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AR113034A2 - Formulación líquida de un conjugado de la hormona del crecimiento humano de efecto prolongado - Google Patents

Formulación líquida de un conjugado de la hormona del crecimiento humano de efecto prolongado

Info

Publication number
AR113034A2
AR113034A2 ARP180100643A ARP180100643A AR113034A2 AR 113034 A2 AR113034 A2 AR 113034A2 AR P180100643 A ARP180100643 A AR P180100643A AR P180100643 A ARP180100643 A AR P180100643A AR 113034 A2 AR113034 A2 AR 113034A2
Authority
AR
Argentina
Prior art keywords
growth hormone
human growth
conjugate
liquid formulation
long
Prior art date
Application number
ARP180100643A
Other languages
English (en)
Inventor
Sung Hee Hong
Dae Seong Im
Se Chang Kwon
Sung Min Bae
Byung Sun Lee
Jae Min Lee
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 AR113034A2 publication Critical patent/AR113034A2/es

Links

Classifications

    • 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
    • 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
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • 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
    • A61K47/26—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
    • A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Reivindicación 1: Una formulación líquida de conjugado de la hormona del crecimiento humano de efecto prolongado, caracterizada porque comprende una cantidad farmacéuticamente eficaz del conjugado de la hormona del crecimiento humano de efecto prolongado, en donde la hormona del crecimiento humano está unida a una región Fc de una inmunoglobulina, y un estabilizante libre de albúmina, donde dicho estabilizante comprende una solución amortiguadora de pH 5,0 ~ 6,0, un alcohol de azúcar, un agente tensioactivo no iónico y una sal. Reivindicación 2: La formulación líquida del conjugado de la hormona del crecimiento humano de efecto prolongado de la reivindicación 1, caracterizada porque el alcohol de azúcar se selecciona del grupo que consiste de manitol, sorbitol y una combinación de los mismos.
ARP180100643A 2010-07-14 2018-03-20 Formulación líquida de un conjugado de la hormona del crecimiento humano de efecto prolongado AR113034A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020100067796A KR101337797B1 (ko) 2010-07-14 2010-07-14 지속형 인간 성장 호르몬 결합체 액상 제제

Publications (1)

Publication Number Publication Date
AR113034A2 true AR113034A2 (es) 2020-01-22

Family

ID=45469941

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP110102545A AR082223A1 (es) 2010-07-14 2011-07-14 Formulacion liquida de un conjugado de hormona del crecimiento humano de efecto prolongado, metodo
ARP180100643A AR113034A2 (es) 2010-07-14 2018-03-20 Formulación líquida de un conjugado de la hormona del crecimiento humano de efecto prolongado

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP110102545A AR082223A1 (es) 2010-07-14 2011-07-14 Formulacion liquida de un conjugado de hormona del crecimiento humano de efecto prolongado, metodo

Country Status (13)

Country Link
US (1) US9061072B2 (es)
EP (1) EP2593084B1 (es)
JP (1) JP5946448B2 (es)
KR (1) KR101337797B1 (es)
AR (2) AR082223A1 (es)
AU (1) AU2011277203B2 (es)
BR (1) BR112013000902A2 (es)
CA (1) CA2805228C (es)
ES (1) ES2673022T3 (es)
IL (1) IL224225B (es)
RU (1) RU2623026C2 (es)
TW (1) TWI459961B (es)
WO (1) WO2012008779A2 (es)

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Also Published As

Publication number Publication date
RU2013106276A (ru) 2014-08-20
EP2593084A4 (en) 2014-11-05
CN103068366A (zh) 2013-04-24
WO2012008779A2 (en) 2012-01-19
WO2012008779A3 (en) 2012-05-24
TW201215404A (en) 2012-04-16
KR101337797B1 (ko) 2013-12-06
US9061072B2 (en) 2015-06-23
IL224225B (en) 2018-07-31
BR112013000902A2 (pt) 2020-08-25
RU2623026C2 (ru) 2017-06-21
EP2593084B1 (en) 2018-03-14
EP2593084A2 (en) 2013-05-22
CA2805228C (en) 2019-05-07
KR20120007182A (ko) 2012-01-20
ES2673022T3 (es) 2018-06-19
JP5946448B2 (ja) 2016-07-06
AR082223A1 (es) 2012-11-21
JP2013531034A (ja) 2013-08-01
CA2805228A1 (en) 2012-01-19
AU2011277203B2 (en) 2015-11-12
TWI459961B (zh) 2014-11-11
US20130115231A1 (en) 2013-05-09
AU2011277203A1 (en) 2013-02-28

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