BR112012011539A2 - formulação para a combinação de hgh e rhigf-1 - Google Patents

formulação para a combinação de hgh e rhigf-1

Info

Publication number
BR112012011539A2
BR112012011539A2 BR112012011539A BR112012011539A BR112012011539A2 BR 112012011539 A2 BR112012011539 A2 BR 112012011539A2 BR 112012011539 A BR112012011539 A BR 112012011539A BR 112012011539 A BR112012011539 A BR 112012011539A BR 112012011539 A2 BR112012011539 A2 BR 112012011539A2
Authority
BR
Brazil
Prior art keywords
combination
hgh
formulation
rhigf
relates
Prior art date
Application number
BR112012011539A
Other languages
English (en)
Other versions
BR112012011539A8 (pt
Inventor
Enona Gopinath
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

    • 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)
  • 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)

Abstract

"formulação para a combinação de hgh e rhigp-1" a presente invenção diz respeito às composições farmacêuticas. mais particularmente, a invenção diz respeito às formulações de composições de combinação de hormônio do crescimento (gh) e fator de crescimento equivalente à insulina (igf-1) que fornecem composições farmacêuticas estáveis sem formação de agregação em um ph desejável, e aos processos de preparação das mesmas.
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 true BR112012011539A2 (pt) 2016-06-28
BR112012011539A8 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 (15)

Country Link
US (2) US20120270782A1 (pt)
EP (1) EP2501367B1 (pt)
JP (2) JP6084036B2 (pt)
KR (1) KR101614983B1 (pt)
CN (1) CN102665691B (pt)
AU (1) AU2010321225B2 (pt)
BR (1) BR112012011539A8 (pt)
CA (1) CA2780554C (pt)
ES (1) ES2532007T3 (pt)
HK (1) HK1175711A1 (pt)
IN (1) IN2012DN02861A (pt)
MX (1) MX2012005195A (pt)
RU (1) RU2558821C2 (pt)
UA (1) UA108994C2 (pt)
WO (1) WO2011060922A1 (pt)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8158582B2 (en) 2005-06-02 2012-04-17 Tercica, Inc. Methods for treatment of insulin-like growth factor-1 deficiency
EP2736490A1 (en) 2011-07-25 2014-06-04 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
EA033444B1 (ru) * 2014-10-23 2019-10-31 Amgen Inc Снижение вязкости фармацевтических составов
WO2016115561A1 (en) * 2015-01-18 2016-07-21 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
US10485870B2 (en) 2015-02-11 2019-11-26 Gmax Biopharm Llc. Stable pharmaceutical solution formulation of GLP-1R antibody fusion protein
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
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
US20230381285A1 (en) * 2020-10-19 2023-11-30 Oak Hill Bio Ltd Compositions suitable for use in neonates
CA3238895A1 (en) * 2021-11-26 2023-06-01 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
CA2489978A1 (en) * 1992-07-31 1994-02-17 Genentech, Inc. Human growth hormone aqueous formulation
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
WO1999024062A1 (en) 1997-11-07 1999-05-20 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
HUP0202189A3 (en) * 1999-07-12 2003-07-28 Sandoz Ag Growth hormone formulations, method for their preparation and device and kit comprising thereof
BR0014486A (pt) * 1999-10-04 2002-09-17 Chiron Corp Composições farmacêuticas contendo polipeptìdeo lìquido estabilizado
JP4583762B2 (ja) * 2002-02-27 2010-11-17 イミュネックス・コーポレーション ポリペプチド製剤
JP2005535652A (ja) * 2002-07-09 2005-11-24 サンド・アクチエンゲゼルシヤフト １，２−プロピレングリコールを含有するヒト成長ホルモン（ｈＧＨ）の高濃度液体製剤
US8158582B2 (en) * 2005-06-02 2012-04-17 Tercica, Inc. Methods for treatment of insulin-like growth factor-1 deficiency
ES2627684T5 (es) * 2005-11-01 2024-04-29 Wyeth Llc Solución de cloruro sódico para la reconstitución o la dilución de fármacos
ES2605022T3 (es) * 2006-07-06 2017-03-10 Daewoong Co., Ltd. Una formulación líquida estable de la hormona del crecimiento humana
JP5168604B2 (ja) * 2008-05-08 2013-03-21 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
IN2012DN02861A (pt) 2015-07-24
MX2012005195A (es) 2012-06-12
HK1175711A1 (en) 2013-07-12
ES2532007T3 (es) 2015-03-23
CN102665691B (zh) 2015-05-27
KR20120104251A (ko) 2012-09-20
KR101614983B1 (ko) 2016-04-22
US20120270782A1 (en) 2012-10-25
EP2501367A1 (en) 2012-09-26
JP6143827B2 (ja) 2017-06-07
US20170143834A1 (en) 2017-05-25
JP2016020395A (ja) 2016-02-04
UA108994C2 (uk) 2015-07-10
CA2780554C (en) 2017-08-15
CA2780554A1 (en) 2011-05-26
EP2501367B1 (en) 2015-01-21
AU2010321225A1 (en) 2012-06-07
CN102665691A (zh) 2012-09-12
JP6084036B2 (ja) 2017-02-22
BR112012011539A8 (pt) 2017-12-26
AU2010321225B2 (en) 2015-12-03
RU2558821C2 (ru) 2015-08-10
RU2012124985A (ru) 2013-12-27
WO2011060922A1 (en) 2011-05-26
JP2013510893A (ja) 2013-03-28

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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