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 PCT/IN2015/000092 priority patent/WO2015151115A1/fr
Priority to IN1248MU2014 priority patent/IN2014MU01248A/en
Priority to EP15774333.7A priority patent/EP3125928A4/fr
Priority to CA2944330A priority patent/CA2944330A1/fr
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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], 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)
  • 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)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
IN1248MU2014 2014-04-02 2015-02-18 IN2014MU01248A (fr)

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
PCT/IN2015/000092 WO2015151115A1 (fr) 2014-04-02 2015-02-18 Composition pharmaceutique liquide d'adalimumab
IN1248MU2014 IN2014MU01248A (fr) 2014-04-02 2015-02-18
EP15774333.7A EP3125928A4 (fr) 2014-04-02 2015-02-18 Composition pharmaceutique liquide d'adalimumab
CA2944330A CA2944330A1 (fr) 2014-04-02 2015-02-18 Composition pharmaceutique liquide d'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 (fr) 2014-04-02 2015-02-18

Publications (1)

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

Family

ID=54239505

Family Applications (1)

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

Country Status (5)

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

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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2018015960A (es) * 2016-06-30 2019-03-21 Celltrion Inc Formulacion farmaceutica liquida estable.
AU2018207367B2 (en) 2017-01-11 2024-02-15 Celltrion Inc. Stable Liquid Formula
RU2756619C2 (ru) * 2017-03-16 2021-10-04 ЭлДжи КЕМ, ЛТД. Жидкая композиция антитела против TNF альфа
EP3927729A4 (fr) 2019-02-18 2023-10-11 Eli Lilly and Company Formulation d'anticorps thérapeutique
US20210101974A1 (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
HU230048B1 (hu) 1996-02-09 2015-06-29 Abbvie Biotechnology Ltd Humán TNFalfa-kötő antitestek alkalmazása
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
ES2618832T3 (es) 2002-02-27 2017-06-22 Immunex Corporation Composición TNFR-FC estabilizada que comprende arginina
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
ME02506B (fr) * 2010-11-11 2017-02-20 Abbvie Biotechnology Ltd FORMULATION LIQUIDE D'ANTICORPS ANTI-TNFalpha HAUTEMENT CONCENTRÉE AMÉLIORÉE
EP2771033A4 (fr) * 2011-10-28 2016-02-17 Integritybio Inc Formulations protéiques contenant des acides aminés
AU2013255413C1 (en) * 2012-03-07 2016-03-24 Cadila Healthcare Limited Pharmaceutical formulations of TNF-alpha antibodies
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
TWI698253B (zh) * 2012-09-07 2020-07-11 美商柯赫勒斯生物科學有限公司 阿達木單抗（ａｄａｌｉｍｕｍａｂ）之穩定水性調配物
ES2600488T3 (es) 2014-05-23 2017-02-09 Ares Trading S.A. Composición farmacéutica líquida
WO2016120413A1 (fr) 2015-01-28 2016-08-04 Mabxience S.A. Formulations pharmaceutiques pour des anticorps anti-tnf-alpha

Cited By (9)

* 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

Also Published As

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

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