ATE340587T1 - Stabilisierte wachstumshormon zubereitung und verfahren zu deren herstellung - Google Patents

Stabilisierte wachstumshormon zubereitung und verfahren zu deren herstellung

Info

Publication number
ATE340587T1
ATE340587T1 AT97902109T AT97902109T ATE340587T1 AT E340587 T1 ATE340587 T1 AT E340587T1 AT 97902109 T AT97902109 T AT 97902109T AT 97902109 T AT97902109 T AT 97902109T AT E340587 T1 ATE340587 T1 AT E340587T1
Authority
AT
Austria
Prior art keywords
growth hormone
buffer
stabilizing agent
production
hormone preparation
Prior art date
Application number
AT97902109T
Other languages
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=ATE340587(T1) "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 ATE340587T1 publication Critical patent/ATE340587T1/de

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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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)
AT97902109T 1996-02-12 1997-02-12 Stabilisierte wachstumshormon zubereitung und verfahren zu deren herstellung ATE340587T1 (de)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
ATE340587T1 true ATE340587T1 (de) 2006-10-15

Family

ID=3792327

Family Applications (1)

Application Number Title Priority Date Filing Date
AT97902109T ATE340587T1 (de) 1996-02-12 1997-02-12 Stabilisierte wachstumshormon zubereitung und verfahren zu deren herstellung

Country Status (12)

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

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
AU2001238540A1 (en) 2000-02-24 2001-09-03 Monsanto Technology Llc Non-aqueous injectable formulations for extended release of somatotropin
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
CN1744914A (zh) * 2002-12-31 2006-03-08 阿尔特斯制药公司 人生长激素晶体和制备它们的方法
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
EP1663296A4 (de) * 2003-09-25 2009-11-25 Cangene Corp Flüssige menschliche wachstumshormonformulierung mit polyethylenglykol
WO2005063298A1 (en) 2003-12-23 2005-07-14 Pharmacia Corporation Stable growth hormone liquid formulation
BRPI0508798A (pt) * 2004-04-07 2007-09-04 Ares Trading Sa formulação lìquida de hormÈnio de crescimento, composição farmacêutica, forma de apresentação da formulação lìquida de hormÈnio de crescimento e uso da formulação lìquida de hormÈnio de crescimento
DE602005009856D1 (de) 2004-11-09 2008-10-30 Ares Trading Sa Verfahren zur reinigung von fsh
WO2007022799A1 (en) 2005-08-26 2007-03-01 Ares Trading S.A. Process for the preparation of glycosylated interferon beta
EP1960419B1 (de) 2005-12-09 2016-03-16 Ares Trading S.A. Verfahren zur aufreinigung von fsh oder einer fsh-mutante
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
BRPI0621841B8 (pt) * 2006-07-06 2021-05-25 Daewoong Co Ltd formulação líquida
ES2640343T3 (es) 2008-04-21 2017-11-02 Novo Nordisk Health Care Ag Composición de transglutaminasa anhidra
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
EP3689335A1 (de) * 2013-09-27 2020-08-05 Hanmi Pharm. Co., Ltd. Menschliches hormonwachstumspräparat mit verzögerter freisetzung

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB131864A (de)
DE3325223A1 (de) * 1983-07-13 1985-01-24 Hoechst Ag, 6230 Frankfurt Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung
PT83095B (en) 1985-07-30 1987-12-23 Int Minerals & Chem Corp Method for the stabilization of growth promoting hormones using polyoxyethylene-polyoxypropylene copolymers
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 (de) 1987-08-21 1998-12-02 Mallinckrodt Group Inc. Stabilisierung von Wachstumshormonen
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 (de) * 1988-12-13 1991-07-31 Monsanto Company Zusammensetzung mit kontrollierter Wirkstoffabgabe von Polypeptiden
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
CA2124690C (en) * 1992-10-02 2007-09-11 Thomas Osterberg Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
AU685784B2 (en) * 1993-02-23 1998-01-29 Genentech Inc. Excipient stabilization of polypeptides treated with organic solvents
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
DK0889733T3 (da) 2007-01-29
HK1017851A1 (en) 1999-12-03
CA2246501C (en) 2012-07-10
EP0889733B1 (de) 2006-09-27
DE69736739D1 (de) 2006-11-09
WO1997029767A1 (en) 1997-08-21
CN1132626C (zh) 2003-12-31
EP0889733A4 (de) 1999-11-03
JP2000504696A (ja) 2000-04-18
DE69736739T2 (de) 2007-08-16
RU2191029C2 (ru) 2002-10-20
TR199801558T2 (xx) 1998-11-23
AUPN801296A0 (en) 1996-03-07
JP4255515B2 (ja) 2009-04-15
US6593296B1 (en) 2003-07-15
CA2246501A1 (en) 1997-08-21
EP0889733A1 (de) 1999-01-13
CN1214633A (zh) 1999-04-21

Similar Documents

Publication Publication Date Title
ATE340587T1 (de) Stabilisierte wachstumshormon zubereitung und verfahren zu deren herstellung
BR9307700A (pt) Formulação para estabilizar uma composição enzimática lìquida, composição enzimática lìquida estabilizada, método para a preparação de uma composição enzimática lìquida estabilizada e método para estabilizar uma composição enzimática lìquida
HUP0301124A2 (hu) Elszíneződésre nem hajlamos. minoxidil-tartalmú kompozíció és eljárás minoxidiltartalmú kompozíció elszíneződésének megakadályozására
NO305281B1 (no) FremgangsmÕte for Õ lagringsstabilisere pereddiksyrel°sninger, samt stabiliserte pereddiksyrel°sninger
RU98117135A (ru) Композиция стабилизированного гормона роста и способ ее приготовления
ATE198149T1 (de) Verfahren zur stabilisierung von duocarmycinderivaten
DE69531314D1 (de) Verwendung von metallionen chelatoren zur stabilisierung von interferon-enthaltenden pharmazeutischen zubereitungen
DE69821741D1 (de) Immunoglobulin enthaltende zusammensetzung
GB9928820D0 (en) Stable high glycerol liquids comprising sulfosuccinic acid monoesters
KR900013964A (ko) 활성형 비타민 d₃류 제제용 조성물 및 이를 함유하는 안정한 활성형 비타민 d₃류 제제의 제조방법
US5538989A (en) Fenbendazole formulations
ATE203392T1 (de) Stabilisierte pseudoemulsionen und verfahren zu ihrer herstellung
CA2463681A1 (en) Ready-to-use paracetamol injection solutions containing propylene glycol as the only cosolvent
EP0010437A2 (de) Stabile Erythromycinlösung und Verfahren zu deren Herstellung
JP4189223B2 (ja) ミノキシジル配合液剤組成物
RU97107154A (ru) Водные композиции, содержащие ципрофлоксацин, их применение и способ получения
DE69501183D1 (de) Feste orale pharmazeutische Zubereitung mit Gemfibrozil als aktiver Inhaltsstoff und Verfahren zur Herstellung
KR880008810A (ko) [벤조-1,2,4-티아디아진]-1,1-디옥사이드 용해 조성물
DE69003297D1 (de) Strahlungssterilisierbare antimikrobielle Salbe sowie Verfahren zu deren Herstellung.
US4579960A (en) Stable solutions containing thimerosal
WO1998029131A3 (en) Aqueous glycerol formulations of somatotropin
JPS5531028A (en) Injection
JP2004196671A (ja) 水溶性アズレン含有点眼剤
KR0149894B1 (ko) 용존 산소 전극용 전해액 조성물
KR950016751A (ko) 퀴놀론 항균제의 신규 주사용 조성물 및 그 제조방법

Legal Events

Date Code Title Description
UEP Publication of translation of european patent specification

Ref document number: 0889733

Country of ref document: EP