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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (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 (enExample) 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 (enExample)
EP (1) EP3125928A4 (enExample)
CA (1) CA2944330A1 (enExample)
IN (1) IN2014MU01248A (enExample)
WO (1) WO2015151115A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE029849T2 (en) * 2014-05-23 2017-04-28 Ares Trading Sa Liquid pharmaceutical composition
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
ES2607489T3 (es) 2014-05-23 2017-03-31 Ares Trading S.A. Composición farmacéutica líquida
CR20180599A (es) * 2016-06-30 2019-04-09 Celltrion Inc Preparación farmacéutica líquida estable
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
CN120392659A (zh) 2017-01-11 2025-08-01 赛特瑞恩股份有限公司 稳定的液体调配物
MX2019010895A (es) * 2017-03-16 2019-11-05 Lg Chemical Ltd Formulacion liquida de anticuerpo anti-tnf alfa.
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
JP2022525556A (ja) * 2019-03-18 2022-05-17 アルヴォテック エイチエフ Ｔｎｆ－アルファ抗体の高濃度水性製剤
AU2020358101A1 (en) * 2019-10-02 2022-04-28 Alamab Therapeutics, Inc. Anto-connexin antibody formulations

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
DE122004000004I1 (de) * 1996-02-09 2004-08-12 Abott Biotechnology Ltd Humane Antikörper welche an Humanen TNFalpha binden.
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
PL215168B1 (pl) 2002-02-27 2013-10-31 Immunex Corp Formulacja polipeptydowa
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
NZ622583A (en) 2007-11-30 2015-08-28 Abbvie Biotechnology Ltd Protein formulations and methods of making same
AU2011325974B2 (en) * 2010-11-11 2016-10-27 Abbvie Biotechnology Ltd. Improved high concentration anti-TNFalpha antibody liquid formulations
CN104023748B (zh) 2011-10-28 2018-03-02 诚信生物公司 含有氨基酸的蛋白质制剂
JP2015509526A (ja) 2012-03-07 2015-03-30 カディラ ヘルスケア リミティド 医薬製剤
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
AU2013312300A1 (en) * 2012-09-07 2015-04-16 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
HUE029849T2 (en) * 2014-05-23 2017-04-28 Ares Trading Sa Liquid pharmaceutical composition
EP3250598A1 (en) 2015-01-28 2017-12-06 Mabxience S.A. Pharmaceutical formulations for anti-tnf-alpha antibodies

Also Published As

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