ATE554792T1 - Stabiles wachstumshormon-flüssigformulierung - Google Patents
Stabiles wachstumshormon-flüssigformulierungInfo
- Publication number
- ATE554792T1 ATE554792T1 AT04801396T AT04801396T ATE554792T1 AT E554792 T1 ATE554792 T1 AT E554792T1 AT 04801396 T AT04801396 T AT 04801396T AT 04801396 T AT04801396 T AT 04801396T AT E554792 T1 ATE554792 T1 AT E554792T1
- Authority
- AT
- Austria
- Prior art keywords
- growth hormone
- present
- formulations
- liquid formulation
- stable growth
- Prior art date
Links
- 102000018997 Growth Hormone Human genes 0.000 title abstract 3
- 108010051696 Growth Hormone Proteins 0.000 title abstract 3
- 239000000122 growth hormone Substances 0.000 title abstract 3
- 239000012669 liquid formulation Substances 0.000 title 1
- 239000003381 stabilizer Substances 0.000 abstract 3
- 238000009472 formulation Methods 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 102000002265 Human Growth Hormone Human genes 0.000 abstract 1
- 108010000521 Human Growth Hormone Proteins 0.000 abstract 1
- 239000000854 Human Growth Hormone Substances 0.000 abstract 1
- 239000002202 Polyethylene glycol Substances 0.000 abstract 1
- 229920001213 Polysorbate 20 Polymers 0.000 abstract 1
- 238000013019 agitation Methods 0.000 abstract 1
- 239000013011 aqueous formulation Substances 0.000 abstract 1
- 239000006172 buffering agent Substances 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 230000007774 longterm Effects 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 229920001223 polyethylene glycol Polymers 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 abstract 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 abstract 1
- 229940068977 polysorbate 20 Drugs 0.000 abstract 1
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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
-
- 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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Physical Education & Sports Medicine (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US53184303P | 2003-12-23 | 2003-12-23 | |
| PCT/IB2004/004159 WO2005063298A1 (en) | 2003-12-23 | 2004-12-13 | Stable growth hormone liquid formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ATE554792T1 true ATE554792T1 (de) | 2012-05-15 |
Family
ID=34738712
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AT04801396T ATE554792T1 (de) | 2003-12-23 | 2004-12-13 | Stabiles wachstumshormon-flüssigformulierung |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US8338374B2 (de) |
| EP (1) | EP1706150B1 (de) |
| JP (1) | JP4845741B2 (de) |
| AT (1) | ATE554792T1 (de) |
| BR (1) | BRPI0418115A (de) |
| CA (1) | CA2551510C (de) |
| ES (1) | ES2383691T3 (de) |
| WO (1) | WO2005063298A1 (de) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2107069T3 (pl) | 2003-08-05 | 2013-06-28 | Novo Nordisk As | Nowe pochodne insuliny |
| DK1969004T3 (da) | 2005-12-28 | 2011-11-28 | Novo Nordisk As | Insulinsammensætninger og metode til at lave en sammensætning |
| TW200806317A (en) * | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| LT2049148T (lt) * | 2006-07-06 | 2016-11-25 | Daewoong Co., Ltd. | Žmogaus augimo hormono skysta stabili kompozicija |
| CN101677947B (zh) | 2007-06-13 | 2013-07-17 | 诺沃-诺迪斯克有限公司 | 包含胰岛素衍生物的药物制剂 |
| MX2009013886A (es) | 2007-06-25 | 2010-01-27 | Amgen Inc | Composiciones de agentes de aglutinacion especifica al factor de crecimiento de los hepatocitos. |
| US9603904B2 (en) | 2008-10-30 | 2017-03-28 | Novo Nordisk A/S | Treating diabetes melitus using insulin injections with less than daily injection frequency |
| WO2011104557A1 (en) * | 2010-02-24 | 2011-09-01 | Arecor Limited | Protein formulations |
| KR101337797B1 (ko) * | 2010-07-14 | 2013-12-06 | 한미사이언스 주식회사 | 지속형 인간 성장 호르몬 결합체 액상 제제 |
| BR112013010345A2 (pt) | 2010-10-27 | 2017-07-25 | Novo Nordisk As | tratamento de diabetes melitus usando as injeções de insulina administradas com intervalos de variação da injeção |
| EP2736490A1 (de) * | 2011-07-25 | 2014-06-04 | Sandoz AG | Wässrige formulierung mit mindestens einem neutralen salz und einem biopharmazeutischen 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 |
| BR112015022587A2 (pt) * | 2013-03-13 | 2017-10-24 | Eleven Biotherapeutics Inc | formulações de citocina quimérica para entrega ocular |
| WO2014177623A1 (en) | 2013-04-30 | 2014-11-06 | Novo Nordisk A/S | Novel administration regime |
| MX2016003705A (es) | 2013-09-27 | 2016-05-16 | Hanmi Pharm Ind Co Ltd | Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada. |
| WO2016011281A1 (en) * | 2014-07-17 | 2016-01-21 | Teva Pharmaceutical Industries Ltd. | FORMULATIONS OF AN ALBUMIN-hGH FUSION PROTEIN |
| US10335464B1 (en) | 2018-06-26 | 2019-07-02 | Novo Nordisk A/S | Device for titrating basal insulin |
| EP3996679B1 (de) | 2019-07-12 | 2023-09-06 | Novo Nordisk A/S | Insulinformulierung mit hoher konzentration |
| 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 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5981485A (en) | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| US5763394A (en) | 1988-04-15 | 1998-06-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| US5272135A (en) | 1991-03-01 | 1993-12-21 | Chiron Ophthalmics, Inc. | Method for the stabilization of methionine-containing polypeptides |
| US5206219A (en) | 1991-11-25 | 1993-04-27 | Applied Analytical Industries, Inc. | Oral compositions of proteinaceous medicaments |
| SE9201073D0 (sv) | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| ES2286868T3 (es) | 1992-07-31 | 2007-12-01 | Genentech, Inc. | Composicion acuosa a base de hormana del crecimiento humana. |
| US5358708A (en) * | 1993-01-29 | 1994-10-25 | Schering Corporation | Stabilization of protein formulations |
| SE9503679D0 (sv) | 1995-10-20 | 1995-10-20 | Pharmacia Ab | Antioxidants |
| 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 |
| US20030162711A1 (en) * | 1996-04-24 | 2003-08-28 | Soren Bjorn | Pharmaceutical formulation |
| ES2181281T5 (es) * | 1997-09-23 | 2008-04-16 | Rentschler Biotechnologie Gmbh | Formulaciones liquidas de interferon beta. |
| JP2003504346A (ja) * | 1999-07-12 | 2003-02-04 | グランデイス・バイオテツク・ゲー・エム・ベー・ハー | 成長ホルモン製剤 |
| HUP0203133A3 (en) * | 1999-10-04 | 2005-07-28 | Chiron Corp Emeryville | Stabilized liquid polypeptide-containing pharmaceutical compositions |
| KR100416242B1 (ko) * | 1999-12-22 | 2004-01-31 | 주식회사 삼양사 | 약물전달체용 생분해성 블록 공중합체의 액체 조성물 및이의 제조방법 |
| EP1930024A3 (de) | 2000-09-01 | 2008-08-06 | Chugai Seiyaku Kabushiki Kaisha | G-CSF Lösungsformulierung mit Langzeitstabilität |
-
2004
- 2004-12-13 BR BRPI0418115-8A patent/BRPI0418115A/pt not_active IP Right Cessation
- 2004-12-13 WO PCT/IB2004/004159 patent/WO2005063298A1/en not_active Ceased
- 2004-12-13 US US10/583,923 patent/US8338374B2/en not_active Expired - Lifetime
- 2004-12-13 ES ES04801396T patent/ES2383691T3/es not_active Expired - Lifetime
- 2004-12-13 JP JP2006546366A patent/JP4845741B2/ja not_active Expired - Lifetime
- 2004-12-13 EP EP04801396A patent/EP1706150B1/de not_active Expired - Lifetime
- 2004-12-13 AT AT04801396T patent/ATE554792T1/de active
- 2004-12-13 CA CA2551510A patent/CA2551510C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CA2551510C (en) | 2013-07-30 |
| CA2551510A1 (en) | 2005-07-14 |
| EP1706150A1 (de) | 2006-10-04 |
| US8338374B2 (en) | 2012-12-25 |
| EP1706150B1 (de) | 2012-04-25 |
| JP4845741B2 (ja) | 2011-12-28 |
| BRPI0418115A (pt) | 2007-04-17 |
| US20080125356A1 (en) | 2008-05-29 |
| WO2005063298A1 (en) | 2005-07-14 |
| ES2383691T3 (es) | 2012-06-25 |
| JP2007516274A (ja) | 2007-06-21 |
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