HRP20120235T1 - Formulacija tekućeg hormona rasta - Google Patents
Formulacija tekućeg hormona rasta Download PDFInfo
- Publication number
- HRP20120235T1 HRP20120235T1 HR20120235T HRP20120235T HRP20120235T1 HR P20120235 T1 HRP20120235 T1 HR P20120235T1 HR 20120235 T HR20120235 T HR 20120235T HR P20120235 T HRP20120235 T HR P20120235T HR P20120235 T1 HRP20120235 T1 HR P20120235T1
- Authority
- HR
- Croatia
- Prior art keywords
- formulation according
- metal salt
- formulation
- growth hormone
- alkaline earth
- Prior art date
Links
- 102000018997 Growth Hormone Human genes 0.000 title claims abstract 4
- 108010051696 Growth Hormone Proteins 0.000 title claims abstract 4
- 239000000122 growth hormone Substances 0.000 title claims abstract 4
- 238000009472 formulation Methods 0.000 title claims 27
- 239000000203 mixture Substances 0.000 title claims 27
- 239000007788 liquid Substances 0.000 title 1
- -1 alkali metal salt Chemical class 0.000 claims abstract 10
- 229910052784 alkaline earth metal Inorganic materials 0.000 claims abstract 6
- 229910052783 alkali metal Inorganic materials 0.000 claims abstract 4
- 239000012669 liquid formulation Substances 0.000 claims abstract 3
- 229920001451 polypropylene glycol Polymers 0.000 claims abstract 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims abstract 2
- 239000007979 citrate buffer Substances 0.000 claims abstract 2
- 230000000694 effects Effects 0.000 claims abstract 2
- 239000008363 phosphate buffer Substances 0.000 claims abstract 2
- 235000002639 sodium chloride Nutrition 0.000 claims 10
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 4
- 235000011147 magnesium chloride Nutrition 0.000 claims 4
- 239000007832 Na2SO4 Substances 0.000 claims 3
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- HQPMKSGTIOYHJT-UHFFFAOYSA-N ethane-1,2-diol;propane-1,2-diol Chemical group OCCO.CC(O)CO HQPMKSGTIOYHJT-UHFFFAOYSA-N 0.000 claims 3
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 3
- 229920001993 poloxamer 188 Polymers 0.000 claims 3
- 239000003755 preservative agent Substances 0.000 claims 3
- 230000002335 preservative effect Effects 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 239000001509 sodium citrate Substances 0.000 claims 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical group O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 3
- 229910052938 sodium sulfate Inorganic materials 0.000 claims 3
- 235000011152 sodium sulphate Nutrition 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- 102000038461 Growth Hormone-Releasing Hormone Human genes 0.000 claims 2
- 239000000095 Growth Hormone-Releasing Hormone Substances 0.000 claims 2
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical compound [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 claims 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- 101710142969 Somatoliberin Proteins 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 2
- 239000001488 sodium phosphate Substances 0.000 claims 2
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 2
- 239000003381 stabilizer Substances 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 2
- 208000030507 AIDS Diseases 0.000 claims 1
- 206010006895 Cachexia Diseases 0.000 claims 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 1
- 206010056438 Growth hormone deficiency Diseases 0.000 claims 1
- 102000002265 Human Growth Hormone Human genes 0.000 claims 1
- 108010000521 Human Growth Hormone Proteins 0.000 claims 1
- 239000000854 Human Growth Hormone Substances 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 208000026928 Turner syndrome Diseases 0.000 claims 1
- 239000000872 buffer Substances 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 235000011148 calcium chloride Nutrition 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 208000020832 chronic kidney disease Diseases 0.000 claims 1
- 208000022831 chronic renal failure syndrome Diseases 0.000 claims 1
- 208000026500 emaciation Diseases 0.000 claims 1
- 229940025708 injectable product Drugs 0.000 claims 1
- 229910052943 magnesium sulfate Inorganic materials 0.000 claims 1
- 235000019341 magnesium sulphate Nutrition 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 235000011164 potassium chloride Nutrition 0.000 claims 1
- 239000001103 potassium chloride Substances 0.000 claims 1
- 235000017550 sodium carbonate Nutrition 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 239000012064 sodium phosphate buffer Substances 0.000 claims 1
- 125000000185 sucrose group Chemical group 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000008215 water for injection Substances 0.000 claims 1
- 208000016261 weight loss Diseases 0.000 claims 1
- 230000004580 weight loss Effects 0.000 claims 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000126 substance Substances 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
- A61K9/08—Solutions
-
- 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
- A61K47/02—Inorganic compounds
-
- 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] (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
- A61K47/08—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- 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
-
- 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
- A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
-
- 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
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP04101444 | 2004-04-07 | ||
| PCT/EP2005/051448 WO2005105148A2 (en) | 2004-04-07 | 2005-03-30 | Liquid growth hormone formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20120235T1 true HRP20120235T1 (hr) | 2012-04-30 |
Family
ID=34928942
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20120235T HRP20120235T1 (hr) | 2004-04-07 | 2012-03-14 | Formulacija tekućeg hormona rasta |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US7662393B2 (de) |
| EP (1) | EP1740213B9 (de) |
| JP (1) | JP4991522B2 (de) |
| KR (1) | KR101120879B1 (de) |
| CN (1) | CN100574801C (de) |
| AT (1) | ATE547121T1 (de) |
| AU (1) | AU2005237775B2 (de) |
| BR (1) | BRPI0508798A (de) |
| CA (1) | CA2559918A1 (de) |
| CY (1) | CY1113834T1 (de) |
| DK (1) | DK1740213T3 (de) |
| EA (1) | EA010626B1 (de) |
| ES (1) | ES2383994T3 (de) |
| HK (1) | HK1098708A1 (de) |
| HR (1) | HRP20120235T1 (de) |
| IL (1) | IL178416A (de) |
| MX (1) | MXPA06011029A (de) |
| NO (1) | NO337249B1 (de) |
| PL (1) | PL1740213T3 (de) |
| PT (1) | PT1740213E (de) |
| RS (1) | RS52310B (de) |
| SI (1) | SI1740213T1 (de) |
| UA (1) | UA89781C2 (de) |
| WO (1) | WO2005105148A2 (de) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1174457B1 (de) * | 1999-12-03 | 2004-12-22 | Toray Industries, Inc. | Biaxial gestreckte polyesterfolie zur formgebung |
| EP2142207A4 (de) * | 2007-04-04 | 2013-01-16 | Theratechnologies Inc | Pharmazeutische formulierungen von ghrh-molekülen |
| EP2525833A2 (de) | 2010-01-22 | 2012-11-28 | Novo Nordisk Health Care AG | Stabile wachstumshormonverbindungen |
| CN106139158A (zh) | 2010-01-22 | 2016-11-23 | 诺沃—诺迪斯克保健股份有限公司 | 体内功效延长的生长激素 |
| EP2417982A1 (de) * | 2010-07-30 | 2012-02-15 | Ferring B.V. | Stabilisierung von Gonadotropinen |
| US20140194356A1 (en) | 2011-07-25 | 2014-07-10 | Sandoz Ag | Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein |
| US8871713B2 (en) * | 2013-03-01 | 2014-10-28 | Theratechnologies Inc. | Formulations of growth hormone releasing factor (GRF) molecules with improved stability |
| US11045523B2 (en) | 2013-04-05 | 2021-06-29 | Novo Nordisk Healthcare Ag | Formulation of growth hormone albumin-binder conjugate |
| EP3431508A4 (de) * | 2016-03-14 | 2019-08-14 | JCR Pharmaceuticals Co., Ltd. | Serumalbumin-20-k-wachstumshormonfusionprotein |
| US20200237652A1 (en) * | 2017-08-08 | 2020-07-30 | Csl Behring Ag | Hemopexin formulations |
| WO2024026224A1 (en) | 2022-07-29 | 2024-02-01 | University Of Rochester | Methods for improving muscle mass, strength, or function with a combination of testosterone and growth hormone |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3325223A1 (de) * | 1983-07-13 | 1985-01-24 | Hoechst Ag, 6230 Frankfurt | Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung |
| JPS60123426A (ja) * | 1983-12-07 | 1985-07-02 | Eisai Co Ltd | 経鼻投与用セクレチン製剤 |
| DE3584560D1 (de) * | 1984-04-09 | 1991-12-05 | Du Pont | Arzneimittelzusammensetzung geeignet zur behandlung oder prophylaxe von herzstoerungen. |
| PT83095B (en) * | 1985-07-30 | 1987-12-23 | Int Minerals & Chem Corp | Method for the stabilization of growth promoting hormones using polyoxyethylene-polyoxypropylene copolymers |
| US5681814A (en) * | 1990-06-07 | 1997-10-28 | Genentech, Inc. | Formulated IGF-I Composition |
| HUT67319A (en) * | 1991-08-30 | 1995-03-28 | Life Medical Sciences Inc | Compositions for treating wounds |
| SE9201073D0 (sv) * | 1992-04-03 | 1992-04-03 | Kabi Pharmacia Ab | Protein formulation |
| ATE359824T1 (de) * | 1992-07-31 | 2007-05-15 | Genentech Inc | Wässrige formulierung enthaltend menschliches wachstumshormon |
| JPH0892125A (ja) * | 1994-09-21 | 1996-04-09 | Nippon Chem Res Kk | 水性医薬組成物 |
| 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 |
| US6759393B1 (en) * | 1999-04-12 | 2004-07-06 | Pfizer Inc. | Growth hormone and growth hormone releasing hormone compositions |
| 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 |
| EP1309312A2 (de) * | 2000-08-07 | 2003-05-14 | Inhale Therapeutic Systems, Inc. | Inhalierbare sprühgetrocknete pulver aus proteinen die bündel aus 4 helices ausbilden mit minimierter aggregation |
| CA2466642C (en) * | 2001-11-14 | 2011-01-18 | Guohua Chen | Injectable depot composition |
| AR040526A1 (es) * | 2002-07-09 | 2005-04-13 | Grandis Biotech Gmbh | Formulaciuones de hgh en alta concentracion que contienen fenol |
| WO2004082707A2 (en) * | 2003-03-18 | 2004-09-30 | Ares Trading Sa | Stabilisation of growth hormones in solution |
-
2005
- 2005-03-30 CA CA002559918A patent/CA2559918A1/en not_active Abandoned
- 2005-03-30 SI SI200531493T patent/SI1740213T1/sl unknown
- 2005-03-30 DK DK05774044.1T patent/DK1740213T3/da active
- 2005-03-30 EP EP05774044A patent/EP1740213B9/de active Active
- 2005-03-30 EA EA200601874A patent/EA010626B1/ru not_active IP Right Cessation
- 2005-03-30 UA UAA200611724A patent/UA89781C2/uk unknown
- 2005-03-30 KR KR1020067018952A patent/KR101120879B1/ko not_active IP Right Cessation
- 2005-03-30 PT PT05774044T patent/PT1740213E/pt unknown
- 2005-03-30 US US11/578,136 patent/US7662393B2/en active Active
- 2005-03-30 AU AU2005237775A patent/AU2005237775B2/en active Active
- 2005-03-30 CN CN200580012183A patent/CN100574801C/zh active Active
- 2005-03-30 ES ES05774044T patent/ES2383994T3/es active Active
- 2005-03-30 WO PCT/EP2005/051448 patent/WO2005105148A2/en active Application Filing
- 2005-03-30 AT AT05774044T patent/ATE547121T1/de active
- 2005-03-30 JP JP2007506768A patent/JP4991522B2/ja active Active
- 2005-03-30 MX MXPA06011029A patent/MXPA06011029A/es active IP Right Grant
- 2005-03-30 BR BRPI0508798-8A patent/BRPI0508798A/pt active Search and Examination
- 2005-03-30 PL PL05774044T patent/PL1740213T3/pl unknown
- 2005-03-30 RS RS20120218A patent/RS52310B/en unknown
-
2006
- 2006-10-03 IL IL178416A patent/IL178416A/en active IP Right Grant
- 2006-11-06 NO NO20065097A patent/NO337249B1/no not_active IP Right Cessation
-
2007
- 2007-06-13 HK HK07106383.5A patent/HK1098708A1/xx not_active IP Right Cessation
-
2012
- 2012-03-14 CY CY20121100258T patent/CY1113834T1/el unknown
- 2012-03-14 HR HR20120235T patent/HRP20120235T1/hr unknown
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