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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 CA2944330A priority patent/CA2944330A1/en
Priority to IN1248MU2014 priority patent/IN2014MU01248A/en
Priority to EP15774333.7A priority patent/EP3125928A4/en
Priority to PCT/IN2015/000092 priority patent/WO2015151115A1/en
Publication of IN2014MU01248A publication Critical patent/IN2014MU01248A/en
Priority to US16/894,196 priority patent/US20200405864A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
IN1248MU2014 2014-04-02 2015-02-18 IN2014MU01248A (es)

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
CA2944330A CA2944330A1 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab
IN1248MU2014 IN2014MU01248A (es) 2014-04-02 2015-02-18
EP15774333.7A EP3125928A4 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab
PCT/IN2015/000092 WO2015151115A1 (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 (es) 2014-04-02 2015-02-18

Publications (1)

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

Family

ID=54239505

Family Applications (1)

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

Country Status (5)

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

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
HRP20240426T1 (hr) * 2016-06-30 2024-06-21 Celltrion Inc. Stabilni tekući farmaceutski pripravak
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
AU2018207367B2 (en) * 2017-01-11 2024-02-15 Celltrion Inc. Stable Liquid Formula
JP7109849B2 (ja) * 2017-03-16 2022-08-01 エルジー・ケム・リミテッド 抗TNFα抗体の液状製剤
JOP20210229A1 (ar) 2019-02-18 2023-01-30 Lilly Co Eli صيغة جسم مضاد علاجي
US20230203147A1 (en) * 2019-03-18 2023-06-29 Alvotech Hf Aqueous formulations of tnf-alpha antibodies in high concentrations
JP2022552152A (ja) * 2019-10-02 2022-12-15 アラマブ セラピューティクス, インコーポレイテッド 抗コネキシン抗体製剤

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
PT929578E (pt) * 1996-02-09 2003-09-30 Abbott Lab Bermuda Ltd Anticorpos humanos que se ligam a tnfalfa humano
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
EP2311492B1 (en) 2000-08-11 2017-10-04 Chugai Seiyaku Kabushiki Kaisha Antibody-containing stabilized 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
CN104740632A (zh) 2007-11-30 2015-07-01 Abbvie公司 蛋白制剂及其制备方法
MX344727B (es) * 2010-11-11 2017-01-05 Abbvie Biotechnology Ltd Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas.
KR101759694B1 (ko) 2011-10-28 2017-07-19 인테그리티 바이오, 아이엔씨. 아미노산을 함유하는 단백질 제제
SG10201609982PA (en) 2012-03-07 2017-01-27 Cadila Healthcare Ltd Pharmaceutical formulations of tnf-alpha anitbodies
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
PL2892550T3 (pl) 2012-09-07 2020-07-27 Coherus Biosciences, Inc. Stabilne wodne formulacje adalimumabu
EP3050557A1 (en) 2014-05-23 2016-08-03 Ares Trading S.A. Liquid pharmaceutical composition
WO2016120413A1 (en) 2015-01-28 2016-08-04 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
US11752209B2 (en) 2014-05-23 2023-09-12 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US11752208B2 (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
WO2015151115A1 (en) 2015-10-08
EP3125928A4 (en) 2017-11-29
CA2944330A1 (en) 2015-10-08
US20200405864A1 (en) 2020-12-31
US10688187B2 (en) 2020-06-23
US20170106090A1 (en) 2017-04-20
EP3125928A1 (en) 2017-02-08

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