MX9306133A - Composicion que comprende una formulacion del factor de coagulacion viii, proceso para su preparacion y uso de un surfactante como estabilizador. - Google Patents
Composicion que comprende una formulacion del factor de coagulacion viii, proceso para su preparacion y uso de un surfactante como estabilizador.Info
- Publication number
- MX9306133A MX9306133A MX9306133A MX9306133A MX9306133A MX 9306133 A MX9306133 A MX 9306133A MX 9306133 A MX9306133 A MX 9306133A MX 9306133 A MX9306133 A MX 9306133A MX 9306133 A MX9306133 A MX 9306133A
- Authority
- MX
- Mexico
- Prior art keywords
- stabilizer
- preparation
- composition
- surfactant
- formulation
- Prior art date
Links
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
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- 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
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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
- A61K47/02—Inorganic compounds
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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
- A61K47/26—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
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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- 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
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- 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
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- 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
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- 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)
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- 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
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- 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)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Wood Science & Technology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Microbiology (AREA)
- Immunology (AREA)
- Biotechnology (AREA)
- Biophysics (AREA)
- Toxicology (AREA)
- General Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Biomedical Technology (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)
- Detergent Compositions (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
La presente invención se relaciona con composiciones novedosas que comprenden el factor de coagulación VIII y un surfactante no iónico tal como copolímeros de bloque, por ejemplo ésteres de ácido graso de polioxámeros o polioxietilén (20) sorbitán, por ejemplo polisorbato 20 o polisorbato 80, como estabilizador. La composición también puede comprender cloruro de sodio, cloruro de calcio, L-histidina y/o azúcares o alcoholes de azúcar. La invención también se relaciona con el uso de surfactante no iónico como estabilizador para una composición que comprende el factor de coagulación VIII.
Applications Claiming Priority (3)
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 |
Publications (1)
Publication Number | Publication Date |
---|---|
MX9306133A true MX9306133A (es) | 1994-04-29 |
Family
ID=27355693
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX9306133A MX9306133A (es) | 1992-10-02 | 1993-10-01 | Composicion que comprende una formulacion del factor de coagulacion viii, proceso para su preparacion y uso de un surfactante como estabilizador. |
Country Status (19)
Country | Link |
---|---|
US (2) | US5733873A (es) |
EP (3) | EP1016673B1 (es) |
JP (1) | JP3905921B2 (es) |
KR (1) | KR100303872B1 (es) |
AT (2) | ATE316981T1 (es) |
CA (1) | CA2124690C (es) |
CZ (1) | CZ290342B6 (es) |
DE (2) | DE69333974T2 (es) |
DK (1) | DK0627924T3 (es) |
ES (1) | ES2154650T3 (es) |
FI (1) | FI111443B (es) |
GR (1) | GR3035472T3 (es) |
HU (2) | HU220194B (es) |
MX (1) | MX9306133A (es) |
NO (1) | NO942033D0 (es) |
NZ (1) | NZ256921A (es) |
PT (1) | PT627924E (es) |
SK (1) | SK282483B6 (es) |
WO (1) | WO1994007510A1 (es) |
Families Citing this family (97)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK0627924T3 (da) * | 1992-10-02 | 2001-04-30 | Genetics Inst | Sammensætning, der omfatter koagulationsfaktor VIII formulering, fremgangsmåde til dens fremstilling og anvendelse af et overfladeaktivt middel som stabilisator |
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 |
IL113010A (en) * | 1994-03-31 | 1999-10-28 | Pharmacia & Upjohn Ab | Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/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 |
US7244824B2 (en) | 1995-01-19 | 2007-07-17 | Quadrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
GB9501040D0 (en) * | 1995-01-19 | 1995-03-08 | Quadrant Holdings Cambridge | Dried composition |
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 |
BR0008405B1 (pt) * | 1999-02-22 | 2014-04-22 | Baxter Int | 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 |
US20060099685A1 (en) * | 1999-04-15 | 2006-05-11 | Yallop Christopher A | Recombinant expression of factor VIII in human cells |
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US11604026B2 (en) | 2019-03-14 | 2023-03-14 | Terumo Bct Biotechnologies, Llc | Lyophilization loading tray assembly and system |
KR20220029733A (ko) | 2019-07-04 | 2022-03-08 | 체에스엘 베링 렝나우 아게 | 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf) |
JP2022553640A (ja) | 2019-10-10 | 2022-12-26 | コディアック サイエンシーズ インコーポレイテッド | 眼障害を処置する方法 |
EP4153613A4 (en) * | 2020-05-22 | 2024-01-24 | R-Pharm Overseas, Inc. | IL-1-R1 DERIVED INHIBITOR OF IL-1B AND ITS USE |
WO2022099223A2 (en) | 2020-11-09 | 2022-05-12 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
JP2024522855A (ja) * | 2021-06-23 | 2024-06-21 | 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因子キメラタンパク質の製剤およびその使用 |
KR20240082408A (ko) * | 2021-10-15 | 2024-06-10 | 바이오버라티브 테라퓨틱스 인크. | 인자 viii 키메라 단백질의 제형 및 이의 용도 |
CN116350801A (zh) * | 2022-11-22 | 2023-06-30 | 四川至善唯新生物科技有限公司 | 一种重组腺相关病毒载体的药物组合物及其用途 |
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US4165370A (en) * | 1976-05-21 | 1979-08-21 | Coval M L | Injectable gamma globulin |
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DE3176491D1 (en) * | 1980-03-05 | 1987-11-26 | Miles Lab | Pasteurized therapeutically active protein compositions |
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DE4111393A1 (de) * | 1991-04-09 | 1992-10-15 | Behringwerke Ag | Stabilisierte faktor viii-praeparationen |
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1993
- 1993-10-01 DK DK93923080T patent/DK0627924T3/da active
- 1993-10-01 EP EP99121997A patent/EP1016673B1/en not_active Expired - Lifetime
- 1993-10-01 PT PT93923080T patent/PT627924E/pt unknown
- 1993-10-01 AT AT99121997T patent/ATE316981T1/de active
- 1993-10-01 CZ CZ19941328A patent/CZ290342B6/cs not_active IP Right Cessation
- 1993-10-01 NZ NZ256921A patent/NZ256921A/en not_active IP Right Cessation
- 1993-10-01 KR KR1019940701858A patent/KR100303872B1/ko not_active IP Right Cessation
- 1993-10-01 MX MX9306133A patent/MX9306133A/es active IP Right Grant
- 1993-10-01 DE DE69333974T patent/DE69333974T2/de not_active Expired - Lifetime
- 1993-10-01 JP JP50895794A patent/JP3905921B2/ja not_active Expired - Lifetime
- 1993-10-01 AT AT93923080T patent/ATE198277T1/de active
- 1993-10-01 WO PCT/SE1993/000793 patent/WO1994007510A1/en active IP Right Grant
- 1993-10-01 HU HU9401382A patent/HU220194B/hu unknown
- 1993-10-01 ES ES93923080T patent/ES2154650T3/es not_active Expired - Lifetime
- 1993-10-01 EP EP06001883A patent/EP1652534A3/en not_active Withdrawn
- 1993-10-01 DE DE69329795T patent/DE69329795T2/de not_active Expired - Lifetime
- 1993-10-01 US US08/244,266 patent/US5733873A/en not_active Expired - Lifetime
- 1993-10-01 SK SK659-94A patent/SK282483B6/sk not_active IP Right Cessation
- 1993-10-01 EP EP93923080A patent/EP0627924B1/en not_active Expired - Lifetime
- 1993-10-01 CA CA002124690A patent/CA2124690C/en not_active Expired - Lifetime
-
1994
- 1994-06-01 FI FI942573A patent/FI111443B/fi not_active IP Right Cessation
- 1994-06-01 NO NO942033A patent/NO942033D0/no not_active Application Discontinuation
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1995
- 1995-06-28 HU HU95P/P00473P patent/HU211670A9/hu unknown
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1997
- 1997-05-27 US US08/863,198 patent/US5919766A/en not_active Expired - Lifetime
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2001
- 2001-02-23 GR GR20010400311T patent/GR3035472T3/el unknown
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