SK279641B6 - Stabilizovaný farmaceutický prípravok obsahujúci r - Google Patents
Stabilizovaný farmaceutický prípravok obsahujúci r Download PDFInfo
- Publication number
- SK279641B6 SK279641B6 SK754-94A SK75494A SK279641B6 SK 279641 B6 SK279641 B6 SK 279641B6 SK 75494 A SK75494 A SK 75494A SK 279641 B6 SK279641 B6 SK 279641B6
- Authority
- SK
- Slovakia
- Prior art keywords
- histidine
- growth hormone
- hgh
- crystals
- pharmaceutical composition
- Prior art date
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- 239000000122 growth hormone Substances 0.000 title claims abstract description 88
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- 238000007872 degassing Methods 0.000 description 1
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- UHMKISIRZFDJRU-UHFFFAOYSA-L diethyl-methyl-[2-(1,1,6-trimethylpiperidin-1-ium-2-carbonyl)oxyethyl]azanium;diiodide Chemical compound [I-].[I-].CC[N+](C)(CC)CCOC(=O)C1CCCC(C)[N+]1(C)C UHMKISIRZFDJRU-UHFFFAOYSA-L 0.000 description 1
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- 239000003814 drug Substances 0.000 description 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 description 1
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- 150000002148 esters Chemical class 0.000 description 1
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- DLRVVLDZNNYCBX-CQUJWQHSSA-N gentiobiose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)C(O)O1 DLRVVLDZNNYCBX-CQUJWQHSSA-N 0.000 description 1
- 239000004220 glutamic acid Substances 0.000 description 1
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- 238000012835 hanging drop method Methods 0.000 description 1
- 229940063911 histidine 1.6 mg/ml Drugs 0.000 description 1
- DQKGOGJIOHUEGK-UHFFFAOYSA-M hydron;2-hydroxyethyl(trimethyl)azanium;carbonate Chemical compound OC([O-])=O.C[N+](C)(C)CCO DQKGOGJIOHUEGK-UHFFFAOYSA-M 0.000 description 1
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- 210000000936 intestine Anatomy 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 125000001449 isopropyl group Chemical group [H]C([H])([H])C([H])(*)C([H])([H])[H] 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- TYQCGQRIZGCHNB-JLAZNSOCSA-N l-ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(O)=C(O)C1=O TYQCGQRIZGCHNB-JLAZNSOCSA-N 0.000 description 1
- 230000037356 lipid metabolism Effects 0.000 description 1
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- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
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- 125000004123 n-propyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
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- HEGSGKPQLMEBJL-RKQHYHRCSA-N octyl beta-D-glucopyranoside Chemical compound CCCCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HEGSGKPQLMEBJL-RKQHYHRCSA-N 0.000 description 1
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- WXZMFSXDPGVJKK-UHFFFAOYSA-N pentaerythritol Chemical compound OCC(CO)(CO)CO WXZMFSXDPGVJKK-UHFFFAOYSA-N 0.000 description 1
- 229940112042 peripherally acting choline derivative muscle relaxants Drugs 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
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- 238000002135 phase contrast microscopy Methods 0.000 description 1
- YHHSONZFOIEMCP-UHFFFAOYSA-O phosphocholine Chemical compound C[N+](C)(C)CCOP(O)(O)=O YHHSONZFOIEMCP-UHFFFAOYSA-O 0.000 description 1
- 229950004354 phosphorylcholine Drugs 0.000 description 1
- 210000003635 pituitary gland Anatomy 0.000 description 1
- 229920000724 poly(L-arginine) polymer Polymers 0.000 description 1
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- 108010064470 polyaspartate Proteins 0.000 description 1
- 229940089531 polyethylene glycol 3500 Drugs 0.000 description 1
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- 235000019515 salmon Nutrition 0.000 description 1
- 229940043230 sarcosine Drugs 0.000 description 1
- 210000002356 skeleton Anatomy 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- HELHAJAZNSDZJO-OLXYHTOASA-L sodium L-tartrate Chemical compound [Na+].[Na+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O HELHAJAZNSDZJO-OLXYHTOASA-L 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- 239000001433 sodium tartrate Substances 0.000 description 1
- 229960002167 sodium tartrate Drugs 0.000 description 1
- 235000011004 sodium tartrates Nutrition 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000000859 sublimation Methods 0.000 description 1
- 230000008022 sublimation Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 229960002317 succinimide Drugs 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 235000010384 tocopherol Nutrition 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 231100000563 toxic property Toxicity 0.000 description 1
- RULSWEULPANCDV-PIXUTMIVSA-N turanose Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](C(=O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O RULSWEULPANCDV-PIXUTMIVSA-N 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
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- 230000029663 wound healing Effects 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 239000004246 zinc acetate Substances 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Classifications
-
- 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
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/61—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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Endocrinology (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Gastroenterology & Hepatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Toxicology (AREA)
- Diabetes (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK204691A DK204691D0 (da) | 1991-12-20 | 1991-12-20 | Hidtil ukendt farmaceutisk praeparat |
| DK136492A DK136492D0 (da) | 1992-11-10 | 1992-11-10 | A pharmaceutical formulation |
| PCT/DK1992/000379 WO1993012812A1 (en) | 1991-12-20 | 1992-12-16 | A stabilized pharmaceutical formulation comprising growth hormone and histidine |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SK75494A3 SK75494A3 (en) | 1995-03-08 |
| SK279641B6 true SK279641B6 (sk) | 1999-01-11 |
Family
ID=26065653
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SK754-94A SK279641B6 (sk) | 1991-12-20 | 1992-12-16 | Stabilizovaný farmaceutický prípravok obsahujúci r |
Country Status (24)
| Country | Link |
|---|---|
| EP (2) | EP0618807B1 (uk) |
| JP (2) | JP2950617B2 (uk) |
| KR (1) | KR100266502B1 (uk) |
| AT (2) | ATE227583T1 (uk) |
| AU (1) | AU667503B2 (uk) |
| BG (1) | BG63075B1 (uk) |
| CA (1) | CA2125855C (uk) |
| CZ (1) | CZ283361B6 (uk) |
| DE (3) | DE10399015I1 (uk) |
| DK (1) | DK0618807T3 (uk) |
| ES (2) | ES2291264T3 (uk) |
| FI (1) | FI115116B (uk) |
| HU (1) | HUT69402A (uk) |
| IL (1) | IL104152A (uk) |
| MX (1) | MX9207374A (uk) |
| NL (1) | NL300126I1 (uk) |
| NO (1) | NO942300L (uk) |
| NZ (1) | NZ246556A (uk) |
| PT (1) | PT618807E (uk) |
| RO (1) | RO111990B1 (uk) |
| RU (1) | RU2122426C1 (uk) |
| SK (1) | SK279641B6 (uk) |
| UA (1) | UA41502C2 (uk) |
| WO (1) | WO1993012812A1 (uk) |
Families Citing this family (59)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5849700A (en) * | 1991-12-20 | 1998-12-15 | Novo Nordisk A/S | Pharmaceutical formulation |
| DK204791D0 (da) * | 1991-12-20 | 1991-12-20 | Novo Nordisk As | Hidtil ukendt farmaceutisk praeparat |
| US6022858A (en) * | 1991-12-20 | 2000-02-08 | Novo Nordisk A/S | Pharmaceutical formulation of human-growth hormone pretreated with zinc salt |
| US5849704A (en) * | 1991-12-20 | 1998-12-15 | Novo Nordisk A/S | Pharmaceutical formulation |
| US6288030B1 (en) * | 1993-12-22 | 2001-09-11 | Amgen Inc. | Stem cell factor formulations and methods |
| JP3829991B2 (ja) * | 1994-06-17 | 2006-10-04 | アプライド リサーチ システムズ エーアールエス ホールディング ナームロゼ ベノートスハップ | Ｈｇｈ含有医薬組成物 |
| TW426737B (en) * | 1994-06-27 | 2001-03-21 | Hayashibara Biochem Lab | Saccharide composition with reduced reducibility, and preparation and uses thereof |
| US5654278A (en) * | 1994-10-13 | 1997-08-05 | Novo Nordisk A/S | Composition and method comprising growth hormone and leucine |
| US5547696A (en) * | 1994-10-13 | 1996-08-20 | Novo Nordisk A/S | Pharmaceutical formulation |
| US5631225A (en) * | 1994-10-13 | 1997-05-20 | Novo Nordisk A/S | Pharmaceutical formulation |
| IL115592A (en) * | 1994-10-13 | 2000-07-26 | Novo Nordisk As | Stabilized pharmaceutical formulation comprising a growth hormone and leucine |
| US5705482A (en) * | 1995-01-13 | 1998-01-06 | Novo Nordisk A/S | Pharmaceutical formulation |
| ZA96122B (en) * | 1995-01-13 | 1996-07-24 | Novo Nordisk As | A pharmaceutical formulation |
| JPH10511964A (ja) * | 1995-01-13 | 1998-11-17 | ノボ ノルディスク アクティーゼルスカブ | 成長ホルモン及びＸ−Ｌｙｓを含む安定化医薬製剤 |
| US5552385A (en) * | 1995-06-05 | 1996-09-03 | Novo Nordisk A/S | Pharmaceutical formulation |
| US6936289B2 (en) | 1995-06-07 | 2005-08-30 | Danisco A/S | Method of improving the properties of a flour dough, a flour dough improving composition and improved food products |
| ZA965367B (en) * | 1995-07-12 | 1997-01-23 | Novo Nordisk As | A pharmaceutical formulation |
| US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| KR100236393B1 (ko) * | 1996-02-02 | 1999-12-15 | 나까니시 히로유끼 | 사람성장호르몬을 함유하는 의약제제 |
| US20020077461A1 (en) * | 1996-04-24 | 2002-06-20 | Soren Bjorn | Pharmaceutical formulation |
| US20070179096A1 (en) | 1996-04-24 | 2007-08-02 | Novo Nordisk A/S | Pharmaceutical Formulation |
| WO1999024071A1 (en) * | 1997-11-12 | 1999-05-20 | Alza Corporation | Method for decreasing self-association of polypeptides |
| EP2311436A1 (en) * | 1998-04-27 | 2011-04-20 | Altus Pharmaceuticals Inc. | Stabilized protein crystals, formulations containing them and methods of making them |
| KR20090007504A (ko) * | 2000-02-24 | 2009-01-16 | 몬산토 테크놀로지 엘엘씨 | 소마토트로핀의 지속적인 방출을 위한 비수성 주사제제들 |
| WO2002000261A2 (en) | 2000-06-26 | 2002-01-03 | Monsanto Technology Llc | Surfactant-containing formulations for extended release of somatotropin |
| US6664234B1 (en) | 2000-06-30 | 2003-12-16 | Monsanto Technology Llc | Non-aqueous injectable formulation preparation with pH adjusted for extended release of somatotropin |
| CA2418960A1 (en) | 2000-08-07 | 2002-02-14 | Inhale Therapeutic Systems, Inc. | Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation |
| PT1314437E (pt) | 2000-08-11 | 2014-08-29 | Chugai Pharmaceutical Co Ltd | Preparações estabilizadas contendo anticorpo |
| NZ528260A (en) | 2001-05-18 | 2005-09-30 | Danisco | Method of improving dough and bread quality with the addition of an enzyme that hydrolyses a glycolipid and a phospholipid and incapable of hydrolysing a triglyceride or monoglyceride |
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| EP0374120A3 (en) * | 1988-12-13 | 1991-07-31 | Monsanto Company | Comosition for controlled release of polypeptides |
| DK168790D0 (uk) * | 1990-07-13 | 1990-07-13 | Novo Nordisk As |
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1992
- 1992-12-16 CA CA002125855A patent/CA2125855C/en not_active Expired - Lifetime
- 1992-12-16 KR KR1019940702139A patent/KR100266502B1/ko not_active IP Right Cessation
- 1992-12-16 DK DK93902089T patent/DK0618807T3/da active
- 1992-12-16 ES ES01128974T patent/ES2291264T3/es not_active Expired - Lifetime
- 1992-12-16 JP JP5511361A patent/JP2950617B2/ja not_active Expired - Lifetime
- 1992-12-16 DE DE10399015C patent/DE10399015I1/de active Granted
- 1992-12-16 RU RU94045932A patent/RU2122426C1/ru active
- 1992-12-16 HU HU9401832A patent/HUT69402A/hu unknown
- 1992-12-16 PT PT93902089T patent/PT618807E/pt unknown
- 1992-12-16 DE DE69233704T patent/DE69233704T2/de not_active Expired - Lifetime
- 1992-12-16 AT AT93902089T patent/ATE227583T1/de active
- 1992-12-16 EP EP93902089A patent/EP0618807B1/en not_active Expired - Lifetime
- 1992-12-16 DE DE69232847T patent/DE69232847T2/de not_active Expired - Lifetime
- 1992-12-16 AU AU33446/93A patent/AU667503B2/en not_active Ceased
- 1992-12-16 WO PCT/DK1992/000379 patent/WO1993012812A1/en active IP Right Grant
- 1992-12-16 NZ NZ246556A patent/NZ246556A/en unknown
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- 1992-12-16 AT AT01128974T patent/ATE368472T1/de not_active IP Right Cessation
- 1992-12-16 SK SK754-94A patent/SK279641B6/sk not_active IP Right Cessation
- 1992-12-16 RO RO94-01056A patent/RO111990B1/ro unknown
- 1992-12-16 ES ES93902089T patent/ES2185625T3/es not_active Expired - Lifetime
- 1992-12-16 UA UA94005308A patent/UA41502C2/uk unknown
- 1992-12-16 EP EP01128974A patent/EP1197222B1/en not_active Expired - Lifetime
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- 1992-12-18 IL IL104152A patent/IL104152A/en not_active IP Right Cessation
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1994
- 1994-05-30 BG BG98806A patent/BG63075B1/bg unknown
- 1994-06-17 FI FI942906A patent/FI115116B/fi not_active IP Right Cessation
- 1994-06-17 NO NO942300A patent/NO942300L/no not_active Application Discontinuation
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1999
- 1999-02-03 JP JP11026405A patent/JPH11315031A/ja active Pending
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2003
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PC4A | Assignment and transfer of rights |
Owner name: NOVO NORDISK HEALTH CARE AG, ZURICH, CH Free format text: FORMER OWNER: NOVO NORDISK A/S, BAGSVAERD, DK Effective date: 20110804 |
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| MK4A | Patent expired |
Expiry date: 20121216 |