DK0889733T3 - Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf - Google Patents

Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf

Info

Publication number
DK0889733T3
DK0889733T3 DK97902109T DK97902109T DK0889733T3 DK 0889733 T3 DK0889733 T3 DK 0889733T3 DK 97902109 T DK97902109 T DK 97902109T DK 97902109 T DK97902109 T DK 97902109T DK 0889733 T3 DK0889733 T3 DK 0889733T3
Authority
DK
Denmark
Prior art keywords
growth hormone
buffer
stabilizing agent
preparation
formulation
Prior art date
Application number
DK97902109T
Other languages
Danish (da)
English (en)
Inventor
Michael Kevin Mcnamara
William Neil Charman
Susan Ann Charman
Original Assignee
Csl Ltd
Univ Monash
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
Family has litigation
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=DK0889733(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Csl Ltd, Univ Monash filed Critical Csl Ltd
Application granted granted Critical
Publication of DK0889733T3 publication Critical patent/DK0889733T3/da

Links

Classifications

    • 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)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (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)
DK97902109T 1996-02-12 1997-02-12 Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf DK0889733T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPN8012A AUPN801296A0 (en) 1996-02-12 1996-02-12 Stabilised growth hormone formulation and method of preparation thereof
PCT/AU1997/000075 WO1997029767A1 (en) 1996-02-12 1997-02-12 Stabilised growth hormone formulation and method of preparation thereof

Publications (1)

Publication Number Publication Date
DK0889733T3 true DK0889733T3 (da) 2007-01-29

Family

ID=3792327

Family Applications (1)

Application Number Title Priority Date Filing Date
DK97902109T DK0889733T3 (da) 1996-02-12 1997-02-12 Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf

Country Status (12)

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

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
TR200200034T2 (tr) * 1999-07-12 2002-05-21 Grandis Biotech Gmbh Büyüme hormonu formülasyonları.
AT408721B (de) * 1999-10-01 2002-02-25 Cistem Biotechnologies Gmbh Pharmazeutische zusammensetzung enthaltend ein antigen
KR20090007504A (ko) 2000-02-24 2009-01-16 몬산토 테크놀로지 엘엘씨 소마토트로핀의 지속적인 방출을 위한 비수성 주사제제들
AU2001271491A1 (en) 2000-06-26 2002-01-08 Monsanto Technology Llc Non-aqueous surfactant-containing formulations for extended release of somatotropin
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
CA2516314C (en) * 2003-03-18 2012-01-03 Ares Trading Sa Liquid growth hormone formulation and process of preparation thereof
EP1663296A4 (en) * 2003-09-25 2009-11-25 Cangene Corp LIQUID FORMULATION OF HUMAN GROWTH HORMONE CONTAINING POLYETHYLENE GLYCOL
CA2551510C (en) * 2003-12-23 2013-07-30 Pharmacia Corporation Stable growth hormone liquid formulation
ES2383994T3 (es) * 2004-04-07 2012-06-28 Ares Trading S.A. Formulación líquida de hormona del crecimiento
MX2007005327A (es) 2004-11-09 2007-08-02 Ares Trading Sa Metodo para purificacion de la hormona foliculo estimulante (hfe).
JP4944112B2 (ja) 2005-08-26 2012-05-30 アレス トレーディング ソシエテ アノニム グリコシル化されたインターフェロンベータの調製方法
EP1960419B1 (en) 2005-12-09 2016-03-16 Ares Trading S.A. Method for purifying fsh or a fsh mutant
US8409586B2 (en) * 2006-07-06 2013-04-02 Daewoong Co., Ltd. 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
MX349837B (es) 2008-04-21 2017-08-16 Novo Nordisk Healthcare Ag Composicion de transglutaminasa seca.
JP6363949B2 (ja) * 2011-07-25 2018-07-25 サンド アクチェンゲゼルシャフト 少なくとも中性塩および生物薬学的タンパク質を含む、水性製剤
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
RU2683823C2 (ru) * 2013-09-27 2019-04-02 Ханми Фарм. Ко., Лтд. Препарат гормона роста человека длительного типа

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB131864A (OSRAM)
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
ES2044941T5 (es) 1987-08-21 1999-02-16 Mallinckrodt Group Inc Estabilizador de hormonas promotoras del crecimiento.
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
DE69329651T3 (de) * 1992-07-31 2008-10-30 Genentech, Inc., South San Francisco Wässrige arzneizusammensetzung, welche das menschliche wachstumshormon enthält
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
WO1994019020A1 (en) * 1993-02-23 1994-09-01 Genentech, Inc. Excipient stabilization of polypeptides treated with organic solvents
EP0736041B1 (en) * 1993-11-17 2006-02-08 Athena Neurosciences, Inc. Transparent liquid for encapsulated drug delivery

Also Published As

Publication number Publication date
EP0889733A4 (en) 1999-11-03
JP4255515B2 (ja) 2009-04-15
JP2000504696A (ja) 2000-04-18
ATE340587T1 (de) 2006-10-15
CN1132626C (zh) 2003-12-31
HK1017851A1 (en) 1999-12-03
DE69736739D1 (de) 2006-11-09
WO1997029767A1 (en) 1997-08-21
EP0889733A1 (en) 1999-01-13
EP0889733B1 (en) 2006-09-27
CA2246501C (en) 2012-07-10
AUPN801296A0 (en) 1996-03-07
RU2191029C2 (ru) 2002-10-20
DE69736739T2 (de) 2007-08-16
CN1214633A (zh) 1999-04-21
TR199801558T2 (xx) 1998-11-23
CA2246501A1 (en) 1997-08-21
US6593296B1 (en) 2003-07-15

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