CN1132626C - 稳定化的生长激素制剂和其制备方法 - Google Patents

稳定化的生长激素制剂和其制备方法 Download PDF

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Publication number
CN1132626C
CN1132626C CN97193316A CN97193316A CN1132626C CN 1132626 C CN1132626 C CN 1132626C CN 97193316 A CN97193316 A CN 97193316A CN 97193316 A CN97193316 A CN 97193316A CN 1132626 C CN1132626 C CN 1132626C
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CN
China
Prior art keywords
hgh
formulation
stabilizer
buffer
growth hormone
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
CN97193316A
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English (en)
Chinese (zh)
Other versions
CN1214633A (zh
Inventor
M·K·麦克纳马拉
W·N·查曼
S·A·查曼
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CSL Ltd
Monash University
Original Assignee
CSL Ltd
Monash University
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.)
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Publication date
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Application filed by CSL Ltd, Monash University filed Critical CSL Ltd
Publication of CN1214633A publication Critical patent/CN1214633A/zh
Application granted granted Critical
Publication of CN1132626C publication Critical patent/CN1132626C/zh
Anticipated expiration legal-status Critical
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    • 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
    • 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
    • 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
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN97193316A 1996-02-12 1997-02-12 稳定化的生长激素制剂和其制备方法 Expired - Fee Related CN1132626C (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPN8012 1996-02-12
AUPN8012A AUPN801296A0 (en) 1996-02-12 1996-02-12 Stabilised growth hormone formulation and method of preparation thereof

Publications (2)

Publication Number Publication Date
CN1214633A CN1214633A (zh) 1999-04-21
CN1132626C true CN1132626C (zh) 2003-12-31

Family

ID=3792327

Family Applications (1)

Application Number Title Priority Date Filing Date
CN97193316A Expired - Fee Related CN1132626C (zh) 1996-02-12 1997-02-12 稳定化的生长激素制剂和其制备方法

Country Status (12)

Country Link
US (1) US6593296B1 (enExample)
EP (1) EP0889733B1 (enExample)
JP (1) JP4255515B2 (enExample)
CN (1) CN1132626C (enExample)
AT (1) ATE340587T1 (enExample)
AU (1) AUPN801296A0 (enExample)
CA (1) CA2246501C (enExample)
DE (1) DE69736739T2 (enExample)
DK (1) DK0889733T3 (enExample)
RU (1) RU2191029C2 (enExample)
TR (1) TR199801558T2 (enExample)
WO (1) WO1997029767A1 (enExample)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6277410B1 (en) * 1992-10-08 2001-08-21 Supratek Pharma Inc. Copolymer compositions for oral delivery
CN1360506A (zh) * 1999-07-12 2002-07-24 格兰迪斯生物技术有限公司 生长激素配方
AT408721B (de) * 1999-10-01 2002-02-25 Cistem Biotechnologies Gmbh Pharmazeutische zusammensetzung enthaltend ein antigen
WO2001062296A2 (en) 2000-02-24 2001-08-30 Monsanto Technology Llc Non-aqueous injectable formulations for extended release of somatotropin
MXPA03000073A (es) 2000-06-26 2003-09-25 Monsanto Technology Llc Formulaciones que contienen agente tensioactivo no acuoso para la liberacion prolongada de somatrotopina.
US6664234B1 (en) 2000-06-30 2003-12-16 Monsanto Technology Llc Non-aqueous injectable formulation preparation with pH adjusted for extended release of somatotropin
GB2371227A (en) * 2001-01-10 2002-07-24 Grandis Biotech Gmbh Crystallisation - resistant aqueous growth hormone formulations
JP4610154B2 (ja) * 2002-05-30 2011-01-12 大塚製薬株式会社 注射用製剤
CN101659701B (zh) * 2002-12-31 2019-03-26 阿尔特斯制药公司 人生长激素晶体和制备它们的方法
US20060252682A1 (en) * 2003-03-18 2006-11-09 Ares Trading S.A. Liquid growth hormone formulation and process of preparation thereof
WO2005027960A1 (en) * 2003-09-25 2005-03-31 Cangene Corporation Liquid human growth hormone formulation containing polyethylene glycol
JP4845741B2 (ja) * 2003-12-23 2011-12-28 ファルマシア コーポレーション 安定な成長ホルモン液体製剤
ES2383994T3 (es) * 2004-04-07 2012-06-28 Ares Trading S.A. Formulación líquida de hormona del crecimiento
EP1809663B1 (en) 2004-11-09 2008-09-17 Ares Trading S.A. Method for purifying fsh
US20080219952A1 (en) 2005-08-26 2008-09-11 Ares Trading S.A. Process For the Preparation of Glycosylated Interferon Beta
JP5199112B2 (ja) 2005-12-09 2013-05-15 アレス トレーディング ソシエテ アノニム Ｆｓｈ又はｆｓｈ変異体を精製するための方法
LT2049148T (lt) * 2006-07-06 2016-11-25 Daewoong Co., Ltd. Žmogaus augimo hormono skysta stabili kompozicija
CN105412910A (zh) * 2006-07-06 2016-03-23 株式会社大熊 稳定的人生长激素液体制剂
WO2009130181A2 (en) * 2008-04-21 2009-10-29 Novo Nordisk Health Care Ag Dry transglutaminase composition
WO2013014196A1 (en) 2011-07-25 2013-01-31 Sandoz Ag Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
CN105848645A (zh) * 2013-09-27 2016-08-10 韩美药品株式会社 持续型人生长激素制剂

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB131864A (enExample)
DE3325223A1 (de) * 1983-07-13 1985-01-24 Hoechst Ag, 6230 Frankfurt Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung
EP0211601A3 (en) 1985-07-30 1988-01-13 International Minerals And Chemical Corporation Stabilization of growth promoting hormones
IT1222395B (it) * 1987-07-30 1990-09-05 Pierrel Spa Composizione farmaceutica per somministrazione intranasale comprendente l'ormone ghrh,un agonista colinergico e/o un sale biliare
EP0303746B2 (en) 1987-08-21 1998-12-02 Mallinckrodt Group Inc. Stabilization of growth promoting hormones
US5096885A (en) * 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
GB8822857D0 (en) * 1988-09-29 1988-11-02 Patralan Ltd Pharmaceutical formulations
EP0374120A3 (en) * 1988-12-13 1991-07-31 Monsanto Company Comosition for controlled release of polypeptides
US5013714A (en) * 1988-12-15 1991-05-07 Lindstrom Richard L Viscoelastic solution
US4994439A (en) * 1989-01-19 1991-02-19 California Biotechnology Inc. Transmembrane formulations for drug administration
US5182258A (en) * 1989-03-20 1993-01-26 Orbon Corporation Systemic delivery of polypeptides through the eye
US5126324A (en) * 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
US5210017A (en) * 1990-11-19 1993-05-11 Genentech, Inc. Ligand-mediated immunofunctional hormone binding protein assay method
DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
SE9201073D0 (sv) 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
DK0955062T3 (da) * 1992-07-31 2007-09-17 Genentech Inc Vandig formulering indeholdende humant væksthormon
ATE198277T1 (de) * 1992-10-02 2001-01-15 Genetics Inst Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
DK0686045T3 (da) * 1993-02-23 2001-03-05 Genentech Inc Stabilisering af med organisk opløsningsmiddel behandlede polypeptider med et hjælpestof
JPH09510182A (ja) * 1993-11-17 1997-10-14 エルディーエス・テクノロジーズ・インコーポレーテッド カプセル封入されたドラッグデリバリー用透明液

Also Published As

Publication number Publication date
TR199801558T2 (xx) 1998-11-23
JP2000504696A (ja) 2000-04-18
HK1017851A1 (en) 1999-12-03
DK0889733T3 (da) 2007-01-29
JP4255515B2 (ja) 2009-04-15
EP0889733B1 (en) 2006-09-27
CN1214633A (zh) 1999-04-21
CA2246501C (en) 2012-07-10
EP0889733A1 (en) 1999-01-13
CA2246501A1 (en) 1997-08-21
AUPN801296A0 (en) 1996-03-07
WO1997029767A1 (en) 1997-08-21
ATE340587T1 (de) 2006-10-15
EP0889733A4 (en) 1999-11-03
DE69736739T2 (de) 2007-08-16
US6593296B1 (en) 2003-07-15
RU2191029C2 (ru) 2002-10-20
DE69736739D1 (de) 2006-11-09

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