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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Japan
Prior art keywords
solution
buffer
igf
pharmaceutical composition
concentration
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Expired - Fee Related
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JP2012539223A
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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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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

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Family Applications (2)

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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 (cg-RX-API-DMAC7.html)
EP (1) EP2501367B1 (cg-RX-API-DMAC7.html)
JP (2) JP6084036B2 (cg-RX-API-DMAC7.html)
KR (1) KR101614983B1 (cg-RX-API-DMAC7.html)
CN (1) CN102665691B (cg-RX-API-DMAC7.html)
AU (1) AU2010321225B2 (cg-RX-API-DMAC7.html)
BR (1) BR112012011539A8 (cg-RX-API-DMAC7.html)
CA (1) CA2780554C (cg-RX-API-DMAC7.html)
ES (1) ES2532007T3 (cg-RX-API-DMAC7.html)
IN (1) IN2012DN02861A (cg-RX-API-DMAC7.html)
MX (1) MX2012005195A (cg-RX-API-DMAC7.html)
RU (1) RU2558821C2 (cg-RX-API-DMAC7.html)
UA (1) UA108994C2 (cg-RX-API-DMAC7.html)
WO (1) WO2011060922A1 (cg-RX-API-DMAC7.html)

Families Citing this family (16)

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EP1901770B1 (en) 2005-06-02 2014-12-24 Ipsen Biopharmaceuticals, Inc. Gh and igf-1 for treatment of growth disorders
BR112014001921B1 (pt) * 2011-07-25 2022-05-10 Sandoz Ag Formulação aquosa farmaceuticamente aceitável, método para aumentar a estabilidade de uma formulação aquosa farmaceuticamente aceitável e embalagem principal
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
BR112017008125B1 (pt) * 2014-10-23 2023-11-21 Amgen Inc. Método para a redução da viscosidade de formulações farmacêuticas, formulações farmacêuticas, método de preparação de um pó liofilizado, pó liofilizado e método para reconstituição de um pó liofilizado
WO2016115561A1 (en) * 2015-01-18 2016-07-21 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
JP6731953B2 (ja) * 2015-02-11 2020-07-29 ジーエムエーエックス バイオファーム エルエルシー． Ｇｌｐ−１ｒ抗体融合タンパク質の安定な医薬溶液製剤
EP3443346B1 (en) * 2016-04-13 2023-08-30 Medimmune, LLC Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
WO2018034867A1 (en) * 2016-08-15 2018-02-22 The University Of North Carolina At Chapel Hill Tardigrade disordered proteins as protein stabilizers
US11459401B2 (en) 2016-10-06 2022-10-04 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
US20230190863A1 (en) * 2020-04-22 2023-06-22 Code Pharma B.V. Pharmaceutical compositions and anti-viral uses thereof
EP4534073A3 (en) * 2020-10-19 2025-05-14 Oak Hill Bio Limited Compositions suitable for use in neonates
KR20230145397A (ko) * 2021-02-12 2023-10-17 뉴렌 파마슈티컬즈 리미티드 프라더-윌리 증후군의 치료
US20250026804A1 (en) * 2021-11-16 2025-01-23 Genexine, Inc. High-concentration administration formulation of hgh fusion protein

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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
US5374620A (en) * 1990-06-07 1994-12-20 Genentech, Inc. Growth-promoting composition and its use
US5681814A (en) * 1990-06-07 1997-10-28 Genentech, Inc. Formulated IGF-I Composition
US5126324A (en) 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
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JPH10511964A (ja) * 1995-01-13 1998-11-17 ノボ ノルディスク アクティーゼルスカブ 成長ホルモン及びＸ−Ｌｙｓを含む安定化医薬製剤
EP1028747A1 (en) * 1997-11-07 2000-08-23 Chiron Corporation Novel igf-i composition and its use
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
NZ516507A (en) * 1999-07-12 2004-02-27 Grandis Biotech Gmbh Growth hormone formulations that are resistant to crystallisation
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Also Published As

Publication number Publication date
RU2012124985A (ru) 2013-12-27
AU2010321225B2 (en) 2015-12-03
JP2013510893A (ja) 2013-03-28
CA2780554C (en) 2017-08-15
CN102665691A (zh) 2012-09-12
RU2558821C2 (ru) 2015-08-10
US20170143834A1 (en) 2017-05-25
BR112012011539A8 (pt) 2017-12-26
EP2501367A1 (en) 2012-09-26
JP2016020395A (ja) 2016-02-04
ES2532007T3 (es) 2015-03-23
BR112012011539A2 (pt) 2016-06-28
JP6143827B2 (ja) 2017-06-07
CN102665691B (zh) 2015-05-27
KR101614983B1 (ko) 2016-04-22
WO2011060922A1 (en) 2011-05-26
US20120270782A1 (en) 2012-10-25
KR20120104251A (ko) 2012-09-20
MX2012005195A (es) 2012-06-12
AU2010321225A1 (en) 2012-06-07
IN2012DN02861A (cg-RX-API-DMAC7.html) 2015-07-24
UA108994C2 (uk) 2015-07-10
HK1175711A1 (en) 2013-07-12
EP2501367B1 (en) 2015-01-21
CA2780554A1 (en) 2011-05-26

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