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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (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) ES2286868T3 (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 (53)

* Cited by examiner, † Cited by third party
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
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
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
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
JP3829991B2 (ja) * 1994-06-17 2006-10-04 アプライド リサーチ システムズ エーアールエス ホールディング ナームロゼ ベノートスハップ Ｈｇｈ含有医薬組成物
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
AU776823B2 (en) * 1998-07-23 2004-09-23 Ares Trading S.A. FSH and FSH variant formulations, products and methods
ATE386501T1 (de) * 1999-07-12 2008-03-15 Sandoz Ag Formulierungen von wachstumshormonen
US6926898B2 (en) 2000-04-12 2005-08-09 Human Genome Sciences, Inc. Albumin fusion proteins
CA2380423A1 (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
ES2500918T3 (es) 2001-12-21 2014-10-01 Human Genome Sciences, Inc. Proteínas de fusión de albúmina e interferón beta
US20080194481A1 (en) 2001-12-21 2008-08-14 Human Genome Sciences, Inc. Albumin Fusion Proteins
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.
JP4686361B2 (ja) 2002-12-31 2011-05-25 アルタス ファーマシューティカルズ インコーポレイテッド ヒト成長ホルモンの結晶およびその調製方法
DK1610822T4 (en) 2003-04-02 2019-01-14 Ares Trading Sa Liquid pharmaceutical FSH and LH formulations together with a nonionic surfactant
CA2526099C (en) 2003-06-20 2013-02-05 Ares Trading Sa Freeze-dried fsh / lh formulations
BRPI0418115A (pt) 2003-12-23 2007-04-17 Pharmacia Corp formulação lìquida estável de hormÈnio de crescimento
SI1729795T1 (sl) 2004-02-09 2016-04-29 Human Genome Sciences, Inc. Albuminski fuzijski proteini
WO2005105148A2 (en) * 2004-04-07 2005-11-10 Ares Trading S.A.- Liquid growth hormone formulation
EP2474318A1 (en) 2006-06-07 2012-07-11 Human Genome Sciences, Inc. Albumin fusion proteins
ES2605022T3 (es) * 2006-07-06 2017-03-10 Daewoong Co., Ltd. Una formulación líquida estable de la hormona del crecimiento humana
JP2010513309A (ja) * 2006-12-18 2010-04-30 アルタス ファーマシューティカルズ インコーポレイテッド ヒト成長ホルモン製剤
CA2767127A1 (en) 2009-07-01 2011-01-06 Protiva Biotherapeutics, Inc. Novel lipid formulations for delivery of therapeutic agents to solid tumors
CA2780554C (en) * 2009-11-17 2017-08-15 Ipsen Pharma S.A.S. Formulation for hgh and rhigf-1 combination
AU2011208625C1 (en) 2010-01-22 2022-08-18 Novo Nordisk Health Care Ag Growth hormones with prolonged in-vivo efficacy
RU2012134974A (ru) 2010-01-22 2014-02-27 Ново Нордиск Хелс Кеа Аг Стабилизированное соединение гормона роста
WO2012000104A1 (en) 2010-06-30 2012-01-05 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
BR112014001921B1 (pt) * 2011-07-25 2022-05-10 Sandoz Ag Formulação aquosa farmaceuticamente aceitável, método para aumentar a estabilidade de uma formulação aquosa farmaceuticamente aceitável e embalagem principal
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
CN105120887A (zh) * 2013-04-05 2015-12-02 诺和诺德保健股份有限公司 生长激素化合物制剂
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
DK0652766T3 (da) 2001-01-29
CA2139358C (en) 2001-02-13
CA2139358A1 (en) 1994-02-17
CA2489978A1 (en) 1994-02-17
GR3035144T3 (en) 2001-04-30
PT652766E (pt) 2001-04-30
EP0652766A1 (en) 1995-05-17
EP0652766B2 (en) 2008-03-19
ES2286868T3 (es) 2007-12-01
EP0955062B1 (en) 2007-04-18
EP0652766B1 (en) 2000-11-08
IL106524A (en) 2000-08-31
AU686567C (en) 2002-08-08
DE69329651T2 (de) 2001-05-23
MX9304613A (es) 1994-03-31
DK0652766T4 (da) 2008-06-09
DK0955062T3 (da) 2007-09-17
JP2007045841A (ja) 2007-02-22
DE69334134T2 (de) 2007-12-20
IL106524A0 (en) 1993-11-15
DE69329651D1 (de) 2000-12-14
ES2153385T5 (es) 2008-09-01
CA2337745C (en) 2005-04-12
ATE359824T1 (de) 2007-05-15
DE69329651T3 (de) 2008-10-30
CA2337745A1 (en) 1994-02-17
NZ255158A (en) 1997-09-22
DE69334134D1 (de) 2007-05-31
WO1994003198A1 (en) 1994-02-17
ES2153385T3 (es) 2001-03-01
AU4792793A (en) 1994-03-03
EP0955062A1 (en) 1999-11-10
MD960246A (ro) 1998-01-31
JPH07509719A (ja) 1995-10-26
ATE197405T1 (de) 2000-11-11
JP4018133B2 (ja) 2007-12-05
AU686567B2 (en) 1998-02-12

Similar Documents

Publication Publication Date Title
MD1699F2 (ro) Compoziţie apoasă a hormonului somatotrop uman şi procedeu de prevenire a denaturării ei
IL152659A (en) Liquid pharmaceutical compositions comprising a pegylated human erythropoietin protein and a multiple charged inorganic anion, in a pharmaceutically acceptable buffer
HK1003978A1 (en) Composition for the treatment of schizophrenia
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
PL312204A1 (en) Preparation for intrarhinal administration of desmopressin
WO2003005954B1 (en) Methods and materials for the treatment of testosterone deficiency in men
MY118526A (en) Method for improving the pharmacokinetics of tipranavir
WO1994008613A3 (en) Use of parathormone, of its biologically active fragments and of related peptides for treatment of pregnancy
ES2160643T3 (es) Composiciones que contienen g-csf y proteina de union al tnf.
TW363973B (en) Stable polypeptide composition and method of preparation the same
UA41326C2 (uk) Фармацевтична композиція для профілактики або лікування вірусних захворювань, засіб для профілактики або лікування вірусних захворювань
IE840977L (en) Pharmaceutical preparations
ATE184489T1 (de) Behandlung fehlender milchabsonderung beim menschen
TW253837B (ro)
LT96094A (en) The active ingredient of pharmaceutical composition for treating constipation
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.
HUP0004475A2 (hu) Gyógyszerkészítmény

Legal Events

Date Code Title Description
PD99 Pending application