CA2944330A1 - Liquid pharmaceutical composition of adalimumab - Google Patents

Liquid pharmaceutical composition of adalimumab Download PDF

Info

Publication number
CA2944330A1
CA2944330A1 CA2944330A CA2944330A CA2944330A1 CA 2944330 A1 CA2944330 A1 CA 2944330A1 CA 2944330 A CA2944330 A CA 2944330A CA 2944330 A CA2944330 A CA 2944330A CA 2944330 A1 CA2944330 A1 CA 2944330A1
Authority
CA
Canada
Prior art keywords
formulation
adalimumab
buffer
pharmaceutical composition
antibody
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.)
Abandoned
Application number
CA2944330A
Other languages
English (en)
French (fr)
Inventor
Himanshu Gadgil
Chandresh CHHATBAR
Vijaykant PANDEY
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.)
Intas Pharmaceuticals Ltd
Original Assignee
Intas Pharmaceuticals 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 Intas Pharmaceuticals Ltd filed Critical Intas Pharmaceuticals Ltd
Publication of CA2944330A1 publication Critical patent/CA2944330A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CA2944330A 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab Abandoned CA2944330A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN1248/MUM/2014 2014-04-02
PCT/IN2015/000092 WO2015151115A1 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab
IN1248MU2014 IN2014MU01248A (2) 2014-04-02 2015-02-18

Publications (1)

Publication Number Publication Date
CA2944330A1 true CA2944330A1 (en) 2015-10-08

Family

ID=54239505

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2944330A Abandoned CA2944330A1 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab

Country Status (5)

Country Link
US (2) US10688187B2 (2)
EP (1) EP3125928A4 (2)
CA (1) CA2944330A1 (2)
IN (1) IN2014MU01248A (2)
WO (1) WO2015151115A1 (2)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
EP3050557A1 (en) 2014-05-23 2016-08-03 Ares Trading S.A. Liquid pharmaceutical composition
ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
GEP20217249B (en) * 2016-06-30 2021-04-26 Inc Celltrion 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
KR20180106974A (ko) * 2017-03-16 2018-10-01 주식회사 엘지화학 항-tnf 알파 항체의 액상 제제
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
CN113727730A (zh) * 2019-03-18 2021-11-30 阿尔沃科技Hf公司 高浓度TNFα抗体的含水制剂
KR20220113355A (ko) * 2019-10-02 2022-08-12 알라맵 테라퓨틱스, 인크. 항-코넥신 항체 제제

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
DK0929578T3 (da) 1996-02-09 2003-08-25 Abbott Lab Bermuda Ltd Humane antistoffer, der binder human TNFalfa
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
PT1946776T (pt) 2002-02-27 2017-03-17 Immunex Corp Composição de tnfr-fc estabilizada compreendendo arginina
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
TWI543768B (zh) 2007-11-30 2016-08-01 艾伯維生物技術有限責任公司 蛋白質調配物及製造其之方法
SG190069A1 (en) * 2010-11-11 2013-06-28 Abbvie Biotechnology Ltd IMPROVED HIGH CONCENTRATION ANTI-TNFa ANTIBODY LIQUID FORMULATIONS
AU2012328524B2 (en) 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
WO2013164837A1 (en) 2012-03-07 2013-11-07 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies
FR2994390B1 (fr) * 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
WO2014039903A2 (en) * 2012-09-07 2014-03-13 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
EP3050557A1 (en) 2014-05-23 2016-08-03 Ares Trading S.A. Liquid pharmaceutical composition
TW201636047A (zh) * 2015-01-28 2016-10-16 麥博賽恩斯有限公司 抗－ＴＮＦ－α抗體之醫藥調配物

Also Published As

Publication number Publication date
US20200405864A1 (en) 2020-12-31
IN2014MU01248A (2) 2015-10-09
EP3125928A1 (en) 2017-02-08
US10688187B2 (en) 2020-06-23
US20170106090A1 (en) 2017-04-20
WO2015151115A1 (en) 2015-10-08
EP3125928A4 (en) 2017-11-29

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20191129

FZDE Discontinued

Effective date: 20220208