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)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Heart & Thoracic Surgery (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Vascular Medicine (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Immunology (AREA)
- Urology & Nephrology (AREA)
- Diabetes (AREA)
- Hematology (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 |
|---|---|---|---|
| BR9809292-8A BR9809292A (pt) | 1997-04-28 | 1998-04-24 | Métodos aperfeiçoados para o processamento de proteìna c ativada |
| BRPI9809304-5A BR9809304B1 (pt) | 1997-04-28 | 1998-04-24 | formulação liofilizada estável, processo para preparação da mesma, bem como forma de dosagem unitária. |
Family Applications Before (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)
Families Citing this family (61)
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| PE84799A1 (es) | 1997-04-28 | 1999-09-16 | Lilly Co Eli | Metodos mejorados para el procesamiento de proteina c activada |
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| 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 |
| CN1326356A (zh) * | 1998-11-20 | 2001-12-12 | 伊莱利利公司 | 治疗病毒性出血热的方法 |
| ATE232739T1 (de) * | 1998-11-23 | 2003-03-15 | Lilly Co Eli | Protein c zur behandlung von sichelzellanämie und thalassämie |
| WO2000033867A1 (en) * | 1998-12-10 | 2000-06-15 | Eli Lilly And Company | Method of treating thrombocytopenic purpura and hemolytic uremic syndrome |
| US6758938B1 (en) * | 1999-08-31 | 2004-07-06 | Micron Technology, Inc. | Delivery of dissolved ozone |
| US7204981B2 (en) | 2000-03-28 | 2007-04-17 | Eli Lilly And Company | Methods of treating diseases with activated protein C |
| 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 |
| EP1366455B1 (en) | 2001-02-19 | 2008-07-02 | MERCK PATENT GmbH | Method for identification of t-cell epitopes and use for preparing molecules with reduced immunogenicity |
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| US20030073636A1 (en) * | 2001-09-19 | 2003-04-17 | Oklahoma Medical Research Foundation | Method of treating diabetes |
| EP1453529A4 (en) | 2001-09-19 | 2007-09-26 | Oklahoma Med Res Found | TREATMENT OF SEPSIS WITH TAFI |
| DE10149030A1 (de) * | 2001-10-05 | 2003-04-10 | Viscum Ag | Stabile galenische gefriergetrocknete Arzneimittelzubereitung von rViscumin |
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| ES2325653T3 (es) | 2001-12-21 | 2009-09-11 | Novo Nordisk Health Care Ag | Composicion liquida de polipeptidos del factor vii. |
| AU2003213146A1 (en) * | 2002-03-08 | 2003-09-22 | Eli Lilly And Company | Activated protein c formulations |
| WO2004000347A1 (en) | 2002-06-21 | 2003-12-31 | Novo Nordisk A/S | Stabilised solid compositions of factor vii polypeptides |
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| JP4658041B2 (ja) * | 2003-06-25 | 2011-03-23 | ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト | Ｖｉｉ因子ポリペプチドの液体組成物 |
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| EP1773371A4 (en) * | 2004-07-23 | 2009-12-30 | Univ Rochester | ACTIVATED PROTEIN C INHIBITS SIDE EFFECTS OF PLASMINOGEN ACTIVATOR IN THE BRAIN |
| CA2612859A1 (en) * | 2005-06-23 | 2006-12-28 | 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 |
| WO2007140625A1 (en) * | 2006-06-09 | 2007-12-13 | The University Of British Columbia | Interferon gamma polymorphisms as indicators of subject outcome in critically ill subjects |
| BRPI0808259A2 (pt) * | 2007-03-05 | 2014-07-08 | Cadila Healthcare Ltd | "formulação, processo de liofilização, formulação liofilizada, e processo para preparar uma formulação liofilizada" |
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| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| CA2707483A1 (en) * | 2007-11-30 | 2009-06-11 | Wolfgang Fraunhofer | Protein formulations and methods of making same |
| EP2242875A4 (en) * | 2008-01-15 | 2012-04-04 | Univ British Columbia | PROTEIN-C-RS2069915 AS RESPONSE PREDICTOR FOR SURVIVAL RATE AND ADMINISTRATION OF AN ACTIVATED PROTEIN-C OR PROTEIN-C-SIMILAR COMPOUND |
| JP2012510468A (ja) * | 2008-11-28 | 2012-05-10 | アボット・ラボラトリーズ | 安定な抗体組成物およびこれを安定させるための方法 |
| 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 |
| US9357765B2 (en) | 2012-04-03 | 2016-06-07 | Smiths Medical Asd, Inc. | Heparain-bulking agent compositions and methods thereof |
| WO2013158273A1 (en) | 2012-04-20 | 2013-10-24 | Abbvie Inc. | Methods to modulate c-terminal lysine variant distribution |
| US9334319B2 (en) | 2012-04-20 | 2016-05-10 | Abbvie Inc. | Low acidic species compositions |
| US9067990B2 (en) | 2013-03-14 | 2015-06-30 | Abbvie, Inc. | Protein purification using displacement chromatography |
| WO2013176754A1 (en) | 2012-05-24 | 2013-11-28 | Abbvie Inc. | Novel purification of antibodies using hydrophobic interaction chromatography |
| CN104394883B (zh) | 2012-07-04 | 2017-05-31 | 悉尼大学 | 炎性皮肤病症的治疗 |
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| WO2014143205A1 (en) | 2013-03-12 | 2014-09-18 | Abbvie Inc. | Human antibodies that bind human tnf-alpha and methods of preparing the same |
| 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 |
| WO2014151878A2 (en) | 2013-03-14 | 2014-09-25 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosacharides |
| 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 |
| US9085618B2 (en) | 2013-10-18 | 2015-07-21 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same |
| US9181337B2 (en) | 2013-10-18 | 2015-11-10 | Abbvie, Inc. | Modulated lysine variant 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 |
| CN106573040B (zh) | 2014-04-16 | 2021-07-06 | Zz生物技术有限责任公司 | 治疗异常皮肤瘢痕形成 |
| US20170035862A1 (en) | 2014-04-16 | 2017-02-09 | 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 |
| MX388814B (es) | 2016-06-01 | 2025-03-20 | Servier Ip Uk Ltd | Formulaciones de oxido de polialquileno-asparaginasa y metodos de preparacion y uso del mismo. |
| 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 |
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-
1998
- 1998-04-24 PE PE1998000311A patent/PE84799A1/es not_active Application Discontinuation
- 1998-04-24 ID IDW991133A patent/ID22933A/id unknown
- 1998-04-24 HU HU0100284A patent/HU224826B1/hu not_active IP Right Cessation
- 1998-04-24 UA UA99105884A patent/UA55448C2/uk unknown
- 1998-04-24 UA UA99105788A patent/UA73071C2/uk unknown
- 1998-04-24 IL IL13232598A patent/IL132325A/xx not_active IP Right Cessation
- 1998-04-24 CZ CZ0381099A patent/CZ298429B6/cs not_active IP Right Cessation
- 1998-04-24 BR BR9809292-8A patent/BR9809292A/pt not_active Application Discontinuation
- 1998-04-24 PL PL98336889A patent/PL195090B1/pl not_active IP Right Cessation
- 1998-04-24 CN CNB988045672A patent/CN1235638C/zh not_active Expired - Fee Related
- 1998-04-24 HU HU0003401A patent/HUP0003401A3/hu unknown
- 1998-04-24 WO PCT/US1998/008384 patent/WO1998048822A1/en not_active Application Discontinuation
- 1998-04-24 AU AU71618/98A patent/AU740753C/en not_active Ceased
- 1998-04-24 PE PE1998000309A patent/PE86299A1/es not_active Application Discontinuation
- 1998-04-24 AR ARP980101908A patent/AR012010A1/es active IP Right Grant
- 1998-04-24 US US09/065,975 patent/US6159468A/en not_active Expired - Lifetime
- 1998-04-24 WO PCT/US1998/008386 patent/WO1998048818A1/en active IP Right Grant
- 1998-04-24 TR TR1999/02631T patent/TR199902631T2/xx unknown
- 1998-04-24 CA CA002287267A patent/CA2287267C/en not_active Expired - Fee Related
- 1998-04-24 NZ NZ500346A patent/NZ500346A/en unknown
- 1998-04-24 EA EA199900980A patent/EA002149B1/ru not_active IP Right Cessation
- 1998-04-24 CN CNB988063824A patent/CN1227025C/zh not_active Expired - Fee Related
- 1998-04-24 EA EA199900979A patent/EA004881B1/ru not_active IP Right Cessation
- 1998-04-24 ID IDW991254A patent/ID23172A/id unknown
- 1998-04-24 US US09/065,872 patent/US6162629A/en not_active Expired - Lifetime
- 1998-04-24 AR ARP980101909A patent/AR015598A1/es active IP Right Grant
- 1998-04-24 KR KR1019997009835A patent/KR100564189B1/ko not_active Expired - Fee Related
- 1998-04-24 TR TR1999/02529T patent/TR199902529T2/xx unknown
- 1998-04-24 PL PL98336420A patent/PL195642B1/pl unknown
- 1998-04-24 CO CO98022609A patent/CO4950523A1/es unknown
- 1998-04-24 ZA ZA9803496A patent/ZA983496B/xx 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 CO CO98022605A patent/CO4940438A1/es unknown
- 1998-04-24 ZA ZA9803497A patent/ZA983497B/xx unknown
- 1998-04-24 KR KR10-1999-7009933A patent/KR100450856B1/ko not_active Expired - Fee Related
- 1998-04-24 CA CA2288143A patent/CA2288143C/en not_active Expired - Fee Related
- 1998-04-24 AU AU72589/98A patent/AU743531B2/en not_active Ceased
- 1998-04-24 BR BRPI9809304-5A patent/BR9809304B1/pt not_active IP Right Cessation
- 1998-04-24 NZ NZ337828A patent/NZ337828A/en unknown
- 1998-04-24 JP JP54721998A patent/JP4383546B2/ja not_active Expired - Fee Related
- 1998-04-26 EG EG45198A patent/EG23685A/xx active
- 1998-04-27 IN IN751CA1998 patent/IN183798B/en unknown
- 1998-04-27 SV SV1998000050A patent/SV1998000050A/es not_active Application Discontinuation
- 1998-04-27 MY MYPI98001899A patent/MY120984A/en unknown
- 1998-04-27 SV SV1998000051A patent/SV1998000051A/es not_active Application Discontinuation
- 1998-04-27 MY MYPI98001900A patent/MY118591A/en unknown
- 1998-04-27 IN IN752CA1998 patent/IN187157B/en unknown
- 1998-04-28 ES ES98303311T patent/ES2234072T3/es not_active Expired - Lifetime
- 1998-04-28 DK DK98303311T patent/DK0875252T3/da active
- 1998-04-28 EP EP98303311A patent/EP0875252B1/en not_active Expired - Lifetime
- 1998-04-28 SI SI9830752T patent/SI0875252T1/xx unknown
- 1998-04-28 TW TW087106549A patent/TW585871B/zh not_active IP Right Cessation
- 1998-04-28 TW TW087106558A patent/TWI242443B/zh not_active IP Right Cessation
- 1998-04-28 PT PT98303311T patent/PT875252E/pt unknown
- 1998-04-28 AT AT98303311T patent/ATE285788T1/de not_active IP Right Cessation
- 1998-04-28 DE DE69828330T patent/DE69828330T2/de not_active Expired - Lifetime
- 1998-04-28 EP EP98303312A patent/EP0875563A3/en not_active Withdrawn
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1999
- 1999-10-21 NO NO995134A patent/NO995134L/no not_active Application Discontinuation
- 1999-10-25 NO NO995198A patent/NO995198L/no not_active Application Discontinuation
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2000
- 2000-09-14 US US09/662,232 patent/US6395270B1/en not_active Expired - Lifetime
- 2000-09-21 US US09/667,570 patent/US6436397B1/en not_active Expired - Lifetime
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