-06-15 Novartis Ag Secukinumab for use in the treatment of ankylosing spondylitis
CN104666242B (zh) * 2013-11-26 2018-01-02 信达生物制药(苏州)有限公司 一种稳定的抗TNF‑α抗体制剂及其用途
KR20170018810A (ko) 2014-06-10 2017-02-20 메이지 세이카 파루마 가부시키가이샤 안정한 아달리무맙 수성 제제
CN105727285B (zh) * 2014-12-10 2018-06-19 信达生物制药(苏州)有限公司 一种单克隆抗体在治疗神经退行性疾病中的应用
CN104922668B (zh) * 2014-12-10 2019-08-23 信达生物制药(苏州)有限公司 一种稳定的抗vegf抗体制剂及其用途
AR103173A1 (es) * 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
FI3769781T3 (fi) 2015-08-19 2023-06-07 Astrazeneca Ab Stabiili anti-ifnar1-formulaatio
GB201612043D0 (en) * 2016-07-11 2016-08-24 Crescendo Biologics Ltd Composition for treatment of disorders
CN109862880A (zh) * 2016-09-27 2019-06-07 德国费森尤斯卡比有限公司 液体药物组合物
JP2021008406A (ja) 2017-09-29 2021-01-28 アステラス製薬株式会社 改良型ヒト化抗ヒトα９インテグリン抗体含有医薬組成物
CN110179746A (zh) * 2019-05-17 2019-08-30 通化东宝生物科技有限公司 一种稳定的苏金单抗注射剂及其制备方法

Also Published As

Publication number Publication date
EP3970744A1 (en) 2022-03-23
CN113840622B (zh) 2023-12-01
JP2022526490A (ja) 2022-05-25
BR112021021359A2 (pt) 2021-12-14
CN110179746A (zh) 2019-08-30
CN113840622A (zh) 2021-12-24
US20220177563A1 (en) 2022-06-09
WO2020233540A1 (zh) 2020-11-26
JP7196333B2 (ja) 2022-12-26
EP3970744A4 (en) 2023-03-08

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