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
- 239000000203 mixture Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 9
- 108020001507 fusion proteins Proteins 0.000 abstract 4
- 102000037865 fusion proteins Human genes 0.000 abstract 4
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 3
- 229930195725 Mannitol Natural products 0.000 abstract 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 3
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 3
- 239000000594 mannitol Substances 0.000 abstract 3
- 235000010355 mannitol Nutrition 0.000 abstract 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 3
- 229920000053 polysorbate 80 Polymers 0.000 abstract 3
- 229940068968 polysorbate 80 Drugs 0.000 abstract 3
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 abstract 2
- 229910019142 PO4 Inorganic materials 0.000 abstract 2
- ZPUCINDJVBIVPJ-LJISPDSOSA-N cocaine Chemical compound O([C@H]1C[C@@H]2CC[C@@H](N2C)[C@H]1C(=O)OC)C(=O)C1=CC=CC=C1 ZPUCINDJVBIVPJ-LJISPDSOSA-N 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 abstract 2
- 239000010452 phosphate Substances 0.000 abstract 2
- 229910052708 sodium Inorganic materials 0.000 abstract 2
- 239000011734 sodium Substances 0.000 abstract 2
- 239000001488 sodium phosphate Substances 0.000 abstract 2
- 229910000162 sodium phosphate Inorganic materials 0.000 abstract 2
- 239000000243 solution Substances 0.000 abstract 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 abstract 2
- 125000003275 alpha amino acid group Chemical group 0.000 abstract 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 229960003920 cocaine Drugs 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Addiction (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 |
|---|---|---|---|---|
| CA2896793A1 (en) | 2013-01-15 | 2014-07-24 | Teva Pharmaceutical Industries Ltd. | Formulations of albu-bche, preparation 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 |
|---|---|---|---|---|
| DE68912270T2 (de) | 1988-11-01 | 1994-04-28 | 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 |
| WO2001077137A1 (en) | 2000-04-12 | 2001-10-18 | Human Genome Sciences, Inc. | Albumin fusion proteins |
| CA2430080A1 (en) | 2000-11-28 | 2002-06-06 | Applied Molecular Evolution, Inc. | Eukaryotic expression libraries based on double lox recombination and methods of use |
| US20030096401A1 (en) | 2000-11-28 | 2003-05-22 | Huse William D. | Eukaryotic expression libraries and methods of use |
| BR0116024A (pt) | 2000-12-07 | 2005-12-13 | Lilly Co Eli | Proteìna de fusão heteróloga e uso da mesma |
| 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 |
| WO2003054182A2 (en) | 2001-12-21 | 2003-07-03 | Nexia Biotechnologies, Inc. | Production of butyrylcholinesterases in transgenic mammals |
| CA2484556A1 (en) | 2001-12-21 | 2003-07-24 | Human Genome Sciences, Inc. | Albumin fusion proteins |
| EP2277889B1 (en) | 2001-12-21 | 2014-07-09 | Human Genome Sciences, Inc. | Fusion proteins of albumin and interferon beta |
| US20080194481A1 (en) | 2001-12-21 | 2008-08-14 | 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 |
| CA2577017A1 (en) | 2004-08-30 | 2006-03-09 | Tercica, Inc. | Method and device for diagnosing and treating insulin-like growth factor deficiency disorders |
| US20070259348A1 (en) | 2005-05-03 | 2007-11-08 | 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 |
| WO2007146038A2 (en) | 2006-06-07 | 2007-12-21 | Human Genome Sciences, Inc. | Albumin fusion proteins |
| CA2657246C (en) | 2006-07-10 | 2017-10-31 | Donald Landry | Anti-cocaine compositions and treatment |
| JP2012515222A (ja) * | 2009-01-16 | 2012-07-05 | 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. |
| EP2509616A4 (en) | 2009-12-08 | 2013-05-29 | Teva Pharma | BCHE-ALBUMIN FUSION PROTEINS FOR THE TREATMENT OF COCAINOMANIA |
| WO2012142281A1 (en) | 2011-04-12 | 2012-10-18 | Endocyte, Inc. | Solid pharmaceutical composition |
| KR20150106887A (ko) | 2012-12-12 | 2015-09-22 | 테바 파마슈티컬 인더스트리즈 리미티드 | 인간 성장 호르몬과 알부민의 융합, 이의 제형 및 용도 |
| CA2896793A1 (en) | 2013-01-15 | 2014-07-24 | Teva Pharmaceutical Industries Ltd. | Formulations of albu-bche, preparation and uses thereof |
| EP2945593A4 (en) | 2013-01-15 | 2016-08-31 | Teva Pharma | METHOD OF LYOPHILIZATION |
-
2014
- 2014-01-14 CA CA2896793A patent/CA2896793A1/en not_active Abandoned
- 2014-01-14 US US14/155,021 patent/US9409662B2/en not_active Expired - Fee Related
- 2014-01-14 HK HK16105646.9A patent/HK1217670A1/zh unknown
- 2014-01-14 MX MX2015009141A patent/MX2015009141A/es unknown
- 2014-01-14 AR ARP140100135A patent/AR094481A1/es unknown
- 2014-01-14 WO PCT/US2014/011401 patent/WO2014113359A1/en not_active Ceased
- 2014-01-14 EP EP14740413.1A patent/EP2945703A4/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| MX2015009141A (es) | 2016-03-16 |
| EP2945703A4 (en) | 2016-08-31 |
| US9409662B2 (en) | 2016-08-09 |
| US20140199283A1 (en) | 2014-07-17 |
| EP2945703A1 (en) | 2015-11-25 |
| WO2014113359A1 (en) | 2014-07-24 |
| CA2896793A1 (en) | 2014-07-24 |
| HK1217670A1 (zh) | 2017-01-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |