TR200200034T2 - Büyüme hormonu formülasyonları. - Google Patents
Büyüme hormonu formülasyonları.Info
- Publication number
- TR200200034T2 TR200200034T2 TR2002/00034T TR200200034T TR200200034T2 TR 200200034 T2 TR200200034 T2 TR 200200034T2 TR 2002/00034 T TR2002/00034 T TR 2002/00034T TR 200200034 T TR200200034 T TR 200200034T TR 200200034 T2 TR200200034 T2 TR 200200034T2
- Authority
- TR
- Turkey
- Prior art keywords
- growth hormone
- temperatures
- aggregation
- level
- formulations
- Prior art date
Links
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)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (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)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Büyüme hormonlarinin baska katki maddeleri olmaksizin sadece yaklasik fizyolojik pH seviyesindeki fosfat tamponu içerisinde formüle edilmesiyle, likit büyüme hormonu formülasyonlarinin 2-8 C araligindaki sicakliklarda 6 aydan daha uzun süreler sabit olarak saklanabilmesi mümkün olur. pH seviyesinin 6.2 ya da daha üzerinde temin edilmesiyle, buzdolabi sicakliklari ya da üzerindeki sicakliklarda saklama esnasinda büyüme hormonu kristallesmesi engellenir ya da azaltilir. Iyonik harici sürfaktana ait düsük konsantrasyonlarin kullanilmasi, dökme formülasyonun dozaj haznelerine otomatize olarak nakledilmesi esnasinda karsilasilan fiziksel kuvvetlerin bir sonucu olarak büyüme hormonu kümelenmesini (agregasyon) azaltmaya yardimci olabilir. Izotonik formülasyonlarin saglanmasi amaciyla mannitol dahil edilir. Bakteri kirlenmesini azaltmak ve böylece 2-8 C sicakliklarda saklanmasi mümkün çoklu dozaj birimlerine olanak vermek amaciyla koruma maddeleri (prezervatifler) dahi edilir.
Applications Claiming Priority (2)
| 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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| TR200200034T2 true TR200200034T2 (tr) | 2002-05-21 |
Family
ID=26315757
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TR2002/00034T TR200200034T2 (tr) | 1999-07-12 | 2000-07-11 | Büyüme hormonu formülasyonları. |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US20060029635A1 (tr) |
| EP (1) | EP1194170B1 (tr) |
| JP (3) | JP2003504346A (tr) |
| KR (1) | KR20020031388A (tr) |
| CN (1) | CN1360506A (tr) |
| AR (1) | AR024728A1 (tr) |
| AT (1) | ATE386501T1 (tr) |
| AU (1) | AU775107C (tr) |
| BR (1) | BR0013162A (tr) |
| CA (1) | CA2378949C (tr) |
| CZ (1) | CZ200260A3 (tr) |
| DE (1) | DE60038118T2 (tr) |
| ES (1) | ES2300268T3 (tr) |
| HK (1) | HK1046358A1 (tr) |
| HU (1) | HUP0202189A3 (tr) |
| IL (2) | IL147253A0 (tr) |
| MX (1) | MXPA02000404A (tr) |
| NO (1) | NO20020151L (tr) |
| NZ (1) | NZ516507A (tr) |
| PL (1) | PL353238A1 (tr) |
| SI (1) | SI1194170T1 (tr) |
| SK (1) | SK252002A3 (tr) |
| TR (1) | TR200200034T2 (tr) |
| TW (1) | TWI247608B (tr) |
| WO (1) | WO2001003741A1 (tr) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070179096A1 (en) * | 1996-04-24 | 2007-08-02 | Novo Nordisk A/S | Pharmaceutical Formulation |
| US20030162711A1 (en) * | 1996-04-24 | 2003-08-28 | Soren Bjorn | Pharmaceutical formulation |
| GB2371227A (en) * | 2001-01-10 | 2002-07-24 | Grandis Biotech Gmbh | Crystallisation - resistant aqueous growth hormone formulations |
| EP1536835A1 (en) * | 2002-07-09 | 2005-06-08 | Sandoz AG | Liquid formulations with high concentration of human growth hormone (hgh) comprising phenol |
| 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 |
| US8293532B2 (en) | 2009-03-26 | 2012-10-23 | Dow AgroSciences, L.L.C. | Method and apparatus for tissue transfer |
| EP2501367B1 (en) * | 2009-11-17 | 2015-01-21 | Ipsen Pharma S.A.S. | Formulation for HGH and RHIGF-1 combination |
| 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 |
| US20130288968A1 (en) * | 2012-04-30 | 2013-10-31 | Sun Pharmaceutical Industries Ltd. | 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 |
| JP6179690B1 (ja) | 2015-12-10 | 2017-08-16 | 三菱瓦斯化学株式会社 | 光硬化性組成物及び光学材料 |
| JP6172880B1 (ja) * | 2017-02-01 | 2017-08-02 | 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 |
| US11738068B2 (en) | 2018-06-25 | 2023-08-29 | Jcr Pharmaceuticals Co., Ltd. | Protein-containing aqueous liquid formulation |
| JP2023549542A (ja) * | 2020-11-16 | 2023-11-27 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティド | 曇点の無い製剤、方法及び予充填複数回投与注入機器 |
| 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 |
| PT83095B (en) * | 1985-07-30 | 1987-12-23 | Int Minerals & Chem Corp | Method for the stabilization of growth promoting hormones using polyoxyethylene-polyoxypropylene copolymers |
| 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 |
| DK0549694T3 (da) * | 1990-09-21 | 1995-10-16 | Novo Nordisk As | Adaptertop |
| 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 |
| JP2000504723A (ja) * | 1996-02-13 | 2000-04-18 | ジー.ディー.サール アンド カンパニー | シクロオキシゲナーゼ―2阻害剤および5―リポキシゲナーゼ阻害剤投与の免疫抑制効果 |
| ZA9711731B (en) * | 1996-12-31 | 1998-07-01 | Monsanto Co | Aqueous glycerol formulations of somatotropin |
| IL122732A0 (en) * | 1997-01-15 | 1998-08-16 | Akzo Nobel Nv | Liquid gonadotropin-containing formulation its preparation and a device containing same |
| 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 DE DE60038118T patent/DE60038118T2/de not_active Expired - Lifetime
- 2000-07-11 PL PL00353238A patent/PL353238A1/xx not_active Application Discontinuation
- 2000-07-11 JP JP2001509214A patent/JP2003504346A/ja active Pending
- 2000-07-11 CZ CZ200260A patent/CZ200260A3/cs unknown
- 2000-07-11 HU HU0202189A patent/HUP0202189A3/hu unknown
- 2000-07-11 SI SI200030992T patent/SI1194170T1/sl unknown
- 2000-07-11 ES ES00946088T patent/ES2300268T3/es not_active Expired - Lifetime
- 2000-07-11 BR BR0013162-8A patent/BR0013162A/pt not_active IP Right Cessation
- 2000-07-11 NZ NZ516507A patent/NZ516507A/xx unknown
- 2000-07-11 KR KR1020027000416A patent/KR20020031388A/ko not_active Ceased
- 2000-07-11 IL IL14725300A patent/IL147253A0/xx not_active IP Right Cessation
- 2000-07-11 SK SK25-2002A patent/SK252002A3/sk unknown
- 2000-07-11 AU AU59975/00A patent/AU775107C/en not_active Expired
- 2000-07-11 CA CA2378949A patent/CA2378949C/en not_active Expired - Lifetime
- 2000-07-11 EP EP00946088A patent/EP1194170B1/en not_active Expired - Lifetime
- 2000-07-11 WO PCT/GB2000/002664 patent/WO2001003741A1/en not_active Ceased
- 2000-07-11 TR TR2002/00034T patent/TR200200034T2/tr unknown
- 2000-07-11 HK HK02106653.3A patent/HK1046358A1/zh unknown
- 2000-07-11 AT AT00946088T patent/ATE386501T1/de active
- 2000-07-11 MX MXPA02000404A patent/MXPA02000404A/es active IP Right Grant
- 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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