AR090583A1 - Formulacion liquida de conjugados de la hormona de crecimiento humana de accion prolongada, altamente concentrada - Google Patents

Formulacion liquida de conjugados de la hormona de crecimiento humana de accion prolongada, altamente concentrada

Info

Publication number
AR090583A1
AR090583A1 ARP130101078A AR090583A1 AR 090583 A1 AR090583 A1 AR 090583A1 AR P130101078 A ARP130101078 A AR P130101078A AR 090583 A1 AR090583 A1 AR 090583A1
Authority
AR
Argentina
Prior art keywords
human
human growth
conjugates
liquid formulation
highly concentrated
Prior art date
Application number
Other languages
English (en)
Inventor
Hee Hong Sung
Min Bae Sung
Uk Kim Hyun
Kyu Lim Hyung
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 AR090583A1 publication Critical patent/AR090583A1/es

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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
    • 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
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • 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
    • 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] (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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • 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
    • C07K14/575—Hormones
    • C07K14/61—Growth hormones [GH] (Somatotropin)
    • 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)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Formulación líquida de conjugados de la hormona de crecimiento humana de acción prolongada, altamente concentrada, que comprende una cantidad farmacéuticamente eficaz del conjugado de la hormona de crecimiento humana de acción prolongada en donde la hormona de crecimiento humana (hGH) está unida a una región Fc de inmunoglobulina, y un estabilizante sin albúmina, donde dicho estabilizante comprende un amortiguador del pH, un agente tensioactivo no iónico, un alcohol de azúcar y cloruro de sodio como agente isotónico, y un método para preparar la misma.
ARP130101078 2012-03-30 2013-04-03 Formulacion liquida de conjugados de la hormona de crecimiento humana de accion prolongada, altamente concentrada AR090583A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR20120033580 2012-03-30

Publications (1)

Publication Number Publication Date
AR090583A1 true AR090583A1 (es) 2014-11-19

Family

ID=49260722

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP130101078 AR090583A1 (es) 2012-03-30 2013-04-03 Formulacion liquida de conjugados de la hormona de crecimiento humana de accion prolongada, altamente concentrada

Country Status (9)

Country Link
US (2) US10064951B2 (es)
EP (1) EP2830649B1 (es)
JP (2) JP6386441B2 (es)
KR (1) KR20130111462A (es)
AR (1) AR090583A1 (es)
DK (1) DK2830649T3 (es)
ES (1) ES2713979T3 (es)
TW (1) TWI617324B (es)
WO (1) WO2013147559A1 (es)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
TW201605468A (zh) * 2013-09-27 2016-02-16 韓美藥品股份有限公司 長效人類生長激素接合物之製劑
SG10202107752PA (en) * 2014-03-31 2021-09-29 Hanmi Pharmaceutical Co Ltd Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage
KR20170079409A (ko) * 2015-12-30 2017-07-10 한미약품 주식회사 지속형 인간 성장 호르몬 결합체의 신규 액상 제제
KR20230005982A (ko) * 2020-05-01 2023-01-10 호야 테크노사지카루 가부시키가이샤 대전물질의 정제 방법

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GB8504099D0 (en) 1985-02-18 1985-03-20 Wellcome Found Physiologically active substances
US5981485A (en) * 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
FR2650598B1 (fr) 1989-08-03 1994-06-03 Rhone Poulenc Sante Derives de l'albumine a fonction therapeutique
US5374620A (en) * 1990-06-07 1994-12-20 Genentech, Inc. Growth-promoting composition and its use
FR2686901A1 (fr) 1992-01-31 1993-08-06 Rhone Poulenc Rorer Sa Nouveaux polypeptides antithrombotiques, leur preparation et compositions pharmaceutiques les contenant.
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
SE9201073D0 (sv) 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
ATE359824T1 (de) * 1992-07-31 2007-05-15 Genentech Inc Wässrige formulierung enthaltend menschliches wachstumshormon
US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
AUPN801296A0 (en) * 1996-02-12 1996-03-07 Csl Limited Stabilised growth hormone formulation and method of preparation thereof
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US7001892B1 (en) * 1999-06-11 2006-02-21 Purdue Research Foundation Pharmaceutical materials and methods for their preparation and use
US6646899B2 (en) * 2001-09-21 2003-11-11 Broadcom Corporation Content addressable memory with power reduction technique
US20050176108A1 (en) 2003-03-13 2005-08-11 Young-Min Kim Physiologically active polypeptide conjugate having prolonged in vivo half-life
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AU2004224466B2 (en) 2003-03-28 2008-01-03 Biopolymed Inc. Biologically active material conjugated with biocompatible polymer with 1:1 complex, preparation method thereof and pharmaceutical composition comprising the same
US7608270B2 (en) * 2003-06-27 2009-10-27 University Of Hull Dosage form
BRPI0406605B8 (pt) * 2003-11-13 2021-05-25 Hanmi Holdings Co Ltd conjugado de proteína, método para a preparação do mesmo e composição farmacêutica para intensificar a duração e estabilidade in vivo de um polipeptídeo fisiologicamente ativo
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KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
WO2012068779A1 (zh) 2010-11-24 2012-05-31 Cai Yinglin 淋浴热水用热能交换装置

Also Published As

Publication number Publication date
TW201343198A (zh) 2013-11-01
WO2013147559A1 (en) 2013-10-03
JP2015514704A (ja) 2015-05-21
US20150118255A1 (en) 2015-04-30
EP2830649A1 (en) 2015-02-04
EP2830649A4 (en) 2015-08-05
ES2713979T3 (es) 2019-05-24
JP6386441B2 (ja) 2018-09-05
US20180344866A1 (en) 2018-12-06
TWI617324B (zh) 2018-03-11
EP2830649B1 (en) 2018-12-05
JP2018115166A (ja) 2018-07-26
US10064951B2 (en) 2018-09-04
DK2830649T3 (en) 2019-03-25
KR20130111462A (ko) 2013-10-10

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