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
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)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (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 (27)
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) |
HK (2) | HK1080713A1 (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 |
AU2003285075B2 (en) * | 2002-10-29 | 2009-10-29 | Durect Corporation | Stabilized, solid-state polypeptide particles |
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 |
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 |
JP2007534633A (ja) * | 2003-11-10 | 2007-11-29 | アライバ−プロメティック インコーポレイティド | ヒト・アルファ1−抗トリプシン製剤 |
EP1750733B1 (en) | 2004-05-03 | 2013-12-11 | Emory University | METHOD OF ADMINISTERING PORCINE B-DOMAINLESS fVIII |
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 |
AU2009284113B2 (en) | 2008-08-21 | 2015-05-14 | Octapharma Ag | Recombinantly produced human factor VIII and IX |
WO2010026186A1 (en) * | 2008-09-03 | 2010-03-11 | Octapharma Ag | New protecting compositions for recombinantly produced factor viii |
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 |
DK2635297T3 (da) | 2010-11-05 | 2019-05-06 | Baxalta GmbH | En ny variant af antihæmofil faktor viii, der har en øget specifik aktivitet |
JP2016518321A (ja) * | 2013-03-15 | 2016-06-23 | バイエル・ヘルスケア・エルエルシーBayer HealthCare LLC | 組み換え因子viii配合物 |
JP6330026B2 (ja) | 2013-03-15 | 2018-05-23 | バイオベラティブ セラピューティクス インコーポレイテッド | 第viii因子ポリペプチド製剤 |
PL3177317T3 (pl) | 2014-08-04 | 2020-07-27 | Csl Limited | Formulacja czynnika viii |
EP3207936B1 (en) * | 2014-11-18 | 2021-04-21 | Shionogi & Co., Ltd. | Stable peptide composition |
CN114072420B (zh) | 2019-07-04 | 2024-06-11 | 康诺贝林伦瑙有限公司 | 用于增加凝血因子viii的体外稳定性的截短的血管性血友病因子(vwf) |
US20220380439A1 (en) | 2020-11-09 | 2022-12-01 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
Family Cites Families (19)
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 |
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 |
EP1154796B1 (en) * | 1999-02-22 | 2007-06-20 | University of Connecticut | Novel albumin-free factor viii formulations |
EP1194161B1 (en) * | 1999-07-13 | 2005-11-23 | Biovitrum Ab | Stable factor viii compositions |
US6586574B1 (en) * | 1999-08-17 | 2003-07-01 | Nn A/S | Stabilization of freeze-dried cake |
JP2003507388A (ja) * | 1999-08-17 | 2003-02-25 | ノボ ノルディスク アクティーゼルスカブ | 凍結乾燥したケーキの安定化 |
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 WO PCT/GB2003/001297 patent/WO2003080108A1/en active Application Filing
- 2003-03-26 AT AT03712418T patent/ATE477814T1/de active
- 2003-03-26 CA CA2480226A patent/CA2480226C/en not_active Expired - Lifetime
- 2003-03-26 CN CN038069911A patent/CN1642570B/zh not_active Expired - Lifetime
- 2003-03-26 KR KR10-2004-7015295A patent/KR20040093482A/ko active Search and Examination
- 2003-03-26 NZ NZ535032A patent/NZ535032A/xx not_active IP Right Cessation
- 2003-03-26 EP EP03712418A patent/EP1490095B1/en not_active Expired - Lifetime
- 2003-03-26 ES ES03712418T patent/ES2350337T3/es not_active Expired - Lifetime
- 2003-03-26 US US10/507,956 patent/US7790680B2/en not_active Expired - Lifetime
- 2003-03-26 BR BR0308442-6A patent/BR0308442A/pt not_active Application Discontinuation
- 2003-03-26 MX MXPA04009275A patent/MXPA04009275A/es active IP Right Grant
- 2003-03-26 CN CN201210563117.1A patent/CN103006540B/zh not_active Expired - Lifetime
- 2003-03-26 IL IL16384903A patent/IL163849A0/xx unknown
- 2003-03-26 DK DK03712418.7T patent/DK1490095T3/da active
- 2003-03-26 PL PL372414A patent/PL208009B1/pl unknown
- 2003-03-26 JP JP2003577934A patent/JP2005530714A/ja active Pending
- 2003-03-26 DE DE60333825T patent/DE60333825D1/de not_active Expired - Lifetime
- 2003-03-26 AU AU2003217030A patent/AU2003217030B2/en not_active Expired
- 2003-03-26 PT PT03712418T patent/PT1490095E/pt unknown
- 2003-03-26 RU RU2004131556/15A patent/RU2314825C2/ru active
- 2003-03-26 EP EP10172869A patent/EP2292216A3/en not_active Withdrawn
-
2004
- 2004-08-31 IL IL163849A patent/IL163849A/en not_active IP Right Cessation
- 2004-09-17 IS IS7458A patent/IS7458A/is unknown
- 2004-09-24 HR HRP20040882AA patent/HRP20040882B1/hr not_active IP Right Cessation
- 2004-10-11 NO NO20044305A patent/NO328450B1/no not_active IP Right Cessation
-
2006
- 2006-01-13 HK HK06100540.9A patent/HK1080713A1/xx 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
- 2013-09-24 HK HK13110894.1A patent/HK1183446A1/xx not_active IP Right Cessation
-
2015
- 2015-03-18 JP JP2015055071A patent/JP2015143245A/ja active Pending
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
AR039123A1 (es) | Composicion farmaceutica estable que contiene el factor viii | |
AR117403A2 (es) | Formulaciones de anticuerpos | |
AR110731A2 (es) | Formulaciones que estabilizan e inhiben la precipitación de composiciones inmunogénicas | |
AR112443A2 (es) | Un kit para reconstitución o dilución de un fármaco | |
AR092919A2 (es) | Composicion farmaceutica liquida | |
AR078885A2 (es) | Composiciones estabilizadas de proteinas que tienen un radical tiol libre. recipiente impermeable. metodo. | |
AR040881A1 (es) | Formulacion de anticuerpos humanos para el tratamiento de trastornos asociados con tnf-alfa | |
ECSP045496A (es) | "preparaciones acidas de insulina con estabilidad mejorada" | |
BR0008405A (pt) | Composição de fator viii formulada sem a adição de albumina, uso de uma composição de fator viii, e, método de liofilizar uma formulação farmacêutica aquosa | |
AR078558A1 (es) | Excipiente estabilizante para una vacuna de virus completo inactivado | |
CO5660273A2 (es) | Formulaciones de proteina y anticuerpo de alta concentracion | |
FI971486A0 (fi) | Alfa-interferonin stabiilit vesiliuosformulaatiot | |
DE60233137D1 (de) | Transporter mit beabstandeten arginin-teilchen | |
AR040527A1 (es) | Formulaciones de hgh en alta concentracion que contienen glicina | |
NO934355L (no) | Proteinformulering omfattende veksthormon | |
AR043863A1 (es) | Composiciones que contienen piperacilina y tazobactam, utiles para inyeccioines | |
PE20130579A1 (es) | Composiciones y metodos para suministro al sistema nervioso central de iduronato-2-sulfatasa | |
CO6290629A2 (es) | Composiciones de limpieza de amino ácido básico y métodos | |
DE602004015725D1 (de) | Stabilisierte lyophilisierte zubereitungen mit gewebefaktor-inhibitor (tfpi) oder varianten des gewebefaktor-inhibitors | |
AR116112A2 (es) | COMPOSICIÓN FARMACÉUTICA LÍQUIDA CON ESTABILIDAD EN EL LARGO PLAZO DE UN FACTOR VON WILLEBRAND (rVWF) RECOMBINANTE | |
BR9908479A (pt) | Composições farmacêuticas que contêm o inibidor de fosfolipase [[3-(2-amino-1,2-dioxoetil)-2-etil-1-(fenilmetil_-1h-indol- 4-il]óxil] acetato de sódio | |
BRPI0606119A2 (pt) | preparações injetáveis de diclofenaco e seus sais farmaceuticamente aceitáveis | |
AR037131A1 (es) | Formulaciones de jarabe de ribavirina | |
ATE268590T1 (de) | Pharmazeutische emulsion enthaltend sorbinsäure, na-edta und borsäure | |
CO5150215A1 (es) | Composiciones que tienen estabilidad mejorada |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
FA | Abandonment or withdrawal | ||
FC | Refusal |