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WO2016163764A3 - Stabilized preparation of interferon beta variant - Google Patents

Stabilized preparation of interferon beta variant Download PDF

Info

Publication number
WO2016163764A3
WO2016163764A3 PCT/KR2016/003632 KR2016003632W WO2016163764A3 WO 2016163764 A3 WO2016163764 A3 WO 2016163764A3 KR 2016003632 W KR2016003632 W KR 2016003632W WO 2016163764 A3 WO2016163764 A3 WO 2016163764A3
Authority
WO
WIPO (PCT)
Prior art keywords
stabilized
pharmaceutical preparation
interferon beta
beta variant
poloxamer
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.)
Ceased
Application number
PCT/KR2016/003632
Other languages
French (fr)
Korean (ko)
Other versions
WO2016163764A2 (en
Inventor
신영기
박상호
송경
이희정
곽은혜
장은진
정성훈
김남아
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.)
Abion Inc
Original Assignee
Abion Inc
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
Priority claimed from KR1020160042320A external-priority patent/KR101781945B1/en
Application filed by Abion Inc filed Critical Abion Inc
Publication of WO2016163764A2 publication Critical patent/WO2016163764A2/en
Publication of WO2016163764A3 publication Critical patent/WO2016163764A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K38/21—Interferons [IFN]
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K9/14—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
    • 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
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/555—Interferons [IFN]
    • C07K14/565—IFN-beta

Landscapes

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

Abstract

The present invention relates to a stabilized pharmaceutical preparation of R27T comprising a human interferon beta variant (R27T), an acetic acid buffer solution, arginine, mannitol, poloxamer 188, and methionine. The stabilized R27T pharmaceutical preparation according to the present invention comprises an acetic acid buffer solution, arginine, mannitol, poloxamer 188, and methionine, and thereby inhibits formation of an aggregate of an R27T protein and enables long-period storage because of an improvement in thermodynamic and structural stability. Thus, it is expected that the stabilized R27T pharmaceutical preparation will be useful in prevention, improvement and treatment of multiple sclerosis, cancer, autoimmune diseases, viral infectious diseases, HIV infectious diseases, hepatitis C, rheumatoid arthritis, etc.
PCT/KR2016/003632 2015-04-07 2016-04-07 Stabilized preparation of interferon beta variant Ceased WO2016163764A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20150049200 2015-04-07
KR10-2015-0049200 2015-04-07
KR10-2016-0042320 2016-04-06
KR1020160042320A KR101781945B1 (en) 2015-04-07 2016-04-06 Stabilized Formulations of Interferon beta Mutant

Publications (2)

Publication Number Publication Date
WO2016163764A2 WO2016163764A2 (en) 2016-10-13
WO2016163764A3 true WO2016163764A3 (en) 2016-12-01

Family

ID=57072138

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2016/003632 Ceased WO2016163764A2 (en) 2015-04-07 2016-04-07 Stabilized preparation of interferon beta variant

Country Status (1)

Country Link
WO (1) WO2016163764A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4144748A4 (en) * 2020-04-29 2024-05-29 Abion Inc. Human interferon-beta variant with double mutation and method for improving stability of human interferon-beta variant
JP7610816B2 (en) * 2020-04-29 2025-01-09 ジェノファーム インク． Recombinant protein in which an interferon beta mutant is fused with an antibody and pharmaceutical composition containing the same

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20060009913A (en) * 2003-05-13 2006-02-01 아레스 트레이딩 에스.에이. Stabilized Liquid Protein Formulations in Coated Pharmaceutical Containers
KR20060039132A (en) * 2004-11-02 2006-05-08 삼성정밀화학 주식회사 Human Interferon-beta Variants
KR20070030855A (en) * 2004-06-01 2007-03-16 아레스 트레이딩 에스.에이. How to stabilize protein
KR20100099298A (en) * 2007-12-20 2010-09-10 메르크 세로노 에스. 에이. Peg-interferon-beta formulations
US20120269770A1 (en) * 2010-11-22 2012-10-25 Mark Brader Stable Preserved Compositions of Interferon-Beta

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20060009913A (en) * 2003-05-13 2006-02-01 아레스 트레이딩 에스.에이. Stabilized Liquid Protein Formulations in Coated Pharmaceutical Containers
KR20070030855A (en) * 2004-06-01 2007-03-16 아레스 트레이딩 에스.에이. How to stabilize protein
KR20060039132A (en) * 2004-11-02 2006-05-08 삼성정밀화학 주식회사 Human Interferon-beta Variants
WO2006049423A1 (en) * 2004-11-02 2006-05-11 Samsung Fine Chemicals Co Ltd Human interferon-beta mutein
KR20100099298A (en) * 2007-12-20 2010-09-10 메르크 세로노 에스. 에이. Peg-interferon-beta formulations
US20120269770A1 (en) * 2010-11-22 2012-10-25 Mark Brader Stable Preserved Compositions of Interferon-Beta

Also Published As

Publication number Publication date
WO2016163764A2 (en) 2016-10-13

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