DK0889733T3 - Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf - Google Patents

Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf

Info

Publication number: DK0889733T3
Authority: DK; Denmark
Prior art keywords: growth hormone; buffer; stabilizing agent; preparation; formulation
Prior art date: 1996-02-12

Application number

DK97902109T

Other languages

English (en)

Inventor

Michael Kevin Mcnamara

William Neil Charman

Susan Ann Charman

Original Assignee

Csl Ltd

Univ Monash

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.)

1996-02-12

Filing date

1997-02-12

Publication date

2007-01-29

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=3792327&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK0889733(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

1997-02-12 Application filed by Csl Ltd, Univ Monash filed Critical Csl Ltd

2007-01-29 Application granted granted Critical

2007-01-29 Publication of DK0889733T3 publication Critical patent/DK0889733T3/da

Links

102000018997 Growth Hormone Human genes 0.000 title abstract 5
108010051696 Growth Hormone Proteins 0.000 title abstract 5
239000000122 growth hormone Substances 0.000 title abstract 5
238000000034 method Methods 0.000 title abstract 3
238000009472 formulation Methods 0.000 title abstract 2
239000000203 mixture Substances 0.000 title abstract 2
239000003381 stabilizer Substances 0.000 abstract 4
239000000872 buffer Substances 0.000 abstract 2
239000006172 buffering agent Substances 0.000 abstract 2
WBWWGRHZICKQGZ-UHFFFAOYSA-N Taurocholic acid Natural products OC1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(=O)NCCS(O)(=O)=O)C)C1(C)C(O)C2 WBWWGRHZICKQGZ-UHFFFAOYSA-N 0.000 abstract 1
239000012669 liquid formulation Substances 0.000 abstract 1
239000002736 nonionic surfactant Substances 0.000 abstract 1
229920001451 polypropylene glycol Polymers 0.000 abstract 1
150000003839 salts Chemical class 0.000 abstract 1
230000000087 stabilizing effect Effects 0.000 abstract 1
WBWWGRHZICKQGZ-GIHLXUJPSA-N taurocholic acid Chemical compound C([C@@H]1C[C@H]2O)[C@@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@@H]([C@@H](CCC(=O)NCCS(O)(=O)=O)C)[C@@]2(C)[C@H](O)C1 WBWWGRHZICKQGZ-GIHLXUJPSA-N 0.000 abstract 1

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)
Bioinformatics & Cheminformatics (AREA)
Oil, Petroleum & Natural Gas (AREA)
Immunology (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Zoology (AREA)
Gastroenterology & Hepatology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Inorganic Chemistry (AREA)
Dermatology (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)

DK97902109T 1996-02-12 1997-02-12 Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf DK0889733T3 (da)

Applications Claiming Priority (2)

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
PCT/AU1997/000075 WO1997029767A1 (en)	1996-02-12	1997-02-12	Stabilised growth hormone formulation and method of preparation thereof

Publications (1)

Publication Number	Publication Date
DK0889733T3 true DK0889733T3 (da)	2007-01-29

Family

ID=3792327

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
DK97902109T DK0889733T3 (da)	1996-02-12	1997-02-12	Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf

Country Status (13)

Country	Link
US (1)	US6593296B1 (da)
EP (1)	EP0889733B1 (da)
JP (1)	JP4255515B2 (da)
CN (1)	CN1132626C (da)
AT (1)	ATE340587T1 (da)
AU (1)	AUPN801296A0 (da)
CA (1)	CA2246501C (da)
DE (1)	DE69736739T2 (da)
DK (1)	DK0889733T3 (da)
HK (1)	HK1017851A1 (da)
RU (1)	RU2191029C2 (da)
TR (1)	TR199801558T2 (da)
WO (1)	WO1997029767A1 (da)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US6277410B1 (en) *	1992-10-08	2001-08-21	Supratek Pharma Inc.	Copolymer compositions for oral delivery
MXPA02000404A (es) *	1999-07-12	2004-05-21	Grandis Biotech Gmbh	Formulaciones de hormona de crecimiento.
AT408721B (de) *	1999-10-01	2002-02-25	Cistem Biotechnologies Gmbh	Pharmazeutische zusammensetzung enthaltend ein antigen
KR20090007504A (ko)	2000-02-24	2009-01-16	몬산토 테크놀로지 엘엘씨	소마토트로핀의 지속적인 방출을 위한 비수성 주사제제들
WO2002000261A2 (en) *	2000-06-26	2002-01-03	Monsanto Technology Llc	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
ZA200505305B (en) *	2002-12-31	2007-07-25	Altus Pharmaceuticals Inc	Human growth hormone crystals and methods for preparing them
EP1603588A2 (en) *	2003-03-18	2005-12-14	Ares Trading S.A.	Stabilisation of growth hormones in solution
CA2540172A1 (en) *	2003-09-25	2005-03-31	Cangene Corporation	Liquid human growth hormone formulation containing polyethylene glycol
CA2551510C (en)	2003-12-23	2013-07-30	Pharmacia Corporation	Stable growth hormone liquid formulation
AU2005237775B2 (en)	2004-04-07	2010-03-04	Ares Trading S.A.	Liquid growth hormone formulation
CN101087805B (zh)	2004-11-09	2012-05-23	阿雷斯贸易股份有限公司	Fsh的纯化方法
US20080219952A1 (en)	2005-08-26	2008-09-11	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
CN101505789A (zh) *	2006-07-06	2009-08-12	株式会社大熊	稳定的人生长激素液体制剂
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
US10391062B2 (en)	2008-04-21	2019-08-27	Novo Nordisk Healthcare Ag	Dry transglutaminase composition
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
TW201605468A (zh) *	2013-09-27	2016-02-16	韓美藥品股份有限公司	長效人類生長激素接合物之製劑

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
GB131864A (da)
DE3325223A1 (de) *	1983-07-13	1985-01-24	Hoechst Ag, 6230 Frankfurt	Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung
BR8603586A (pt) *	1985-07-30	1987-03-10	Int Minerals & Chem Corp	Processo para manter a fluidez de um homonio;processo para efetuar a promocao de crescimento em animais e formulacao promotora de crescimento
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
DE3782737T3 (de)	1987-08-21	1999-05-20	Imcera Group Inc	Stabilisierung von Wachstumshormonen.
US5096885A (en) *	1988-04-15	1992-03-17	Genentech, Inc.	Human growth hormone formulation
GB8822857D0 (en)	1988-09-29	1988-11-02	Patralan Ltd	Pharmaceutical formulations
EP0374120A3 (en) *	1988-12-13	1991-07-31	Monsanto Company	Comosition for controlled release of polypeptides
US5013714A (en) *	1988-12-15	1991-05-07	Lindstrom Richard L	Viscoelastic solution
US4994439A (en) *	1989-01-19	1991-02-19	California Biotechnology Inc.	Transmembrane formulations for drug administration
US5182258A (en) *	1989-03-20	1993-01-26	Orbon Corporation	Systemic delivery of polypeptides through the eye
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
SE9201073D0 (sv)	1992-04-03	1992-04-03	Kabi Pharmacia Ab	Protein formulation
AU686567C (en) *	1992-07-31	2002-08-08	Genentech Inc.	Human growth hormone aqueous formulation
KR100303872B1 (ko) *	1992-10-02	2001-11-22	크리스터 발스트룀, 프레드릭 베르그, 하랄트 알름	응고인자ⅷ제형을포함하는조성물,이것의제조방법및안정화제로서의계면활성제의사용방법
NZ262634A (en) *	1993-02-23	1997-02-24	Genentech Inc	Stabilizing polypeptides against degradation by organic solvents by admixing the peptide with trehalose or mannitol
US5707648A (en) *	1993-11-17	1998-01-13	Lds Technologies, Inc.	Transparent liquid for encapsulated drug delivery

1996
- 1996-02-12 AU AUPN8012A patent/AUPN801296A0/en not_active Abandoned
1997
- 1997-02-12 DE DE69736739T patent/DE69736739T2/de not_active Expired - Lifetime
- 1997-02-12 AT AT97902109T patent/ATE340587T1/de active
- 1997-02-12 CA CA2246501A patent/CA2246501C/en not_active Expired - Fee Related
- 1997-02-12 US US09/125,267 patent/US6593296B1/en not_active Expired - Fee Related
- 1997-02-12 DK DK97902109T patent/DK0889733T3/da active
- 1997-02-12 RU RU98117135/14A patent/RU2191029C2/ru active
- 1997-02-12 TR TR1998/01558T patent/TR199801558T2/xx unknown
- 1997-02-12 JP JP52882197A patent/JP4255515B2/ja not_active Expired - Lifetime
- 1997-02-12 EP EP97902109A patent/EP0889733B1/en not_active Revoked
- 1997-02-12 WO PCT/AU1997/000075 patent/WO1997029767A1/en active IP Right Grant
- 1997-02-12 CN CN97193316A patent/CN1132626C/zh not_active Expired - Fee Related
1999
- 1999-07-09 HK HK99102933A patent/HK1017851A1/xx not_active IP Right Cessation

Also Published As

Publication number	Publication date
EP0889733B1 (en)	2006-09-27
US6593296B1 (en)	2003-07-15
ATE340587T1 (de)	2006-10-15
EP0889733A1 (en)	1999-01-13
DE69736739D1 (de)	2006-11-09
CN1214633A (zh)	1999-04-21
AUPN801296A0 (en)	1996-03-07
DE69736739T2 (de)	2007-08-16
CN1132626C (zh)	2003-12-31
EP0889733A4 (en)	1999-11-03
CA2246501A1 (en)	1997-08-21
CA2246501C (en)	2012-07-10
TR199801558T2 (xx)	1998-11-23
WO1997029767A1 (en)	1997-08-21
HK1017851A1 (en)	1999-12-03
JP2000504696A (ja)	2000-04-18
RU2191029C2 (ru)	2002-10-20
JP4255515B2 (ja)	2009-04-15

Publication	Publication Date	Title
DK0889733T3 (da)	2007-01-29	Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf
BR9307700A (pt)	1999-08-31	Formulação para estabilizar uma composição enzimática lìquida, composição enzimática lìquida estabilizada, método para a preparação de uma composição enzimática lìquida estabilizada e método para estabilizar uma composição enzimática lìquida
ES2196474T3 (es)	2003-12-16	Formulaciones liquidas que contienen una gonadotropina.
ATE196092T1 (de)	2000-09-15	Wachstumshormon-enthaltendeproteinformulierung
NO305281B1 (no)	1999-05-03	FremgangsmÕte for Õ lagringsstabilisere pereddiksyrel°sninger, samt stabiliserte pereddiksyrel°sninger
JPS6440433A (en)	1989-02-10	Aqueous liquid composition of thrombin
GB2199328B (en)	1990-10-24	Use of a 5' untranslated leader sequence of an rna virus to enhance translation
ATE259656T1 (de)	2004-03-15	Immunoglobulin enthaltende zusammensetzung
RU98117135A (ru)	2000-06-27	Композиция стабилизированного гормона роста и способ ее приготовления
AR040527A1 (es)	2005-04-13	Formulaciones de hgh en alta concentracion que contienen glicina
OIKAWA et al.	1957	The role of calcium in Taka-amylase A
GB9928820D0 (en)	2000-02-02	Stable high glycerol liquids comprising sulfosuccinic acid monoesters
ATE340798T1 (de)	2006-10-15	Stabile, flüssige konzentrierte seltenerd- carboxylate
US4289764A (en)	1981-09-15	Steroid compositions
CA2463681A1 (en)	2003-04-24	Ready-to-use paracetamol injection solutions containing propylene glycol as the only cosolvent
IE49086B1 (en)	1985-07-24	Stable erythromycin solution and process therefor
JPS5677209A (en)	1981-06-25	Iodophor composition
ATE94400T1 (de)	1993-10-15	Strahlungssterilisierbare antimikrobielle salbe sowie verfahren zu deren herstellung.
JPH02105898A (ja)	1990-04-18	糖質分解酵素の安定化法
EP0653212A4 (en)	1997-08-20	ANTITHROMBIN III COMPOSITION IN LIQUID FORM AND METHOD FOR STABILIZING IT.
SE9302006D0 (sv)	1993-06-11	Protein formulation
ES8605755A1 (es)	1986-04-01	Procedimiento para la preparacion de una composicion fungi- cida para el tratamiento de infecciones producidas por hon- gos en plantas cultivadas