ATE554792T1 - Stabiles wachstumshormon-flüssigformulierung - Google Patents

Stabiles wachstumshormon-flüssigformulierung

Info

Publication number
ATE554792T1
ATE554792T1 AT04801396T AT04801396T ATE554792T1 AT E554792 T1 ATE554792 T1 AT E554792T1 AT 04801396 T AT04801396 T AT 04801396T AT 04801396 T AT04801396 T AT 04801396T AT E554792 T1 ATE554792 T1 AT E554792T1
Authority
AT
Austria
Prior art keywords
growth hormone
present
formulations
liquid formulation
stable growth
Prior art date
Application number
AT04801396T
Other languages
English (en)
Inventor
Advait Badkar
Sandeep Nema
Manpreet Wadhwa
Original Assignee
Pharmacia Corp
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 Pharmacia Corp filed Critical Pharmacia Corp
Application granted granted Critical
Publication of ATE554792T1 publication Critical patent/ATE554792T1/de

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
    • A61K47/08Organic 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
    • 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
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Zoology (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AT04801396T 2003-12-23 2004-12-13 Stabiles wachstumshormon-flüssigformulierung ATE554792T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US53184303P 2003-12-23 2003-12-23
PCT/IB2004/004159 WO2005063298A1 (en) 2003-12-23 2004-12-13 Stable growth hormone liquid formulation

Publications (1)

Publication Number Publication Date
ATE554792T1 true ATE554792T1 (de) 2012-05-15

Family

ID=34738712

Family Applications (1)

Application Number Title Priority Date Filing Date
AT04801396T ATE554792T1 (de) 2003-12-23 2004-12-13 Stabiles wachstumshormon-flüssigformulierung

Country Status (8)

Country Link
US (1) US8338374B2 (de)
EP (1) EP1706150B1 (de)
JP (1) JP4845741B2 (de)
AT (1) ATE554792T1 (de)
BR (1) BRPI0418115A (de)
CA (1) CA2551510C (de)
ES (1) ES2383691T3 (de)
WO (1) WO2005063298A1 (de)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101159559B1 (ko) 2003-08-05 2012-06-26 노보 노르디스크 에이/에스 신규의 인슐린 유도체
US20090074882A1 (en) 2005-12-28 2009-03-19 Novo Nordisk A/S Insulin compositions and method of making a composition
TW200806317A (en) * 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
WO2008004717A1 (en) 2006-07-06 2008-01-10 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
WO2008152106A1 (en) 2007-06-13 2008-12-18 Novo Nordisk A/S Pharmaceutical formulation comprising an insulin derivative
WO2009002521A2 (en) 2007-06-25 2008-12-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
CA2738615A1 (en) 2008-10-30 2010-05-06 Novo Nordisk A/S Treating diabetes melitus using insulin injections with less than daily injection frequency
CA2790895C (en) * 2010-02-24 2016-08-23 Jan Jezek Protein formulations
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
JP6049625B2 (ja) 2010-10-27 2016-12-21 ノヴォ ノルディスク アー/エス 様々な注射間隔を用いて施されるインスリン注射を使用する、真性糖尿病の治療
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
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
JP5487276B2 (ja) * 2012-11-12 2014-05-07 デウン カンパニー,リミテッド ヒト成長ホルモンを含有する安定した液状製剤
PL2968468T3 (pl) * 2013-03-13 2021-12-20 Buzzard Pharmaceuticals AB Preparaty chimerycznej cytokiny do dostarczania do oka
WO2014177623A1 (en) 2013-04-30 2014-11-06 Novo Nordisk A/S Novel administration regime
CN114288254A (zh) 2013-09-27 2022-04-08 韩美药品株式会社 长效人生长激素缀合物的制剂
WO2016011281A1 (en) * 2014-07-17 2016-01-21 Teva Pharmaceutical Industries Ltd. FORMULATIONS OF AN ALBUMIN-hGH FUSION PROTEIN
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
CN114096269B (zh) 2019-07-12 2024-06-11 诺和诺德股份有限公司 高浓度胰岛素制剂
CN112494638B (zh) * 2020-12-22 2023-12-19 深圳科兴药业有限公司 一种人生长激素注射剂组合物及其制备方法

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5763394A (en) 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
US5981485A (en) 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
US5272135A (en) * 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
US5206219A (en) 1991-11-25 1993-04-27 Applied Analytical Industries, Inc. Oral compositions of proteinaceous medicaments
SE9201073D0 (sv) 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
EP0652766B2 (de) 1992-07-31 2008-03-19 Genentech, Inc. Wässrige arzneizusammensetzung, welche das menschliche wachstumshormon enthält
US5358708A (en) * 1993-01-29 1994-10-25 Schering Corporation Stabilization of protein formulations
SE9503679D0 (sv) * 1995-10-20 1995-10-20 Pharmacia Ab Antioxidants
AUPN801296A0 (en) * 1996-02-12 1996-03-07 Csl Limited Stabilised growth hormone formulation and method of preparation thereof
US20030162711A1 (en) * 1996-04-24 2003-08-28 Soren Bjorn Pharmaceutical formulation
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn Pharmaceutical formulation
DE59805732D1 (de) * 1997-09-23 2002-10-31 Rentschler Biotech Gmbh Flüssige interferon-beta-formulierungen
NZ516507A (en) 1999-07-12 2004-02-27 Grandis Biotech Gmbh Growth hormone formulations that are resistant to crystallisation
ATE464062T1 (de) * 1999-10-04 2010-04-15 Novartis Vaccines & Diagnostic Stabilisierte flüssige pharmazeutische zusammensetzung enthaltend tfpi
KR100416242B1 (ko) * 1999-12-22 2004-01-31 주식회사 삼양사 약물전달체용 생분해성 블록 공중합체의 액체 조성물 및이의 제조방법
KR20030027077A (ko) * 2000-09-01 2003-04-03 쥬가이 세이야쿠 가부시키가이샤 장기 안정화 용액 제제

Also Published As

Publication number Publication date
US8338374B2 (en) 2012-12-25
JP4845741B2 (ja) 2011-12-28
US20080125356A1 (en) 2008-05-29
EP1706150B1 (de) 2012-04-25
CA2551510A1 (en) 2005-07-14
ES2383691T3 (es) 2012-06-25
EP1706150A1 (de) 2006-10-04
BRPI0418115A (pt) 2007-04-17
JP2007516274A (ja) 2007-06-21
CA2551510C (en) 2013-07-30
WO2005063298A1 (en) 2005-07-14

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