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.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=3792327&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN1132626(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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

Landscapes

  • 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)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (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
WO2001003741A1 (en) * 1999-07-12 2001-01-18 Grandis Biotech Gmbh Growth hormone formulations
AT408721B (de) * 1999-10-01 2002-02-25 Cistem Biotechnologies Gmbh Pharmazeutische zusammensetzung enthaltend ein antigen
KR20080011353A (ko) 2000-02-24 2008-02-01 몬산토 테크놀로지 엘엘씨 소마토트로핀의 지속적인 방출을 위한 비수성 주사제제들
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
ZA200505305B (en) * 2002-12-31 2007-07-25 Altus Pharmaceuticals Inc Human growth hormone crystals and methods for preparing them
JP4949828B2 (ja) * 2003-03-18 2012-06-13 アレス トレーディング ソシエテ アノニム 溶液中での成長ホルモンの安定化
WO2005027960A1 (en) * 2003-09-25 2005-03-31 Cangene Corporation Liquid human growth hormone formulation containing polyethylene glycol
WO2005063298A1 (en) 2003-12-23 2005-07-14 Pharmacia Corporation Stable growth hormone liquid formulation
KR101120879B1 (ko) * 2004-04-07 2012-02-27 아레스 트레이딩 에스.아. 액체 성장 호르몬 제제
DE602005009856D1 (de) 2004-11-09 2008-10-30 Ares Trading Sa Verfahren zur reinigung von fsh
LT1917276T (lt) 2005-08-26 2018-05-25 Ares Trading S.A. Glikozilinto interferono beta gavimo būdas
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
WO2008004717A1 (en) * 2006-07-06 2008-01-10 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
CN105363022A (zh) * 2006-07-06 2016-03-02 株式会社大熊 稳定的人生长激素液体制剂
KR101897534B1 (ko) 2008-04-21 2018-09-12 노보 노르디스크 헬스 케어 악티엔게젤샤프트 건조한 트랜스글루타미나제 조성물
EP2736490A1 (en) * 2011-07-25 2014-06-04 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
HK1225976A1 (en) * 2013-09-27 2017-09-22 Hanmi Pharm. Co., Ltd. Sustained type human growth hormone preparation

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
IL79552A0 (en) * 1985-07-30 1986-10-31 Int Minerals & Chem Corp 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
ATE359824T1 (de) 1992-07-31 2007-05-15 Genentech Inc Wässrige formulierung enthaltend menschliches wachstumshormon
MX9306133A (es) * 1992-10-02 1994-04-29 Kabi Pharmacia Ab Composicion que comprende una formulacion del factor de coagulacion viii, proceso para su preparacion y uso de un surfactante como estabilizador.
CN1108823C (zh) * 1993-02-23 2003-05-21 基因技术股份有限公司 运用赋形剂对有机溶剂处理的多肽的稳定化方法
US5707648A (en) * 1993-11-17 1998-01-13 Lds Technologies, Inc. Transparent liquid for encapsulated drug delivery

Also Published As

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

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Granted publication date: 20031231

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