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AR107276A1 - Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada - Google Patents

Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada

Info

Publication number
AR107276A1
AR107276A1 ARP160104091A ARP160104091A AR107276A1 AR 107276 A1 AR107276 A1 AR 107276A1 AR P160104091 A ARP160104091 A AR P160104091A AR P160104091 A ARP160104091 A AR P160104091A AR 107276 A1 AR107276 A1 AR 107276A1
Authority
AR
Argentina
Prior art keywords
human
liquid formulation
conjugate
hgh
prolonged action
Prior art date
Application number
ARP160104091A
Other languages
English (en)
Inventor
Se Chang Kwon
Sung Min Bae
Joo Young Dong
Hyung Kyu Lim
Original Assignee
Hanmi Pharm Ind 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 Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of AR107276A1 publication Critical patent/AR107276A1/es

Links

Classifications

    • 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
    • A61K38/1796—Receptors; Cell surface antigens; Cell surface determinants for hormones
    • 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
    • A61K38/22—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
    • 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
    • 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
    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

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

Abstract

Reivindicación 1: Una formulación líquida de un conjugado de hormona del crecimiento humana (hGH) de acción prolongada que comprende: (i) un conjugado de hGH de acción prolongada en el que la hGH está unida a una región Fc de inmunoglobulina; y (ii) un estabilizante exento de albúmina que comprende una solución tampón, un alcohol de azúcar, un tensioactivo no iónico y un conservante, sin un agente isotónico. Reivindicación 24: Un procedimiento de preparación de la formulación de la reivindicación 1, que comprende mezclar un conjugado de hGH de acción prolongada, en el que el conjugado de hGH está unido a la región Fc de inmunoglobulina, con un tampón, un alcohol de azúcar, un tensioactivo no iónico y un conservante.
ARP160104091A 2015-12-30 2016-12-30 Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada AR107276A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020150189919A KR20170079409A (ko) 2015-12-30 2015-12-30 지속형 인간 성장 호르몬 결합체의 신규 액상 제제

Publications (1)

Publication Number Publication Date
AR107276A1 true AR107276A1 (es) 2018-04-11

Family

ID=59227383

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP160104091A AR107276A1 (es) 2015-12-30 2016-12-30 Una formulación líquida de conjugado de hormona del crecimiento humana de acción prolongada

Country Status (15)

Country Link
US (1) US20190022183A1 (es)
EP (1) EP3398586A4 (es)
JP (1) JP2019500390A (es)
KR (1) KR20170079409A (es)
CN (1) CN108697642A (es)
AR (1) AR107276A1 (es)
AU (1) AU2016382383A1 (es)
BR (1) BR112018013535A2 (es)
CA (1) CA3009627A1 (es)
HK (1) HK1258240A1 (es)
IL (1) IL260316A (es)
MX (1) MX2018008026A (es)
RU (1) RU2018125963A (es)
TW (1) TW201735940A (es)
WO (1) WO2017116191A2 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20200029374A (ko) * 2018-09-10 2020-03-18 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
EP3937904A1 (en) * 2019-03-15 2022-01-19 Eli Lilly and Company Preserved formulations
WO2021085518A1 (ja) * 2019-10-30 2021-05-06 Ｊｃｒファーマ株式会社 血清アルブミンと成長ホルモンの融合蛋白質を含有する水性医薬組成物

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HK1044471A1 (en) * 1999-05-31 2002-10-25 Mitsubishi Chemical Corporation Freeze dried hgf preparations
RU2352583C2 (ru) * 2003-11-13 2009-04-20 Ханми Фарм. Инд. Ко., Лтд. ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ Fc-ОБЛАСТЬ ИММУНОГЛОБУЛИНА В КАЧЕСТВЕ НОСИТЕЛЯ
US8729015B2 (en) * 2007-12-21 2014-05-20 Merck Patent Gmbh Solid lipid microcapsules containing growth hormone inner core microparticles
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
HK1225976A1 (en) * 2013-09-27 2017-09-22 Hanmi Pharm. Co., Ltd. Sustained type human growth hormone preparation

Also Published As

Publication number Publication date
MX2018008026A (es) 2018-11-29
JP2019500390A (ja) 2019-01-10
WO2017116191A3 (ko) 2018-03-08
CN108697642A (zh) 2018-10-23
WO2017116191A2 (ko) 2017-07-06
IL260316A (en) 2019-02-28
US20190022183A1 (en) 2019-01-24
RU2018125963A (ru) 2020-01-30
HK1258240A1 (en) 2019-11-08
EP3398586A4 (en) 2019-08-07
CA3009627A1 (en) 2017-07-06
TW201735940A (zh) 2017-10-16
KR20170079409A (ko) 2017-07-10
EP3398586A2 (en) 2018-11-07
AU2016382383A1 (en) 2018-07-26
BR112018013535A2 (pt) 2018-12-04

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