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)
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

    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (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 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 (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
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
EA038462B1 (ru) * 2014-10-23 2021-08-31 Эмджен Инк. Снижение вязкости фармацевтических составов
WO2016115561A1 (en) * 2015-01-18 2016-07-21 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
CA2975633A1 (en) 2015-02-11 2016-08-18 Gmax Biopharm Llc. Stable pharmaceutical solution formulation of 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
US20210087236A1 (en) * 2016-08-15 2021-03-25 The University Of North Carolina At Chapel Hill Tardigrade disordered proteins as protein stabilizers
WO2018067987A1 (en) 2016-10-06 2018-04-12 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
MX2023004426A (es) * 2020-10-19 2023-08-04 Oak Hill Bio Ltd Composiciones adecuadas para su uso en neonatos.
WO2023096475A1 (ko) * 2021-11-26 2023-06-01 주식회사 제넥신 Hgh 융합단백질의 고농도 투여 제형

Family Cites Families (19)

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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
CA2337745C (en) * 1992-07-31 2005-04-12 Genentech, Inc. Human growth hormone aqueous formulation
US6207640B1 (en) * 1994-04-07 2001-03-27 Genentech, Inc. Treatment of partial growth hormone insensitivity syndrome
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
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
WO1999024062A1 (en) 1997-11-07 1999-05-20 Chiron Corporation Novel igf-i composition and its use
DE60038118T2 (de) * 1999-07-12 2009-03-05 Sandoz Ag Formulierungen von wachstumshormonen
CZ20021186A3 (cs) * 1999-10-04 2002-11-13 Chiron Corporation Farmaceutické prostředky obsahující stabilizovaný kapalný polypeptid
US20030180287A1 (en) * 2002-02-27 2003-09-25 Immunex Corporation Polypeptide formulation
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
EP1901770B1 (en) 2005-06-02 2014-12-24 Ipsen Biopharmaceuticals, Inc. Gh and igf-1 for treatment of growth disorders
PE20151284A1 (es) * 2005-11-01 2015-10-05 Wyeth Corp Solucion de cloruro de sodio para reconstitucion o dilucion de farmaco
PT2049148T (pt) * 2006-07-06 2016-12-30 Daewoong Co Ltd Formulação líquida estável da hormona do crescimento humana
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Also Published As

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

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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