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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WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulation
stable pharmaceutical
stabilizer
present
fusion protein
Prior art date
Application number
PCT/KR2017/011909
Other languages
English (en)
French (fr)
Other versions
WO2018080196A2 (ko
Inventor
이준원
한원용
김수정
오준석
김소영
김광우
신연경
Original Assignee
(주)셀트리온
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 (주)셀트리온 filed Critical (주)셀트리온
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
    • 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
    • C07K14/715—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

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
KR20160142184 2016-10-28
KR10-2016-0142184 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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KR20140056218A (ko) * 2011-07-01 2014-05-09 바이오겐 아이덱 엠에이 인코포레이티드 아르기닌-없는 tnfr : fc-융합 폴리펩티드 조성물 및 이용 방법
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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UY34105A (es) 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
WO2013059406A1 (en) * 2011-10-18 2013-04-25 Coherus Biosciences, Inc. Etanercept formulations stabilized with metal ions
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Patent Citations (5)

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

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