AU2018236651B2 - Liquid formulation of anti-TNF alpha antibody - Google Patents

Liquid formulation of anti-TNF alpha antibody Download PDF

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Publication number
AU2018236651B2
AU2018236651B2 AU2018236651A AU2018236651A AU2018236651B2 AU 2018236651 B2 AU2018236651 B2 AU 2018236651B2 AU 2018236651 A AU2018236651 A AU 2018236651A AU 2018236651 A AU2018236651 A AU 2018236651A AU 2018236651 B2 AU2018236651 B2 AU 2018236651B2
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AU
Australia
Prior art keywords
formulation
adalimumab
arginine
formulations
liquid formulation
Prior art date
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Active
Application number
AU2018236651A
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English (en)
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AU2018236651A1 (en
Inventor
Youn Kyung Ko
Jin Eon So
Sora YUN
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.)
LG Chem Ltd
Original Assignee
LG Chem 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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63522490&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2018236651(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by LG Chem Ltd filed Critical LG Chem Ltd
Publication of AU2018236651A1 publication Critical patent/AU2018236651A1/en
Application granted granted Critical
Publication of AU2018236651B2 publication Critical patent/AU2018236651B2/en
Active legal-status Critical Current
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Classifications

    • 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
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
AU2018236651A 2017-03-16 2018-03-16 Liquid formulation of anti-TNF alpha antibody Active AU2018236651B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2017-0033188 2017-03-16
KR20170033188 2017-03-16
PCT/KR2018/003097 WO2018169348A1 (ko) 2017-03-16 2018-03-16 항-tnf 알파 항체의 액상 제제

Publications (2)

Publication Number Publication Date
AU2018236651A1 AU2018236651A1 (en) 2019-10-31
AU2018236651B2 true AU2018236651B2 (en) 2020-12-10

Family

ID=63522490

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018236651A Active AU2018236651B2 (en) 2017-03-16 2018-03-16 Liquid formulation of anti-TNF alpha antibody

Country Status (15)

Country Link
JP (2) JP7109849B2 (uk)
KR (2) KR20180106974A (uk)
CN (1) CN110621303A (uk)
AU (1) AU2018236651B2 (uk)
BR (1) BR112019019162A2 (uk)
CO (1) CO2019010860A2 (uk)
MA (1) MA46988A1 (uk)
MX (1) MX2019010895A (uk)
MY (1) MY197202A (uk)
NZ (1) NZ757965A (uk)
PH (1) PH12019502075A1 (uk)
RU (1) RU2756619C2 (uk)
UA (1) UA123847C2 (uk)
WO (1) WO2018169348A1 (uk)
ZA (1) ZA201906696B (uk)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
TW202102260A (zh) * 2019-03-21 2021-01-16 美商再生元醫藥公司 含有抗il-33抗體之穩定調配物
WO2021164717A1 (zh) * 2020-02-20 2021-08-26 百奥泰生物制药股份有限公司 抗TNF-α的抗体制剂及其制备方法和用途

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015151115A1 (en) * 2014-04-02 2015-10-08 Intas Pharmaceuticals Limited Liquid pharmaceutical composition of adalimumab
WO2016066688A1 (en) * 2014-10-28 2016-05-06 Richter Gedeon Nyrt. Pharmaceutical anti-tnf-alpha antibody formulation

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140186361A1 (en) * 2012-09-07 2014-07-03 Coherus Biosciences, Inc. Stable Aqueous Formulations of Adalimumab
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
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
MX363700B (es) * 2012-03-07 2019-03-29 Cadila Healthcare Ltd Formulaciones farmaceuticas de anticuerpos tnf-alfa.
BR112015017619A2 (pt) * 2013-01-24 2017-11-21 Glaxosmithkline Ip Dev Ltd formulação líquida, uso de uma formulação, e, kit
JP2016515515A (ja) * 2013-03-15 2016-05-30 バイエル・ヘルスケア・エルエルシーBayer HealthCare LLC 抗プロラクチン受容体抗体製剤
WO2015134406A1 (en) * 2014-03-03 2015-09-11 La Jolla Biologics, Inc. Stable aqueous recombinant protein formulations
PT2946765T (pt) * 2014-05-23 2016-11-10 Ares Trading Sa Composição farmacêutica líquida
US9821059B2 (en) * 2014-10-17 2017-11-21 Alteogen Inc. Composition for stabilizing protein and pharmaceutical formulation comprising the same
UY36542A (es) * 2015-01-28 2016-08-31 Mabxience S A Formulaciones farmacéuticas para anticuerpos anti-tnf-alfa
WO2016162819A1 (en) * 2015-04-07 2016-10-13 Lupin Limited Stable aqueous pharmaceutical composition of anti-tnf alpha antibody

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015151115A1 (en) * 2014-04-02 2015-10-08 Intas Pharmaceuticals Limited Liquid pharmaceutical composition of adalimumab
WO2016066688A1 (en) * 2014-10-28 2016-05-06 Richter Gedeon Nyrt. Pharmaceutical anti-tnf-alpha antibody formulation

Also Published As

Publication number Publication date
ZA201906696B (en) 2020-08-26
UA123847C2 (uk) 2021-06-09
JP2020510079A (ja) 2020-04-02
KR102342292B1 (ko) 2021-12-24
RU2756619C2 (ru) 2021-10-04
WO2018169348A1 (ko) 2018-09-20
JP2022097600A (ja) 2022-06-30
NZ757965A (en) 2022-07-01
PH12019502075A1 (en) 2020-09-14
CN110621303A (zh) 2019-12-27
JP7109849B2 (ja) 2022-08-01
RU2019130728A3 (uk) 2021-04-16
CO2019010860A2 (es) 2020-01-17
RU2019130728A (ru) 2021-04-16
MX2019010895A (es) 2019-11-05
MY197202A (en) 2023-05-31
KR20180106974A (ko) 2018-10-01
BR112019019162A2 (pt) 2020-04-14
KR20200096472A (ko) 2020-08-12
MA46988A1 (fr) 2020-06-30
AU2018236651A1 (en) 2019-10-31

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