DE69329367T2 - Wachstumshormon-enthaltendeproteinformulierung - Google Patents

Wachstumshormon-enthaltendeproteinformulierung

Info

Publication number
DE69329367T2
DE69329367T2 DE69329367T DE69329367T DE69329367T2 DE 69329367 T2 DE69329367 T2 DE 69329367T2 DE 69329367 T DE69329367 T DE 69329367T DE 69329367 T DE69329367 T DE 69329367T DE 69329367 T2 DE69329367 T2 DE 69329367T2
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
DE69329367D1 (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 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(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pharmacia AB filed Critical Pharmacia AB
Publication of DE69329367D1 publication Critical patent/DE69329367D1/de
Application granted granted Critical
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

    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (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 DE69329367D1 (de) 2000-10-12
DE69329367T2 true 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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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
DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
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
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
US5654278A (en) * 1994-10-13 1997-08-05 Novo Nordisk A/S Composition and method comprising growth hormone and leucine
IL115592A (en) * 1994-10-13 2000-07-26 Novo Nordisk As Stabilized pharmaceutical formulation comprising a 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
MXPA02000404A (es) * 1999-07-12 2004-05-21 Grandis Biotech Gmbh Formulaciones de hormona de crecimiento.
JP2004515467A (ja) * 2000-08-07 2004-05-27 ネクター セラピューティックス 吸入可能な、噴霧乾燥した、最少の凝集物を有する４−ヘリックスバンドルタンパク質粉末
GB2371227A (en) * 2001-01-10 2002-07-24 Grandis Biotech Gmbh Crystallisation - resistant aqueous growth hormone formulations
AU2002342653A1 (en) 2001-05-14 2002-11-25 The Gouvernment Of The United States Of America, Represented By The Secretary, Department Of Health Modified growth hormone
AU2002364587A1 (en) 2001-12-21 2003-07-30 Human Genome Sciences, Inc. Albumin fusion proteins
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
AU2003250915A1 (en) * 2002-07-09 2004-01-23 Sandoz Ag LIQUID FORMULATIONS WITH HIGH CONCENTRATION OF HUMAN GROWTH HORMONE (hgh) COMPRISING 1,2-PROLPYLENE GLYCOL
EP1603588A2 (de) * 2003-03-18 2005-12-14 Ares Trading S.A. Stabilisierung von wachstumshormonen in lösung
CA2551510C (en) 2003-12-23 2013-07-30 Pharmacia Corporation Stable growth hormone liquid formulation
AU2005237775B2 (en) * 2004-04-07 2010-03-04 Ares Trading S.A. Liquid growth hormone formulation
JP5188804B2 (ja) 2004-08-03 2013-04-24 トランステック ファーマ，インコーポレイティド Ｒａｇｅ融合タンパク質及びその使用方法
UA92154C2 (ru) * 2004-08-03 2010-10-11 Транстек Фарма, Инк. Rage-слитые белки и способы их применения
BRPI0514408B8 (pt) * 2004-08-24 2021-05-25 Asubio Pharma Co Ltd preparação liquida de peptídeo fisiologicamente ativo
CN101087805B (zh) * 2004-11-09 2012-05-23 阿雷斯贸易股份有限公司 Fsh的纯化方法
US20070015689A1 (en) * 2005-06-23 2007-01-18 Alza Corporation Complexation of metal ions with polypeptides
US20080219952A1 (en) 2005-08-26 2008-09-11 Ares Trading S.A. Process For the Preparation of Glycosylated Interferon Beta
WO2007056105A2 (en) * 2005-11-02 2007-05-18 Transpharma Medical Ltd. Human growth hormone patch formulations
EP1960419B1 (de) * 2005-12-09 2016-03-16 Ares Trading S.A. Verfahren zur aufreinigung von fsh oder einer fsh-mutante
AU2006327353B2 (en) * 2005-12-23 2011-11-24 Gcoder Systems Ab Positioning pattern
NZ569545A (en) * 2006-02-09 2011-11-25 Transtech Pharma Inc Rage fusion proteins and methods of use for treating inflammation
BRPI0711193A2 (pt) * 2006-05-05 2013-06-18 Transtech Pharma Inc proteÍnas de fusço rage, formulaÇÕes e mÉtodos de uso dos mesmos
WO2008100470A2 (en) * 2007-02-15 2008-08-21 Transtech Pharma, Inc. Rage - immunoglobulin fusion proteins
EP2162540A2 (de) 2007-05-22 2010-03-17 Amgen Inc. Zusammensetzungen und verfahren zur herstellung biologisch aktiver fusionsproteine
AU2008314689A1 (en) * 2007-10-22 2009-04-30 Merck Serono S.A. Method for purifying an Fc-containing protein
AU2008314687A1 (en) * 2007-10-22 2009-04-30 Merck Serono S.A. Method for purifying Fc-fusion proteins
KR20110139292A (ko) 2009-04-20 2011-12-28 화이자 인코포레이티드 단백질 글리코실화의 제어 및 그와 관련된 조성물 및 방법
US20120108512A1 (en) * 2009-05-07 2012-05-03 Novo Nordisk Health Care Ag Stable pharmaceutical compositions of peptide derivatized using an oxime linker
KR101614983B1 (ko) * 2009-11-17 2016-04-22 입센 파마 에스.에이.에스 Ｈｇｈ 및 ｒｈｉｇｆ―１의 조합물을 위한 제제
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
TW201605468A (zh) * 2013-09-27 2016-02-16 韓美藥品股份有限公司 長效人類生長激素接合物之製劑
US20160303242A1 (en) 2013-12-09 2016-10-20 Durect Corporation Pharmaceutically Active Agent Complexes, Polymer Complexes, and Compositions and Methods Involving the Same
WO2016011281A1 (en) * 2014-07-17 2016-01-21 Teva Pharmaceutical Industries Ltd. FORMULATIONS OF AN ALBUMIN-hGH FUSION PROTEIN

Family Cites Families (19)

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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
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
US4917685A (en) * 1986-05-16 1990-04-17 International Minerals & Chem. Corp. Delivery device for the administration of stabilized growth promoting hormones
US4816568A (en) * 1986-05-16 1989-03-28 International Minerals & Chemical Corp. Stabilization of growth hormones
DE3782737T3 (de) * 1987-08-21 1999-05-20 Imcera Group Inc 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
WO1992017200A2 (en) * 1991-03-28 1992-10-15 Genentech, Inc. Stable growth hormone metal ion formulations
DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
AU679913B2 (en) * 1992-04-30 1997-07-17 Millennium Pharmaceuticals, Inc. Stable polypeptide composition
AU686567C (en) * 1992-07-31 2002-08-08 Genentech Inc. Human growth hormone aqueous formulation

Also Published As

Publication number Publication date
AU3913593A (en) 1993-11-08
DE69329367T3 (de) 2008-06-19
ATE196092T1 (de) 2000-09-15
JPH06508156A (ja) 1994-09-14
PT587858E (pt) 2001-02-28
DE69329367D1 (de) 2000-10-12
SE9201073D0 (sv) 1992-04-03
WO1993019776A1 (en) 1993-10-14
NO310804B1 (no) 2001-09-03
EP0587858A1 (de) 1994-03-23
AU666007B2 (en) 1996-01-25
EP0587858B1 (de) 2000-09-06
NO934355D0 (no) 1993-11-30
DK0587858T3 (da) 2000-12-18
ES2150940T5 (es) 2008-04-16
US5567677A (en) 1996-10-22
CA2102693C (en) 2008-06-17
EP0587858B2 (de) 2007-11-14
CA2102693A1 (en) 1993-10-04
JP3268557B2 (ja) 2002-03-25
NO934355L (no) 1993-12-01
NZ251498A (en) 1995-07-26
ES2150940T3 (es) 2000-12-16
GR3034925T3 (en) 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