BR9809304B1 - formulação liofilizada estável, processo para preparação da mesma, bem como forma de dosagem unitária. - Google Patents
formulação liofilizada estável, processo para preparação da mesma, bem como forma de dosagem unitária. Download PDFInfo
- Publication number
- BR9809304B1 BR9809304B1 BRPI9809304-5A BR9809304A BR9809304B1 BR 9809304 B1 BR9809304 B1 BR 9809304B1 BR 9809304 A BR9809304 A BR 9809304A BR 9809304 B1 BR9809304 B1 BR 9809304B1
- Authority
- BR
- Brazil
- Prior art keywords
- formulation
- apc
- sucrose
- activated protein
- protein
- Prior art date
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- 229940046010 vitamin k Drugs 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
-
- 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)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4866—Protein C (3.4.21.69)
-
- 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
-
- 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
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
-
- 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
- C12N9/14—Hydrolases (3)
- C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
- C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
- C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
- C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
- C12N9/6424—Serine endopeptidases (3.4.21)
- C12N9/6464—Protein C (3.4.21.69)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21069—Protein C activated (3.4.21.69)
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Genetics & Genomics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biotechnology (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Vascular Medicine (AREA)
- Gastroenterology & Hepatology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Urology & Nephrology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US4525597P | 1997-04-28 | 1997-04-28 | |
| US60/045,255 | 1997-04-28 | ||
| PCT/US1998/008386 WO1998048818A1 (en) | 1997-04-28 | 1998-04-24 | Activated protein c formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR9809304A BR9809304A (pt) | 2000-10-17 |
| BR9809304B1 true BR9809304B1 (pt) | 2011-02-08 |
Family
ID=21936854
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI9809304-5A BR9809304B1 (pt) | 1997-04-28 | 1998-04-24 | formulação liofilizada estável, processo para preparação da mesma, bem como forma de dosagem unitária. |
| BR9809292-8A BR9809292A (pt) | 1997-04-28 | 1998-04-24 | Métodos aperfeiçoados para o processamento de proteìna c ativada |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR9809292-8A BR9809292A (pt) | 1997-04-28 | 1998-04-24 | Métodos aperfeiçoados para o processamento de proteìna c ativada |
Country Status (34)
| Country | Link |
|---|---|
| US (4) | US6159468A (https=) |
| EP (2) | EP0875252B1 (https=) |
| JP (2) | JP4383547B2 (https=) |
| KR (2) | KR100450856B1 (https=) |
| CN (2) | CN1227025C (https=) |
| AR (2) | AR015598A1 (https=) |
| AT (1) | ATE285788T1 (https=) |
| AU (2) | AU743531B2 (https=) |
| BR (2) | BR9809304B1 (https=) |
| CA (2) | CA2287267C (https=) |
| CO (2) | CO4940438A1 (https=) |
| CZ (1) | CZ298429B6 (https=) |
| DE (1) | DE69828330T2 (https=) |
| DK (1) | DK0875252T3 (https=) |
| EA (2) | EA004881B1 (https=) |
| EG (1) | EG23685A (https=) |
| ES (1) | ES2234072T3 (https=) |
| HU (2) | HUP0003401A3 (https=) |
| ID (2) | ID22933A (https=) |
| IL (2) | IL132502A0 (https=) |
| IN (2) | IN187157B (https=) |
| MY (2) | MY118591A (https=) |
| NO (2) | NO995134L (https=) |
| NZ (2) | NZ500346A (https=) |
| PE (2) | PE86299A1 (https=) |
| PL (2) | PL195642B1 (https=) |
| PT (1) | PT875252E (https=) |
| SI (1) | SI0875252T1 (https=) |
| SV (2) | SV1998000050A (https=) |
| TR (2) | TR199902631T2 (https=) |
| TW (2) | TW585871B (https=) |
| UA (2) | UA55448C2 (https=) |
| WO (2) | WO1998048822A1 (https=) |
| ZA (2) | ZA983497B (https=) |
Families Citing this family (61)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6630137B1 (en) | 1997-04-28 | 2003-10-07 | Eli Lilly And Company | Activated protein C formulations |
| CZ298429B6 (cs) * | 1997-04-28 | 2007-10-03 | Eli Lilly And Company | Stabilní lyofilizovaný prostredek |
| HUP0001237A3 (en) * | 1997-10-20 | 2002-01-28 | Lilly Co Eli | Methods for treating vascular disorders |
| US6815533B1 (en) | 1998-07-31 | 2004-11-09 | Eli Lilly And Company | Cryogranulation of activated protein C |
| CN1326355A (zh) * | 1998-11-13 | 2001-12-12 | 伊莱利利公司 | 治疗肝素诱导的血小板减少症的方法 |
| CA2351470A1 (en) * | 1998-11-20 | 2000-06-02 | Charles Jack Fisher | Method of treating viral hemorrhagic fever |
| ATE232739T1 (de) * | 1998-11-23 | 2003-03-15 | Lilly Co Eli | Protein c zur behandlung von sichelzellanämie und thalassämie |
| CN1329503A (zh) * | 1998-12-10 | 2002-01-02 | 伊莱利利公司 | 治疗血小板减少性紫癜和溶血性尿毒综合征的方法 |
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| AU2001262939A1 (en) * | 2000-05-24 | 2001-12-03 | Eli Lilly And Company | Formulations and use of activated protein c and protein c zymogen for treating hypercoagulable states |
| WO2002069232A2 (en) | 2001-02-19 | 2002-09-06 | Merck Patent Gmbh | Method for identification of t-cell epitopes and use for preparing molecules with reeduced immunogenicity |
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| EP1453529A4 (en) | 2001-09-19 | 2007-09-26 | Oklahoma Med Res Found | TREATMENT OF SEPSIS WITH TAFI |
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| EP1485121A4 (en) * | 2002-03-08 | 2007-11-07 | Lilly Co Eli | ACTIVE C PROTEIN FORMULATIONS |
| CN1671410B (zh) | 2002-06-21 | 2010-05-12 | 诺和诺德医疗保健公司 | 因子ⅶ多肽的稳定化固体组合物 |
| RU2329823C2 (ru) * | 2002-10-29 | 2008-07-27 | Алза Корпорейшн | Стабилизированные твердые полипептидные частицы |
| US20070142272A1 (en) * | 2003-01-24 | 2007-06-21 | Zlokovic Berislav V | Neuroprotective activity of activated protein c independent of its anticoagulant activity |
| US7897734B2 (en) | 2003-03-26 | 2011-03-01 | Novo Nordisk Healthcare Ag | Method for the production of proteins |
| EP1641487B1 (en) * | 2003-06-25 | 2012-02-29 | Novo Nordisk Health Care AG | Liquid composition of factor vii polypeptides |
| EP1729791A2 (en) * | 2004-03-17 | 2006-12-13 | Chiron Corporation | Treatment of severe community-acquired pneumonia by admistration of tissue factor pathway inhibitor (tfpi) |
| JP2008507561A (ja) * | 2004-07-23 | 2008-03-13 | ザ ユニバーシティ オブ ロチェスター | 活性化プロテインｃによる、脳内のプラスミノゲン活性化因子の不都合な作用の阻害 |
| US20090148458A1 (en) * | 2005-06-23 | 2009-06-11 | The University Of British Columbia | Coagulation factor iii polymorphisms associated with prediction of subject outcome and response to therapy |
| EP2029740B1 (en) * | 2006-05-31 | 2012-06-20 | Genzyme Corporation | Use of polysaccharides for promotion of enzymatic activity |
| CA2654761A1 (en) * | 2006-06-09 | 2007-12-13 | The University Of British Columbia | Interferon gamma polymorphisms as indicators of subject outcome in critically ill subjects |
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| RU2476442C2 (ru) | 2007-03-29 | 2013-02-27 | Эббот Лэборетриз | Кристаллические антитела против il-12 человека |
| US8420081B2 (en) * | 2007-11-30 | 2013-04-16 | Abbvie, Inc. | Antibody formulations and methods of making same |
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| US20110171200A1 (en) * | 2008-01-15 | 2011-07-14 | Walley Keith R | Protein c rs2069915 as a response predictor to survival and administration of activated protein c or protein c-like compound |
| RU2011126338A (ru) * | 2008-11-28 | 2013-01-10 | Эбботт Лэборетриз | Стабильные композиции антител и способы их стабилизации |
| WO2012068519A2 (en) | 2010-11-19 | 2012-05-24 | Sirius Genomics Inc. | Markers associated with response to activated protein c administration, and uses thereof |
| US9062106B2 (en) | 2011-04-27 | 2015-06-23 | Abbvie Inc. | Methods for controlling the galactosylation profile of recombinantly-expressed proteins |
| WO2013151727A1 (en) | 2012-04-03 | 2013-10-10 | Smith Medical Asd, Inc. | Heparin-bulking agent compositions and methods thereof |
| WO2013158273A1 (en) | 2012-04-20 | 2013-10-24 | Abbvie Inc. | Methods to modulate c-terminal lysine variant distribution |
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| JP6273272B2 (ja) | 2012-07-04 | 2018-01-31 | ジージー バイオテック エルエルシー | 炎症性皮膚障害の治療 |
| HK1211981A1 (en) | 2012-09-02 | 2016-06-03 | Abbvie Inc. | Methods to control protein heterogeneity |
| US9512214B2 (en) | 2012-09-02 | 2016-12-06 | Abbvie, Inc. | Methods to control protein heterogeneity |
| HK1207960A1 (en) | 2013-03-12 | 2016-02-19 | Abbvie Inc. | Human antibodies that bind human tnf-alpha and methods of preparing the same |
| US9499614B2 (en) | 2013-03-14 | 2016-11-22 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides |
| US9017687B1 (en) | 2013-10-18 | 2015-04-28 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same using displacement chromatography |
| WO2014159579A1 (en) | 2013-03-14 | 2014-10-02 | Abbvie Inc. | MUTATED ANTI-TNFα ANTIBODIES AND METHODS OF THEIR USE |
| US9598667B2 (en) | 2013-10-04 | 2017-03-21 | Abbvie Inc. | Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins |
| US9181337B2 (en) | 2013-10-18 | 2015-11-10 | Abbvie, Inc. | Modulated lysine variant species compositions and methods for producing and using the same |
| US9085618B2 (en) | 2013-10-18 | 2015-07-21 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same |
| US8946395B1 (en) | 2013-10-18 | 2015-02-03 | Abbvie Inc. | Purification of proteins using hydrophobic interaction chromatography |
| US20150139988A1 (en) | 2013-11-15 | 2015-05-21 | Abbvie, Inc. | Glycoengineered binding protein compositions |
| JP2017513944A (ja) | 2014-04-16 | 2017-06-01 | ジージー バイオテック エルエルシー | 異常な皮膚瘢痕化の治療 |
| CA2946032C (en) | 2014-04-16 | 2022-06-14 | Zz Biotech Llc | Use of apc analogue for wound healing |
| US11058750B2 (en) | 2015-12-03 | 2021-07-13 | Mor Research Applications Ltd. | Compositions and methods for treatment of ocular diseases |
| CN109640961B (zh) * | 2016-06-01 | 2021-11-02 | 施维雅知识产权英国有限公司 | 聚亚烷基氧化物-天冬酰胺酶制剂及其制备和使用方法 |
| CN108159399B (zh) * | 2017-12-29 | 2020-07-24 | 华中科技大学同济医学院附属同济医院 | 一种凝血蛋白酶aPC在防治糖尿病心肌病药物中的应用 |
| WO2023119230A1 (en) | 2021-12-22 | 2023-06-29 | L'oreal | Coagulation pathway and nicotinamide-adenine dinucleotide pathway modulating compositions and methods of their use |
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| US4775624A (en) * | 1985-02-08 | 1988-10-04 | Eli Lilly And Company | Vectors and compounds for expression of human protein C |
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| AT399095B (de) * | 1986-03-27 | 1995-03-27 | Vukovich Thomas Dr | Verfahren zur auftrennung von proteinen mittels gradientenelution und vorrichtung zur durchführung des verfahrens |
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| CA1329760C (en) * | 1987-10-29 | 1994-05-24 | Ted C. K. Lee | Plasma and recombinant protein formulations in high ionic strength media |
| US4877608A (en) * | 1987-11-09 | 1989-10-31 | Rorer Pharmaceutical Corporation | Pharmaceutical plasma protein formulations in low ionic strength media |
| US4992373A (en) * | 1987-12-04 | 1991-02-12 | Eli Lilly And Company | Vectors and compounds for direct expression of activated human protein C |
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-
1998
- 1998-04-24 CZ CZ0381099A patent/CZ298429B6/cs not_active IP Right Cessation
- 1998-04-24 EA EA199900979A patent/EA004881B1/ru not_active IP Right Cessation
- 1998-04-24 AR ARP980101909A patent/AR015598A1/es active IP Right Grant
- 1998-04-24 CA CA002287267A patent/CA2287267C/en not_active Expired - Fee Related
- 1998-04-24 US US09/065,975 patent/US6159468A/en not_active Expired - Lifetime
- 1998-04-24 AR ARP980101908A patent/AR012010A1/es active IP Right Grant
- 1998-04-24 PE PE1998000309A patent/PE86299A1/es not_active Application Discontinuation
- 1998-04-24 WO PCT/US1998/008384 patent/WO1998048822A1/en not_active Ceased
- 1998-04-24 HU HU0003401A patent/HUP0003401A3/hu unknown
- 1998-04-24 KR KR10-1999-7009933A patent/KR100450856B1/ko not_active Expired - Fee Related
- 1998-04-24 CO CO98022605A patent/CO4940438A1/es unknown
- 1998-04-24 UA UA99105884A patent/UA55448C2/uk unknown
- 1998-04-24 NZ NZ500346A patent/NZ500346A/en unknown
- 1998-04-24 CO CO98022609A patent/CO4950523A1/es unknown
- 1998-04-24 TR TR1999/02631T patent/TR199902631T2/xx unknown
- 1998-04-24 PL PL98336420A patent/PL195642B1/pl unknown
- 1998-04-24 JP JP54722198A patent/JP4383547B2/ja not_active Expired - Lifetime
- 1998-04-24 IL IL13250298A patent/IL132502A0/xx unknown
- 1998-04-24 CA CA2288143A patent/CA2288143C/en not_active Expired - Fee Related
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