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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Mycology (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
PCT/IN2015/000092 WO2015151115A1 (en) 2014-04-02 2015-02-18 Liquid pharmaceutical composition of adalimumab
IN1248MU2014 IN2014MU01248A (enExample) 2014-04-02 2015-02-18

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
ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
PH12018502670B1 (en) * 2016-06-30 2023-03-24 Celltrion Inc Stable liquid pharmaceutical preparation
US20200087390A1 (en) 2016-12-21 2020-03-19 Amgen Inc. Anti-tnf alpha antibody formulations
CN110167531B (zh) * 2017-01-11 2025-06-03 赛特瑞恩股份有限公司 稳定的液体调配物
MA46988A1 (fr) * 2017-03-16 2020-06-30 Lg Chemical Ltd Formulation liquide d'anticorps anti-tnf alpha
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
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
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
SI1478394T1 (sl) 2002-02-27 2008-12-31 Immunex Corp STABILIZIRAN TNFR-Fc SESTAVEK Z ARGININOM
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
KR20210049186A (ko) 2007-11-30 2021-05-04 애브비 바이오테크놀로지 리미티드 단백질 제형 및 이의 제조방법
CN103458926B (zh) * 2010-11-11 2016-10-26 艾伯维生物技术有限公司 改进的高浓度抗TNF α 抗体液体制剂
WO2013063510A1 (en) 2011-10-28 2013-05-02 Integritybio Inc. Protein formulations containing amino acids
US10093728B2 (en) 2012-03-07 2018-10-09 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
MX2015003007A (es) 2012-09-07 2015-06-05 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab.
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
AR103544A1 (es) 2015-01-28 2017-05-17 Mabxience S A FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-a

Also Published As

Publication number Publication date
EP3125928A1 (en) 2017-02-08
US20200405864A1 (en) 2020-12-31
US20170106090A1 (en) 2017-04-20
US10688187B2 (en) 2020-06-23
WO2015151115A1 (en) 2015-10-08
EP3125928A4 (en) 2017-11-29
IN2014MU01248A (enExample) 2015-10-09

Similar Documents

Publication Publication Date Title
US20200405864A1 (en) Liquid pharmaceutical composition of adalimumab
AU2013255413C1 (en) Pharmaceutical formulations of TNF-alpha antibodies
CN102458469B (zh) 人抗TNF-α抗体的稳定高蛋白质浓度制剂
TWI548424B (zh) 依那西普之安定的液體調配劑
CN103998060B (zh) 使用糖与多元醇的结合物稳定的依那西普制剂
EP2568960B1 (en) Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
CN106061468B (zh) 包含TNFR和Fc区的融合蛋白的液体制剂
JP2023018090A (ja) 高濃度のタンパク質ベース治療薬を含有する医薬組成物における安定化化合物としてのアミノ酸の使用
BR112016025126B1 (pt) Composição aquosa compreendendo anticorpo neutralizante de gmcsf, e uso da mesma
KR102106914B1 (ko) Gm-csf를 중화하는 화합물을 포함하는 액체 제제
JP2018535242A (ja) 高濃度のタンパク質ベースの治療剤を含有する医薬組成物中の非晶質安定化化合物としてのアミノ酸と糖との最適比
US10918698B2 (en) Lyophilized pharmaceutical composition of Fc-peptide fusion protein
JP2022551622A (ja) インテグリン抗体の安定な製剤
JP2015536932A (ja) Ｇｍ−ｃｓｆ中和化合物を含む凍結乾燥製剤
AU2021250949A1 (en) Liquid Pharmaceutical Composition
CN110621302A (zh) 结合肌生成抑制蛋白的纤连蛋白基支架结构域蛋白质的稳定制剂
WO2018124948A1 (ru) ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα
RU2665966C2 (ru) Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОα
CN115518151B (zh) 一种人类免疫缺陷病毒中和抗体制剂及其用途
CN104740609A (zh) 一种受体抗体融合蛋白的药物组合物
CA2946230C (en) Liquid formulation comprising gm-csf neutralizing compound
HK40010132B (zh) 重组单克隆抗TNF α 抗体的水性药用组合物
HK1204921B (en) Stable liquid formulation of etanercept

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20191129

FZDE Discontinued

Effective date: 20220208