MX2012005195A - Formulacion para combinacion de rgh y rhlgf-1. - Google Patents

Formulacion para combinacion de rgh y rhlgf-1.

Info

Publication number
MX2012005195A
MX2012005195A MX2012005195A MX2012005195A MX2012005195A MX 2012005195 A MX2012005195 A MX 2012005195A MX 2012005195 A MX2012005195 A MX 2012005195A MX 2012005195 A MX2012005195 A MX 2012005195A MX 2012005195 A MX2012005195 A MX 2012005195A
Authority
MX
Mexico
Prior art keywords
solution
igf
pharmaceutical composition
buffer
aggregating agent
Prior art date
Application number
MX2012005195A
Other languages
English (en)
Spanish (es)
Inventor
Tsutomu Arakawa
Joel Richard
Enona Gopinath
Susan Park
Fabio Fais
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 MX2012005195A publication Critical patent/MX2012005195A/es

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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (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)
  • 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)
MX2012005195A 2009-11-17 2010-11-17 Formulacion para combinacion de rgh y rhlgf-1. MX2012005195A (es)

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
MX2012005195A true MX2012005195A (es) 2012-06-12

Family

ID=43661042

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2012005195A MX2012005195A (es) 2009-11-17 2010-11-17 Formulacion para combinacion de rgh y rhlgf-1.

Country Status (14)

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

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006130769A2 (en) 2005-06-02 2006-12-07 Tercica, Inc. Methods for treatment of growth disorders
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
MA54716A (fr) 2014-10-23 2021-11-17 Amgen Inc Réduction de la viscosité de formulations pharmaceutiques
EP3247400A1 (en) * 2015-01-18 2017-11-29 Biogen MA Inc. Formulations and screening of biological therapeutic agents
CN105854000A (zh) 2015-02-11 2016-08-17 杭州鸿运华宁生物医药工程有限公司 一种药用glp-1r抗体融合蛋白的稳定溶液制剂
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
MA46466A (fr) 2016-10-06 2019-08-14 Amgen Inc Formulations pharmaceutiques de protéines à viscosité réduite
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
PT4228676T (pt) * 2020-10-19 2025-01-24 Oak Hill Bio Ltd Composições adequadas para utilização em recém-nascidos
CA3207384A1 (en) * 2021-02-12 2022-08-18 Lawrence Irwin Glass Treatments of prader-willi syndrome
US20250026804A1 (en) * 2021-11-16 2025-01-23 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
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
AU4329596A (en) * 1995-01-13 1996-07-31 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
MXPA02000404A (es) * 1999-07-12 2004-05-21 Grandis Biotech Gmbh Formulaciones de hormona de crecimiento.
CN100389821C (zh) * 1999-10-04 2008-05-28 希龙公司 稳定化的含多肽的液体药物组合物
US20030180287A1 (en) * 2002-02-27 2003-09-25 Immunex Corporation Polypeptide formulation
EP1536835A1 (en) * 2002-07-09 2005-06-08 Sandoz AG Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
WO2006130769A2 (en) 2005-06-02 2006-12-07 Tercica, Inc. Methods for treatment of growth disorders
ES2749574T3 (es) * 2005-11-01 2020-03-23 Wyeth Llc Solución de cloruro sódico para la reconstitución de fármacos
WO2008004717A1 (en) * 2006-07-06 2008-01-10 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
WO2009136568A1 (ja) * 2008-05-08 2009-11-12 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
WO2011060922A1 (en) 2011-05-26
JP6084036B2 (ja) 2017-02-22
CN102665691A (zh) 2012-09-12
JP6143827B2 (ja) 2017-06-07
BR112012011539A8 (pt) 2017-12-26
KR101614983B1 (ko) 2016-04-22
RU2012124985A (ru) 2013-12-27
ES2532007T3 (es) 2015-03-23
CN102665691B (zh) 2015-05-27
AU2010321225A1 (en) 2012-06-07
JP2013510893A (ja) 2013-03-28
RU2558821C2 (ru) 2015-08-10
JP2016020395A (ja) 2016-02-04
BR112012011539A2 (pt) 2016-06-28
CA2780554A1 (en) 2011-05-26
EP2501367A1 (en) 2012-09-26
KR20120104251A (ko) 2012-09-20
US20120270782A1 (en) 2012-10-25
CA2780554C (en) 2017-08-15
UA108994C2 (uk) 2015-07-10
HK1175711A1 (en) 2013-07-12
IN2012DN02861A (enExample) 2015-07-24
EP2501367B1 (en) 2015-01-21
AU2010321225B2 (en) 2015-12-03
US20170143834A1 (en) 2017-05-25

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