KR101614983B1 - Ｈｇｈ 및 ｒｈｉｇｆ―１의 조합물을 위한 제제 - Google Patents

Ｈｇｈ 및 ｒｈｉｇｆ―１의 조합물을 위한 제제 Download PDF

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KR101614983B1
KR101614983B1 KR1020127015526A KR20127015526A KR101614983B1 KR 101614983 B1 KR101614983 B1 KR 101614983B1 KR 1020127015526 A KR1020127015526 A KR 1020127015526A KR 20127015526 A KR20127015526 A KR 20127015526A KR 101614983 B1 KR101614983 B1 KR 101614983B1
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South Korea
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solution
buffer
igf
pharmaceutical composition
agent
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English (en)
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KR20120104251A (ko
Inventor
에노나 고피나트
수잔 파크
쯔또무 아라까와
조엘 리차드
파비오 파이스
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입센 파마 에스.에이.에스
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    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020127015526A 2009-11-17 2010-11-17 Ｈｇｈ 및 ｒｈｉｇｆ―１의 조합물을 위한 제제 Expired - Fee Related KR101614983B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26185909P 2009-11-17 2009-11-17
US61/261,859 2009-11-17

Publications (2)

Publication Number Publication Date
KR20120104251A KR20120104251A (ko) 2012-09-20
KR101614983B1 true KR101614983B1 (ko) 2016-04-22

Family

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KR1020127015526A Expired - Fee Related KR101614983B1 (ko) 2009-11-17 2010-11-17 Ｈｇｈ 및 ｒｈｉｇｆ―１의 조합물을 위한 제제

Country Status (14)

Country Link
US (2) US20120270782A1 (https=)
EP (1) EP2501367B1 (https=)
JP (2) JP6084036B2 (https=)
KR (1) KR101614983B1 (https=)
CN (1) CN102665691B (https=)
AU (1) AU2010321225B2 (https=)
BR (1) BR112012011539A8 (https=)
CA (1) CA2780554C (https=)
ES (1) ES2532007T3 (https=)
IN (1) IN2012DN02861A (https=)
MX (1) MX2012005195A (https=)
RU (1) RU2558821C2 (https=)
UA (1) UA108994C2 (https=)
WO (1) WO2011060922A1 (https=)

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JP2008545752A (ja) 2005-06-02 2008-12-18 テルシカ インコーポレーティッド 成長障害を処置するための方法
JP6363949B2 (ja) * 2011-07-25 2018-07-25 サンド アクチェンゲゼルシャフト 少なくとも中性塩および生物薬学的タンパク質を含む、水性製剤
US9216219B2 (en) 2012-06-12 2015-12-22 Novartis Ag Anti-BAFFR antibody formulation
CN104371019B (zh) 2013-08-13 2019-09-10 鸿运华宁（杭州）生物医药有限公司 一种能与glp-1r特异性结合的抗体及其与glp-1的融合蛋白质
AU2015335743B2 (en) * 2014-10-23 2020-12-24 Amgen Inc. Reducing viscosity of pharmaceutical formulations
US20190064147A1 (en) * 2015-01-18 2019-02-28 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
PL3257524T3 (pl) 2015-02-11 2021-03-08 Gmax Biopharm Llc Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r
US20190060241A1 (en) * 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
US20210087236A1 (en) * 2016-08-15 2021-03-25 The University Of North Carolina At Chapel Hill Tardigrade disordered proteins as protein stabilizers
EP3522918A1 (en) 2016-10-06 2019-08-14 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
US10953074B2 (en) * 2017-01-08 2021-03-23 Richard D. Lippman Composition and method for improving sensorineural hearing
JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
IL297504A (en) * 2020-04-22 2022-12-01 Code Pharma B V Pharmaceutical compounds and their antiviral uses
EP4228676B1 (en) * 2020-10-19 2025-01-08 Oak Hill Bio Limited Compositions suitable for use in neonates
GEAP202316350A (en) * 2021-02-12 2023-10-25 Neuren Pharmaceuticals Ltd Treatments of prader-willi syndrome
WO2023096475A1 (ko) * 2021-11-26 2023-06-01 주식회사 제넥신 Hgh 융합단백질의 고농도 투여 제형

Citations (2)

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US5374620A (en) 1990-06-07 1994-12-20 Genentech, Inc. Growth-promoting composition and its use
WO1999024062A1 (en) 1997-11-07 1999-05-20 Chiron Corporation Novel igf-i composition and its use

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IL71991A (en) 1983-06-06 1994-05-30 Genentech Inc Preparation of human FGI and FGE in their processed form through recombinant AND tranology in prokaryotes
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
US5126324A (en) 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
US5681814A (en) * 1990-06-07 1997-10-28 Genentech, Inc. Formulated IGF-I Composition
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
ES2153385T5 (es) * 1992-07-31 2008-09-01 Genentech, Inc. Composicion acuosa a base de hormona del crecimiento humana.
US6207640B1 (en) * 1994-04-07 2001-03-27 Genentech, Inc. Treatment of partial growth hormone insensitivity syndrome
EP0805689A1 (en) * 1995-01-13 1997-11-12 Novo Nordisk A/S A stabilized pharmaceutical formulation comprising a growth hormone and x-lys
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
ES2300268T3 (es) * 1999-07-12 2008-06-16 Sandoz Ag Formulaciones de las hormonas de crecimiento.
DE60031999T2 (de) * 1999-10-04 2007-06-06 Novartis Vaccines and Diagnostics, Inc., Emeryville Stabilisierte flüssige polypeptid-haltige pharmazeutische zusammensetzungen
PT1946776T (pt) * 2002-02-27 2017-03-17 Immunex Corp Composição de tnfr-fc estabilizada compreendendo arginina
CA2491682A1 (en) * 2002-07-09 2004-01-15 Sandoz Ag Liquid formulations with a high concentration of human growth hormone (hgh) comprising glycine
JP2008545752A (ja) * 2005-06-02 2008-12-18 テルシカ インコーポレーティッド 成長障害を処置するための方法
UA97234C2 (ru) * 2005-11-01 2012-01-25 Уайєт Раствор хлорида натрия для восстановления влагосодержания композиции лиофилизированного фактора ix
EP2049148B1 (en) * 2006-07-06 2016-09-28 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
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US5374620A (en) 1990-06-07 1994-12-20 Genentech, Inc. Growth-promoting composition and its use
WO1999024062A1 (en) 1997-11-07 1999-05-20 Chiron Corporation Novel igf-i composition and its use
JP2001522813A (ja) * 1997-11-07 2001-11-20 カイロン コーポレイション 新規のｉｇｆ−ｉ組成物およびその使用

Also Published As

Publication number Publication date
JP2013510893A (ja) 2013-03-28
HK1175711A1 (en) 2013-07-12
JP6143827B2 (ja) 2017-06-07
IN2012DN02861A (https=) 2015-07-24
BR112012011539A2 (pt) 2016-06-28
KR20120104251A (ko) 2012-09-20
BR112012011539A8 (pt) 2017-12-26
AU2010321225B2 (en) 2015-12-03
CN102665691A (zh) 2012-09-12
CA2780554C (en) 2017-08-15
CN102665691B (zh) 2015-05-27
MX2012005195A (es) 2012-06-12
RU2558821C2 (ru) 2015-08-10
EP2501367A1 (en) 2012-09-26
US20170143834A1 (en) 2017-05-25
RU2012124985A (ru) 2013-12-27
ES2532007T3 (es) 2015-03-23
CA2780554A1 (en) 2011-05-26
UA108994C2 (uk) 2015-07-10
JP2016020395A (ja) 2016-02-04
AU2010321225A1 (en) 2012-06-07
US20120270782A1 (en) 2012-10-25
WO2011060922A1 (en) 2011-05-26
EP2501367B1 (en) 2015-01-21
JP6084036B2 (ja) 2017-02-22

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