ES2150940T3 - Formulacion proteinica que comprende hormona del crecimiento. - Google Patents

Formulacion proteinica que comprende hormona del crecimiento.

Info

Publication number
ES2150940T3
ES2150940T3 ES93908252T ES93908252T ES2150940T3 ES 2150940 T3 ES2150940 T3 ES 2150940T3 ES 93908252 T ES93908252 T ES 93908252T ES 93908252 T ES93908252 T ES 93908252T ES 2150940 T3 ES2150940 T3 ES 2150940T3
Authority
ES
Spain
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 - Lifetime
Application number
ES93908252T
Other languages
English (en)
Other versions
ES2150940T5 (es
Inventor
Staffan Castensson
Ebba Florin-Robertsson
Elvy Hokby
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=ES2150940(T3) "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
Publication of ES2150940T3 publication Critical patent/ES2150940T3/es
Application granted granted Critical
Publication of ES2150940T5 publication Critical patent/ES2150940T5/es
Anticipated expiration legal-status Critical
Expired - Lifetime 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)

Abstract

LA INVENCION SE REFIERE A FORMULACIONES INYECTABLES DE HORMONA DE DESARROLLO O CUALQUIER ANALOGO FUNCIONAL DE LAS MISMAS, COMPRENDIENDO CITRATO COMO SUSTANCIA REGULADORA. LA FORMULACION PUEDE SER UNA SOLUCION ACUOSA DE HORMONA DE DESARROLLO Y CUALQUIER ANALOGO FUNCIONAL DE LA MISMA, Y CITRATO COMO SUSTANCIA REGULADORA, EN UNA CONCENTRACION DE 2-50 MM. LA FORMULACION DE LA HORMONA DEL DESARROLLO O CUALQUIER ANALOGO FUNCIONAL DE LA MISMA PUEDE COMPRENDER FACTORES DE DESARROLLO, AMINOACIDOS TALES COMO, POR EJEMPLO, GLICINA Y ALANINA Y/O MANNITOL O MANNITA, O BIEN OTROS ALCOHOLES DEL AZUCAR Y/O GLICEROL Y/O OTROS CARBOHIDRATOS Y, OPCIONALMENTE, UN PRESERVADOR TAL COMO ALCOHOL DE BENZILO. LA INVENCION TAMBIEN SE REFIERE A UN PROCESO PARA LA PREPARACION DE LA FORMULACION MEDIANTE LA MEZCLA DE LA HORMONA DEL DESARROLLO O DE CUALQUIER ANALOGO FUNCIONAL DE LA MISMA, CON CITRATO COMO SUSTANCIA REGULADORA, O BIEN AÑADIENDO LOS COMPONENTESA DE LA FORMULACION FINAL SOBRE LA FASE DE DEPURACION DEL GEL.
ES93908252T 1992-04-03 1993-04-01 Formulacion proteinica que comprende hormona del crecimiento. Expired - Lifetime ES2150940T5 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9201073A SE9201073D0 (sv) 1992-04-03 1992-04-03 Protein formulation
SE9201073 1992-04-03

Publications (2)

Publication Number Publication Date
ES2150940T3 true ES2150940T3 (es) 2000-12-16
ES2150940T5 ES2150940T5 (es) 2008-04-16

Family

ID=20385860

Family Applications (1)

Application Number Title Priority Date Filing Date
ES93908252T Expired - Lifetime ES2150940T5 (es) 1992-04-03 1993-04-01 Formulacion proteinica que comprende hormona del crecimiento.

Country Status (15)

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

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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
US5849704A (en) * 1991-12-20 1998-12-15 Novo Nordisk A/S Pharmaceutical 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
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.
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
US5631225A (en) * 1994-10-13 1997-05-20 Novo Nordisk A/S Pharmaceutical formulation
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
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
RU2298415C2 (ru) * 2000-07-11 2007-05-10 Сандоз Аг Композиции, включающие гормон роста
MXPA03001092A (es) 2000-08-07 2003-09-25 Nektar Therapeutics Al Corp Polvos de proteina de haz de 4 helices secados por rocio, inhalables, que tienen agregacion minimizada.
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
WO2003059934A2 (en) 2001-12-21 2003-07-24 Human Genome Sciences, Inc. Albumin fusion proteins
AU2003217783A1 (en) * 2002-02-27 2003-09-09 Wake Forest University Angiotensin-(1-7) and angiotensin-(1-7) agonists for inhibition of cancer cell growth
AU2003249992A1 (en) * 2002-07-09 2004-01-23 Sandoz Ag Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
US20070065469A1 (en) * 2002-07-09 2007-03-22 Michael Betz Liquid formulations with high concentration of human growth hormone (high) comprising glycine
US20060252682A1 (en) * 2003-03-18 2006-11-09 Ares Trading S.A. Liquid growth hormone formulation and process of preparation thereof
JP4845741B2 (ja) 2003-12-23 2011-12-28 ファルマシア コーポレーション 安定な成長ホルモン液体製剤
ES2383994T3 (es) * 2004-04-07 2012-06-28 Ares Trading S.A. Formulación líquida de hormona del crecimiento
ES2473587T3 (es) * 2004-08-03 2014-07-07 Transtech Pharma, Inc. Proteínas de fusión de RAGE y métodos de uso
EP1776459A1 (en) * 2004-08-03 2007-04-25 Transtech Pharma, Inc. Rage fusion proteins and methods of use
BRPI0514408B8 (pt) * 2004-08-24 2021-05-25 Asubio Pharma Co Ltd preparação liquida de peptídeo fisiologicamente ativo
EP1809663B1 (en) * 2004-11-09 2008-09-17 Ares Trading S.A. Method for purifying fsh
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
JP5522939B2 (ja) * 2005-11-02 2014-06-18 トランスファーマ メディカル リミテッド ヒト成長ホルモンパッチ製剤
JP5199112B2 (ja) * 2005-12-09 2013-05-15 アレス トレーディング ソシエテ アノニム Ｆｓｈ又はｆｓｈ変異体を精製するための方法
EP1963786B1 (en) * 2005-12-23 2013-07-24 GCoder Systems AB Positioning pattern
WO2007094926A2 (en) * 2006-02-09 2007-08-23 Transtech Pharma, Inc. Rage fusion proteins and methods of use
EA017291B1 (ru) * 2006-05-05 2012-11-30 Транстек Фарма, Инк. Белки слияния на основе rage, их композиции и способы их применения
WO2008100470A2 (en) * 2007-02-15 2008-08-21 Transtech Pharma, Inc. Rage - immunoglobulin fusion proteins
MX2009012609A (es) 2007-05-22 2009-12-07 Amgen Inc Composiciones y metodos para producir proteinas de fusion bioactivas.
CA2702448A1 (en) * 2007-10-22 2009-04-30 Merck Serono S.A. Method for purifying fc-fusion proteins
EP2203465A1 (en) * 2007-10-22 2010-07-07 Merck Serono S.A. Method for purifying an fc-containing protein
US9034341B2 (en) 2009-04-20 2015-05-19 Transtech Pharma, Llc Control of RAGE fusion protein glycosylation and RAGE fusion protein compositions
EP2427215A1 (en) * 2009-05-07 2012-03-14 Novo Nordisk Health Care AG Stable pharmaceutical compositions of peptide derivatized using an oxime linker
RU2558821C2 (ru) * 2009-11-17 2015-08-10 Ипсен Фарма С.А.С. ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1
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
CN105848645A (zh) * 2013-09-27 2016-08-10 韩美药品株式会社 持续型人生长激素制剂
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
CN112566652A (zh) * 2018-06-25 2021-03-26 Jcr制药股份有限公司 含有蛋白的水性液体制剂

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US4774091A (en) * 1983-10-14 1988-09-27 Sumitomo Pharmaceuticals Company, Ltd. Long-term sustained-release preparation
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US4917685A (en) * 1986-05-16 1990-04-17 International Minerals & Chem. Corp. Delivery device for the administration of stabilized growth promoting hormones
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US4837202A (en) † 1987-09-14 1989-06-06 Pitman-Moore, Inc. Method for stimulating the immune system
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JPH01308235A (ja) * 1988-06-03 1989-12-12 Yamanouchi Pharmaceut Co Ltd ヒト成長ホルモン経鼻剤
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Also Published As

Publication number Publication date
NO310804B1 (no) 2001-09-03
GR3034925T3 (en) 2001-02-28
DE69329367T2 (de) 2001-06-21
EP0587858B1 (en) 2000-09-06
NO934355L (no) 1993-12-01
WO1993019776A1 (en) 1993-10-14
PT587858E (pt) 2001-02-28
EP0587858A1 (en) 1994-03-23
US5567677A (en) 1996-10-22
DE69329367T3 (de) 2008-06-19
CA2102693C (en) 2008-06-17
NO934355D0 (no) 1993-11-30
CA2102693A1 (en) 1993-10-04
AU3913593A (en) 1993-11-08
ES2150940T5 (es) 2008-04-16
JP3268557B2 (ja) 2002-03-25
NZ251498A (en) 1995-07-26
EP0587858B2 (en) 2007-11-14
DK0587858T3 (da) 2000-12-18
AU666007B2 (en) 1996-01-25
JPH06508156A (ja) 1994-09-14
SE9201073D0 (sv) 1992-04-03
ATE196092T1 (de) 2000-09-15
DE69329367D1 (de) 2000-10-12

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