RU2558821C2 - ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1 - Google Patents

ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1 Download PDF

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Publication number
RU2558821C2
RU2558821C2 RU2012124985/15A RU2012124985A RU2558821C2 RU 2558821 C2 RU2558821 C2 RU 2558821C2 RU 2012124985/15 A RU2012124985/15 A RU 2012124985/15A RU 2012124985 A RU2012124985 A RU 2012124985A RU 2558821 C2 RU2558821 C2 RU 2558821C2
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Russia
Prior art keywords
solution
igf
buffer
pharmaceutical composition
concentration
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RU2012124985/15A
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English (en)
Russian (ru)
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RU2012124985A (ru
Inventor
Энона ГОПИНАТ
Сьюзан ПАРК
Цутому АРАКАВА
Жоэль Ришар
Фабио ФЭ
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Ипсен Фарма С.А.С.
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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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (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)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
RU2012124985/15A 2009-11-17 2010-11-17 ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1 RU2558821C2 (ru)

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
RU2012124985A RU2012124985A (ru) 2013-12-27
RU2558821C2 true RU2558821C2 (ru) 2015-08-10

Family

ID=43661042

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2012124985/15A RU2558821C2 (ru) 2009-11-17 2010-11-17 ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1

Country Status (14)

Country Link
US (2) US20120270782A1 (cg-RX-API-DMAC10.html)
EP (1) EP2501367B1 (cg-RX-API-DMAC10.html)
JP (2) JP6084036B2 (cg-RX-API-DMAC10.html)
KR (1) KR101614983B1 (cg-RX-API-DMAC10.html)
CN (1) CN102665691B (cg-RX-API-DMAC10.html)
AU (1) AU2010321225B2 (cg-RX-API-DMAC10.html)
BR (1) BR112012011539A8 (cg-RX-API-DMAC10.html)
CA (1) CA2780554C (cg-RX-API-DMAC10.html)
ES (1) ES2532007T3 (cg-RX-API-DMAC10.html)
IN (1) IN2012DN02861A (cg-RX-API-DMAC10.html)
MX (1) MX2012005195A (cg-RX-API-DMAC10.html)
RU (1) RU2558821C2 (cg-RX-API-DMAC10.html)
UA (1) UA108994C2 (cg-RX-API-DMAC10.html)
WO (1) WO2011060922A1 (cg-RX-API-DMAC10.html)

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US8158582B2 (en) 2005-06-02 2012-04-17 Tercica, Inc. Methods for treatment of insulin-like growth factor-1 deficiency
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
ES2964713T3 (es) * 2014-10-23 2024-04-09 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
WO2016115561A1 (en) * 2015-01-18 2016-07-21 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
EP3257524B1 (en) * 2015-02-11 2020-08-26 Gmax Biopharm LLC Stabilized solution preparation of pharmaceutical glp-1r antibody fusion protein
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
WO2018034867A1 (en) * 2016-08-15 2018-02-22 The University Of North Carolina At Chapel Hill Tardigrade disordered proteins as protein stabilizers
JP7275027B2 (ja) 2016-10-06 2023-05-17 アムジェン インコーポレイテッド 粘度低下タンパク質医薬製剤
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
EP3681602B1 (en) 2017-09-11 2026-04-15 Oak Hill Bio Limited Compositions for reducing the incidence of bpd
CA3176341A1 (en) * 2020-04-22 2021-10-28 Zyon AYNI Pharmaceutical compositions and anti-viral uses thereof
KR20230113287A (ko) * 2020-10-19 2023-07-28 오크 힐 바이오 리미티드 신생아에 사용하기에 적합한 조성물
IL305132A (en) * 2021-02-12 2023-10-01 Neuren Pharmaceuticals Ltd Preparations for the treatment of the Prader-Willi phenomenon
MX2024006318A (es) * 2021-11-26 2024-08-14 Genexine Inc Formulacion para administracion de alta concentracion de proteina de fusion de hormona del crecimiento.

Citations (2)

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Publication number Priority date Publication date Assignee Title
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

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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
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
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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
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AU2003249992A1 (en) * 2002-07-09 2004-01-23 Sandoz Ag Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
US8158582B2 (en) * 2005-06-02 2012-04-17 Tercica, Inc. Methods for treatment of insulin-like growth factor-1 deficiency
US20070135343A1 (en) * 2005-11-01 2007-06-14 Wyeth Sodium chloride solution for drug reconstitution or dilution
LT2049148T (lt) * 2006-07-06 2016-11-25 Daewoong Co., Ltd. Žmogaus augimo hormono skysta stabili kompozicija
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Patent Citations (2)

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

Also Published As

Publication number Publication date
CN102665691A (zh) 2012-09-12
UA108994C2 (uk) 2015-07-10
IN2012DN02861A (cg-RX-API-DMAC10.html) 2015-07-24
US20120270782A1 (en) 2012-10-25
BR112012011539A2 (pt) 2016-06-28
CA2780554C (en) 2017-08-15
HK1175711A1 (en) 2013-07-12
KR101614983B1 (ko) 2016-04-22
US20170143834A1 (en) 2017-05-25
JP2016020395A (ja) 2016-02-04
MX2012005195A (es) 2012-06-12
EP2501367B1 (en) 2015-01-21
JP6084036B2 (ja) 2017-02-22
EP2501367A1 (en) 2012-09-26
CA2780554A1 (en) 2011-05-26
JP2013510893A (ja) 2013-03-28
CN102665691B (zh) 2015-05-27
KR20120104251A (ko) 2012-09-20
AU2010321225B2 (en) 2015-12-03
WO2011060922A1 (en) 2011-05-26
JP6143827B2 (ja) 2017-06-07
AU2010321225A1 (en) 2012-06-07
BR112012011539A8 (pt) 2017-12-26
ES2532007T3 (es) 2015-03-23
RU2012124985A (ru) 2013-12-27

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Effective date: 20201118