UA108994C2 - Фармацевтична композиція, що містить комбінацію hgh і rhigf-1, і процес її приготування (варіанти) - Google Patents

Фармацевтична композиція, що містить комбінацію hgh і rhigf-1, і процес її приготування (варіанти) Download PDF

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Publication number
UA108994C2
UA108994C2 UAA201207340A UAA201207340A UA108994C2 UA 108994 C2 UA108994 C2 UA 108994C2 UA A201207340 A UAA201207340 A UA A201207340A UA A201207340 A UAA201207340 A UA A201207340A UA 108994 C2 UA108994 C2 UA 108994C2
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UA
Ukraine
Prior art keywords
solution
buffer
pharmaceutical composition
arginine
preparation
Prior art date
Application number
UAA201207340A
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English (en)
Ukrainian (uk)
Inventor
Энона ГОПИНАТ
Original Assignee
Ипсен Фарма С.А.С.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ипсен Фарма С.А.С. filed Critical Ипсен Фарма С.А.С.
Publication of UA108994C2 publication Critical patent/UA108994C2/uk

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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)
UAA201207340A 2009-11-17 2010-11-17 Фармацевтична композиція, що містить комбінацію hgh і rhigf-1, і процес її приготування (варіанти) UA108994C2 (uk)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
UA108994C2 true UA108994C2 (uk) 2015-07-10

Family

ID=43661042

Family Applications (1)

Application Number Title Priority Date Filing Date
UAA201207340A UA108994C2 (uk) 2009-11-17 2010-11-17 Фармацевтична композиція, що містить комбінацію hgh і rhigf-1, і процес її приготування (варіанти)

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)

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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
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
DE69334134T2 (de) * 1992-07-31 2007-12-20 Genentech, Inc., South San Francisco Wässrige Formulierung enthaltend Menschliches Wachstumshormon
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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
JP6084036B2 (ja) 2017-02-22
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
HK1175711A1 (en) 2013-07-12
EP2501367B1 (en) 2015-01-21
CA2780554A1 (en) 2011-05-26

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