BR0013162A - Formulações de hormÈnio de crescimento - Google Patents
Formulações de hormÈnio de crescimentoInfo
- Publication number
- BR0013162A BR0013162A BR0013162-8A BR0013162A BR0013162A BR 0013162 A BR0013162 A BR 0013162A BR 0013162 A BR0013162 A BR 0013162A BR 0013162 A BR0013162 A BR 0013162A
- Authority
- BR
- Brazil
- Prior art keywords
- growth hormone
- formulations
- storage
- hormone formulations
- growth
- Prior art date
Links
- 239000000122 growth hormone Substances 0.000 title abstract 6
- 102000018997 Growth Hormone Human genes 0.000 title abstract 5
- 108010051696 Growth Hormone Proteins 0.000 title abstract 5
- 238000009472 formulation Methods 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 239000000654 additive Substances 0.000 abstract 1
- 238000004220 aggregation Methods 0.000 abstract 1
- 230000002776 aggregation Effects 0.000 abstract 1
- 230000001580 bacterial effect Effects 0.000 abstract 1
- 238000011109 contamination Methods 0.000 abstract 1
- 238000002425 crystallisation Methods 0.000 abstract 1
- 230000008025 crystallization Effects 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 239000008363 phosphate buffer Substances 0.000 abstract 1
- 239000003755 preservative agent Substances 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
- A61K47/26—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
- 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
- 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
- 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
-
- 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
- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Zoology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
"FORMULAçõES DE HORMÈNIO DE CRESCIMENTO". Formulações de hormónio de crescimento líquidas são estáveis em armazenamento por mais do que seis meses em temperaturas no limite de 2-8<198>C simplesmente formulando hormónios de crescimento em tampão de tosfato sem nenhum outro aditivo em torno de pH fisiológico. Assegurando um pH de aproximadamente 6,2 ou mais, cristalização de hormónio de crescimento durante armazenamento em temperaturas de refrigeração ou acima é inibida ou reduzida. Baixas concentrações de tensoativo não-iónico podem ajudar a reduzir agregação de hormónio de crescimento surgindo como um resultado de forças físicas encontradas durante transferência automatizada de formulação volumosa em recipientes de armazenamento. Manitol é incluído a fim de fornecer uma formulação isotónica. Conservantes são incluídos para reduzir contaminação bacterial e desse modo permitir unidades de dosagem múltiplas as quais podem ser armazenadas a 2-8<198>C.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB9916252.1A GB9916252D0 (en) | 1999-07-12 | 1999-07-12 | Growth hormone formulation |
| GBGB9918902.9A GB9918902D0 (en) | 1999-08-12 | 1999-08-12 | Growth hormone formulation |
| PCT/GB2000/002664 WO2001003741A1 (en) | 1999-07-12 | 2000-07-11 | Growth hormone formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR0013162A true BR0013162A (pt) | 2002-05-28 |
Family
ID=26315757
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR0013162-8A BR0013162A (pt) | 1999-07-12 | 2000-07-11 | Formulações de hormÈnio de crescimento |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US20060029635A1 (pt) |
| EP (1) | EP1194170B1 (pt) |
| JP (3) | JP2003504346A (pt) |
| KR (1) | KR20020031388A (pt) |
| CN (1) | CN1360506A (pt) |
| AR (1) | AR024728A1 (pt) |
| AT (1) | ATE386501T1 (pt) |
| AU (1) | AU775107C (pt) |
| BR (1) | BR0013162A (pt) |
| CA (1) | CA2378949C (pt) |
| CZ (1) | CZ200260A3 (pt) |
| DE (1) | DE60038118T2 (pt) |
| ES (1) | ES2300268T3 (pt) |
| HK (1) | HK1046358A1 (pt) |
| HU (1) | HUP0202189A3 (pt) |
| IL (2) | IL147253A0 (pt) |
| MX (1) | MXPA02000404A (pt) |
| NO (1) | NO20020151L (pt) |
| NZ (1) | NZ516507A (pt) |
| PL (1) | PL353238A1 (pt) |
| SI (1) | SI1194170T1 (pt) |
| SK (1) | SK252002A3 (pt) |
| TR (1) | TR200200034T2 (pt) |
| TW (1) | TWI247608B (pt) |
| WO (1) | WO2001003741A1 (pt) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030162711A1 (en) * | 1996-04-24 | 2003-08-28 | Soren Bjorn | Pharmaceutical formulation |
| US20070179096A1 (en) * | 1996-04-24 | 2007-08-02 | Novo Nordisk A/S | Pharmaceutical Formulation |
| GB2371227A (en) * | 2001-01-10 | 2002-07-24 | Grandis Biotech Gmbh | Crystallisation - resistant aqueous growth hormone formulations |
| AU2003249992A1 (en) * | 2002-07-09 | 2004-01-23 | Sandoz Ag | Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol |
| 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 |
| US8293532B2 (en) | 2009-03-26 | 2012-10-23 | Dow AgroSciences, L.L.C. | Method and apparatus for tissue transfer |
| RU2558821C2 (ru) * | 2009-11-17 | 2015-08-10 | Ипсен Фарма С.А.С. | ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1 |
| WO2013014196A1 (en) | 2011-07-25 | 2013-01-31 | Sandoz Ag | Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein |
| EP2659902A1 (en) * | 2012-04-30 | 2013-11-06 | Sun Pharmaceutical Industries Limited | Leuprolide injection |
| JP6001401B2 (ja) * | 2012-09-28 | 2016-10-05 | ユニ・チャーム株式会社 | ウェットティッシュ用薬液及びウェットティッシュ |
| CN107735429B (zh) | 2015-12-10 | 2021-05-07 | 三菱瓦斯化学株式会社 | 光固化性组合物和光学材料 |
| WO2018142514A1 (ja) * | 2017-02-01 | 2018-08-09 | 協和発酵キリン株式会社 | ダルベポエチンを含む液体医薬組成物 |
| CN112566652A (zh) * | 2018-06-25 | 2021-03-26 | Jcr制药股份有限公司 | 含有蛋白的水性液体制剂 |
| EP4243770A1 (en) * | 2020-11-16 | 2023-09-20 | W. L. Gore & Associates, Inc. | Formulations, methods, and pre-filled multi-dose injection devices without cloud point |
| 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 (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4783441A (en) * | 1979-04-30 | 1988-11-08 | Hoechst Aktiengesellschaft | Aqueous protein solutions stable to denaturation |
| 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 |
| US4857505A (en) * | 1987-03-09 | 1989-08-15 | American Cyanamid Company | Sustained release compositions for parenteral administration and their use |
| IL86799A (en) * | 1987-07-02 | 1993-03-15 | Kabi Pharmacia Ab | Method and device for injection |
| US5151265A (en) * | 1987-11-03 | 1992-09-29 | Genentech, Inc. | Gamma interferon formulation |
| CA1331133C (en) * | 1988-03-01 | 1994-08-02 | Michael Jon Pikal | Pharmaceutical growth hormone formulations |
| US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| US5763394A (en) * | 1988-04-15 | 1998-06-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| JPH0383931A (ja) * | 1989-08-29 | 1991-04-09 | Sumitomo Pharmaceut Co Ltd | 低刺激性grf経鼻投与製剤 |
| US5681814A (en) * | 1990-06-07 | 1997-10-28 | Genentech, Inc. | Formulated IGF-I Composition |
| US5126324A (en) * | 1990-06-07 | 1992-06-30 | Genentech, Inc. | Method of enhancing growth in patients using combination therapy |
| RU2068273C1 (ru) * | 1990-09-21 | 1996-10-27 | Ново Нордиск А/С | Переходная головка |
| 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 |
| US5334162A (en) * | 1993-03-15 | 1994-08-02 | Eli Lilly And Company | Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same |
| US5496801A (en) * | 1993-12-23 | 1996-03-05 | Allelix Biopharmaceuticals Inc. | Parathyroid hormone formulation |
| US5610134A (en) * | 1994-04-15 | 1997-03-11 | Genentech, Inc. | Treatment of congestive heart failure |
| JPH0892125A (ja) * | 1994-09-21 | 1996-04-09 | Nippon Chem Res Kk | 水性医薬組成物 |
| SE9502927D0 (sv) * | 1995-08-24 | 1995-08-24 | Pharmacia Ab | Solution containing IGF-I |
| AUPN801296A0 (en) * | 1996-02-12 | 1996-03-07 | Csl Limited | Stabilised growth hormone formulation and method of preparation thereof |
| WO1997029776A1 (en) * | 1996-02-13 | 1997-08-21 | G.D. Searle & Co. | Combinations having immunosuppressive effects, containing cyclooxygenase-2-inhibitors and 5-lipoxygenase inhibitors |
| ZA9711731B (en) * | 1996-12-31 | 1998-07-01 | Monsanto Co | Aqueous glycerol formulations of somatotropin |
| TW518235B (en) * | 1997-01-15 | 2003-01-21 | Akzo Nobel Nv | A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage |
| 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 |
-
2000
- 2000-07-11 CN CN00810174A patent/CN1360506A/zh active Pending
- 2000-07-11 TR TR2002/00034T patent/TR200200034T2/xx unknown
- 2000-07-11 SI SI200030992T patent/SI1194170T1/sl unknown
- 2000-07-11 CA CA2378949A patent/CA2378949C/en not_active Expired - Lifetime
- 2000-07-11 WO PCT/GB2000/002664 patent/WO2001003741A1/en not_active Ceased
- 2000-07-11 IL IL14725300A patent/IL147253A0/xx not_active IP Right Cessation
- 2000-07-11 KR KR1020027000416A patent/KR20020031388A/ko not_active Ceased
- 2000-07-11 NZ NZ516507A patent/NZ516507A/xx unknown
- 2000-07-11 ES ES00946088T patent/ES2300268T3/es not_active Expired - Lifetime
- 2000-07-11 SK SK25-2002A patent/SK252002A3/sk unknown
- 2000-07-11 MX MXPA02000404A patent/MXPA02000404A/es active IP Right Grant
- 2000-07-11 JP JP2001509214A patent/JP2003504346A/ja active Pending
- 2000-07-11 AT AT00946088T patent/ATE386501T1/de active
- 2000-07-11 PL PL00353238A patent/PL353238A1/xx not_active Application Discontinuation
- 2000-07-11 DE DE60038118T patent/DE60038118T2/de not_active Expired - Lifetime
- 2000-07-11 EP EP00946088A patent/EP1194170B1/en not_active Expired - Lifetime
- 2000-07-11 HU HU0202189A patent/HUP0202189A3/hu unknown
- 2000-07-11 AU AU59975/00A patent/AU775107C/en not_active Expired
- 2000-07-11 CZ CZ200260A patent/CZ200260A3/cs unknown
- 2000-07-11 BR BR0013162-8A patent/BR0013162A/pt not_active IP Right Cessation
- 2000-07-11 HK HK02106653.3A patent/HK1046358A1/zh unknown
- 2000-07-13 AR ARP000103593A patent/AR024728A1/es unknown
- 2000-08-24 TW TW089117050A patent/TWI247608B/zh not_active IP Right Cessation
-
2001
- 2001-12-24 IL IL147253A patent/IL147253A/en unknown
-
2002
- 2002-01-11 NO NO20020151A patent/NO20020151L/no not_active Application Discontinuation
-
2005
- 2005-10-03 US US11/242,499 patent/US20060029635A1/en not_active Abandoned
-
2011
- 2011-09-26 JP JP2011208852A patent/JP2012051891A/ja active Pending
-
2014
- 2014-06-02 JP JP2014113773A patent/JP5941496B2/ja not_active Expired - Lifetime
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: CONFORME ARTIGO 10O DA RESOLUCAO 124/06, CABE SER ARQUIVADO REFERENTE AO NAO RECOLHIMENTO DA 9A, 10A E 11A ANUIDADES. |
|
| B08K | Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette] |
Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2138 DE 27/12/2011. |