AR094481A1 - Formulaciones de albu-bche (albúmina-butirilcolinesterasa), preparación y sus usos - Google Patents
Formulaciones de albu-bche (albúmina-butirilcolinesterasa), preparación y sus usosInfo
- Publication number
- AR094481A1 AR094481A1 ARP140100135A ARP140100135A AR094481A1 AR 094481 A1 AR094481 A1 AR 094481A1 AR P140100135 A ARP140100135 A AR P140100135A AR P140100135 A ARP140100135 A AR P140100135A AR 094481 A1 AR094481 A1 AR 094481A1
- Authority
- AR
- Argentina
- Prior art keywords
- pharmaceutical composition
- fusion protein
- lyophilized
- aqueous
- trehalose
- Prior art date
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/04—Methods of, or means for, filling the material into the containers or receptacles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
-
- 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
- A61K38/385—Serum albumin
-
- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Addiction (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Mechanical Engineering (AREA)
- Psychiatry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
Una composición farmacéutica acuosa que comprende la proteína de fusión cuya secuencia de aminoácidos se indica como SEQ ID Nº 1 y una solución acuosa que comprende entre 40 y 60 mM de fosfato de sodio. La presente además provee una composición farmacéutica liofilizada, una solución reconstituida, un envase sellado que comprende la composición farmacéutica liofilizada, y un vial que comprende el fármaco liofilizado o la solución reconstituida. La presente también provee un método para producir la composición farmacéutica liofilizada y el envase sellado. La presente también provee un método para tratar un humano que tiene ansia de consumo de cocaína, y métodos para usar la composición farmacéutica acuosa y composición farmacéutica liofilizada. Reivindicación 2: La composición farmacéutica acuosa de la reivindicación 1, caracterizada porque además comprende uno o más de entre 100 y 150 mM de manitol, entre 20 y 40 mM de trehalosa o entre 0,02 y 0,05 por ciento de polisorbato 80. Reivindicación 3: La composición farmacéutica acuosa de la reivindicación 2, caracterizada porque comprende (a) la proteína de fusión, 50 mM de fosfato de sodio, manitol 115 mM, trehalosa 35 mM, y 0,03 por ciento de polisorbato 80, o (b) la proteína de fusión, 2,2 mg/mI de fosfato monobásico de sodio, 4,9 mg/ml de fosfato dibásico de sodio, 21 mg/ml de manitol, 13 mg/mI de trehalosa, y 0,3 mg/ml de polisorbato 80. Reivindicación 4: La composición farmacéutica acuosa de cualquiera de las reivindicaciones 1 a 3, caracterizada porque la concentración de la proteína de fusión es (a) entre 80 y 120 mg/mI, o (b) 100 mg/mI.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361752740P | 2013-01-15 | 2013-01-15 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR094481A1 true AR094481A1 (es) | 2015-08-05 |
Family
ID=51165300
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP140100135A AR094481A1 (es) | 2013-01-15 | 2014-01-14 | Formulaciones de albu-bche (albúmina-butirilcolinesterasa), preparación y sus usos |
Country Status (7)
Country | Link |
---|---|
US (1) | US9409662B2 (es) |
EP (1) | EP2945703A4 (es) |
AR (1) | AR094481A1 (es) |
CA (1) | CA2896793A1 (es) |
HK (1) | HK1217670A1 (es) |
MX (1) | MX2015009141A (es) |
WO (1) | WO2014113359A1 (es) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2945703A4 (en) | 2013-01-15 | 2016-08-31 | Teva Pharma | ALBU-BCHE FORMULATIONS, PREPARATION THEREOF AND USES THEREOF |
US11178899B2 (en) * | 2015-07-13 | 2021-11-23 | Philip Morris Products S.A. | Producing an aerosol-forming composition |
Family Cites Families (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ATE100210T1 (de) | 1988-11-01 | 1994-01-15 | Sanol Arznei Schwarz Gmbh | Lyophilisiertes mdm enthaltende zusammensetzung und verfahren zu deren herstellung. |
US6001625A (en) | 1995-05-19 | 1999-12-14 | The United States Of America As Represented By The Secretary Of The Army | Site-directed mutagenesis of esterases |
GB9526733D0 (en) | 1995-12-30 | 1996-02-28 | Delta Biotechnology Ltd | Fusion proteins |
WO2001079442A2 (en) | 2000-04-12 | 2001-10-25 | Human Genome Sciences, Inc. | Albumin fusion proteins |
US20030096401A1 (en) | 2000-11-28 | 2003-05-22 | Huse William D. | Eukaryotic expression libraries and methods of use |
EP1337631A2 (en) | 2000-11-28 | 2003-08-27 | Applied Molecular Evolution, Inc. | Eukaryotic expression libraries based on double lox recombination and methods of use |
US7271149B2 (en) | 2000-12-07 | 2007-09-18 | Eli Lilly And Company | GLP-1 fusion proteins |
US7070973B2 (en) | 2000-12-26 | 2006-07-04 | Board Of Regents Of The University Of Nebraska | Butyrylcholinesterase variants and methods of use |
US20030153062A1 (en) | 2001-12-20 | 2003-08-14 | Watkins Jeffry D. | Butyrylcholinesterase variant polypeptides with increased catalytic efficiency and methods of use |
IL142875A (en) | 2001-04-30 | 2009-08-03 | Avigdor Shafferman | PEG-linked cholinesterases for the detoxification of circulating organophosphorus |
US6989261B2 (en) | 2001-12-20 | 2006-01-24 | Eli Lilly And Company | Butyrylcholinesterase variant polypeptides with increased catalytic efficiency and methods of use |
US7049121B2 (en) | 2001-12-20 | 2006-05-23 | Applied Molecular Evolution | Butyrylcholinesterase variant polypeptides with increased catalytic efficiency and methods of use |
US20080194481A1 (en) * | 2001-12-21 | 2008-08-14 | Human Genome Sciences, Inc. | Albumin Fusion Proteins |
ES2500918T3 (es) | 2001-12-21 | 2014-10-01 | Human Genome Sciences, Inc. | Proteínas de fusión de albúmina e interferón beta |
AU2002353374A1 (en) | 2001-12-21 | 2003-07-09 | Nexia Biotechnologies, Inc. | Production of butyrylcholinesterases in transgenic mammals |
WO2003059934A2 (en) | 2001-12-21 | 2003-07-24 | Human Genome Sciences, Inc. | Albumin fusion proteins |
US20050136044A1 (en) | 2003-12-04 | 2005-06-23 | Watkins Jeffry D. | Butyrylcholinesterase variants that alter the activity of chemotherapeutic agents |
US20060039870A1 (en) | 2004-08-20 | 2006-02-23 | Turner Jeffrey D | Pulmonary delivery of enzymatic medical countermeasures |
ES2788699T3 (es) | 2004-08-30 | 2020-10-22 | Ipsen Biopharmaceuticals Inc | Procedimiento y dispositivo para diagnosticar y tratar trastornos de deficiencia del factor de crecimiento similar a la insulina |
WO2006119280A2 (en) | 2005-05-03 | 2006-11-09 | Handylab, Inc. | Lyophilized pellets |
US7438904B1 (en) | 2005-10-04 | 2008-10-21 | University Of Kentucky Research Foundation | High-activity mutants of butyrylcholinesterase for cocaine hydrolysis and method of generating the same |
AU2007258609B2 (en) | 2006-06-07 | 2013-01-24 | Human Genome Sciences, Inc. | Albumin fusion proteins |
US8318156B2 (en) | 2006-07-10 | 2012-11-27 | The Trustees Of Columbia University In The City Of New York | Anti-cocaine compositions and treatment |
JP5753095B2 (ja) * | 2009-01-16 | 2015-07-22 | テバ ファーマシューティカル インダストリーズ リミテッド | 組換えヒトアルブミン−ヒト顆粒球コロニー刺激因子融合タンパク質の安定な製剤 |
AR078161A1 (es) | 2009-09-11 | 2011-10-19 | Hoffmann La Roche | Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento. |
EP2826489A1 (en) | 2009-12-08 | 2015-01-21 | Teva Pharmaceutical Industries, Ltd. | BChE albumin fusions for the treatment of cocaine abuse |
US20140030321A1 (en) | 2011-04-12 | 2014-01-30 | Endocyte, Inc. | Solid pharmaceutical composition |
EA201591108A1 (ru) | 2012-12-12 | 2015-11-30 | Тева Фармасьютикал Индастриз Лтд. | Слитый гормон роста человека и альбумин, составы и их применения |
EP2945703A4 (en) | 2013-01-15 | 2016-08-31 | Teva Pharma | ALBU-BCHE FORMULATIONS, PREPARATION THEREOF AND USES THEREOF |
US20140199286A1 (en) | 2013-01-15 | 2014-07-17 | Teva Pharmaceutical Industries, Ltd. | Lyophilization process |
-
2014
- 2014-01-14 EP EP14740413.1A patent/EP2945703A4/en not_active Withdrawn
- 2014-01-14 CA CA2896793A patent/CA2896793A1/en not_active Abandoned
- 2014-01-14 AR ARP140100135A patent/AR094481A1/es unknown
- 2014-01-14 WO PCT/US2014/011401 patent/WO2014113359A1/en active Application Filing
- 2014-01-14 US US14/155,021 patent/US9409662B2/en not_active Expired - Fee Related
- 2014-01-14 MX MX2015009141A patent/MX2015009141A/es unknown
-
2016
- 2016-05-17 HK HK16105646.9A patent/HK1217670A1/zh unknown
Also Published As
Publication number | Publication date |
---|---|
EP2945703A4 (en) | 2016-08-31 |
HK1217670A1 (zh) | 2017-01-20 |
US20140199283A1 (en) | 2014-07-17 |
US9409662B2 (en) | 2016-08-09 |
WO2014113359A1 (en) | 2014-07-24 |
CA2896793A1 (en) | 2014-07-24 |
MX2015009141A (es) | 2016-03-16 |
EP2945703A1 (en) | 2015-11-25 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
FB | Suspension of granting procedure |