AR039123A1 - Composicion farmaceutica estable que contiene el factor viii - Google Patents
Composicion farmaceutica estable que contiene el factor viiiInfo
- Publication number
- AR039123A1 AR039123A1 ARP030101024A ARP030101024A AR039123A1 AR 039123 A1 AR039123 A1 AR 039123A1 AR P030101024 A ARP030101024 A AR P030101024A AR P030101024 A ARP030101024 A AR P030101024A AR 039123 A1 AR039123 A1 AR 039123A1
- Authority
- AR
- Argentina
- Prior art keywords
- pharmaceutical composition
- factor viii
- composition containing
- stable pharmaceutical
- containing factor
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 4
- 229960000301 factor viii Drugs 0.000 title abstract 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 4
- 102000001690 Factor VIII Human genes 0.000 abstract 2
- 108010054218 Factor VIII Proteins 0.000 abstract 2
- 239000011780 sodium chloride Substances 0.000 abstract 2
- 239000007787 solid Substances 0.000 abstract 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 abstract 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 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- 150000001413 amino acids Chemical class 0.000 abstract 1
- 239000001110 calcium chloride Substances 0.000 abstract 1
- 229910001628 calcium chloride Inorganic materials 0.000 abstract 1
- 238000007865 diluting Methods 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000001509 sodium citrate Substances 0.000 abstract 1
- 239000008223 sterile water Substances 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 abstract 1
- 229940038773 trisodium citrate Drugs 0.000 abstract 1
- 239000008215 water for injection 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- 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
- 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
- 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
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
Composición farmacéutica sólida estable que comprende el factor VIII. Tal composición carece de aminoácidos y comprende: a) factor VIII; b) un tensioactivo, c) Cloruro de calcio, d) sacarosa, e) Cloruro de sodio, f)citrato trisódico; y g) un búfer; y tiene un pH de 6 a 8 antes de la liofilización y luego de la reconstitución en agua para inyección. Composición farmacéutica líquida que puede obtenerse luego de diluir dicha composición farmacéutica sólida estable con agua estéril con contenido opcional de cloruro de sodio.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0207092.8A GB0207092D0 (en) | 2002-03-26 | 2002-03-26 | Stable pharmaceutical composition containing factor VIII |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR039123A1 true AR039123A1 (es) | 2005-02-09 |
Family
ID=9933726
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP030101024A AR039123A1 (es) | 2002-03-26 | 2003-03-25 | Composicion farmaceutica estable que contiene el factor viii |
Country Status (26)
| Country | Link |
|---|---|
| US (1) | US7790680B2 (es) |
| EP (2) | EP1490095B1 (es) |
| JP (4) | JP2005530714A (es) |
| KR (1) | KR20040093482A (es) |
| CN (2) | CN1642570B (es) |
| AR (1) | AR039123A1 (es) |
| AT (1) | ATE477814T1 (es) |
| AU (1) | AU2003217030B2 (es) |
| BR (1) | BR0308442A (es) |
| CA (1) | CA2480226C (es) |
| DE (1) | DE60333825D1 (es) |
| DK (1) | DK1490095T3 (es) |
| ES (1) | ES2350337T3 (es) |
| GB (1) | GB0207092D0 (es) |
| HR (1) | HRP20040882B1 (es) |
| IL (2) | IL163849A0 (es) |
| IS (1) | IS7458A (es) |
| MX (1) | MXPA04009275A (es) |
| MY (1) | MY149831A (es) |
| NO (1) | NO328450B1 (es) |
| NZ (1) | NZ535032A (es) |
| PL (1) | PL208009B1 (es) |
| PT (1) | PT1490095E (es) |
| RU (1) | RU2314825C2 (es) |
| TW (1) | TWI285106B (es) |
| WO (1) | WO2003080108A1 (es) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7560107B2 (en) | 1996-06-26 | 2009-07-14 | Emory University | Modified factor VIII |
| CA2502378A1 (en) * | 2002-10-29 | 2004-05-13 | Alza Corporation | Stabilized, solid-state polypeptide particles |
| JP4644663B2 (ja) | 2003-06-03 | 2011-03-02 | セル ジェネシス インコーポレイテッド | ペプチド開裂部位を用いた単一ベクターからの組換えポリペプチドの高められた発現のための構成と方法 |
| US7485291B2 (en) | 2003-06-03 | 2009-02-03 | Cell Genesys, Inc. | Compositions and methods for generating multiple polypeptides from a single vector using a virus derived peptide cleavage site, and uses thereof |
| CA2545458A1 (en) * | 2003-11-10 | 2005-05-26 | Arriva-Prometic Inc. | Dry recombinant human alpha 1-antitrypsin formulation |
| JP2007536230A (ja) | 2004-05-03 | 2007-12-13 | エモリー ユニバーシティ | ブタＢドメイン欠損ｆＶＩＩＩの投与方法 |
| AU2009240026B2 (en) | 2008-04-21 | 2014-05-29 | Novo Nordisk Health Care Ag | Dry transglutaminase composition |
| EP2113564A1 (en) | 2008-05-01 | 2009-11-04 | Arecor Limited | Protein formulation |
| US9120873B2 (en) | 2008-08-21 | 2015-09-01 | Octapharma Ag | Recombinantly produced human factor VIII and IX |
| CN107049964B (zh) * | 2008-09-03 | 2020-06-02 | 奥克塔法马股份有限公司 | 重组制备的因子viii的新型保护组合物 |
| BRPI0921429B1 (pt) | 2008-11-07 | 2022-07-12 | Takeda Pharmaceutical Company Limited | Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável |
| GB0915480D0 (en) * | 2009-09-04 | 2009-10-07 | Arecor Ltd | Stable formulation of factor viii |
| CA2816575C (en) | 2010-11-05 | 2019-06-11 | Baxter Healthcare S.A. | A new variant of antihemophilic factor viii having increased specific activity |
| HUE047933T2 (hu) | 2013-03-15 | 2020-05-28 | Bioverativ Therapeutics Inc | Faktor VIII polipeptid készítmények |
| EP2970430A4 (en) * | 2013-03-15 | 2017-01-11 | Bayer HealthCare LLC | Recombinant factor viii formulations |
| JP6516829B2 (ja) | 2014-08-04 | 2019-05-22 | シーエスエル、リミテッド | 第ｖｉｉｉ因子製剤 |
| EP3207936B1 (en) | 2014-11-18 | 2021-04-21 | Shionogi & Co., Ltd. | Stable peptide composition |
| AU2020300820A1 (en) | 2019-07-04 | 2022-03-03 | CSL Behring Lengnau AG | A truncated von willebrand factor (vWF) for increasing the in vitro stability of coagulation factor VIII |
| CN116322920A (zh) | 2020-11-09 | 2023-06-23 | 武田药品工业株式会社 | 使用氧化硅吸附从血浆中纯化fviii |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6281327A (ja) * | 1985-10-04 | 1987-04-14 | Green Cross Corp:The | 人トロンビン製剤の加熱処理方法 |
| JPS6485927A (en) * | 1987-09-29 | 1989-03-30 | Green Cross Corp | Hepatitis b vaccine |
| US5605884A (en) | 1987-10-29 | 1997-02-25 | Rhone-Poulenc Rorer Pharmaceuticals Inc. | Factor VIII formulations in high ionic strength media |
| WO1989009784A1 (en) * | 1988-04-08 | 1989-10-19 | Commonwealth Serum Laboratories Commission | Production of heat-stable factor viii concentrate |
| GB8822857D0 (en) * | 1988-09-29 | 1988-11-02 | Patralan Ltd | Pharmaceutical formulations |
| SE465222C5 (sv) | 1989-12-15 | 1998-02-10 | Pharmacia & Upjohn Ab | Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning |
| IE64738B1 (en) * | 1990-03-20 | 1995-09-06 | Akzo Nv | Stabilized gonadotropin containing preparations |
| DE4111393A1 (de) * | 1991-04-09 | 1992-10-15 | Behringwerke Ag | Stabilisierte faktor viii-praeparationen |
| KR100303872B1 (ko) | 1992-10-02 | 2001-11-22 | 크리스터 발스트룀, 프레드릭 베르그, 하랄트 알름 | 응고인자ⅷ제형을포함하는조성물,이것의제조방법및안정화제로서의계면활성제의사용방법 |
| SE9301581D0 (sv) | 1993-05-07 | 1993-05-07 | Kabi Pharmacia Ab | Protein formulation |
| SE504074C2 (sv) | 1993-07-05 | 1996-11-04 | Pharmacia Ab | Proteinberedning för subkutan, intramuskulär eller intradermal administrering |
| ZA955642B (en) * | 1994-07-07 | 1997-05-06 | Ortho Pharma Corp | Lyophilized imaging agent formulation |
| JPH0899999A (ja) * | 1994-09-30 | 1996-04-16 | Chemo Sero Therapeut Res Inst | α１プロテアーゼインヒビターの製造方法 |
| US6458563B1 (en) * | 1996-06-26 | 2002-10-01 | Emory University | Modified factor VIII |
| US5763401A (en) | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
| EP2130554B1 (en) * | 1999-02-22 | 2012-09-05 | University of Connecticut | Albumin-free factor VIII formulations |
| NZ516400A (en) | 1999-07-13 | 2004-02-27 | Biovitrum Ab | Stable factor VIII compositions |
| US6586574B1 (en) * | 1999-08-17 | 2003-07-01 | Nn A/S | Stabilization of freeze-dried cake |
| ATE264340T1 (de) * | 1999-08-17 | 2004-04-15 | Novo Nordisk Healthcare Ag | Stabilisierung von gefriergetrocknetem kuchen |
| US7576182B1 (en) * | 1999-08-31 | 2009-08-18 | Genentech, Inc. | Compositions and methods for the treatment of immune related diseases |
-
2002
- 2002-03-26 GB GBGB0207092.8A patent/GB0207092D0/en not_active Ceased
-
2003
- 2003-03-14 TW TW092105665A patent/TWI285106B/zh not_active IP Right Cessation
- 2003-03-19 MY MYPI20030960A patent/MY149831A/en unknown
- 2003-03-25 AR ARP030101024A patent/AR039123A1/es not_active Application Discontinuation
- 2003-03-26 DK DK03712418.7T patent/DK1490095T3/da active
- 2003-03-26 EP EP03712418A patent/EP1490095B1/en not_active Expired - Lifetime
- 2003-03-26 CN CN038069911A patent/CN1642570B/zh not_active Expired - Lifetime
- 2003-03-26 HR HRP20040882AA patent/HRP20040882B1/hr not_active IP Right Cessation
- 2003-03-26 CN CN201210563117.1A patent/CN103006540B/zh not_active Expired - Lifetime
- 2003-03-26 PL PL372414A patent/PL208009B1/pl unknown
- 2003-03-26 RU RU2004131556/15A patent/RU2314825C2/ru active
- 2003-03-26 NZ NZ535032A patent/NZ535032A/xx not_active IP Right Cessation
- 2003-03-26 EP EP10172869A patent/EP2292216A3/en not_active Withdrawn
- 2003-03-26 ES ES03712418T patent/ES2350337T3/es not_active Expired - Lifetime
- 2003-03-26 DE DE60333825T patent/DE60333825D1/de not_active Expired - Lifetime
- 2003-03-26 AT AT03712418T patent/ATE477814T1/de active
- 2003-03-26 PT PT03712418T patent/PT1490095E/pt unknown
- 2003-03-26 AU AU2003217030A patent/AU2003217030B2/en not_active Expired
- 2003-03-26 US US10/507,956 patent/US7790680B2/en not_active Expired - Lifetime
- 2003-03-26 MX MXPA04009275A patent/MXPA04009275A/es active IP Right Grant
- 2003-03-26 JP JP2003577934A patent/JP2005530714A/ja active Pending
- 2003-03-26 KR KR10-2004-7015295A patent/KR20040093482A/ko not_active Ceased
- 2003-03-26 CA CA2480226A patent/CA2480226C/en not_active Expired - Lifetime
- 2003-03-26 IL IL16384903A patent/IL163849A0/xx unknown
- 2003-03-26 WO PCT/GB2003/001297 patent/WO2003080108A1/en not_active Ceased
- 2003-03-26 BR BR0308442-6A patent/BR0308442A/pt not_active Application Discontinuation
-
2004
- 2004-08-31 IL IL163849A patent/IL163849A/en not_active IP Right Cessation
- 2004-09-17 IS IS7458A patent/IS7458A/is unknown
- 2004-10-11 NO NO20044305A patent/NO328450B1/no not_active IP Right Cessation
-
2011
- 2011-01-07 JP JP2011002185A patent/JP2011079862A/ja active Pending
-
2013
- 2013-04-16 JP JP2013085801A patent/JP5770775B2/ja not_active Expired - Lifetime
-
2015
- 2015-03-18 JP JP2015055071A patent/JP2015143245A/ja active Pending
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA | Abandonment or withdrawal | ||
| FC | Refusal |