IN2014MU01248A - - Google Patents

Info

Publication number
IN2014MU01248A
IN2014MU01248A IN1248MU2014A IN2014MU01248A IN 2014MU01248 A IN2014MU01248 A IN 2014MU01248A IN 1248MU2014 A IN1248MU2014 A IN 1248MU2014A IN 2014MU01248 A IN2014MU01248 A IN 2014MU01248A
Authority
IN
India
Prior art keywords
stabilizer
surfactant
buffer
pharmaceutical composition
relates
Prior art date
Application number
Other languages
English (en)
Inventor
Gadgil Himanshu
Chhatbar Chandresh
Pandey Vijaykant
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
Priority to US15/301,421 priority Critical patent/US10688187B2/en
Priority to IN1248MU2014 priority patent/IN2014MU01248A/en
Priority to PCT/IN2015/000092 priority patent/WO2015151115A1/en
Priority to CA2944330A priority patent/CA2944330A1/en
Priority to EP15774333.7A priority patent/EP3125928A4/en
Publication of IN2014MU01248A publication Critical patent/IN2014MU01248A/en
Priority to US16/894,196 priority patent/US20200405864A1/en

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)
IN1248MU2014 2014-04-02 2015-02-18 IN2014MU01248A (enExample)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US15/301,421 US10688187B2 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab
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
CA2944330A CA2944330A1 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab
EP15774333.7A EP3125928A4 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab
US16/894,196 US20200405864A1 (en) 2014-04-02 2020-06-05 Liquid pharmaceutical composition of adalimumab

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN1248MU2014 IN2014MU01248A (enExample) 2014-04-02 2015-02-18

Publications (1)

Publication Number Publication Date
IN2014MU01248A true IN2014MU01248A (enExample) 2015-10-09

Family

ID=54239505

Family Applications (1)

Application Number Title Priority Date Filing Date
IN1248MU2014 IN2014MU01248A (enExample) 2014-04-02 2015-02-18

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)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10426832B2 (en) 2014-05-23 2019-10-01 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US10426833B2 (en) 2014-05-23 2019-10-01 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US10493152B2 (en) 2014-05-23 2019-12-03 Fresenius Kabi Deutschland Gmbh Adalimumab formulations

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10426832B2 (en) 2014-05-23 2019-10-01 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US10426833B2 (en) 2014-05-23 2019-10-01 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US10493152B2 (en) 2014-05-23 2019-12-03 Fresenius Kabi Deutschland Gmbh Adalimumab formulations
US10729769B2 (en) 2014-05-23 2020-08-04 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US10772961B2 (en) 2014-05-23 2020-09-15 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US11707524B2 (en) 2014-05-23 2023-07-25 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US11712471B2 (en) 2014-05-23 2023-08-01 Fresenius Kabi Deustschland GmbH Liquid pharmaceutical composition
US11752208B2 (en) 2014-05-23 2023-09-12 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US11752209B2 (en) 2014-05-23 2023-09-12 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US12109267B2 (en) 2014-05-23 2024-10-08 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition

Also Published As

Publication number Publication date
US20200405864A1 (en) 2020-12-31
US10688187B2 (en) 2020-06-23
US20170106090A1 (en) 2017-04-20
CA2944330A1 (en) 2015-10-08
EP3125928A1 (en) 2017-02-08
EP3125928A4 (en) 2017-11-29
WO2015151115A1 (en) 2015-10-08

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