DE69329367D1 - Wachstumshormon-enthaltendeproteinformulierung - Google Patents

Wachstumshormon-enthaltendeproteinformulierung

Info

Publication number
DE69329367D1
DE69329367D1 DE69329367T DE69329367T DE69329367D1 DE 69329367 D1 DE69329367 D1 DE 69329367D1 DE 69329367 T DE69329367 T DE 69329367T DE 69329367 T DE69329367 T DE 69329367T DE 69329367 D1 DE69329367 D1 DE 69329367D1
Authority
DE
Germany
Prior art keywords
growth hormone
pct
formulation
citrate
buffer substance
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
DE69329367T
Other languages
English (en)
Other versions
DE69329367T3 (de
DE69329367T2 (de
Inventor
Staffan Castensson
Ebba Florin-Robertsson
Elvy Hoekby
Sirkka Thome
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.)
Pfizer Health AB
Original Assignee
Pharmacia and Upjohn AB
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=20385860&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE69329367(D1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pharmacia and Upjohn AB filed Critical Pharmacia and Upjohn AB
Application granted granted Critical
Publication of DE69329367D1 publication Critical patent/DE69329367D1/de
Publication of DE69329367T2 publication Critical patent/DE69329367T2/de
Publication of DE69329367T3 publication Critical patent/DE69329367T3/de
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
DE69329367T 1992-04-03 1993-04-01 Wachstumshormon-enthaltende proteinformulierung Expired - Fee Related DE69329367T3 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9201073A SE9201073D0 (sv) 1992-04-03 1992-04-03 Protein formulation
SE9201073 1992-04-03
PCT/SE1993/000281 WO1993019776A1 (en) 1992-04-03 1993-04-01 Protein formulation comprising growth hormone

Publications (3)

Publication Number Publication Date
DE69329367D1 true DE69329367D1 (de) 2000-10-12
DE69329367T2 DE69329367T2 (de) 2001-06-21
DE69329367T3 DE69329367T3 (de) 2008-06-19

Family

ID=20385860

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69329367T Expired - Fee Related DE69329367T3 (de) 1992-04-03 1993-04-01 Wachstumshormon-enthaltende proteinformulierung

Country Status (15)

Country Link
US (1) US5567677A (de)
EP (1) EP0587858B2 (de)
JP (1) JP3268557B2 (de)
AT (1) ATE196092T1 (de)
AU (1) AU666007B2 (de)
CA (1) CA2102693C (de)
DE (1) DE69329367T3 (de)
DK (1) DK0587858T3 (de)
ES (1) ES2150940T5 (de)
GR (1) GR3034925T3 (de)
NO (1) NO310804B1 (de)
NZ (1) NZ251498A (de)
PT (1) PT587858E (de)
SE (1) SE9201073D0 (de)
WO (1) WO1993019776A1 (de)

Families Citing this family (56)

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Publication number Priority date Publication date Assignee Title
US5763394A (en) * 1988-04-15 1998-06-09 Genentech, Inc. Human growth hormone aqueous formulation
US5981485A (en) * 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
US5849700A (en) * 1991-12-20 1998-12-15 Novo Nordisk A/S Pharmaceutical formulation
US6022858A (en) * 1991-12-20 2000-02-08 Novo Nordisk A/S Pharmaceutical formulation of human-growth hormone pretreated with zinc salt
US5849704A (en) * 1991-12-20 1998-12-15 Novo Nordisk A/S Pharmaceutical formulation
DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
FR2719479B1 (fr) * 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.
US5631225A (en) * 1994-10-13 1997-05-20 Novo Nordisk A/S Pharmaceutical formulation
IL115592A (en) * 1994-10-13 2000-07-26 Novo Nordisk As Stabilized pharmaceutical formulation comprising a growth hormone and leucine
US5654278A (en) * 1994-10-13 1997-08-05 Novo Nordisk A/S Composition and method comprising growth hormone and leucine
US5547696A (en) * 1994-10-13 1996-08-20 Novo Nordisk A/S Pharmaceutical formulation
US5705482A (en) * 1995-01-13 1998-01-06 Novo Nordisk A/S Pharmaceutical formulation
US5552385A (en) * 1995-06-05 1996-09-03 Novo Nordisk A/S Pharmaceutical formulation
DE19539574A1 (de) 1995-10-25 1997-04-30 Boehringer Mannheim Gmbh Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren
GB9526733D0 (en) * 1995-12-30 1996-02-28 Delta Biotechnology Ltd Fusion proteins
AUPN801296A0 (en) 1996-02-12 1996-03-07 Csl Limited Stabilised growth hormone formulation and method of preparation thereof
US20070179096A1 (en) 1996-04-24 2007-08-02 Novo Nordisk A/S Pharmaceutical Formulation
ZA9711733B (en) 1996-12-31 1998-07-01 Monsanto Co Method for solubilization and naturation of somatotropins
ZA9711731B (en) * 1996-12-31 1998-07-01 Monsanto Co Aqueous glycerol formulations of somatotropin
JP3723857B2 (ja) * 1998-02-04 2005-12-07 日本ケミカルリサーチ株式会社 ヒト成長ホルモン含有水性医薬組成物
US6979442B1 (en) 1998-08-17 2005-12-27 Pfizer Inc. Stabilized protein compositions
ATE386501T1 (de) * 1999-07-12 2008-03-15 Sandoz Ag Formulierungen von wachstumshormonen
AU8111301A (en) * 2000-08-07 2002-02-18 Inhale Therapeutic Syst Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation
GB2371227A (en) * 2001-01-10 2002-07-24 Grandis Biotech Gmbh Crystallisation - resistant aqueous growth hormone formulations
US7271150B2 (en) * 2001-05-14 2007-09-18 United States Of America, Represented By The Secretary, Department Of Health And Human Services Modified growth hormone
EP1463752A4 (de) 2001-12-21 2005-07-13 Human Genome Sciences Inc Albuminfusionsproteine
EP1485116A4 (de) * 2002-02-27 2006-06-07 Univ Wake Forest Angiotensin-(1-7)- und angiotensin-(1-7)-agonisten zur hemmung des krebszellenwachstums
US20070065469A1 (en) * 2002-07-09 2007-03-22 Michael Betz Liquid formulations with high concentration of human growth hormone (high) comprising glycine
MXPA05000413A (es) * 2002-07-09 2005-07-22 Sandoz Ag Formulaciones liquidas con una alta concentracion de hormona de crecimiento humana (hgh) que comprenden 1,2-propilenglicol.
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
BRPI0418115A (pt) 2003-12-23 2007-04-17 Pharmacia Corp formulação lìquida estável de hormÈnio de crescimento
WO2005105148A2 (en) * 2004-04-07 2005-11-10 Ares Trading S.A.- Liquid growth hormone formulation
CA2570324C (en) * 2004-08-03 2014-07-22 Transtech Pharma, Inc. Rage fusion proteins and methods of use
US20090060925A1 (en) * 2004-08-03 2009-03-05 The Trustees Of Columbia University In The City Of Rage Fusion Proteins and Methods of Use
CA2576473C (en) * 2004-08-24 2015-06-30 Daiichi Asubio Pharma Co., Ltd. Liquid preparation of physiologically active peptide
EP1809663B1 (de) * 2004-11-09 2008-09-17 Ares Trading S.A. Verfahren zur reinigung von fsh
US20070015689A1 (en) * 2005-06-23 2007-01-18 Alza Corporation Complexation of metal ions with polypeptides
RS57549B1 (sr) * 2005-08-26 2018-10-31 Ares Trading Sa Proces za pripremu glikoziliranog interferona beta
US7947304B2 (en) 2005-11-02 2011-05-24 Transpharma Medical Ltd. Human growth hormone patch formulations
CA2625978A1 (en) * 2005-12-09 2007-06-14 Ares Trading S.A. Method for purifying fsh or a fsh mutant
EP1963786B1 (de) * 2005-12-23 2013-07-24 GCoder Systems AB Positionierungsmuster
WO2007094926A2 (en) * 2006-02-09 2007-08-23 Transtech Pharma, Inc. Rage fusion proteins and methods of use
SG171670A1 (en) * 2006-05-05 2011-06-29 Transtech Pharma Inc Rage fusion proteins, formulations, and methods of use thereof
WO2008100470A2 (en) * 2007-02-15 2008-08-21 Transtech Pharma, Inc. Rage - immunoglobulin fusion proteins
CA2687141C (en) 2007-05-22 2014-04-01 Amgen Inc. Compositions and methods for producing bioactive fusion proteins
CA2702448A1 (en) * 2007-10-22 2009-04-30 Merck Serono S.A. Method for purifying fc-fusion proteins
WO2009053360A1 (en) * 2007-10-22 2009-04-30 Merck Serono S.A. Method for purifying an fc-containing protein
EP2421892A1 (de) 2009-04-20 2012-02-29 Pfizer Inc. Steuerung der proteinglycosylierung und damit in zusammenhang stehende zusammensetzungen und verfahren
EP2427215A1 (de) * 2009-05-07 2012-03-14 Novo Nordisk Health Care AG Stabile pharmazeutische zusammensetzungen von mit einem oxim-linker derivatisiertem peptid
CA2780554C (en) * 2009-11-17 2017-08-15 Ipsen Pharma S.A.S. Formulation for hgh and rhigf-1 combination
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
MX2016003705A (es) * 2013-09-27 2016-05-16 Hanmi Pharm Ind Co Ltd Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada.
WO2015088990A1 (en) 2013-12-09 2015-06-18 Durect Corporation Pharmaceutically active agent complexes, polymer complexes, and compositions and methods involving the same
US20160015789A1 (en) * 2014-07-17 2016-01-21 Teva Pharmaceutical Industries, Ltd. FORMULATIONS OF AN ALBUMIN hGH FUSION PROTEIN

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4783441A (en) * 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
US4774091A (en) * 1983-10-14 1988-09-27 Sumitomo Pharmaceuticals Company, Ltd. Long-term sustained-release preparation
EP0189673B1 (de) * 1984-12-24 1990-09-26 Sumitomo Pharmaceuticals Company, Limited Stabiles GRF-Präparat
AU6073386A (en) * 1985-07-30 1987-02-05 International Minerals & Chemical Corporation Stabilization of growth promoting hormones
US4816568A (en) * 1986-05-16 1989-03-28 International Minerals & Chemical Corp. Stabilization of growth hormones
US4917685A (en) * 1986-05-16 1990-04-17 International Minerals & Chem. Corp. Delivery device for the administration of stabilized growth promoting hormones
DE3782737T3 (de) * 1987-08-21 1999-05-20 Imcera Group Inc., Northbrook, Ill. Stabilisierung von Wachstumshormonen.
US4837202A (en) 1987-09-14 1989-06-06 Pitman-Moore, Inc. Method for stimulating the immune system
US5096885A (en) * 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
JPH01308235A (ja) * 1988-06-03 1989-12-12 Yamanouchi Pharmaceut Co Ltd ヒト成長ホルモン経鼻剤
US5008244A (en) * 1989-05-15 1991-04-16 Pitman-Moore, Inc. Method for increasing fertility in animals
CA2020654A1 (en) * 1989-07-07 1991-01-08 Yohko Akiyama Stabilized fgf composition and production thereof
IN172427B (de) * 1989-11-14 1993-07-24 Fidia Spa
US5217954A (en) * 1990-04-04 1993-06-08 Scios Nova Inc. Formulations for stabilizing fibroblast growth factor
US5126324A (en) * 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
AU1757092A (en) * 1991-03-28 1992-11-02 Genentech Inc. Stable growth hormone metal ion formulations
DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
CA2133205C (en) * 1992-04-30 2007-04-17 Robert L. Swift Stable polypeptide composition
NZ255158A (en) * 1992-07-31 1997-09-22 Genentech Inc Human growth hormone; stable pharmaceutically acceptable aqueous formulation and means for preparing and storing it

Also Published As

Publication number Publication date
AU3913593A (en) 1993-11-08
NZ251498A (en) 1995-07-26
ES2150940T5 (es) 2008-04-16
NO310804B1 (no) 2001-09-03
CA2102693A1 (en) 1993-10-04
DE69329367T3 (de) 2008-06-19
GR3034925T3 (en) 2001-02-28
NO934355D0 (no) 1993-11-30
SE9201073D0 (sv) 1992-04-03
ATE196092T1 (de) 2000-09-15
EP0587858B1 (de) 2000-09-06
DK0587858T3 (da) 2000-12-18
DE69329367T2 (de) 2001-06-21
ES2150940T3 (es) 2000-12-16
CA2102693C (en) 2008-06-17
AU666007B2 (en) 1996-01-25
NO934355L (no) 1993-12-01
US5567677A (en) 1996-10-22
WO1993019776A1 (en) 1993-10-14
JP3268557B2 (ja) 2002-03-25
EP0587858B2 (de) 2007-11-14
EP0587858A1 (de) 1994-03-23
JPH06508156A (ja) 1994-09-14
PT587858E (pt) 2001-02-28

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Legal Events

Date Code Title Description
8327 Change in the person/name/address of the patent owner

Owner name: PHARMACIA AB, STOCKHOLM, SE

8363 Opposition against the patent
8366 Restricted maintained after opposition proceedings
8327 Change in the person/name/address of the patent owner

Owner name: PFIZER HEALTH AB, STOCKHOLM, SE

8339 Ceased/non-payment of the annual fee