JP6084036B2 - ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物 - Google Patents

ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物 Download PDF

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Publication number
JP6084036B2
JP6084036B2 JP2012539223A JP2012539223A JP6084036B2 JP 6084036 B2 JP6084036 B2 JP 6084036B2 JP 2012539223 A JP2012539223 A JP 2012539223A JP 2012539223 A JP2012539223 A JP 2012539223A JP 6084036 B2 JP6084036 B2 JP 6084036B2
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solution
buffer
igf
pharmaceutical composition
concentration
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Expired - Fee Related
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Japanese (ja)
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JP2013510893A (ja
Inventor
イーノナ・ゴピナス
スーザン・パーク
力 荒川
力 荒川
ジョエル・リシャール
ファビオ・ファイス
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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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (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)
  • 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)
JP2012539223A 2009-11-17 2010-11-17 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物 Expired - Fee Related JP6084036B2 (ja)

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015215192A Division JP6143827B2 (ja) 2009-11-17 2015-10-30 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物

Publications (2)

Publication Number Publication Date
JP2013510893A JP2013510893A (ja) 2013-03-28
JP6084036B2 true JP6084036B2 (ja) 2017-02-22

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
JP2012539223A Expired - Fee Related JP6084036B2 (ja) 2009-11-17 2010-11-17 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物
JP2015215192A Expired - Fee Related JP6143827B2 (ja) 2009-11-17 2015-10-30 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物

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JP2015215192A Expired - Fee Related JP6143827B2 (ja) 2009-11-17 2015-10-30 ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物

Country Status (14)

Country Link
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)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
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
AU4329596A (en) * 1995-01-13 1996-07-31 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
AU1384799A (en) 1997-11-07 1999-05-31 Chiron Corporation Novel igf-i composition and its use
MXPA02000404A (es) * 1999-07-12 2004-05-21 Grandis Biotech Gmbh Formulaciones de hormona de crecimiento.
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
EP1536835A1 (en) * 2002-07-09 2005-06-08 Sandoz AG Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
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
WO2008004717A1 (en) * 2006-07-06 2008-01-10 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
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

Also Published As

Publication number Publication date
WO2011060922A1 (en) 2011-05-26
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
CN102665691B (zh) 2015-05-27
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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