DK0627924T3 - Sammensætning, der omfatter koagulationsfaktor VIII formulering, fremgangsmåde til dens fremstilling og anvendelse af et overfladeaktivt middel som stabilisator - Google Patents
Sammensætning, der omfatter koagulationsfaktor VIII formulering, fremgangsmåde til dens fremstilling og anvendelse af et overfladeaktivt middel som stabilisatorInfo
- Publication number
- DK0627924T3 DK0627924T3 DK93923080T DK93923080T DK0627924T3 DK 0627924 T3 DK0627924 T3 DK 0627924T3 DK 93923080 T DK93923080 T DK 93923080T DK 93923080 T DK93923080 T DK 93923080T DK 0627924 T3 DK0627924 T3 DK 0627924T3
- Authority
- DK
- Denmark
- Prior art keywords
- stabilizer
- preparation
- composition
- surfactant
- factor viii
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 2
- 239000003381 stabilizer Substances 0.000 title abstract 2
- 102000001690 Factor VIII Human genes 0.000 title 1
- 108010054218 Factor VIII Proteins 0.000 title 1
- 229940105778 coagulation factor viii Drugs 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000004094 surface-active agent Substances 0.000 title 1
- 230000015271 coagulation Effects 0.000 abstract 1
- 238000005345 coagulation Methods 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
Classifications
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- 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
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- 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
- 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
- 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
-
- 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
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/829—Blood
- Y10S530/83—Plasma; serum
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Wood Science & Technology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Immunology (AREA)
- General Engineering & Computer Science (AREA)
- Toxicology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9202878A SE9202878D0 (sv) | 1992-10-02 | 1992-10-02 | Protein formulation |
| SE9301580A SE9301580D0 (sv) | 1993-05-07 | 1993-05-07 | Protein formulation |
| SE9302006A SE9302006D0 (sv) | 1992-10-02 | 1993-06-11 | Protein formulation |
| PCT/SE1993/000793 WO1994007510A1 (en) | 1992-10-02 | 1993-10-01 | Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK0627924T3 true DK0627924T3 (da) | 2001-04-30 |
Family
ID=27355693
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK93923080T DK0627924T3 (da) | 1992-10-02 | 1993-10-01 | Sammensætning, der omfatter koagulationsfaktor VIII formulering, fremgangsmåde til dens fremstilling og anvendelse af et overfladeaktivt middel som stabilisator |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US5733873A (cs) |
| EP (3) | EP1016673B1 (cs) |
| JP (1) | JP3905921B2 (cs) |
| KR (1) | KR100303872B1 (cs) |
| AT (2) | ATE198277T1 (cs) |
| CA (1) | CA2124690C (cs) |
| CZ (1) | CZ290342B6 (cs) |
| DE (2) | DE69333974T2 (cs) |
| DK (1) | DK0627924T3 (cs) |
| ES (1) | ES2154650T3 (cs) |
| FI (1) | FI111443B (cs) |
| GR (1) | GR3035472T3 (cs) |
| HU (2) | HU220194B (cs) |
| MX (1) | MX9306133A (cs) |
| NO (1) | NO942033L (cs) |
| NZ (1) | NZ256921A (cs) |
| PT (1) | PT627924E (cs) |
| SK (1) | SK282483B6 (cs) |
| WO (1) | WO1994007510A1 (cs) |
Families Citing this family (101)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CZ290342B6 (cs) * | 1992-10-02 | 2002-07-17 | Genetics Institute Inc. | Kompozice stabilní při skladování, obsahující koagulační faktor VIII a neiontovou povrchově aktivní látku a způsob její výroby |
| SE504074C2 (sv) † | 1993-07-05 | 1996-11-04 | Pharmacia Ab | Proteinberedning för subkutan, intramuskulär eller intradermal administrering |
| US6288030B1 (en) * | 1993-12-22 | 2001-09-11 | Amgen Inc. | Stem cell factor formulations and methods |
| US6242417B1 (en) * | 1994-03-08 | 2001-06-05 | Somatogen, Inc. | Stabilized compositions containing hemoglobin |
| IL113010A0 (en) * | 1994-03-31 | 1995-10-31 | Pharmacia Ab | Pharmaceutical formulation comprising factor VIII or factor ix with an activity of at least 200 IU/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration |
| US5514781A (en) * | 1994-04-11 | 1996-05-07 | Bayer Corporation | Use of azoles as virucidal agents in solutions of biologically active proteins |
| US6372716B1 (en) * | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
| SE503424C2 (sv) * | 1994-11-14 | 1996-06-10 | Pharmacia Ab | Process för rening av rekombinant koagulationsfaktor VIII |
| SE9403915D0 (sv) * | 1994-11-14 | 1994-11-14 | Annelie Almstedt | Process A |
| US7253262B2 (en) | 1995-01-19 | 2007-08-07 | Quandrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
| GB9501040D0 (en) * | 1995-01-19 | 1995-03-08 | Quadrant Holdings Cambridge | Dried composition |
| US7244824B2 (en) | 1995-01-19 | 2007-07-17 | Quadrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
| SE9501189D0 (sv) * | 1995-03-31 | 1995-03-31 | Pharmacia Ab | Protein formulation |
| US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| AUPN801296A0 (en) * | 1996-02-12 | 1996-03-07 | Csl Limited | Stabilised growth hormone formulation and method of preparation thereof |
| US7560107B2 (en) * | 1996-06-26 | 2009-07-14 | 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 |
| EP0852951A1 (de) * | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| US6475725B1 (en) | 1997-06-20 | 2002-11-05 | Baxter Aktiengesellschaft | Recombinant cell clones having increased stability and methods of making and using the same |
| PL198123B1 (pl) * | 1999-02-22 | 2008-05-30 | Baxter Int | Kompozycja czynnika VIII bez dodatku albuminy i jej zastosowanie |
| US20060099685A1 (en) * | 1999-04-15 | 2006-05-11 | Yallop Christopher A | Recombinant expression of factor VIII in human cells |
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| US6413537B1 (en) | 2000-03-10 | 2002-07-02 | Wisconsin Alumni Research Foundation | Nystatin formulation having reduced toxicity |
| GB0207092D0 (en) | 2002-03-26 | 2002-05-08 | Sod Conseils Rech Applic | Stable pharmaceutical composition containing factor VIII |
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| BR112018002150A2 (pt) | 2015-08-03 | 2018-09-18 | Bioverativ Therapeutics Inc | proteínas de fusão do fator ix e métodos de fabricação e uso das mesmas |
| WO2017076967A1 (en) * | 2015-11-05 | 2017-05-11 | Novo Nordisk A/S | Fviii formulation |
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| SG11202010767SA (en) | 2018-05-18 | 2020-11-27 | Bioverativ Therapeutics Inc | Methods of treating hemophilia a |
| US11609042B2 (en) | 2019-03-14 | 2023-03-21 | Terumo Bct Biotechnologies, Llc | Multi-part lyophilization container and method of use |
| KR20220029733A (ko) | 2019-07-04 | 2022-03-08 | 체에스엘 베링 렝나우 아게 | 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf) |
| US11912784B2 (en) | 2019-10-10 | 2024-02-27 | Kodiak Sciences Inc. | Methods of treating an eye disorder |
| CN115768787A (zh) * | 2020-05-22 | 2023-03-07 | 阿法姆海外股份有限公司 | IL1-R1衍生的IL-1β抑制剂及其用途 |
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| BR112023026782A2 (pt) * | 2021-06-23 | 2024-03-12 | Bioverativ Therapeutics Inc | Formulações de proteínas quiméricas de fator viii e usos das mesmas |
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| US4165370A (en) * | 1976-05-21 | 1979-08-21 | Coval M L | Injectable gamma globulin |
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-
1993
- 1993-10-01 CZ CZ19941328A patent/CZ290342B6/cs not_active IP Right Cessation
- 1993-10-01 ES ES93923080T patent/ES2154650T3/es not_active Expired - Lifetime
- 1993-10-01 EP EP99121997A patent/EP1016673B1/en not_active Expired - Lifetime
- 1993-10-01 AT AT93923080T patent/ATE198277T1/de active
- 1993-10-01 DE DE69333974T patent/DE69333974T2/de not_active Expired - Lifetime
- 1993-10-01 EP EP06001883A patent/EP1652534A3/en not_active Withdrawn
- 1993-10-01 PT PT93923080T patent/PT627924E/pt unknown
- 1993-10-01 KR KR1019940701858A patent/KR100303872B1/ko not_active Expired - Lifetime
- 1993-10-01 JP JP50895794A patent/JP3905921B2/ja not_active Expired - Lifetime
- 1993-10-01 AT AT99121997T patent/ATE316981T1/de active
- 1993-10-01 NZ NZ256921A patent/NZ256921A/en not_active IP Right Cessation
- 1993-10-01 MX MX9306133A patent/MX9306133A/es active IP Right Grant
- 1993-10-01 DE DE69329795T patent/DE69329795T2/de not_active Expired - Lifetime
- 1993-10-01 DK DK93923080T patent/DK0627924T3/da active
- 1993-10-01 US US08/244,266 patent/US5733873A/en not_active Expired - Lifetime
- 1993-10-01 CA CA002124690A patent/CA2124690C/en not_active Expired - Lifetime
- 1993-10-01 HU HU9401382A patent/HU220194B/hu unknown
- 1993-10-01 EP EP93923080A patent/EP0627924B1/en not_active Expired - Lifetime
- 1993-10-01 WO PCT/SE1993/000793 patent/WO1994007510A1/en not_active Ceased
- 1993-10-01 SK SK659-94A patent/SK282483B6/sk not_active IP Right Cessation
-
1994
- 1994-06-01 FI FI942573A patent/FI111443B/fi not_active IP Right Cessation
- 1994-06-01 NO NO942033A patent/NO942033L/no not_active Application Discontinuation
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1995
- 1995-06-28 HU HU95P/P00473P patent/HU211670A9/hu unknown
-
1997
- 1997-05-27 US US08/863,198 patent/US5919766A/en not_active Expired - Lifetime
-
2001
- 2001-02-23 GR GR20010400311T patent/GR3035472T3/el unknown
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