DK1794524T3 - Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler) - Google Patents

Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler)

Info

Publication number
DK1794524T3
DK1794524T3 DK05769919.1T DK05769919T DK1794524T3 DK 1794524 T3 DK1794524 T3 DK 1794524T3 DK 05769919 T DK05769919 T DK 05769919T DK 1794524 T3 DK1794524 T3 DK 1794524T3
Authority
DK
Denmark
Prior art keywords
drying
sfd
parenteral
freezing
analyzing
Prior art date
Application number
DK05769919.1T
Other languages
Danish (da)
English (en)
Inventor
Dietrich Gehrmann
Thomas Daun
Heinz Mueller
Deqian Wang
Ariane Firus
Original Assignee
Bayer Technology Services Gmbh
Bayer Healthcare Llc
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, Bayer Healthcare Llc filed Critical Bayer Technology Services Gmbh
Application granted granted Critical
Publication of DK1794524T3 publication Critical patent/DK1794524T3/da

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)
DK05769919.1T 2004-07-23 2005-07-09 Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler) DK1794524T3 (da)

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
DK1794524T3 true DK1794524T3 (da) 2012-04-16

Family

ID=35426977

Family Applications (1)

Application Number Title Priority Date Filing Date
DK05769919.1T DK1794524T3 (da) 2004-07-23 2005-07-09 Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler)

Country Status (9)

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

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Also Published As

Publication number Publication date
CA2574614A1 (en) 2006-01-26
IL180898A0 (en) 2007-07-04
IL180898A (en) 2011-10-31
JP2008507307A (ja) 2008-03-13
US7836606B2 (en) 2010-11-23
EP1794524B1 (en) 2012-01-18
AU2005263465B2 (en) 2010-07-29
WO2006008006A1 (en) 2006-01-26
AU2005263465A1 (en) 2006-01-26
EP1794524A1 (en) 2007-06-13
JP4829229B2 (ja) 2011-12-07
ATE542095T1 (de) 2012-02-15
CA2574614C (en) 2013-12-03
US20080060213A1 (en) 2008-03-13

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