TR199801558T2 - Stabile edilmis büyüme hormonu formülasyonu ve hazirlama yöntemi. - Google Patents

Stabile edilmis büyüme hormonu formülasyonu ve hazirlama yöntemi.

Info

Publication number
TR199801558T2
TR199801558T2 TR1998/01558T TR9801558T TR199801558T2 TR 199801558 T2 TR199801558 T2 TR 199801558T2 TR 1998/01558 T TR1998/01558 T TR 1998/01558T TR 9801558 T TR9801558 T TR 9801558T TR 199801558 T2 TR199801558 T2 TR 199801558T2
Authority
TR
Turkey
Prior art keywords
growth hormone
buffer
stabilizing agent
preparation
formulation
Prior art date
Application number
TR1998/01558T
Other languages
English (en)
Inventor
Kerin Mcnamara Michael
Neil Charman William
Ann Charman Susan
Original Assignee
Csl Limited
Monash University
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=3792327&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=TR199801558(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Csl Limited, Monash University filed Critical Csl Limited
Publication of TR199801558T2 publication Critical patent/TR199801558T2/tr

Links

Classifications

    • 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
    • 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
    • A61K47/10—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
    • 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
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61P5/06—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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Büyüme hormonu, bir tampon ve (i) polietilen-polipropilen glikol noniyonik surfaktantlar, (ii) tarokolik asit veya tuzlari ya da onun türevleri ve (iii) metil selüloz türevlerini içeren gruptan seçilmis en azindan bir dengeleyici ajanin etkili dengeleyici miktarini içeren dengelenmis bir sivi büyüme hormonu formülasyonu hazirlama yöntemi. Yöntem, büyüme hormonu, tampon ve dengeleyici ajan(lar)in konsantrasyonunun, formül içindeki tampon ve dengeleyici ajan(lar)in son konsantrasyonlarinin iki katindan fazlasina maruz birakilmadigi sartlar altinda, büyüme hormonunun tampon ve dengeleyici ajan(lar)iyla karisimini içerir.
TR1998/01558T 1996-02-12 1997-02-12 Stabile edilmis büyüme hormonu formülasyonu ve hazirlama yöntemi. TR199801558T2 (tr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AUPN8012A AUPN801296A0 (en) 1996-02-12 1996-02-12 Stabilised growth hormone formulation and method of preparation thereof

Publications (1)

Publication Number Publication Date
TR199801558T2 true TR199801558T2 (tr) 1998-11-23

Family

ID=3792327

Family Applications (1)

Application Number Title Priority Date Filing Date
TR1998/01558T TR199801558T2 (tr) 1996-02-12 1997-02-12 Stabile edilmis büyüme hormonu formülasyonu ve hazirlama yöntemi.

Country Status (12)

Country Link
US (1) US6593296B1 (tr)
EP (1) EP0889733B1 (tr)
JP (1) JP4255515B2 (tr)
CN (1) CN1132626C (tr)
AT (1) ATE340587T1 (tr)
AU (1) AUPN801296A0 (tr)
CA (1) CA2246501C (tr)
DE (1) DE69736739T2 (tr)
DK (1) DK0889733T3 (tr)
RU (1) RU2191029C2 (tr)
TR (1) TR199801558T2 (tr)
WO (1) WO1997029767A1 (tr)

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US6277410B1 (en) * 1992-10-08 2001-08-21 Supratek Pharma Inc. Copolymer compositions for oral delivery
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
AT408721B (de) * 1999-10-01 2002-02-25 Cistem Biotechnologies Gmbh Pharmazeutische zusammensetzung enthaltend ein antigen
AU2001238540A1 (en) 2000-02-24 2001-09-03 Monsanto Technology Llc Non-aqueous injectable formulations for extended release of somatotropin
AU2001271491A1 (en) * 2000-06-26 2002-01-08 Monsanto Technology Llc Non-aqueous surfactant-containing formulations for extended release of somatotropin
US6664234B1 (en) 2000-06-30 2003-12-16 Monsanto Technology Llc Non-aqueous injectable formulation preparation with pH adjusted for extended release of somatotropin
GB2371227A (en) * 2001-01-10 2002-07-24 Grandis Biotech Gmbh Crystallisation - resistant aqueous growth hormone formulations
JP4610154B2 (ja) * 2002-05-30 2011-01-12 大塚製薬株式会社 注射用製剤
CN1744914A (zh) * 2002-12-31 2006-03-08 阿尔特斯制药公司 人生长激素晶体和制备它们的方法
JP4949828B2 (ja) * 2003-03-18 2012-06-13 アレス トレーディング ソシエテ アノニム 溶液中での成長ホルモンの安定化
EP1663296A4 (en) * 2003-09-25 2009-11-25 Cangene Corp LIQUID FORMULATION OF HUMAN GROWTH HORMONE CONTAINING POLYETHYLENE GLYCOL
WO2005063298A1 (en) 2003-12-23 2005-07-14 Pharmacia Corporation Stable growth hormone liquid formulation
BRPI0508798A (pt) * 2004-04-07 2007-09-04 Ares Trading Sa formulação lìquida de hormÈnio de crescimento, composição farmacêutica, forma de apresentação da formulação lìquida de hormÈnio de crescimento e uso da formulação lìquida de hormÈnio de crescimento
DE602005009856D1 (de) 2004-11-09 2008-10-30 Ares Trading Sa Verfahren zur reinigung von fsh
WO2007022799A1 (en) 2005-08-26 2007-03-01 Ares Trading S.A. Process for the preparation of glycosylated interferon beta
EP1960419B1 (en) 2005-12-09 2016-03-16 Ares Trading S.A. Method for purifying fsh or a fsh mutant
CN105363022A (zh) * 2006-07-06 2016-03-02 株式会社大熊 稳定的人生长激素液体制剂
BRPI0621841B8 (pt) * 2006-07-06 2021-05-25 Daewoong Co Ltd formulação líquida
ES2640343T3 (es) 2008-04-21 2017-11-02 Novo Nordisk Health Care Ag Composición de transglutaminasa anhidra
JP6363949B2 (ja) * 2011-07-25 2018-07-25 サンド アクチェンゲゼルシャフト 少なくとも中性塩および生物薬学的タンパク質を含む、水性製剤
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
EP3689335A1 (en) * 2013-09-27 2020-08-05 Hanmi Pharm. Co., Ltd. Sustained type human growth hormone preparation

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DE3325223A1 (de) * 1983-07-13 1985-01-24 Hoechst Ag, 6230 Frankfurt Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung
PT83095B (en) 1985-07-30 1987-12-23 Int Minerals & Chem Corp Method for the stabilization of growth promoting hormones using polyoxyethylene-polyoxypropylene copolymers
IT1222395B (it) * 1987-07-30 1990-09-05 Pierrel Spa Composizione farmaceutica per somministrazione intranasale comprendente l'ormone ghrh,un agonista colinergico e/o un sale biliare
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US5096885A (en) * 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
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EP0374120A3 (en) * 1988-12-13 1991-07-31 Monsanto Company Comosition for controlled release of polypeptides
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US5182258A (en) * 1989-03-20 1993-01-26 Orbon Corporation Systemic delivery of polypeptides through the eye
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DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
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DK0955062T3 (da) * 1992-07-31 2007-09-17 Genentech Inc Vandig formulering indeholdende humant væksthormon
CA2124690C (en) * 1992-10-02 2007-09-11 Thomas Osterberg Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
AU685784B2 (en) * 1993-02-23 1998-01-29 Genentech Inc. Excipient stabilization of polypeptides treated with organic solvents
JPH09510182A (ja) * 1993-11-17 1997-10-14 エルディーエス・テクノロジーズ・インコーポレーテッド カプセル封入されたドラッグデリバリー用透明液

Also Published As

Publication number Publication date
DK0889733T3 (da) 2007-01-29
HK1017851A1 (en) 1999-12-03
CA2246501C (en) 2012-07-10
EP0889733B1 (en) 2006-09-27
DE69736739D1 (de) 2006-11-09
WO1997029767A1 (en) 1997-08-21
CN1132626C (zh) 2003-12-31
EP0889733A4 (en) 1999-11-03
JP2000504696A (ja) 2000-04-18
DE69736739T2 (de) 2007-08-16
RU2191029C2 (ru) 2002-10-20
AUPN801296A0 (en) 1996-03-07
JP4255515B2 (ja) 2009-04-15
US6593296B1 (en) 2003-07-15
CA2246501A1 (en) 1997-08-21
EP0889733A1 (en) 1999-01-13
CN1214633A (zh) 1999-04-21
ATE340587T1 (de) 2006-10-15

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