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)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (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) DE69329651T3 (ro)
DK (2) DK0652766T4 (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)

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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
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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.
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
ES2139081T3 (es) * 1994-06-17 2000-02-01 Applied Res Systems Ars Holding N V Composiciones farmaceuticas que contienen la hormona humana del crecimiento.
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
US5631225A (en) * 1994-10-13 1997-05-20 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
US20070179096A1 (en) 1996-04-24 2007-08-02 Novo Nordisk A/S Pharmaceutical Formulation
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn 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
WO2000004913A1 (en) * 1998-07-23 2000-02-03 Eli Lilly And Company Fsh and fsh variant formulations, products and methods
US20030166525A1 (en) 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
WO2001003741A1 (en) * 1999-07-12 2001-01-18 Grandis Biotech Gmbh Growth hormone formulations
WO2001079444A2 (en) 2000-04-12 2001-10-25 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
EP2277888A3 (en) 2001-12-21 2011-04-27 Human Genome Sciences, Inc. Fusion proteins of albumin and erythropoietin
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.
RU2357750C2 (ru) 2002-12-31 2009-06-10 Элтус Фармасьютикалз Инк. Кристаллы человеческого гормона роста и способы их получения
EP1594530A4 (en) 2003-01-22 2006-10-11 Human Genome Sciences Inc HYBRID PROTEINS OF ALBUMIN
RS57872B1 (sr) 2003-04-02 2018-12-31 Ares Trading Sa Tečne farmaceutske formulacije fsh i lh zajedno sa nejonskim surfaktantom
PL1638595T3 (pl) 2003-06-20 2013-06-28 Ares Trading Sa Liofilizowane formulacje FSH/LH
WO2005063298A1 (en) 2003-12-23 2005-07-14 Pharmacia Corporation Stable growth hormone liquid formulation
PL1729795T3 (pl) 2004-02-09 2016-08-31 Human Genome Sciences Inc Białka fuzyjne albuminy
KR101120879B1 (ko) * 2004-04-07 2012-02-27 아레스 트레이딩 에스.아. 액체 성장 호르몬 제제
US8334365B2 (en) 2006-06-07 2012-12-18 Human Genome Sciences, Inc. Albumin fusion proteins
WO2008004717A1 (en) 2006-07-06 2008-01-10 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
EP2120869A2 (en) * 2006-12-18 2009-11-25 Altus Pharmaceuticals Inc. Human growth hormone 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
CA2780554C (en) * 2009-11-17 2017-08-15 Ipsen Pharma S.A.S. Formulation for hgh and rhigf-1 combination
JP5980689B2 (ja) 2010-01-22 2016-08-31 ノヴォ・ノルディスク・ヘルス・ケア・アーゲー 安定な成長ホルモン化合物
AU2011208625C1 (en) 2010-01-22 2022-08-18 Novo Nordisk Health Care Ag Growth hormones with prolonged in-vivo efficacy
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
EP2736490A1 (en) * 2011-07-25 2014-06-04 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
WO2014166836A1 (en) * 2013-04-05 2014-10-16 Novo Nordisk A/S Growth hormone compound formulation
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

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EP0303746A1 (en) * 1987-08-21 1989-02-22 Mallinckrodt Group Inc. Stabilization of growth promoting hormones
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Also Published As

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

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Legal Events

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PD99 Pending application