NO322048B1 - Lagringsstabil vannopplosning for infusjon inneholdende en trombininhibitor, fremgangsmate for fremstilling av slik vannopplosning og anvendelse derav. - Google Patents
Lagringsstabil vannopplosning for infusjon inneholdende en trombininhibitor, fremgangsmate for fremstilling av slik vannopplosning og anvendelse derav. Download PDFInfo
- Publication number
- NO322048B1 NO322048B1 NO19972065A NO972065A NO322048B1 NO 322048 B1 NO322048 B1 NO 322048B1 NO 19972065 A NO19972065 A NO 19972065A NO 972065 A NO972065 A NO 972065A NO 322048 B1 NO322048 B1 NO 322048B1
- Authority
- NO
- Norway
- Prior art keywords
- hooc
- solution
- pic
- nag
- cha
- Prior art date
Links
- 229940122388 Thrombin inhibitor Drugs 0.000 title claims abstract description 21
- 239000003868 thrombin inhibitor Substances 0.000 title claims abstract description 21
- 238000003860 storage Methods 0.000 title claims abstract description 15
- 101000712605 Theromyzon tessulatum Theromin Proteins 0.000 title claims abstract description 10
- 238000001802 infusion Methods 0.000 title claims abstract description 7
- 239000000243 solution Substances 0.000 title claims description 41
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 title claims description 18
- 239000007864 aqueous solution Substances 0.000 title claims description 11
- 238000004519 manufacturing process Methods 0.000 title description 3
- 239000012458 free base Substances 0.000 claims abstract description 10
- 150000003839 salts Chemical class 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims abstract description 6
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 8
- 150000001875 compounds Chemical class 0.000 claims description 8
- 239000002253 acid Substances 0.000 claims description 4
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 4
- 239000003814 drug Substances 0.000 claims description 3
- 108090000190 Thrombin Proteins 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 229960004072 thrombin Drugs 0.000 claims 1
- 239000000203 mixture Substances 0.000 abstract description 23
- 238000009472 formulation Methods 0.000 abstract description 10
- 230000015556 catabolic process Effects 0.000 description 10
- 239000007853 buffer solution Substances 0.000 description 9
- 238000006731 degradation reaction Methods 0.000 description 9
- 108090000765 processed proteins & peptides Proteins 0.000 description 9
- 230000007423 decrease Effects 0.000 description 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000008351 acetate buffer Substances 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- 238000007911 parenteral administration Methods 0.000 description 3
- 239000008194 pharmaceutical composition Substances 0.000 description 3
- 102000004196 processed proteins & peptides Human genes 0.000 description 3
- 230000002378 acidificating effect Effects 0.000 description 2
- 239000002585 base Substances 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- BMYNFMYTOJXKLE-UHFFFAOYSA-N 3-azaniumyl-2-hydroxypropanoate Chemical compound NCC(O)C(O)=O BMYNFMYTOJXKLE-UHFFFAOYSA-N 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 1
- 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 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical class Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 description 1
- 206010020608 Hypercoagulation Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000000337 buffer salt Substances 0.000 description 1
- 239000013065 commercial product Substances 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000003027 hypercoagulation Effects 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose 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@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 description 1
- 239000000644 isotonic solution Substances 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 238000004366 reverse phase liquid chromatography Methods 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000013193 stability-indicating method Methods 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 239000012086 standard solution Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000000825 ultraviolet detection Methods 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K5/00—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof
- C07K5/02—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing at least one abnormal peptide link
- C07K5/022—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing at least one abnormal peptide link containing the structure -X-C(=O)-(C)n-N-C-C(=O)-Y-; X and Y being heteroatoms; n being 1 or 2
- C07K5/0222—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing at least one abnormal peptide link containing the structure -X-C(=O)-(C)n-N-C-C(=O)-Y-; X and Y being heteroatoms; n being 1 or 2 with the first amino acid being heterocyclic, e.g. Pro, Trp
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
-
- 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
- A61K38/55—Protease inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K5/00—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof
- C07K5/04—Peptides containing up to four amino acids in a fully defined sequence; Derivatives thereof containing only normal peptide links
- C07K5/06—Dipeptides
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9403831A SE504185C2 (sv) | 1994-11-08 | 1994-11-08 | Lagringsstabil vattenlösning för infusion av trombininhibitorer |
| PCT/SE1995/001228 WO1996014084A1 (fr) | 1994-11-08 | 1995-10-19 | Solution aqueuse stable au stockage destinee a l'injection, qui contient un inhibiteur de thrombine |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO972065D0 NO972065D0 (no) | 1997-05-05 |
| NO972065L NO972065L (no) | 1997-05-05 |
| NO322048B1 true NO322048B1 (no) | 2006-08-07 |
Family
ID=20395892
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO19972065A NO322048B1 (no) | 1994-11-08 | 1997-05-05 | Lagringsstabil vannopplosning for infusjon inneholdende en trombininhibitor, fremgangsmate for fremstilling av slik vannopplosning og anvendelse derav. |
Country Status (31)
| Country | Link |
|---|---|
| US (1) | US5830865A (fr) |
| EP (1) | EP0789585B1 (fr) |
| JP (1) | JPH10508598A (fr) |
| KR (1) | KR100416677B1 (fr) |
| CN (1) | CN1090508C (fr) |
| AT (1) | ATE205399T1 (fr) |
| AU (1) | AU695719B2 (fr) |
| BR (1) | BR9509634A (fr) |
| CA (1) | CA2203396A1 (fr) |
| CZ (1) | CZ287256B6 (fr) |
| DE (1) | DE69522702T2 (fr) |
| DK (1) | DK0789585T3 (fr) |
| EE (1) | EE9700218A (fr) |
| ES (1) | ES2163528T3 (fr) |
| FI (1) | FI971949A0 (fr) |
| HU (1) | HU217073B (fr) |
| IL (1) | IL115879A (fr) |
| IS (1) | IS4468A (fr) |
| MX (1) | MX9703339A (fr) |
| MY (1) | MY112593A (fr) |
| NO (1) | NO322048B1 (fr) |
| NZ (1) | NZ295492A (fr) |
| PL (1) | PL320342A1 (fr) |
| PT (1) | PT789585E (fr) |
| RU (1) | RU2164803C2 (fr) |
| SE (1) | SE504185C2 (fr) |
| SK (1) | SK53597A3 (fr) |
| TR (1) | TR199501391A2 (fr) |
| TW (1) | TW407057B (fr) |
| WO (1) | WO1996014084A1 (fr) |
| ZA (1) | ZA959377B (fr) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6984627B1 (en) * | 1993-06-03 | 2006-01-10 | Astrazeneca Ab | Peptide derivatives |
| SE9301916D0 (sv) * | 1993-06-03 | 1993-06-03 | Ab Astra | New peptides derivatives |
| AR005245A1 (es) * | 1995-12-21 | 1999-04-28 | Astrazeneca Ab | Prodrogas de inhibidores de trombina, una formulación farmaceutica que las comprende, el uso de dichas prodrogas para la manufactura de un medicamento y un procedimiento para su preparacion |
| SE9802974D0 (sv) * | 1998-09-03 | 1998-09-03 | Astra Ab | New crystalline forms |
| US6462021B1 (en) | 2000-11-06 | 2002-10-08 | Astrazeneca Ab | Use of low molecular weight thrombin inhibitor |
| ES2543588T3 (es) | 2002-12-03 | 2015-08-20 | Pharmacyclics Llc | Derivados de 2-(2-hidroxibifenil-3-il)-1H-benzoimidazol-5-carboxamidina como inhibidores del factor VIIa |
| US7345093B2 (en) * | 2004-04-27 | 2008-03-18 | Formatech, Inc. | Methods of enhancing solubility of compounds |
| US20110070294A1 (en) * | 2009-09-23 | 2011-03-24 | Javeri Indu | Methods for the Administration of Drugs Using Liposomes |
| US10143652B2 (en) | 2009-09-23 | 2018-12-04 | Curirx Inc. | Methods for the preparation of liposomes |
| WO2011038073A1 (fr) | 2009-09-23 | 2011-03-31 | Formatech, Inc. | Méthodes de préparation de liposomes contenant du docétaxel |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9103612D0 (sv) * | 1991-12-04 | 1991-12-04 | Astra Ab | New peptide derivatives |
| US5466131A (en) * | 1994-03-22 | 1995-11-14 | Micropump Corporation | Multiple-chamber gear pump with hydraulically connected chambers |
-
1994
- 1994-11-08 SE SE9403831A patent/SE504185C2/sv not_active IP Right Cessation
-
1995
- 1995-10-04 TW TW084110363A patent/TW407057B/zh not_active IP Right Cessation
- 1995-10-19 WO PCT/SE1995/001228 patent/WO1996014084A1/fr active IP Right Grant
- 1995-10-19 ES ES95938085T patent/ES2163528T3/es not_active Expired - Lifetime
- 1995-10-19 JP JP8515235A patent/JPH10508598A/ja not_active Ceased
- 1995-10-19 US US08/557,189 patent/US5830865A/en not_active Expired - Fee Related
- 1995-10-19 CA CA002203396A patent/CA2203396A1/fr not_active Abandoned
- 1995-10-19 DK DK95938085T patent/DK0789585T3/da active
- 1995-10-19 EE EE9700218A patent/EE9700218A/xx unknown
- 1995-10-19 NZ NZ295492A patent/NZ295492A/en unknown
- 1995-10-19 EP EP95938085A patent/EP0789585B1/fr not_active Expired - Lifetime
- 1995-10-19 SK SK535-97A patent/SK53597A3/sk unknown
- 1995-10-19 DE DE69522702T patent/DE69522702T2/de not_active Expired - Fee Related
- 1995-10-19 KR KR1019970703043A patent/KR100416677B1/ko not_active IP Right Cessation
- 1995-10-19 CN CN95196108A patent/CN1090508C/zh not_active Expired - Fee Related
- 1995-10-19 BR BR9509634A patent/BR9509634A/pt active Search and Examination
- 1995-10-19 AT AT95938085T patent/ATE205399T1/de not_active IP Right Cessation
- 1995-10-19 AU AU38846/95A patent/AU695719B2/en not_active Ceased
- 1995-10-19 PL PL95320342A patent/PL320342A1/xx unknown
- 1995-10-19 MX MX9703339A patent/MX9703339A/es not_active IP Right Cessation
- 1995-10-19 HU HU9800400A patent/HU217073B/hu not_active IP Right Cessation
- 1995-10-19 RU RU97108965/14A patent/RU2164803C2/ru active
- 1995-10-19 PT PT95938085T patent/PT789585E/pt unknown
- 1995-10-19 CZ CZ19971294A patent/CZ287256B6/cs not_active IP Right Cessation
- 1995-10-26 MY MYPI95003226A patent/MY112593A/en unknown
- 1995-11-06 IL IL11587995A patent/IL115879A/en not_active IP Right Cessation
- 1995-11-06 ZA ZA959377A patent/ZA959377B/xx unknown
- 1995-11-08 TR TR95/01391A patent/TR199501391A2/xx unknown
-
1997
- 1997-04-21 IS IS4468A patent/IS4468A/is unknown
- 1997-05-05 NO NO19972065A patent/NO322048B1/no unknown
- 1997-05-07 FI FI971949A patent/FI971949A0/fi not_active Application Discontinuation
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