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 PCT/IN2015/000092 priority Critical patent/WO2015151115A1/en
Priority to CA2944330A priority patent/CA2944330A1/en
Priority to EP15774333.7A priority patent/EP3125928A4/en
Priority to US15/301,421 priority patent/US10688187B2/en
Priority to IN1248MU2014 priority patent/IN2014MU01248A/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)
  • 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 (it)

Priority Applications (6)

Application Number Priority Date Filing Date Title
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
US15/301,421 US10688187B2 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab
IN1248MU2014 IN2014MU01248A (it) 2014-04-02 2015-02-18
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 (it) 2014-04-02 2015-02-18

Publications (1)

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

Family

ID=54239505

Family Applications (1)

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

Country Status (5)

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

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10426833B2 (en) 2014-05-23 2019-10-01 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US10426832B2 (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 (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT3479819T (pt) * 2016-06-30 2024-04-15 Celltrion Inc Preparação farmacêutica líquida estável
WO2018131893A1 (ko) * 2017-01-11 2018-07-19 ㈜셀트리온 안정한 액체 제제
UA123847C2 (uk) * 2017-03-16 2021-06-09 Лг Кем, Лтд. Рідка композиція анти-tnf альфа антитіла
BR112021015034A2 (pt) 2019-02-18 2021-10-05 Eli Lilly And Company Formulação de anticorpo terapêutico
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
WO2021067775A1 (en) * 2019-10-02 2021-04-08 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
NZ512006A (en) * 1996-02-09 2005-05-27 Abbott Biotech Ltd Medical treatment with human TNF-alpha antibodies
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
JP5485489B2 (ja) 2000-08-11 2014-05-07 中外製薬株式会社 抗体含有安定化製剤
WO2003072060A2 (en) * 2002-02-27 2003-09-04 Immunex Corporation Polypeptide formulation
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
TWI661833B (zh) 2007-11-30 2019-06-11 百慕達商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
KR101841527B1 (ko) * 2010-11-11 2018-03-23 애브비 바이오테크놀로지 리미티드 개선된 고농도 항-TNFα 항체 액체 제형
EP3578203A1 (en) * 2011-10-28 2019-12-11 Integritybio Inc. Protein formulations containing amino acids
TR201810815T4 (tr) * 2012-03-07 2018-08-27 Cadila Healthcare Ltd Tnf-alfa antikorlarının farmasötik formülasyonları.
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
EA029215B1 (ru) * 2012-09-07 2018-02-28 Кохерус Байосайенсис, Инк. Стабильные водные составы адалимумаба
DK2946765T3 (en) 2014-05-23 2016-10-31 Ares Trading Sa 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
US10426833B2 (en) 2014-05-23 2019-10-01 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
US10426832B2 (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
EP3125928A1 (en) 2017-02-08
EP3125928A4 (en) 2017-11-29
US20170106090A1 (en) 2017-04-20
CA2944330A1 (en) 2015-10-08
US20200405864A1 (en) 2020-12-31
WO2015151115A1 (en) 2015-10-08
US10688187B2 (en) 2020-06-23

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