MD1699F2 - Compoziţie apoasă a hormonului somatotrop uman şi procedeu de prevenire a denaturării ei - Google Patents

Compoziţie apoasă a hormonului somatotrop uman şi procedeu de prevenire a denaturării ei

Info

Publication number
MD1699F2
MD1699F2 MD96-0246A MD960246A MD1699F2 MD 1699 F2 MD1699 F2 MD 1699F2 MD 960246 A MD960246 A MD 960246A MD 1699 F2 MD1699 F2 MD 1699F2
Authority
MD
Moldova
Prior art keywords
aqueous composition
preventing denaturation
somatotropic hormone
human somatotropic
human
Prior art date
Application number
MD96-0246A
Other languages
English (en)
Russian (ru)
Other versions
MD960246A (ro
Inventor
Barbara H. O'connor
James Q. Oeswein
Original Assignee
Genentech, Inc.
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=25448638&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MD1699(F2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech, Inc. filed Critical Genentech, Inc.
Publication of MD960246A publication Critical patent/MD960246A/ro
Publication of MD1699F2 publication Critical patent/MD1699F2/ro

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
    • A61K47/10—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
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • 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)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Invenţia se referă la medicină, şi anume la farmacologie.Este propusă o compoziţie apoasă stabilă, farmaceutic acceptabilă a hormonului somatotrop uman, ce conţine tampon, surfactant neionic şi, opţional, o sare neutră, manită şi conservant. De asemenea, este propus un procedeu de prevenire a denaturării compoziţiei solicitate.
MD96-0246A 1992-07-31 1993-07-29 Compoziţie apoasă a hormonului somatotrop uman şi procedeu de prevenire a denaturării ei MD1699F2 (ro)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US92340192A 1992-07-31 1992-07-31
PCT/US1993/007149 WO1994003198A1 (en) 1992-07-31 1993-07-29 Human growth hormone aqueous formulation

Publications (2)

Publication Number Publication Date
MD960246A MD960246A (ro) 1998-01-31
MD1699F2 true MD1699F2 (ro) 2001-07-31

Family

ID=25448638

Family Applications (1)

Application Number Title Priority Date Filing Date
MD96-0246A MD1699F2 (ro) 1992-07-31 1993-07-29 Compoziţie apoasă a hormonului somatotrop uman şi procedeu de prevenire a denaturării ei

Country Status (15)

Country Link
EP (2) EP0652766B2 (ro)
JP (2) JP4018133B2 (ro)
AT (2) ATE359824T1 (ro)
AU (1) AU686567C (ro)
CA (3) CA2337745C (ro)
DE (2) DE69334134T2 (ro)
DK (2) DK0955062T3 (ro)
ES (2) ES2153385T5 (ro)
GR (1) GR3035144T3 (ro)
IL (1) IL106524A (ro)
MD (1) MD1699F2 (ro)
MX (1) MX9304613A (ro)
NZ (1) NZ255158A (ro)
PT (1) PT652766E (ro)
WO (1) WO1994003198A1 (ro)

Families Citing this family (56)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5981485A (en) * 1997-07-14 1999-11-09 Genentech, Inc. Human growth hormone aqueous formulation
US5763394A (en) * 1988-04-15 1998-06-09 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.
SE9201073D0 (sv) * 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
US5877016A (en) 1994-03-18 1999-03-02 Genentech, Inc. Human trk receptors and neurotrophic factor inhibitors
DE69420872T2 (de) * 1994-06-17 2000-01-13 Applied Research Systems Ars Holding N.V., Curacao Hgh enthaltende pharmazeutische zubereitungen
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
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
US6790439B1 (en) 1995-06-07 2004-09-14 Zymogenetics, Inc. Thrombopoietin compositions
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
SE9502927D0 (sv) * 1995-08-24 1995-08-24 Pharmacia Ab Solution containing IGF-I
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
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn Pharmaceutical formulation
US20070179096A1 (en) 1996-04-24 2007-08-02 Novo Nordisk A/S Pharmaceutical Formulation
SE9704405D0 (sv) * 1997-11-28 1997-11-28 Pharmacia & Upjohn Ab New syringe
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
US20030166525A1 (en) 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
CA2335340C (en) * 1998-07-23 2013-03-05 Eli Lilly And Company Fsh and fsh variant formulations, products and methods
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
US6926898B2 (en) 2000-04-12 2005-08-09 Human Genome Sciences, Inc. Albumin fusion proteins
WO2001087322A2 (en) * 2000-05-17 2001-11-22 Bionebraska, Inc. Peptide pharmaceutical formulations
GB2371227A (en) * 2001-01-10 2002-07-24 Grandis Biotech Gmbh Crystallisation - resistant aqueous growth hormone formulations
US7507413B2 (en) 2001-04-12 2009-03-24 Human Genome Sciences, Inc. Albumin fusion proteins
US20080194481A1 (en) 2001-12-21 2008-08-14 Human Genome Sciences, Inc. Albumin Fusion Proteins
WO2005003296A2 (en) 2003-01-22 2005-01-13 Human Genome Sciences, Inc. Albumin fusion proteins
CA2841097A1 (en) 2001-12-21 2003-07-24 Human Genome Sciences, Inc. Albumin and g-csf fusion proteins
AU2003249992A1 (en) * 2002-07-09 2004-01-23 Sandoz Ag Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol
DK1581251T3 (da) 2002-12-31 2016-06-27 Althea Tech Inc Krystaller af humant væksthormon og fremgangsmåder til fremstilling deraf
WO2004087213A1 (en) 2003-04-02 2004-10-14 Ares Trading S.A. Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant
WO2004112826A1 (en) 2003-06-20 2004-12-29 Ares Trading Sa Freeze-dried fsh / lh formulations
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
CN102816241B (zh) 2004-02-09 2015-07-22 人类基因科学公司 清蛋白融合蛋白
ES2383994T3 (es) * 2004-04-07 2012-06-28 Ares Trading S.A. Formulación líquida de hormona del crecimiento
EP2474318A1 (en) 2006-06-07 2012-07-11 Human Genome Sciences, Inc. Albumin fusion proteins
LT2049148T (lt) 2006-07-06 2016-11-25 Daewoong Co., Ltd. Žmogaus augimo hormono skysta stabili kompozicija
US8071544B2 (en) * 2006-12-18 2011-12-06 Althea Technologies, Inc. Crystallized recombinant human growth factor formulations
ES2613498T3 (es) 2009-07-01 2017-05-24 Protiva Biotherapeutics Inc. Nuevas formulaciones de lípidos para el suministro de agentes terapéuticos a tumores sólidos
RU2558821C2 (ru) * 2009-11-17 2015-08-10 Ипсен Фарма С.А.С. ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1
RU2012134974A (ru) 2010-01-22 2014-02-27 Ново Нордиск Хелс Кеа Аг Стабилизированное соединение гормона роста
PL2525834T3 (pl) 2010-01-22 2020-10-19 Novo Nordisk Health Care Ag Hormony wzrostu o przedłużonej skuteczności in-vivo
US9006417B2 (en) 2010-06-30 2015-04-14 Protiva Biotherapeutics, Inc. Non-liposomal systems for nucleic acid delivery
KR101337797B1 (ko) * 2010-07-14 2013-12-06 한미사이언스 주식회사 지속형 인간 성장 호르몬 결합체 액상 제제
WO2013014196A1 (en) * 2011-07-25 2013-01-31 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
JP5487276B2 (ja) * 2012-11-12 2014-05-07 デウン カンパニー，リミテッド ヒト成長ホルモンを含有する安定した液状製剤
ES2841123T3 (es) * 2013-04-05 2021-07-07 Formulacion Del Compuesto De La Hormona De Crecimiento Formulación del compuesto de la hormona de crecimiento
CN113425835B (zh) * 2020-03-23 2024-03-19 常州健益生物制药有限公司 一种生长激素原料药溶液、水针剂及其制备方法
CN112494638B (zh) * 2020-12-22 2023-12-19 深圳科兴药业有限公司 一种人生长激素注射剂组合物及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0211601A2 (en) * 1985-07-30 1987-02-25 International Minerals And Chemical Corporation Stabilization of growth promoting hormones
EP0303746A1 (en) * 1987-08-21 1989-02-22 Mallinckrodt Group Inc. Stabilization of growth promoting hormones
WO1989009614A1 (en) * 1988-04-15 1989-10-19 Genentech, Inc. Human growth hormone formulation

Family Cites Families (7)

* 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
DE3325223A1 (de) * 1983-07-13 1985-01-24 Hoechst Ag, 6230 Frankfurt Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung
US4904043A (en) * 1988-06-15 1990-02-27 American Telephone And Telegraph Company, At&T Bell Laboratories Optical data link dual wavelength coupler
US5182258A (en) * 1989-03-20 1993-01-26 Orbon Corporation Systemic delivery of polypeptides through the eye
GB9007052D0 (en) * 1990-03-29 1990-05-30 Skua Investments Ltd Pharmaceutical formulations
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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0211601A2 (en) * 1985-07-30 1987-02-25 International Minerals And Chemical Corporation Stabilization of growth promoting hormones
EP0303746A1 (en) * 1987-08-21 1989-02-22 Mallinckrodt Group Inc. Stabilization of growth promoting hormones
WO1989009614A1 (en) * 1988-04-15 1989-10-19 Genentech, Inc. Human growth hormone formulation

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Pearlman et al. Currebt Communication in Molecular Biology, eds. D. Marshak and D. Liu, p.23-30 *
Physician(s Desk Reference. Medical Economics Co., Orawell, NJ, 1992, p. 1049-1050 *
Physician(s Desk Reference. Medical Economics Co., Orawell, NJ, 1992, p. 1266-1267 *

Also Published As

Publication number Publication date
EP0955062B1 (en) 2007-04-18
DK0652766T3 (da) 2001-01-29
AU4792793A (en) 1994-03-03
DE69334134D1 (de) 2007-05-31
EP0652766B2 (en) 2008-03-19
CA2139358C (en) 2001-02-13
JP4018133B2 (ja) 2007-12-05
JPH07509719A (ja) 1995-10-26
IL106524A (en) 2000-08-31
DE69329651T2 (de) 2001-05-23
CA2139358A1 (en) 1994-02-17
AU686567B2 (en) 1998-02-12
ES2153385T5 (es) 2008-09-01
ES2153385T3 (es) 2001-03-01
AU686567C (en) 2002-08-08
NZ255158A (en) 1997-09-22
DE69329651D1 (de) 2000-12-14
PT652766E (pt) 2001-04-30
EP0955062A1 (en) 1999-11-10
DK0955062T3 (da) 2007-09-17
CA2489978A1 (en) 1994-02-17
JP2007045841A (ja) 2007-02-22
DE69329651T3 (de) 2008-10-30
WO1994003198A1 (en) 1994-02-17
CA2337745C (en) 2005-04-12
MX9304613A (es) 1994-03-31
GR3035144T3 (en) 2001-04-30
ATE359824T1 (de) 2007-05-15
IL106524A0 (en) 1993-11-15
EP0652766A1 (en) 1995-05-17
DK0652766T4 (da) 2008-06-09
MD960246A (ro) 1998-01-31
ES2286868T3 (es) 2007-12-01
EP0652766B1 (en) 2000-11-08
DE69334134T2 (de) 2007-12-20
CA2337745A1 (en) 1994-02-17
ATE197405T1 (de) 2000-11-11

Similar Documents

Publication Publication Date Title
ATE197405T1 (de) Wässrige arzneizusammensetzung, welche das menschliche wachstumshormon enthält
IL152659A (en) Liquid pharmaceutical compositions comprising a pegylated human erythropoietin protein and a multiple charged inorganic anion, in a pharmaceutically acceptable buffer
UA66758C2 (en) Pharmaceutical formulations comprising growth hormone, method for its production and method for treatment
NZ505324A (en) Liquid and lyophilised KGF-2 polypeptide formulations used to accelerate soft tissue growth or regeneration
WO1997049373A3 (en) Treatment and prevention of hiv infection by administration of derivatives of human chorionic gonadotropin
NO891007D0 (no) Farmasoeytiske polypeptidholdige preparater.
IL89276A0 (en) Human relaxin formulation
PL312204A1 (en) Preparation for intrarhinal administration of desmopressin
WO2003005954B1 (en) Methods and materials for the treatment of testosterone deficiency in men
MX9710206A (es) Composicion farmaceutica de amiodarone para administracion parenteral.
MY118526A (en) Method for improving the pharmacokinetics of tipranavir
ES2160643T3 (es) Composiciones que contienen g-csf y proteina de union al tnf.
WO1994008613A3 (en) Use of parathormone, of its biologically active fragments and of related peptides for treatment of pregnancy
TW363973B (en) Stable polypeptide composition and method of preparation the same
ES2078175A1 (es) Formulacion farmaceutica conteniendo clobetasona y tobramicina y sus aplicaciones.
UA41326C2 (uk) Фармацевтична композиція для профілактики або лікування вірусних захворювань, засіб для профілактики або лікування вірусних захворювань
LT96094A (en) The active ingredient of pharmaceutical composition for treating constipation
IE840977L (en) Pharmaceutical preparations
ATE184489T1 (de) Behandlung fehlender milchabsonderung beim menschen
TW253837B (ro)
IE890275L (en) Pharmaceutical composition for 4-aroylimidazol-2-ones
GB9015774D0 (en) Novel treatment
TW333453B (en) Pharmaceutical composition comprising toremifene for use in the treatment of autoimmune diseases
ATE350026T1 (de) Erhaltung von körpereigenen proteinen
MY110416A (en) Composition for the treatment of schizophrenia.

Legal Events

Date Code Title Description
PD99 Pending application