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MX2013004595A - Formulaciones liquidas de un conjugado de alfa interferon de accion prolongada. - Google Patents

Formulaciones liquidas de un conjugado de alfa interferon de accion prolongada.

Info

Publication number
MX2013004595A
MX2013004595A MX2013004595A MX2013004595A MX2013004595A MX 2013004595 A MX2013004595 A MX 2013004595A MX 2013004595 A MX2013004595 A MX 2013004595A MX 2013004595 A MX2013004595 A MX 2013004595A MX 2013004595 A MX2013004595 A MX 2013004595A
Authority
MX
Mexico
Prior art keywords
interferon alpha
liquid formulations
long
long acting
alpha conjugate
Prior art date
Application number
MX2013004595A
Other languages
English (en)
Other versions
MX349441B (es
Inventor
Dae Seong Im
Min Lee Jae
Soo Lee Jong
Min Bae Sung
Chang Kwon Se
Original Assignee
Hanmi Science Co 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 Hanmi Science Co Ltd filed Critical Hanmi Science Co Ltd
Publication of MX2013004595A publication Critical patent/MX2013004595A/es
Publication of MX349441B publication Critical patent/MX349441B/es

Links

Classifications

    • 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]
    • C07K14/56—IFN-alpha
    • 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]
    • A61K38/212—IFN-alpha
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6813—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin the drug being a peptidic cytokine, e.g. an interleukin or interferon
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • 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

Landscapes

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

Abstract

Se describe una formulación líquida en la cual un conjugado de INFa de acción prolongada que tiene una duración y estabilidad mejoradas in vivo puede almacenarse de forma estable durante un periodo de tiempo largo. Comprende un estabilizador que comprende una solución amortiguadora, un alcohol de azúcar, un tensoactivo no iónico y un agente isotónico. Al estar libre de albúmina de suero humana y de otros factores potenciales perjudiciales para el cuerpo, la formulación líquida está libre de preocupaciones acerca de infecciones virales y garantiza una estabilidad excelente al almacenamiento para conjugados INFa de acción prolongada.
MX2013004595A 2010-10-26 2011-10-26 Formulaciones liquidas de un conjugado de alfa interferon de accion prolongada. MX349441B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020100104383A KR101303388B1 (ko) 2010-10-26 2010-10-26 지속형 인터페론 알파 결합체의 액상 제제
PCT/KR2011/008038 WO2012057525A2 (en) 2010-10-26 2011-10-26 Liquid formulations of long acting interferon alpha conjugate

Publications (2)

Publication Number Publication Date
MX2013004595A true MX2013004595A (es) 2013-12-02
MX349441B MX349441B (es) 2017-07-27

Family

ID=45994559

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2013004595A MX349441B (es) 2010-10-26 2011-10-26 Formulaciones liquidas de un conjugado de alfa interferon de accion prolongada.

Country Status (13)

Country Link
US (1) US9669105B2 (es)
EP (1) EP2632433A4 (es)
JP (1) JP6047495B2 (es)
KR (1) KR101303388B1 (es)
CN (2) CN103228265A (es)
AR (1) AR083568A1 (es)
AU (1) AU2011321165B2 (es)
BR (1) BR112013010311A8 (es)
CA (1) CA2816052C (es)
MX (1) MX349441B (es)
RU (1) RU2613905C2 (es)
TW (1) TWI494120B (es)
WO (1) WO2012057525A2 (es)

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RU2440825C2 (ru) 2007-07-10 2012-01-27 Меди-Токс, Инк. Жидкая фармацевтическая композиция ботулинического токсина
DK3878859T5 (da) 2011-06-10 2024-06-10 Hanmi Science Co Ltd Hidtil ukendte oxyntomodulinderivater og farmaceutisk præparat til behandling af fedme omfattende disse
SI2721062T1 (sl) 2011-06-17 2019-03-29 Hanmi Science Co., Ltd. Konjugat, obsegajoč oksintomodulinski in imunoglobinski fragment, in uporaba le-tega
CN103611163A (zh) * 2011-09-05 2014-03-05 韩美科学株式会社 一种包含干扰素α-缀合物的抗癌用药物组合物
KR20130049671A (ko) 2011-11-04 2013-05-14 한미사이언스 주식회사 생리활성 폴리펩타이드 결합체 제조 방법
AR090281A1 (es) 2012-03-08 2014-10-29 Hanmi Science Co Ltd Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo
AR094821A1 (es) * 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
AR091902A1 (es) 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
KR101968344B1 (ko) 2012-07-25 2019-04-12 한미약품 주식회사 옥신토모듈린 유도체를 포함하는 고지혈증 치료용 조성물
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
US10441665B2 (en) 2012-07-25 2019-10-15 Hanmi Pharm. Co., Ltd. Liquid formulation of long acting insulinotropic peptide conjugate
MY168536A (en) * 2012-11-06 2018-11-12 Hanmi Pharm Ind Co Ltd Liquid formulation of protein conjugate comprising an oxyntomodulin derivative covalently linked to a non-peptidyl polymer to an immunoglobulin fc region
KR101993393B1 (ko) 2012-11-06 2019-10-01 한미약품 주식회사 옥신토모듈린 유도체를 포함하는 당뇨병 또는 비만성 당뇨병 치료용 조성물
MX387560B (es) * 2014-03-31 2025-03-18 Hanmi Pharmaceutical Co Ltd Procedimiento para mejorar la solubilidad de proteínas y péptidos usando un enlace del fragmento fc de inmunoglobulina.
TWI802396B (zh) 2014-09-16 2023-05-11 南韓商韓美藥品股份有限公司 長效glp-1/高血糖素受體雙促效劑治療非酒精性脂肝疾病之用途
KR102418477B1 (ko) 2014-12-30 2022-07-08 한미약품 주식회사 글루카곤 유도체

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Also Published As

Publication number Publication date
AU2011321165A1 (en) 2013-05-09
TW201223541A (en) 2012-06-16
BR112013010311A2 (pt) 2016-09-20
RU2013124059A (ru) 2014-12-10
EP2632433A4 (en) 2014-04-16
US20130287734A1 (en) 2013-10-31
AU2011321165B2 (en) 2015-11-05
JP6047495B2 (ja) 2016-12-21
RU2613905C2 (ru) 2017-03-21
CA2816052A1 (en) 2012-05-03
CN108283714A (zh) 2018-07-17
US9669105B2 (en) 2017-06-06
JP2013544803A (ja) 2013-12-19
CA2816052C (en) 2018-07-24
CN103228265A (zh) 2013-07-31
WO2012057525A2 (en) 2012-05-03
TWI494120B (zh) 2015-08-01
MX349441B (es) 2017-07-27
AR083568A1 (es) 2013-03-06
EP2632433A2 (en) 2013-09-04
WO2012057525A3 (en) 2012-06-28
KR101303388B1 (ko) 2013-09-03
BR112013010311A8 (pt) 2018-01-16
KR20120043206A (ko) 2012-05-04

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