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)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (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
IN1248MU2014 IN2014MU01248A (enExample) 2014-04-02 2015-02-18
PCT/IN2015/000092 WO2015151115A1 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab

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
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
PL2946765T3 (pl) * 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
UA122610C2 (uk) * 2016-06-30 2020-12-10 Селлтріон Інк. Стабільний рідкий фармацевтичний склад
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
US10980881B2 (en) 2017-01-11 2021-04-20 Celltrion Inc. Stable liquid formula having an anti-TNFalpha antibody, acetate buffer and glycine
NZ757965A (en) * 2017-03-16 2022-07-01 Lg Chemical Ltd Liquid formulation of anti-tnf alpha antibody
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
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
CA3156812A1 (en) 2019-10-02 2021-04-08 Alamab Therapeutics, Inc. Anti-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
ATE239041T1 (de) * 1996-02-09 2003-05-15 Basf Ag 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
US20140186361A1 (en) 2012-09-07 2014-07-03 Coherus Biosciences, Inc. Stable Aqueous Formulations of Adalimumab
CA2476934C (en) * 2002-02-27 2009-06-16 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
US8420081B2 (en) 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
TWI603739B (zh) * 2010-11-11 2017-11-01 艾伯維生物技術有限責任公司 具有增進高濃度之抗－ＴＮＦα抗體之液體調配物
AU2012328524B2 (en) * 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
KR20160105535A (ko) 2012-03-07 2016-09-06 카딜라 핼쓰캐어 리미티드 TNF-α 항체의 약제학적 제형
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
PL2946765T3 (pl) * 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
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
US20200405864A1 (en) 2020-12-31
IN2014MU01248A (enExample) 2015-10-09
US10688187B2 (en) 2020-06-23
US20170106090A1 (en) 2017-04-20
EP3125928A1 (en) 2017-02-08
EP3125928A4 (en) 2017-11-29
WO2015151115A1 (en) 2015-10-08

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20191129

FZDE Discontinued

Effective date: 20220208