WO2018080196A3 - 안정한 약제학적 제제 - Google Patents

안정한 약제학적 제제 Download PDF

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Publication number
WO2018080196A3
WO2018080196A3 PCT/KR2017/011909 KR2017011909W WO2018080196A3 WO 2018080196 A3 WO2018080196 A3 WO 2018080196A3 KR 2017011909 W KR2017011909 W KR 2017011909W WO 2018080196 A3 WO2018080196 A3 WO 2018080196A3
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WIPO (PCT)
Prior art keywords
pharmaceutical formulation
stable pharmaceutical
stabilizer
present
fusion protein
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PCT/KR2017/011909
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English (en)
French (fr)
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WO2018080196A2 (ko
Inventor
이준원
한원용
김수정
오준석
김소영
김광우
신연경
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(주)셀트리온
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Priority to US16/345,453 priority Critical patent/US11236146B2/en
Priority to EP17863573.6A priority patent/EP3533441A4/en
Publication of WO2018080196A2 publication Critical patent/WO2018080196A2/ko
Publication of WO2018080196A3 publication Critical patent/WO2018080196A3/ko

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    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/191—Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7151—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for tumor necrosis factor [TNF], for lymphotoxin [LT]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

본 발명에 따른 안정한 약제학적 제제는 인간 p75 종양괴사인자 수용체의 세포외 리간드 결합부가 인간 IgG의 Fc 도메인에 융합된 융합 단백질 및 숙신산염 완충제를 포함하고, 안정화제를 포함하지 않은 안정한 약제학적 제제이다. 본 발명에 따른 안정한 약제학적 제제는 TNFR-Fc 융합 단백질 제제를 장기간 보관 가능하게 하고, 보관 조건을 까다롭게 유지하지 않아도 되는 우수한 저장 안정성을 제공한다. 본 발명은 안정화제를 포함하지 않는 간단한 제제로 다른 안정화 포함 제제에 비해 경제적이다.
PCT/KR2017/011909 2016-10-28 2017-10-26 안정한 약제학적 제제 WO2018080196A2 (ko)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US16/345,453 US11236146B2 (en) 2016-10-28 2017-10-26 Stable pharmaceutical formulation
EP17863573.6A EP3533441A4 (en) 2016-10-28 2017-10-26 STABLE PHARMACEUTICAL FORMULATION

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2016-0142184 2016-10-28
KR20160142184 2016-10-28

Publications (2)

Publication Number Publication Date
WO2018080196A2 WO2018080196A2 (ko) 2018-05-03
WO2018080196A3 true WO2018080196A3 (ko) 2018-08-09

Family

ID=62025184

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2017/011909 WO2018080196A2 (ko) 2016-10-28 2017-10-26 안정한 약제학적 제제

Country Status (5)

Country Link
US (1) US11236146B2 (ko)
EP (1) EP3533441A4 (ko)
KR (1) KR20180046888A (ko)
TW (1) TWI771335B (ko)
WO (1) WO2018080196A2 (ko)

Citations (5)

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KR20150063305A (ko) * 2013-11-29 2015-06-09 한화케미칼 주식회사 TNFR 및 면역글로블린 Fc 영역을 포함하는 융합 단백질을 포함하는 액상 제제
KR20160008575A (ko) * 2013-05-02 2016-01-22 마브사이언스 에스. 에이. ＴＮＦＲ: Ｆｃ 융합 폴리펩티드에 대한 대체 제제

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US4362661A (en) 1979-08-09 1982-12-07 Teijin Limited Immunoglobulin composition having a high monomer content, and process for production thereof
US5945098A (en) 1990-02-01 1999-08-31 Baxter International Inc. Stable intravenously-administrable immune globulin preparation
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7276477B2 (en) * 2003-08-01 2007-10-02 Amgen Inc. Crystals of etanercept and methods of making thereof
KR20140056218A (ko) * 2011-07-01 2014-05-09 바이오겐 아이덱 엠에이 인코포레이티드 아르기닌-없는 tnfr : fc-융합 폴리펩티드 조성물 및 이용 방법
US20130101583A1 (en) * 2011-10-18 2013-04-25 Coherus Biosciences, Inc. Etanercept Formulations Stabilized with Sodium Chloride
KR20160008575A (ko) * 2013-05-02 2016-01-22 마브사이언스 에스. 에이. ＴＮＦＲ: Ｆｃ 융합 폴리펩티드에 대한 대체 제제
KR20150063305A (ko) * 2013-11-29 2015-06-09 한화케미칼 주식회사 TNFR 및 면역글로블린 Fc 영역을 포함하는 융합 단백질을 포함하는 액상 제제

Also Published As

Publication number Publication date
US11236146B2 (en) 2022-02-01
US20190248871A1 (en) 2019-08-15
EP3533441A2 (en) 2019-09-04
WO2018080196A2 (ko) 2018-05-03
TWI771335B (zh) 2022-07-21
EP3533441A4 (en) 2019-12-04
KR20180046888A (ko) 2018-05-09
TW201825109A (zh) 2018-07-16

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