BR112012011539A8 - formulação para a combinação de hgh e rhigf-1 - Google Patents

formulação para a combinação de hgh e rhigf-1

Info

Publication number
BR112012011539A8
BR112012011539A8 BR112012011539A BR112012011539A BR112012011539A8 BR 112012011539 A8 BR112012011539 A8 BR 112012011539A8 BR 112012011539 A BR112012011539 A BR 112012011539A BR 112012011539 A BR112012011539 A BR 112012011539A BR 112012011539 A8 BR112012011539 A8 BR 112012011539A8
Authority
BR
Brazil
Prior art keywords
combination
hgh
formulation
rhigf
relates
Prior art date
Application number
BR112012011539A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112012011539A2 (pt
Inventor
Gopinath Enona
Fais Fabio
Richard Joël
Park Susan
Arakawa Tsutomu
Original Assignee
Ipsen Pharma Sas
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 Ipsen Pharma Sas filed Critical Ipsen Pharma Sas
Publication of BR112012011539A2 publication Critical patent/BR112012011539A2/pt
Publication of BR112012011539A8 publication Critical patent/BR112012011539A8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/30Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (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)
  • 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)
BR112012011539A 2009-11-17 2010-11-17 formulação para a combinação de hgh e rhigf-1 BR112012011539A8 (pt)

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 (2)

Publication Number Publication Date
BR112012011539A2 BR112012011539A2 (pt) 2016-06-28
BR112012011539A8 true BR112012011539A8 (pt) 2017-12-26

Family

ID=43661042

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012011539A BR112012011539A8 (pt) 2009-11-17 2010-11-17 formulação para a combinação de hgh e rhigf-1

Country Status (14)

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

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JP2008545752A (ja) 2005-06-02 2008-12-18 テルシカ インコーポレーティッド 成長障害を処置するための方法
JP6363949B2 (ja) * 2011-07-25 2018-07-25 サンド アクチェンゲゼルシャフト 少なくとも中性塩および生物薬学的タンパク質を含む、水性製剤
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
AU2015335743B2 (en) * 2014-10-23 2020-12-24 Amgen Inc. Reducing viscosity of pharmaceutical formulations
US20190064147A1 (en) * 2015-01-18 2019-02-28 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
PL3257524T3 (pl) 2015-02-11 2021-03-08 Gmax Biopharm Llc Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r
US20190060241A1 (en) * 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
US20210087236A1 (en) * 2016-08-15 2021-03-25 The University Of North Carolina At Chapel Hill Tardigrade disordered proteins as protein stabilizers
EP3522918A1 (en) 2016-10-06 2019-08-14 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
IL297504A (en) * 2020-04-22 2022-12-01 Code Pharma B V Pharmaceutical compounds and their antiviral uses
EP4228676B1 (en) * 2020-10-19 2025-01-08 Oak Hill Bio Limited Compositions suitable for use in neonates
GEAP202316350A (en) * 2021-02-12 2023-10-25 Neuren Pharmaceuticals Ltd Treatments of prader-willi syndrome
WO2023096475A1 (ko) * 2021-11-26 2023-06-01 주식회사 제넥신 Hgh 융합단백질의 고농도 투여 제형

Family Cites Families (19)

* Cited by examiner, † Cited by third party
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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
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
EP0805689A1 (en) * 1995-01-13 1997-11-12 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
ES2300268T3 (es) * 1999-07-12 2008-06-16 Sandoz Ag Formulaciones de las hormonas de crecimiento.
DE60031999T2 (de) * 1999-10-04 2007-06-06 Novartis Vaccines and Diagnostics, Inc., Emeryville Stabilisierte flüssige polypeptid-haltige pharmazeutische zusammensetzungen
PT1946776T (pt) * 2002-02-27 2017-03-17 Immunex Corp Composição de tnfr-fc estabilizada compreendendo arginina
CA2491682A1 (en) * 2002-07-09 2004-01-15 Sandoz Ag Liquid formulations with a high concentration of human growth hormone (hgh) comprising glycine
JP2008545752A (ja) * 2005-06-02 2008-12-18 テルシカ インコーポレーティッド 成長障害を処置するための方法
UA97234C2 (ru) * 2005-11-01 2012-01-25 Уайєт Раствор хлорида натрия для восстановления влагосодержания композиции лиофилизированного фактора ix
EP2049148B1 (en) * 2006-07-06 2016-09-28 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
CN102089319B (zh) * 2008-05-08 2013-11-13 味之素株式会社 蛋白质的重折叠方法

Also Published As

Publication number Publication date
JP2013510893A (ja) 2013-03-28
HK1175711A1 (en) 2013-07-12
JP6143827B2 (ja) 2017-06-07
IN2012DN02861A (https=) 2015-07-24
BR112012011539A2 (pt) 2016-06-28
KR20120104251A (ko) 2012-09-20
AU2010321225B2 (en) 2015-12-03
CN102665691A (zh) 2012-09-12
CA2780554C (en) 2017-08-15
CN102665691B (zh) 2015-05-27
MX2012005195A (es) 2012-06-12
RU2558821C2 (ru) 2015-08-10
EP2501367A1 (en) 2012-09-26
US20170143834A1 (en) 2017-05-25
RU2012124985A (ru) 2013-12-27
ES2532007T3 (es) 2015-03-23
CA2780554A1 (en) 2011-05-26
KR101614983B1 (ko) 2016-04-22
UA108994C2 (uk) 2015-07-10
JP2016020395A (ja) 2016-02-04
AU2010321225A1 (en) 2012-06-07
US20120270782A1 (en) 2012-10-25
WO2011060922A1 (en) 2011-05-26
EP2501367B1 (en) 2015-01-21
JP6084036B2 (ja) 2017-02-22

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 6.20 NA RPI NO 2529 DE 25/06/2019 POR TER SIDO INDEVIDA.

B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements