ATE542095T1 - Verfahren zum sterilen gefrieren, trocknen, lagern, analysieren und füllen (sfd-saf- verfahren) (verfahren zur gefriertrocknung von granulat für parenterale biopharmazeutika) - Google Patents

Verfahren zum sterilen gefrieren, trocknen, lagern, analysieren und füllen (sfd-saf- verfahren) (verfahren zur gefriertrocknung von granulat für parenterale biopharmazeutika)

Info

Publication number
ATE542095T1
ATE542095T1 AT05769919T AT05769919T ATE542095T1 AT E542095 T1 ATE542095 T1 AT E542095T1 AT 05769919 T AT05769919 T AT 05769919T AT 05769919 T AT05769919 T AT 05769919T AT E542095 T1 ATE542095 T1 AT E542095T1
Authority
AT
Austria
Prior art keywords
drying
biopharmaceutics
sfd
parenteral
analyzing
Prior art date
Application number
AT05769919T
Other languages
English (en)
Inventor
Dietrich Gehrmann
Ariane Firus
Thomas Daun
Heinz Mueller
Deqian Wang
Original Assignee
Bayer Technology Services Gmbh
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 Bayer Technology Services Gmbh filed Critical Bayer Technology Services Gmbh
Application granted granted Critical
Publication of ATE542095T1 publication Critical patent/ATE542095T1/de

Links

Classifications

    • 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
    • F26B5/065—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 the product to be freeze-dried being sprayed, dispersed or pulverised
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Drying Of Solid Materials (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
AT05769919T 2004-07-23 2005-07-09 Verfahren zum sterilen gefrieren, trocknen, lagern, analysieren und füllen (sfd-saf- verfahren) (verfahren zur gefriertrocknung von granulat für parenterale biopharmazeutika) ATE542095T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US59088104P 2004-07-23 2004-07-23
PCT/EP2005/007455 WO2006008006A1 (en) 2004-07-23 2005-07-09 Sterile freezing, drying, storing, assaying and filling process (sfd-saf process) (pellet freeze-drying process for parenteral biopharmaceuticals)

Publications (1)

Publication Number Publication Date
ATE542095T1 true ATE542095T1 (de) 2012-02-15

Family

ID=35426977

Family Applications (1)

Application Number Title Priority Date Filing Date
AT05769919T ATE542095T1 (de) 2004-07-23 2005-07-09 Verfahren zum sterilen gefrieren, trocknen, lagern, analysieren und füllen (sfd-saf- verfahren) (verfahren zur gefriertrocknung von granulat für parenterale biopharmazeutika)

Country Status (9)

Country Link
US (1) US7836606B2 (de)
EP (1) EP1794524B1 (de)
JP (1) JP4829229B2 (de)
AT (1) ATE542095T1 (de)
AU (1) AU2005263465B2 (de)
CA (1) CA2574614C (de)
DK (1) DK1794524T3 (de)
IL (1) IL180898A (de)
WO (1) WO2006008006A1 (de)

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Also Published As

Publication number Publication date
AU2005263465B2 (en) 2010-07-29
CA2574614C (en) 2013-12-03
JP2008507307A (ja) 2008-03-13
US20080060213A1 (en) 2008-03-13
AU2005263465A1 (en) 2006-01-26
US7836606B2 (en) 2010-11-23
EP1794524B1 (de) 2012-01-18
CA2574614A1 (en) 2006-01-26
JP4829229B2 (ja) 2011-12-07
IL180898A0 (en) 2007-07-04
DK1794524T3 (da) 2012-04-16
WO2006008006A1 (en) 2006-01-26
EP1794524A1 (de) 2007-06-13
IL180898A (en) 2011-10-31

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