AR083568A1 - FORMULACIONES LIQUIDAS DE CONJUGADO DE a INTERFERON DE ACCION PROLONGADA - Google Patents

FORMULACIONES LIQUIDAS DE CONJUGADO DE a INTERFERON DE ACCION PROLONGADA

Info

Publication number
AR083568A1
AR083568A1 ARP110103966A ARP110103966A AR083568A1 AR 083568 A1 AR083568 A1 AR 083568A1 AR P110103966 A ARP110103966 A AR P110103966A AR P110103966 A ARP110103966 A AR P110103966A AR 083568 A1 AR083568 A1 AR 083568A1
Authority
AR
Argentina
Prior art keywords
liquid formulation
interferon
conjugate
infa
immunoglobulin
Prior art date
Application number
ARP110103966A
Other languages
English (en)
Inventor
Jae Min Lee
Jong Soo Lee
Sung Min Bae
Se Chang Kwon
Dae Seong Im
Original Assignee
Hanmi Holdings 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 Holdings Co Ltd filed Critical Hanmi Holdings Co Ltd
Publication of AR083568A1 publication Critical patent/AR083568A1/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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Toxicology (AREA)
  • Virology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Formulación líquida en la cual es posible almacenar en forma estable por un largo periodo de tiempo un conjugado de INFa que tiene propiedades mejoradas de duración y estabilidad. Comprende un estabilizador que contiene una solución amortiguadora, un alcohol de azúcar, un tensioactivo no iónico y un agente isotónico. Al carecer de albúmina de suero humano y otros factores potencialmente perjudiciales para el organismo, la formulación líquida descarta riesgos de infecciones virales y garantiza una excelente estabilidad durante el almacenamiento para los conjugados de INFa de acción prolongada.Reivindicación 1: Una formulación líquida, que comprende una cantidad farmacéuticamente eficaz de un conjugado de interferón a de acción prolongada en el cual interferón a y una región Fc de inmunoglobulina están unidos covalentemente entre sí, y un estabilizante libre de albúmina que contiene una solución amortiguadora, un alcohol de azúcar, un tensioactivo no iónico y un agente isotónico. Reivindicación 8: La formulación líquida de la reivindicación 1, en donde el interferón a está unido covalentemente a la región Fc de inmunoglobulina por medio de un polímero no peptídico. Reivindicación 9: La formulación líquida de la reivindicación 8, en donde el polímero no peptídico se selecciona del grupo que consiste en polietilenglicol, polipropilenglicol, copolímeros de etilenglicol y propilenglicol polioles polioxietilados, polivinilalcohol, polisacáridos, dextrano, éter poliviniletílico, polímeros biodegradables, polímeros lipídicos, quitinas, ácido hialuránico, y una combinación de los mismos.
ARP110103966A 2010-10-26 2011-10-26 FORMULACIONES LIQUIDAS DE CONJUGADO DE a INTERFERON DE ACCION PROLONGADA AR083568A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020100104383A KR101303388B1 (ko) 2010-10-26 2010-10-26 지속형 인터페론 알파 결합체의 액상 제제

Publications (1)

Publication Number Publication Date
AR083568A1 true AR083568A1 (es) 2013-03-06

Family

ID=45994559

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP110103966A AR083568A1 (es) 2010-10-26 2011-10-26 FORMULACIONES LIQUIDAS DE CONJUGADO DE a 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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ES2391798T3 (es) * 2007-07-10 2012-11-30 Medy-Tox, Inc. Composición líquida farmacéutica de toxina botulínica con estabilidad mejorada
DK3878859T5 (da) 2011-06-10 2024-06-10 Hanmi Science Co Ltd Hidtil ukendte oxyntomodulinderivater og farmaceutisk præparat til behandling af fedme omfattende disse
CN109306015B (zh) 2011-06-17 2022-04-26 韩美科学株式会社 包括泌酸调节肽和免疫球蛋白片段的结合物以及其应用
CA2847837A1 (en) * 2011-09-05 2013-03-14 Hanmi Science Co., Ltd. A pharmaceutical composition for treating cancer, comprising interferon alpha conjugate
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
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
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
KR101993393B1 (ko) 2012-11-06 2019-10-01 한미약품 주식회사 옥신토모듈린 유도체를 포함하는 당뇨병 또는 비만성 당뇨병 치료용 조성물
DK2916819T3 (da) * 2012-11-06 2019-10-14 Hanmi Pharm Ind Co Ltd Væskeformig formulering af proteinkonjugat omfattende oxyntomodulinet og et immunoglobulin-fragment
EP3127923B1 (en) * 2014-03-31 2021-08-18 Hanmi Pharm. Co., Ltd. Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage
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
TWI594762B (zh) * 2016-03-23 2017-08-11 Rui-Lin Gong Fish interferon nanocapsules encapsulated in chitosan-polylactic acid-polyglycolic acid copolymer by ultrasonic vibration method to effectively prevent its destruction in fish gastrointestinal tract

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Also Published As

Publication number Publication date
WO2012057525A2 (en) 2012-05-03
TWI494120B (zh) 2015-08-01
BR112013010311A8 (pt) 2018-01-16
CN103228265A (zh) 2013-07-31
JP2013544803A (ja) 2013-12-19
CN108283714A (zh) 2018-07-17
JP6047495B2 (ja) 2016-12-21
US9669105B2 (en) 2017-06-06
KR20120043206A (ko) 2012-05-04
AU2011321165B2 (en) 2015-11-05
WO2012057525A3 (en) 2012-06-28
MX349441B (es) 2017-07-27
CA2816052C (en) 2018-07-24
US20130287734A1 (en) 2013-10-31
RU2013124059A (ru) 2014-12-10
BR112013010311A2 (pt) 2016-09-20
AU2011321165A1 (en) 2013-05-09
KR101303388B1 (ko) 2013-09-03
EP2632433A2 (en) 2013-09-04
TW201223541A (en) 2012-06-16
EP2632433A4 (en) 2014-04-16
MX2013004595A (es) 2013-12-02
CA2816052A1 (en) 2012-05-03
RU2613905C2 (ru) 2017-03-21

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