DK0889733T3 - Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling deraf - Google Patents
Stabiliseret væksthormonformulering og fremgangsmåde til fremstilling derafInfo
- Publication number
- DK0889733T3 DK0889733T3 DK97902109T DK97902109T DK0889733T3 DK 0889733 T3 DK0889733 T3 DK 0889733T3 DK 97902109 T DK97902109 T DK 97902109T DK 97902109 T DK97902109 T DK 97902109T DK 0889733 T3 DK0889733 T3 DK 0889733T3
- Authority
- DK
- Denmark
- Prior art keywords
- growth hormone
- buffer
- stabilizing agent
- preparation
- formulation
- Prior art date
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)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Immunology (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)
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 (12)
| Country | Link |
|---|---|
| US (1) | US6593296B1 (enExample) |
| EP (1) | EP0889733B1 (enExample) |
| JP (1) | JP4255515B2 (enExample) |
| CN (1) | CN1132626C (enExample) |
| AT (1) | ATE340587T1 (enExample) |
| AU (1) | AUPN801296A0 (enExample) |
| CA (1) | CA2246501C (enExample) |
| DE (1) | DE69736739T2 (enExample) |
| DK (1) | DK0889733T3 (enExample) |
| RU (1) | RU2191029C2 (enExample) |
| TR (1) | TR199801558T2 (enExample) |
| WO (1) | WO1997029767A1 (enExample) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| WO2001062296A2 (en) | 2000-02-24 | 2001-08-30 | Monsanto Technology Llc | Non-aqueous injectable formulations for extended release of somatotropin |
| MXPA03000073A (es) | 2000-06-26 | 2003-09-25 | Monsanto Technology Llc | Formulaciones que contienen agente tensioactivo no acuoso para la liberacion prolongada de somatrotopina. |
| 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 |
| CN101659701B (zh) * | 2002-12-31 | 2019-03-26 | 阿尔特斯制药公司 | 人生长激素晶体和制备它们的方法 |
| US20060252682A1 (en) * | 2003-03-18 | 2006-11-09 | Ares Trading S.A. | Liquid growth hormone formulation and process of preparation thereof |
| WO2005027960A1 (en) * | 2003-09-25 | 2005-03-31 | Cangene Corporation | Liquid human growth hormone formulation containing polyethylene glycol |
| 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 |
| ES2383994T3 (es) * | 2004-04-07 | 2012-06-28 | Ares Trading S.A. | Formulación líquida de hormona del crecimiento |
| EP1809663B1 (en) | 2004-11-09 | 2008-09-17 | Ares Trading S.A. | Method for purifying fsh |
| US20080219952A1 (en) | 2005-08-26 | 2008-09-11 | Ares Trading S.A. | Process For the Preparation of Glycosylated Interferon Beta |
| JP5199112B2 (ja) | 2005-12-09 | 2013-05-15 | アレス トレーディング ソシエテ アノニム | Ｆｓｈ又はｆｓｈ変異体を精製するための方法 |
| LT2049148T (lt) * | 2006-07-06 | 2016-11-25 | Daewoong Co., Ltd. | Žmogaus augimo hormono skysta stabili kompozicija |
| CN105412910A (zh) * | 2006-07-06 | 2016-03-23 | 株式会社大熊 | 稳定的人生长激素液体制剂 |
| WO2009130181A2 (en) * | 2008-04-21 | 2009-10-29 | Novo Nordisk Health Care Ag | Dry transglutaminase composition |
| 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 |
| CN105848645A (zh) * | 2013-09-27 | 2016-08-10 | 韩美药品株式会社 | 持续型人生长激素制剂 |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB131864A (enExample) | ||||
| DE3325223A1 (de) * | 1983-07-13 | 1985-01-24 | Hoechst Ag, 6230 Frankfurt | Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung |
| EP0211601A3 (en) | 1985-07-30 | 1988-01-13 | International Minerals And Chemical Corporation | Stabilization of growth promoting hormones |
| 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 |
| EP0303746B2 (en) | 1987-08-21 | 1998-12-02 | Mallinckrodt Group Inc. | Stabilization of growth promoting hormones |
| 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 |
| DK204791D0 (da) * | 1991-12-20 | 1991-12-20 | Novo Nordisk As | Hidtil ukendt farmaceutisk praeparat |
| SE9201073D0 (sv) | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| DK0955062T3 (da) * | 1992-07-31 | 2007-09-17 | Genentech Inc | Vandig formulering indeholdende humant væksthormon |
| ATE198277T1 (de) * | 1992-10-02 | 2001-01-15 | Genetics Inst | Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator |
| DK0686045T3 (da) * | 1993-02-23 | 2001-03-05 | Genentech Inc | Stabilisering af med organisk opløsningsmiddel behandlede polypeptider med et hjælpestof |
| 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 |
-
1996
- 1996-02-12 AU AUPN8012A patent/AUPN801296A0/en not_active Abandoned
-
1997
- 1997-02-12 EP EP97902109A patent/EP0889733B1/en not_active Revoked
- 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 WO PCT/AU1997/000075 patent/WO1997029767A1/en not_active Ceased
- 1997-02-12 RU RU98117135/14A patent/RU2191029C2/ru active
- 1997-02-12 CA CA2246501A patent/CA2246501C/en not_active Expired - Fee Related
- 1997-02-12 CN CN97193316A patent/CN1132626C/zh not_active Expired - Fee Related
- 1997-02-12 DK DK97902109T patent/DK0889733T3/da active
- 1997-02-12 AT AT97902109T patent/ATE340587T1/de active
- 1997-02-12 US US09/125,267 patent/US6593296B1/en not_active Expired - Fee Related
- 1997-02-12 DE DE69736739T patent/DE69736739T2/de not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| TR199801558T2 (xx) | 1998-11-23 |
| JP2000504696A (ja) | 2000-04-18 |
| HK1017851A1 (en) | 1999-12-03 |
| JP4255515B2 (ja) | 2009-04-15 |
| EP0889733B1 (en) | 2006-09-27 |
| CN1214633A (zh) | 1999-04-21 |
| CA2246501C (en) | 2012-07-10 |
| EP0889733A1 (en) | 1999-01-13 |
| CA2246501A1 (en) | 1997-08-21 |
| AUPN801296A0 (en) | 1996-03-07 |
| WO1997029767A1 (en) | 1997-08-21 |
| ATE340587T1 (de) | 2006-10-15 |
| EP0889733A4 (en) | 1999-11-03 |
| DE69736739T2 (de) | 2007-08-16 |
| US6593296B1 (en) | 2003-07-15 |
| RU2191029C2 (ru) | 2002-10-20 |
| DE69736739D1 (de) | 2006-11-09 |
| CN1132626C (zh) | 2003-12-31 |
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