AUPN801296A0 - Stabilised growth hormone formulation and method of preparation thereof - Google Patents

Stabilised growth hormone formulation and method of preparation thereof

Info

Publication number
AUPN801296A0
AUPN801296A0 AUPN8012A AUPN801296A AUPN801296A0 AU PN801296 A0 AUPN801296 A0 AU PN801296A0 AU PN8012 A AUPN8012 A AU PN8012A AU PN801296 A AUPN801296 A AU PN801296A AU PN801296 A0 AUPN801296 A0 AU PN801296A0
Authority
AU
Australia
Prior art keywords
growth hormone
buffer
stabilizing agent
preparation
formulation
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.)
Abandoned
Application number
AUPN8012A
Other languages
English (en)
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
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
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=AUPN801296(A0) "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
Priority to AUPN8012A priority Critical patent/AUPN801296A0/en
Publication of AUPN801296A0 publication Critical patent/AUPN801296A0/en
Priority to CA2246501A priority patent/CA2246501C/en
Priority to EP97902109A priority patent/EP0889733B1/en
Priority to JP52882197A priority patent/JP4255515B2/ja
Priority to US09/125,267 priority patent/US6593296B1/en
Priority to DK97902109T priority patent/DK0889733T3/da
Priority to TR1998/01558T priority patent/TR199801558T2/xx
Priority to HK99102933.8A priority patent/HK1017851B/en
Priority to CN97193316A priority patent/CN1132626C/zh
Priority to AT97902109T priority patent/ATE340587T1/de
Priority to RU98117135/14A priority patent/RU2191029C2/ru
Priority to DE69736739T priority patent/DE69736739T2/de
Priority to AU15855/97A priority patent/AU716747B2/en
Priority to PCT/AU1997/000075 priority patent/WO1997029767A1/en
Abandoned legal-status Critical Current

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)
  • 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)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
AUPN8012A 1996-02-12 1996-02-12 Stabilised growth hormone formulation and method of preparation thereof Abandoned AUPN801296A0 (en)

Priority Applications (14)

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
AU15855/97A AU716747B2 (en) 1996-02-12 1997-02-12 Stabilised growth hormone formulation and method of preparation thereof
DK97902109T DK0889733T3 (da) 1996-02-12 1997-02-12 Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf
CN97193316A CN1132626C (zh) 1996-02-12 1997-02-12 稳定化的生长激素制剂和其制备方法
JP52882197A JP4255515B2 (ja) 1996-02-12 1997-02-12 安定化された成長ホルモン処方物およびその製造方法
US09/125,267 US6593296B1 (en) 1996-02-12 1997-02-12 Stabilized growth hormone formulation and method of preparation thereof
CA2246501A CA2246501C (en) 1996-02-12 1997-02-12 Stabilised growth hormone formulation and method of preparation thereof
TR1998/01558T TR199801558T2 (xx) 1996-02-12 1997-02-12 Stabile edilmi� b�y�me hormonu form�lasyonu ve haz�rlama y�ntemi.
HK99102933.8A HK1017851B (en) 1996-02-12 1997-02-12 Stabilised growth hormone formulation and method of preparation thereof
EP97902109A EP0889733B1 (en) 1996-02-12 1997-02-12 Stabilised growth hormone formulation and method of preparation thereof
AT97902109T ATE340587T1 (de) 1996-02-12 1997-02-12 Stabilisierte wachstumshormon zubereitung und verfahren zu deren herstellung
RU98117135/14A RU2191029C2 (ru) 1996-02-12 1997-02-12 Композиция стабилизированного гормона роста и способ ее приготовления
DE69736739T DE69736739T2 (de) 1996-02-12 1997-02-12 Stabilisierte wachstumshormon zubereitung und verfahren zu deren herstellung

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
AUPN801296A0 true AUPN801296A0 (en) 1996-03-07

Family

ID=3792327

Family Applications (1)

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

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
CA2378949C (en) * 1999-07-12 2015-03-31 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
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
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
JP2007506683A (ja) * 2003-09-25 2007-03-22 カンジェーン コーポレイション ヒト成長ホルモン剤およびその調整方法と使用方法
US8338374B2 (en) 2003-12-23 2012-12-25 Pharmacia Corporation Stable growth hormone liquid formulation
UA89781C2 (uk) * 2004-04-07 2010-03-10 Арес Трейдінг С.А. Рідкий склад гормона росту
DE602005009856D1 (de) 2004-11-09 2008-10-30 Ares Trading Sa Verfahren zur reinigung von fsh
DK1917276T3 (en) 2005-08-26 2018-05-07 Ares Trading Sa Process for Preparation of Glycosylated Interferon Beta
AU2006323925B2 (en) 2005-12-09 2012-08-02 Ares Trading S.A. Method for purifying FSH or a FSH mutant
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
PT2049148T (pt) * 2006-07-06 2016-12-30 Daewoong Co Ltd Formulação líquida estável da hormona do crescimento humana
US10391062B2 (en) 2008-04-21 2019-08-27 Novo Nordisk Healthcare Ag Dry transglutaminase composition
US20140194356A1 (en) * 2011-07-25 2014-07-10 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
BR112016006455A2 (pt) * 2013-09-27 2017-08-01 Hanmi Pharm Ind Co Ltd ?formulação de conjugado de hormônio de crescimento humano de ação prolongada?

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
BR8603586A (pt) * 1985-07-30 1987-03-10 Int Minerals & Chem Corp Processo para manter a fluidez de um homonio;processo para efetuar a promocao de crescimento em animais e formulacao promotora de crescimento
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
ATE82506T1 (de) 1987-08-21 1992-12-15 Imcera 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 (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
MD1699F2 (ro) * 1992-07-31 2001-07-31 Genentech, Inc. Compoziţie apoasă a hormonului somatotrop uman şi procedeu de prevenire a denaturării ei
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
JP3698721B2 (ja) * 1993-02-23 2005-09-21 ジェネンテク・インコーポレイテッド 有機溶媒を用いて処理したポリペプチドの賦形剤安定化
CA2176927C (en) * 1993-11-17 2010-03-23 Seang H. Yiv Transparent liquid for encapsulated drug delivery

Also Published As

Publication number Publication date
CN1214633A (zh) 1999-04-21
CN1132626C (zh) 2003-12-31
US6593296B1 (en) 2003-07-15
ATE340587T1 (de) 2006-10-15
RU2191029C2 (ru) 2002-10-20
CA2246501C (en) 2012-07-10
DE69736739T2 (de) 2007-08-16
JP4255515B2 (ja) 2009-04-15
CA2246501A1 (en) 1997-08-21
HK1017851A1 (en) 1999-12-03
TR199801558T2 (xx) 1998-11-23
WO1997029767A1 (en) 1997-08-21
DE69736739D1 (de) 2006-11-09
EP0889733B1 (en) 2006-09-27
EP0889733A4 (en) 1999-11-03
EP0889733A1 (en) 1999-01-13
JP2000504696A (ja) 2000-04-18
DK0889733T3 (da) 2007-01-29

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