CN102665691B - hGH和rhIGF-1组合的制剂 - Google Patents

hGH和rhIGF-1组合的制剂 Download PDF

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Publication number
CN102665691B
CN102665691B CN201080052050.4A CN201080052050A CN102665691B CN 102665691 B CN102665691 B CN 102665691B CN 201080052050 A CN201080052050 A CN 201080052050A CN 102665691 B CN102665691 B CN 102665691B
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China
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solution
pharmaceutical composition
igf
buffer
concentration
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Expired - Fee Related
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CN201080052050.4A
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English (en)
Chinese (zh)
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CN102665691A (zh
Inventor
E·戈皮纳特
S·帕克
荒川务
J·理查德
F·费斯
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Ipsen Pharma SAS
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Ipsen Pharma SAS
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    • 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
    • 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
    • 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)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201080052050.4A 2009-11-17 2010-11-17 hGH和rhIGF-1组合的制剂 Expired - Fee Related CN102665691B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US26185909P 2009-11-17 2009-11-17
US61/261,859 2009-11-17
PCT/EP2010/006996 WO2011060922A1 (en) 2009-11-17 2010-11-17 Formulation for hgh and rhigf-1 combination

Publications (2)

Publication Number Publication Date
CN102665691A CN102665691A (zh) 2012-09-12
CN102665691B true CN102665691B (zh) 2015-05-27

Family

ID=43661042

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CN201080052050.4A Expired - Fee Related CN102665691B (zh) 2009-11-17 2010-11-17 hGH和rhIGF-1组合的制剂

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

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WO2006130769A2 (en) 2005-06-02 2006-12-07 Tercica, Inc. Methods for treatment of growth disorders
WO2013014196A1 (en) * 2011-07-25 2013-01-31 Sandoz Ag Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein
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
MA54716A (fr) 2014-10-23 2021-11-17 Amgen Inc Réduction de la viscosité de formulations pharmaceutiques
EP3247400A1 (en) * 2015-01-18 2017-11-29 Biogen MA Inc. Formulations and screening of biological therapeutic agents
CN105854000A (zh) 2015-02-11 2016-08-17 杭州鸿运华宁生物医药工程有限公司 一种药用glp-1r抗体融合蛋白的稳定溶液制剂
ES2962373T3 (es) * 2016-04-13 2024-03-18 Medimmune Llc Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas
US20210087236A1 (en) * 2016-08-15 2021-03-25 The University Of North Carolina At Chapel Hill Tardigrade disordered proteins as protein stabilizers
MA46466A (fr) 2016-10-06 2019-08-14 Amgen Inc Formulations pharmaceutiques de protéines à viscosité réduite
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
PT4228676T (pt) * 2020-10-19 2025-01-24 Oak Hill Bio Ltd Composições adequadas para utilização em recém-nascidos
CA3207384A1 (en) * 2021-02-12 2022-08-18 Lawrence Irwin Glass Treatments of prader-willi syndrome
US20250026804A1 (en) * 2021-11-16 2025-01-23 Genexine, Inc. High-concentration administration formulation of hgh fusion protein

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996021460A1 (en) * 1995-01-13 1996-07-18 Novo Nordisk A/S A stabilized pharmaceutical formulation comprising a growth hormone and x-lys
US5597802A (en) * 1990-06-07 1997-01-28 Genentech, Inc. Method of formulating IGF-I with growth hormone
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
EP0955062A1 (en) * 1992-07-31 1999-11-10 Genentech, Inc. Human growth hormone aqueous formulation
WO2001003741A1 (en) * 1999-07-12 2001-01-18 Grandis Biotech Gmbh Growth hormone formulations
EP1369125A1 (en) * 1996-05-03 2003-12-10 Genentech, Inc. Treatment of partial growth hormone insensitivity syndrome
CA2491478A1 (en) * 2002-07-09 2004-01-15 Sandoz Ag Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
CN101505789A (zh) * 2006-07-06 2009-08-12 株式会社大熊 稳定的人生长激素液体制剂

Family Cites Families (10)

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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
US5126324A (en) * 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
US5374620A (en) 1990-06-07 1994-12-20 Genentech, Inc. Growth-promoting composition and its use
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
AU1384799A (en) 1997-11-07 1999-05-31 Chiron Corporation Novel igf-i composition and its use
CN100389821C (zh) * 1999-10-04 2008-05-28 希龙公司 稳定化的含多肽的液体药物组合物
US20030180287A1 (en) * 2002-02-27 2003-09-25 Immunex Corporation Polypeptide formulation
WO2006130769A2 (en) 2005-06-02 2006-12-07 Tercica, Inc. Methods for treatment of growth disorders
ES2749574T3 (es) * 2005-11-01 2020-03-23 Wyeth Llc Solución de cloruro sódico para la reconstitución de fármacos
WO2009136568A1 (ja) * 2008-05-08 2009-11-12 味の素株式会社 タンパク質のリフォールディング方法

Patent Citations (9)

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Publication number Priority date Publication date Assignee Title
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
US5597802A (en) * 1990-06-07 1997-01-28 Genentech, Inc. Method of formulating IGF-I with growth hormone
EP0955062A1 (en) * 1992-07-31 1999-11-10 Genentech, Inc. Human growth hormone aqueous formulation
WO1996021460A1 (en) * 1995-01-13 1996-07-18 Novo Nordisk A/S A stabilized pharmaceutical formulation comprising a growth hormone and x-lys
EP1369125A1 (en) * 1996-05-03 2003-12-10 Genentech, Inc. Treatment of partial growth hormone insensitivity syndrome
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
WO2001003741A1 (en) * 1999-07-12 2001-01-18 Grandis Biotech Gmbh Growth hormone formulations
CA2491478A1 (en) * 2002-07-09 2004-01-15 Sandoz Ag Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
CN101505789A (zh) * 2006-07-06 2009-08-12 株式会社大熊 稳定的人生长激素液体制剂

Also Published As

Publication number Publication date
WO2011060922A1 (en) 2011-05-26
JP6084036B2 (ja) 2017-02-22
CN102665691A (zh) 2012-09-12
JP6143827B2 (ja) 2017-06-07
BR112012011539A8 (pt) 2017-12-26
KR101614983B1 (ko) 2016-04-22
RU2012124985A (ru) 2013-12-27
ES2532007T3 (es) 2015-03-23
AU2010321225A1 (en) 2012-06-07
JP2013510893A (ja) 2013-03-28
RU2558821C2 (ru) 2015-08-10
JP2016020395A (ja) 2016-02-04
BR112012011539A2 (pt) 2016-06-28
CA2780554A1 (en) 2011-05-26
EP2501367A1 (en) 2012-09-26
KR20120104251A (ko) 2012-09-20
US20120270782A1 (en) 2012-10-25
CA2780554C (en) 2017-08-15
UA108994C2 (uk) 2015-07-10
HK1175711A1 (en) 2013-07-12
MX2012005195A (es) 2012-06-12
IN2012DN02861A (enExample) 2015-07-24
EP2501367B1 (en) 2015-01-21
AU2010321225B2 (en) 2015-12-03
US20170143834A1 (en) 2017-05-25

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