BRPI0509117A - método de liofilização para melhorar a cristalização de excipientes - Google Patents
método de liofilização para melhorar a cristalização de excipientesInfo
- Publication number
- BRPI0509117A BRPI0509117A BRPI0509117-9A BRPI0509117A BRPI0509117A BR PI0509117 A BRPI0509117 A BR PI0509117A BR PI0509117 A BRPI0509117 A BR PI0509117A BR PI0509117 A BRPI0509117 A BR PI0509117A
- Authority
- BR
- Brazil
- Prior art keywords
- crystallization
- high temperature
- excipient
- cooling step
- excipients
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
- A61K48/0008—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Wood Science & Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Molecular Biology (AREA)
- Veterinary Medicine (AREA)
- Biotechnology (AREA)
- Organic Chemistry (AREA)
- General Engineering & Computer Science (AREA)
- Zoology (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Microbiology (AREA)
- Virology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Mechanical Engineering (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
MéTODO DE LIOFILIZAçãO PARA MELHORAR A CRISTALIZAçãO DE EXCIPIENTES.A presente invenção fornece métodos melhorados para liofilizar (congelamento a vácuo) componentes ativos como proteína, ácidos nucléicos e vírus. Os presentes métodos melhoram o grau de cristalização do excipiente durante o processo de liofilização em comparação aos métodos an teriores. A melhora na cristalização do excipiente é baseada, em parte, em uma etapa de arrefecimento a alta temperatura que é conduzida antes da ou ao menos tempo que a secagem secundária. De modo importante, a etapa de arrefecimento a alta temperatura não desestabiliza os componentes ativos. Além disso, a etapa de arrefecimento a alta temperatura não necessita das etapas de arrefecimento sub-zero antes da sua ratificação de modo a fornecer a completa cristalização do excipiente.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US55002004P | 2004-03-04 | 2004-03-04 | |
US58014004P | 2004-06-15 | 2004-06-15 | |
PCT/US2005/006872 WO2005089712A1 (en) | 2004-03-04 | 2005-03-04 | Lyophilization method to improve excipient crystallization |
Publications (1)
Publication Number | Publication Date |
---|---|
BRPI0509117A true BRPI0509117A (pt) | 2007-08-28 |
Family
ID=34993419
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BRPI0509117-9A BRPI0509117A (pt) | 2004-03-04 | 2005-03-04 | método de liofilização para melhorar a cristalização de excipientes |
Country Status (7)
Country | Link |
---|---|
US (1) | US20050226893A1 (pt) |
EP (1) | EP1720519A1 (pt) |
JP (1) | JP2007526329A (pt) |
AU (1) | AU2005225000A1 (pt) |
BR (1) | BRPI0509117A (pt) |
CA (1) | CA2554018A1 (pt) |
WO (1) | WO2005089712A1 (pt) |
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102004007526A1 (de) * | 2004-02-17 | 2005-09-01 | Oetjen, Georg-Wilhelm, Dr. | Verfahren und Einrichtung zur Gefriertrocknung von Produkten |
ES2390354T3 (es) * | 2005-07-22 | 2012-11-12 | Amgen, Inc | Liofilizados de proteínas concentrados, procedimientos y usos |
US20070135343A1 (en) * | 2005-11-01 | 2007-06-14 | Wyeth | Sodium chloride solution for drug reconstitution or dilution |
AU2006318583A1 (en) * | 2005-11-22 | 2007-05-31 | Wyeth | Immunoglobulin fusion protein formulations |
US20070149552A1 (en) * | 2005-12-16 | 2007-06-28 | Wyeth | Lyophilized compositions of a triazolopyrimidine compound |
CA2868998A1 (en) | 2006-02-03 | 2007-08-16 | Actelion Pharmaceuticals Ltd. | Novel epoprostenol formulation and method of making thereof |
EP1870649A1 (en) * | 2006-06-20 | 2007-12-26 | Octapharma AG | Lyophilisation targetting defined residual moisture by limited desorption energy levels |
EP1870650A1 (en) * | 2006-06-20 | 2007-12-26 | Octapharma AG | Lyophilisation targeting defined residual moisture by limited desorption energy levels |
EP2086581B1 (en) * | 2006-11-07 | 2014-08-13 | Sanofi Pasteur Biologics, LLC | Stabilization of vaccines by lyophilization |
JP5484041B2 (ja) * | 2007-02-23 | 2014-05-07 | 学校法人関西学院 | 蛋白質結晶化剤および蛋白質結晶化剤を用いた蛋白質結晶化方法 |
RU2555332C2 (ru) | 2009-11-03 | 2015-07-10 | Грифольс Терапьютикс Инк. | Композиция, способ и набор для альфа-1 ингибитора протеазы |
JP5810091B2 (ja) * | 2009-11-24 | 2015-11-11 | グリフオルス・セラピユーテイクス・インコーポレーテツドGrifols Therapeutics,Inc. | 凍結乾燥方法、組成物、及びキット |
US9045728B2 (en) | 2010-12-02 | 2015-06-02 | Oncolytics Biotech Inc. | Liquid viral formulations |
WO2012075376A2 (en) | 2010-12-02 | 2012-06-07 | Oncolytics Biotech Inc. | Lyophilized viral formulations |
WO2013016449A2 (en) | 2011-07-26 | 2013-01-31 | Indicator Systems International, Inc. | Assays for the detection of microbes |
AU2014228938B2 (en) | 2013-03-15 | 2019-05-02 | Bioverativ Therapeutics Inc. | Factor IX polypeptide formulations |
MX2016012447A (es) | 2014-03-24 | 2017-01-06 | Biogen Ma Inc | Formulaciones de factor ix liofilizadas. |
US11273127B2 (en) | 2014-05-06 | 2022-03-15 | The Regents Of The University Of Colorado, A Body Corporate | Compositions, methods and uses for thermally stable multi-targeted antigens |
EP3241546B1 (en) | 2014-12-30 | 2021-02-17 | Samyang Biopharmaceuticals Corporation | Polymer nanoparticle freeze-dried product, and preparation method therefor |
TW202220639A (zh) * | 2020-08-06 | 2022-06-01 | 英商4D製藥有限公司 | 凍乾方法 |
WO2023233277A1 (en) * | 2022-05-31 | 2023-12-07 | Zydus Lifesciences Limited | Lyophilized pharmaceutical compositions of copper histidinate |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3904354A1 (de) * | 1989-02-14 | 1990-08-16 | Behringwerke Ag | Pasteurisiertes, gereinigtes von willebrand-faktor-konzentrat und verfahren zu seiner herstellung |
US5424471A (en) * | 1992-07-31 | 1995-06-13 | U.S. Bioscience, Inc. | Crystalline amifostine compositions and methods of the preparation and use of same |
US5665760A (en) * | 1995-09-18 | 1997-09-09 | Sanofi Winthrop, Inc. | Lyophilized thioxanthenone antitumor agents |
US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
BR0008405B1 (pt) * | 1999-02-22 | 2014-04-22 | Baxter Int | Composição de fator viii formulada sem a adição de albumina, uso de uma composição de fator viii, e, método de liofilizar uma formulação farmacêutica aquosa |
-
2005
- 2005-03-04 JP JP2007501970A patent/JP2007526329A/ja not_active Withdrawn
- 2005-03-04 EP EP05724417A patent/EP1720519A1/en not_active Withdrawn
- 2005-03-04 BR BRPI0509117-9A patent/BRPI0509117A/pt not_active Application Discontinuation
- 2005-03-04 CA CA002554018A patent/CA2554018A1/en not_active Abandoned
- 2005-03-04 WO PCT/US2005/006872 patent/WO2005089712A1/en not_active Application Discontinuation
- 2005-03-04 US US11/071,960 patent/US20050226893A1/en not_active Abandoned
- 2005-03-04 AU AU2005225000A patent/AU2005225000A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
JP2007526329A (ja) | 2007-09-13 |
US20050226893A1 (en) | 2005-10-13 |
CA2554018A1 (en) | 2005-09-29 |
EP1720519A1 (en) | 2006-11-15 |
AU2005225000A1 (en) | 2005-09-29 |
WO2005089712A1 (en) | 2005-09-29 |
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Legal Events
Date | Code | Title | Description |
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B10A | Cessation: cessation confirmed |
Free format text: HOMOLOGADA A DESISTENCIA DO PEDIDO, REQUERIDA ATRAVES DA PETICAO NO 20090051073/RJ DE 26.05.2009. |