IN2012DN02861A - - Google Patents

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Publication number
IN2012DN02861A
IN2012DN02861A IN2861DEN2012A IN2012DN02861A IN 2012DN02861 A IN2012DN02861 A IN 2012DN02861A IN 2861DEN2012 A IN2861DEN2012 A IN 2861DEN2012A IN 2012DN02861 A IN2012DN02861 A IN 2012DN02861A
Authority
IN
India
Prior art keywords
relates
pharmaceutical compositions
compositions
igf
insulin
Prior art date
Application number
Inventor
Enona Gopinath
Susan Park
Tsutomu Arakawa
Joel Richard
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 IN2012DN02861A publication Critical patent/IN2012DN02861A/en

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Classifications

    • 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] (Somatotropin)
    • 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
    • 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 (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

Abstract

The present invention relates to pharmaceutical compositions. More particularly, the invention relates to formulations of growth hormone (GH) and insulin-like growth factor (IGF-1) combination compositions which provide stable pharmaceutical compositions without aggregation formation at a desirable pH, and to processes of preparation thereof.
IN2861DEN2012 2009-11-17 2010-11-17 IN2012DN02861A (en)

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
IN2012DN02861A true IN2012DN02861A (en) 2015-07-24

Family

ID=43661042

Family Applications (1)

Application Number Title Priority Date Filing Date
IN2861DEN2012 IN2012DN02861A (en) 2009-11-17 2010-11-17

Country Status (15)

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

Families Citing this family (14)

* 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
BR112014001921B1 (en) 2011-07-25 2022-05-10 Sandoz Ag Pharmaceutically acceptable aqueous formulation, method of increasing the stability of a pharmaceutically acceptable aqueous formulation and main packaging
US9216219B2 (en) 2012-06-12 2015-12-22 Novartis Ag Anti-BAFFR antibody formulation
CN104371019B (en) 2013-08-13 2019-09-10 鸿运华宁（杭州）生物医药有限公司 It is a kind of can with GLP-1R specifically bind antibody and its with the fused protein of GLP-1
WO2016065181A1 (en) * 2014-10-23 2016-04-28 Amgen Inc. Reducing viscosity of pharmaceutical formulations
EP3247400A1 (en) * 2015-01-18 2017-11-29 Biogen MA Inc. Formulations and screening of biological therapeutic agents
EP3257524B1 (en) * 2015-02-11 2020-08-26 Gmax Biopharm LLC Stabilized solution preparation of pharmaceutical glp-1r antibody fusion protein
JP2019511531A (en) * 2016-04-13 2019-04-25 メディミューン，エルエルシー Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein based therapeutics
US20210087236A1 (en) * 2016-08-15 2021-03-25 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 (en) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド Low viscosity, high concentration evolocumab formulations and their manufacturing method
AU2021364523A1 (en) * 2020-10-19 2023-04-06 Oak Hill Bio Limited Compositions suitable for use in neonates
WO2023096475A1 (en) * 2021-11-26 2023-06-01 주식회사 제넥신 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 mature human IGF and EGF via prokaryotic recombinant DNA technology
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
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
US5126324A (en) * 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
SE9201073D0 (en) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab PROTEIN FORMULATION
DK0955062T3 (en) * 1992-07-31 2007-09-17 Genentech Inc Aqueous formulation containing human growth hormone
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
TR200200034T2 (en) * 1999-07-12 2002-05-21 Grandis Biotech Gmbh Growth hormone formulations.
PL211886B1 (en) * 1999-10-04 2012-07-31 Novartis Vaccines & Diagnostic Stabilized liquid polypeptide-containing pharmaceutical compositions
SI1946776T1 (en) * 2002-02-27 2017-07-31 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
MXPA05000412A (en) * 2002-07-09 2005-07-22 Sandoz Ag Liquid formulations with a high concentration of human growth hormone (hgh) comprising glycine.
WO2006130769A2 (en) 2005-06-02 2006-12-07 Tercica, Inc. Methods for treatment of growth disorders
PE20070714A1 (en) * 2005-11-01 2007-07-20 Wyeth Corp SODIUM CHLORIDE SOLUTION FOR DRUG RECONSTITUTION OR DILUTION
CN101505789A (en) * 2006-07-06 2009-08-12 株式会社大熊 A stable liquid formulation of human growth hormone
EP2281827B1 (en) * 2008-05-08 2013-08-21 Ajinomoto Co., Inc. Protein refolding method

Also Published As

Publication number Publication date
JP2013510893A (en) 2013-03-28
KR101614983B1 (en) 2016-04-22
AU2010321225B2 (en) 2015-12-03
JP6143827B2 (en) 2017-06-07
JP6084036B2 (en) 2017-02-22
RU2012124985A (en) 2013-12-27
HK1175711A1 (en) 2013-07-12
KR20120104251A (en) 2012-09-20
US20120270782A1 (en) 2012-10-25
CA2780554A1 (en) 2011-05-26
MX2012005195A (en) 2012-06-12
EP2501367A1 (en) 2012-09-26
AU2010321225A1 (en) 2012-06-07
UA108994C2 (en) 2015-07-10
EP2501367B1 (en) 2015-01-21
CN102665691B (en) 2015-05-27
RU2558821C2 (en) 2015-08-10
CA2780554C (en) 2017-08-15
ES2532007T3 (en) 2015-03-23
WO2011060922A1 (en) 2011-05-26
US20170143834A1 (en) 2017-05-25
BR112012011539A2 (en) 2016-06-28
JP2016020395A (en) 2016-02-04
CN102665691A (en) 2012-09-12
BR112012011539A8 (en) 2017-12-26

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