ES2220256T1 - Albumina humana terapeutica con baja actividad para la fijacion de aluminio. - Google Patents
Albumina humana terapeutica con baja actividad para la fijacion de aluminio.Info
- Publication number
- ES2220256T1 ES2220256T1 ES04000874T ES04000874T ES2220256T1 ES 2220256 T1 ES2220256 T1 ES 2220256T1 ES 04000874 T ES04000874 T ES 04000874T ES 04000874 T ES04000874 T ES 04000874T ES 2220256 T1 ES2220256 T1 ES 2220256T1
- Authority
- ES
- Spain
- Prior art keywords
- mmol
- less
- therapeutic human
- therapeutic
- albumin solution
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 230000001225 therapeutic effect Effects 0.000 title claims abstract 5
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 title claims abstract 4
- 229910052782 aluminium Inorganic materials 0.000 title claims abstract 4
- 230000000694 effects Effects 0.000 title 1
- 102000009027 Albumins Human genes 0.000 claims abstract 4
- 108010088751 Albumins Proteins 0.000 claims abstract 4
- 102000008100 Human Serum Albumin Human genes 0.000 claims abstract 4
- 108091006905 Human Serum Albumin Proteins 0.000 claims abstract 4
- 239000000203 mixture Substances 0.000 claims abstract 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims abstract 3
- 238000011026 diafiltration Methods 0.000 claims abstract 3
- 239000007858 starting material Substances 0.000 claims abstract 3
- 108010058936 Cohn fraction V Proteins 0.000 claims abstract 2
- 239000011521 glass Substances 0.000 claims abstract 2
- 238000001990 intravenous administration Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
Classifications
-
- 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
- A61K38/38—Albumins
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Gastroenterology & Hepatology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Solución de albúmina humana terapéutica para introducir en viales de vidrio de tipo II en una concentración del 20% o 25% que presenta una baja capacidad para la fijación de aluminio, obtenida por diafiltración a partir de la fracción V de Cohn como material de partida, siendo ajustada la composición final de la solución de albúmina de manera aceptable en cuanto a estabilidad e isotonicidad y que presenta un contenido de citratos en la composición final de albúmina igual o inferior a 0, 5 mmol/l, y preferentemente igual o inferior a 0, 037 mmol/l.
Claims (3)
1. Solución de albúmina humana terapéutica para
introducir en viales de vidrio de tipo II en una concentración del
20% o 25% que presenta una baja capacidad para la fijación de
aluminio, obtenida por diafiltración a partir de la fracción V de
Cohn como material de partida, siendo ajustada la composición final
de la solución de albúmina de manera aceptable en cuanto a
estabilidad e isotonicidad y que presenta un contenido de citratos
en la composición final de albúmina igual o inferior a 0,5 mmol/l, y
preferentemente igual o inferior a 0,037 mmol/l.
2. Procedimiento para preparar una solución de
albúmina humana terapéutica que presenta una baja capacidad de
fijación de aluminio, obtenida a partir de la fracción V de Cohn
como material de partida, que comprende la etapa de diafiltración
hasta que la concentración de citrato es 0,5 mmol/l o menos, y
preferentemente 0,037 mmol/l o menos.
3. Uso de la solución de albúmina humana
terapéutica, según la reivindicación 1, para preparar una
preparación farmacéutica aceptable para administración por vía
intravenosa.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES09600200A ES2103236B1 (es) | 1996-01-30 | 1996-01-30 | Albumina humana terapeutica con baja capacidad para la fijacion de aluminio. |
| ES9600200 | 1996-01-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2220256T1 true ES2220256T1 (es) | 2004-12-16 |
Family
ID=8293596
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES09600200A Expired - Fee Related ES2103236B1 (es) | 1996-01-30 | 1996-01-30 | Albumina humana terapeutica con baja capacidad para la fijacion de aluminio. |
| ES04000874T Pending ES2220256T1 (es) | 1996-01-30 | 1996-12-18 | Albumina humana terapeutica con baja actividad para la fijacion de aluminio. |
| ES96500164T Expired - Lifetime ES2220967T3 (es) | 1996-01-30 | 1996-12-18 | Albumina humana terapeutica con baja capacidad para la fijacion de aliuminio. |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES09600200A Expired - Fee Related ES2103236B1 (es) | 1996-01-30 | 1996-01-30 | Albumina humana terapeutica con baja capacidad para la fijacion de aluminio. |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES96500164T Expired - Lifetime ES2220967T3 (es) | 1996-01-30 | 1996-12-18 | Albumina humana terapeutica con baja capacidad para la fijacion de aliuminio. |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US5846930A (es) |
| EP (2) | EP1413312A3 (es) |
| JP (1) | JP3054371B2 (es) |
| AR (1) | AR005374A1 (es) |
| AT (1) | ATE269717T1 (es) |
| CZ (1) | CZ289782B6 (es) |
| DE (2) | DE69632771T2 (es) |
| DK (1) | DK0787498T3 (es) |
| ES (3) | ES2103236B1 (es) |
| HU (1) | HUP9603601A3 (es) |
| PT (1) | PT787498E (es) |
| SK (1) | SK284297B6 (es) |
| UY (1) | UY24448A1 (es) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AT403989B (de) | 1996-09-16 | 1998-07-27 | Immuno Ag | Verfahren zur herstellung eines plasmaprotein-hältigen arzneimittels |
| DE69929022T2 (de) | 1998-10-21 | 2006-07-13 | Nipro Corp. | Verfahren zur Herstellung eines Kunststoffbehälters für eine Albuminzubereitung |
| US6693173B2 (en) * | 2000-12-26 | 2004-02-17 | Alpha Therapeutic Corporation | Method to remove citrate and aluminum from proteins |
| GB0117879D0 (en) | 2001-07-21 | 2001-09-12 | Common Services Agency | Storage of liquid compositions |
| JP2003040798A (ja) * | 2001-07-26 | 2003-02-13 | Nihon Pharmaceutical Co Ltd | 低アルミニウム含有アルブミン製剤およびその製造法 |
| US6718735B2 (en) * | 2002-03-19 | 2004-04-13 | Baxter International Inc. | Albumin in a flexible polymeric container |
| ES2221817B1 (es) | 2004-07-26 | 2005-10-01 | Probitas Pharma, S.A. | "soluciones de albumina humana terapeutica con baja actividad del activador de precalicreina (pka) y procedimiento de obtencion de las mismas". |
| ES2294976B1 (es) * | 2007-11-12 | 2008-12-16 | Grifols, S.A. | "procedimiento de obtencion de albumina humana de alta eficacia para su uso en terapia de detoxificacion". |
| US12629445B2 (en) | 2020-03-20 | 2026-05-19 | Bard Peripheral Vascular, Inc. | Reactive hydrogel forming formulations and related methods, including methods of preparation |
| US11739166B2 (en) | 2020-07-02 | 2023-08-29 | Davol Inc. | Reactive polysaccharide-based hemostatic agent |
| US12161777B2 (en) | 2020-07-02 | 2024-12-10 | Davol Inc. | Flowable hemostatic suspension |
| WO2022146917A1 (en) | 2020-12-28 | 2022-07-07 | Davol Inc. | Reactive dry powdered hemostatic materials comprising a protein and a multifunctionalized modified polyethylene glycol based crosslinking agent |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE405549B (sv) * | 1975-10-09 | 1978-12-18 | Pharmacia Fine Chemicals Ab | Forfarande for isolering av albumin ur plasmaprodukter genom kromatografisk fraktionering |
| SE500110C2 (sv) * | 1989-06-27 | 1994-04-18 | Kabi Pharmacia Ab | Sätt att rena ett protein från därtill bundna flervärda metalljoner |
| DE69133399T2 (de) * | 1990-04-19 | 2005-06-30 | Bayer Corp. | Methode zur Herstellung von im Wesentlichen monomeren normalen menschlichen Serum-Albumin |
| US5561115A (en) * | 1994-08-10 | 1996-10-01 | Bayer Corporation | Low temperature albumin fractionation using sodium caprylate as a partitioning agent |
| AT403989B (de) * | 1996-09-16 | 1998-07-27 | Immuno Ag | Verfahren zur herstellung eines plasmaprotein-hältigen arzneimittels |
-
1996
- 1996-01-30 ES ES09600200A patent/ES2103236B1/es not_active Expired - Fee Related
- 1996-12-18 AT AT96500164T patent/ATE269717T1/de active
- 1996-12-18 PT PT96500164T patent/PT787498E/pt unknown
- 1996-12-18 DE DE69632771T patent/DE69632771T2/de not_active Expired - Lifetime
- 1996-12-18 DK DK96500164T patent/DK0787498T3/da active
- 1996-12-18 ES ES04000874T patent/ES2220256T1/es active Pending
- 1996-12-18 DE DE0787498T patent/DE787498T1/de active Pending
- 1996-12-18 ES ES96500164T patent/ES2220967T3/es not_active Expired - Lifetime
- 1996-12-18 EP EP04000874A patent/EP1413312A3/en not_active Withdrawn
- 1996-12-18 EP EP96500164A patent/EP0787498B1/en not_active Revoked
- 1996-12-27 HU HU9603601A patent/HUP9603601A3/hu unknown
-
1997
- 1997-01-03 CZ CZ19976A patent/CZ289782B6/cs not_active IP Right Cessation
- 1997-01-07 AR ARP970100050A patent/AR005374A1/es not_active Application Discontinuation
- 1997-01-10 SK SK35-97A patent/SK284297B6/sk not_active IP Right Cessation
- 1997-01-24 UY UY24448A patent/UY24448A1/es not_active IP Right Cessation
- 1997-01-24 US US08/788,275 patent/US5846930A/en not_active Expired - Lifetime
- 1997-01-28 JP JP9013792A patent/JP3054371B2/ja not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CZ289782B6 (cs) | 2002-04-17 |
| EP0787498A3 (en) | 1998-10-21 |
| ES2220967T3 (es) | 2004-12-16 |
| MX9700617A (es) | 1997-07-31 |
| DE69632771D1 (de) | 2004-07-29 |
| PT787498E (pt) | 2004-10-29 |
| EP1413312A2 (en) | 2004-04-28 |
| ES2103236A1 (es) | 1997-09-01 |
| US5846930A (en) | 1998-12-08 |
| SK3597A3 (en) | 1997-08-06 |
| JP3054371B2 (ja) | 2000-06-19 |
| CZ697A3 (en) | 1997-08-13 |
| EP0787498B1 (en) | 2004-06-23 |
| DE69632771T2 (de) | 2005-07-07 |
| EP1413312A3 (en) | 2004-09-01 |
| HUP9603601A3 (en) | 1998-01-28 |
| DK0787498T3 (da) | 2004-10-11 |
| SK284297B6 (sk) | 2005-01-03 |
| EP0787498A2 (en) | 1997-08-06 |
| HU9603601D0 (en) | 1997-02-28 |
| UY24448A1 (es) | 1997-02-18 |
| DE787498T1 (de) | 1999-05-20 |
| JPH09221431A (ja) | 1997-08-26 |
| ATE269717T1 (de) | 2004-07-15 |
| AR005374A1 (es) | 1999-04-28 |
| ES2103236B1 (es) | 1998-04-16 |
| HUP9603601A2 (en) | 1997-08-28 |
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