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BRPI0509117A - método de liofilização para melhorar a cristalização de excipientes - Google Patents

método de liofilização para melhorar a cristalização de excipientes

Info

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
Application number
BRPI0509117-9A
Other languages
English (en)
Inventor
Jennifer Juneau
Susan Knowles
Original Assignee
Wyeth Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Wyeth Corp filed Critical Wyeth Corp
Publication of BRPI0509117A publication Critical patent/BRPI0509117A/pt

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)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Virology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (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.
BRPI0509117-9A 2004-03-04 2005-03-04 método de liofilização para melhorar a cristalização de excipientes BRPI0509117A (pt)

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 (24)

* Cited by examiner, † Cited by third party
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
US7956160B2 (en) * 2005-07-22 2011-06-07 Amgen Inc. Concentrated protein lyophilates, methods, and uses
KR20110128957A (ko) * 2005-11-01 2011-11-30 와이어쓰 엘엘씨 약물 재구성 또는 희석을 위한 염화나트륨 용액
RU2008118166A (ru) * 2005-11-22 2009-12-27 Вайет (Us) Составы, содержащие гибридные белки, включающие иммуноглобулин
CA2632540A1 (en) * 2005-12-16 2007-07-05 Wyeth Lyophilized compositions of a triazolopyrimidine compound
SI1993557T1 (sl) 2006-02-03 2016-01-29 Actelion Pharmaceuticals Ltd. Nova formulacija epoprostenola in postopek izdelave le-te
RU2423130C2 (ru) * 2006-02-03 2011-07-10 Актелион Уан Са Композиция, содержащая эпопростенол, и способ ее получения
EP1870650A1 (en) * 2006-06-20 2007-12-26 Octapharma AG Lyophilisation targeting defined residual moisture by limited desorption energy levels
EP1870649A1 (en) * 2006-06-20 2007-12-26 Octapharma AG Lyophilisation targetting defined residual moisture by limited desorption energy levels
US9132184B2 (en) * 2006-11-07 2015-09-15 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
ES2679819T3 (es) 2009-11-03 2018-08-31 Grifols Therapeutics Inc. Composición, método y kit para inhibidor de alfa-1 proteinasa
CA2781120C (en) * 2009-11-24 2015-01-27 Jianxin Guo Lyophilization methods, compositions, and kits
MX373096B (es) 2010-12-02 2020-04-27 Oncolytics Biotech Inc Formulaciones virales líquidas.
EA201390812A1 (ru) 2010-12-02 2013-11-29 Онколитикс Байотек Инк. Лиофилизированные вирусные составы
WO2013016449A2 (en) 2011-07-26 2013-01-31 Indicator Systems International, Inc. Assays for the detection of microbes
UY35463A (es) 2013-03-15 2014-10-31 Biogen Idec Inc Formulaciones de polipéptido fc-factor ix.
SG10201913735SA (en) 2014-03-24 2020-03-30 Bioverativ Therapeutics Inc Lyophilized factor ix formulations
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
CN107106496B (zh) 2014-12-30 2020-09-15 株式会社三养生物制药 聚合物纳米粒子冷冻干燥物及其制备方法
TW202220639A (zh) * 2020-08-06 2022-06-01 英商４Ｄ製藥有限公司 凍乾方法
JP2025518231A (ja) * 2022-05-31 2025-06-12 ザイダス・ライフサイエンシーズ・リミテッド ヒスチジン酸銅の凍結乾燥医薬組成物
CN115950213B (zh) * 2022-12-20 2025-08-01 福州华为医药技术开发有限公司 一种注射用尼可地尔及其冷冻干燥方法
WO2024184722A1 (en) * 2023-03-03 2024-09-12 Pfizer Inc. Systems and methods for annealing frozen bulk in dynamic bulk freeze drying

Family Cites Families (5)

* Cited by examiner, † Cited by third party
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
DK1820516T3 (da) * 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater

Also Published As

Publication number Publication date
WO2005089712A1 (en) 2005-09-29
US20050226893A1 (en) 2005-10-13
EP1720519A1 (en) 2006-11-15
JP2007526329A (ja) 2007-09-13
AU2005225000A1 (en) 2005-09-29
CA2554018A1 (en) 2005-09-29

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Free format text: HOMOLOGADA A DESISTENCIA DO PEDIDO, REQUERIDA ATRAVES DA PETICAO NO 20090051073/RJ DE 26.05.2009.