Critical factors in the design and optimisation of lyophilisation processes

Innovations in Pharmaceutical Technology

Volumn , Issue 26, 2008, Pages 70-74

  Hardwick, Lisa M ^a   Paunicka, Christine ^a   Akers, Michael J ^a  

^a Baxter Pharmaceuticals   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ABSORPTION SPECTROSCOPY; ACCURACY; ARTICLE; DRUG FORMULATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG STABILITY; DRUG STORAGE; FREEZE DRYING; PRESSURE CHAMBER; PROCESS DESIGN; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; STORAGE TEMPERATURE; TUNABLE DIODE LASER ABSORPTION SPECTROSCOPY; WATER CONTENT; WATER VAPOR;

EID: 55049088202     PISSN: 14717204     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (6)

1. FDA Guide to Inspections of Lyophilisation of Parenterals, July 1993
2. Searles J, Observation and implications of sonic water vapour flow during freeze-drying, American Pharmaceutical Review 7(2), pp 58-69, 2004
3. Plackett R and Burman J, The Design of Optimum Multifactorial Experiments, Biometrika 33(4), pp305-25, 1946
4. French A, Poulsen J and Yu A, Multivariate Analysis of Variance (MANOVA) http://online.sfsu.edu/~efc/classes/biol710/manova/manovanew.htm
5. Kuu W, Hardwick L and Akers M, Correlation of laboratory and production freeze drying cycles, International Journal of Pharmaceutics 302, pp56-67, 2005
6. Kuu W, Hardwick L and Akers M, Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles, International Journal of Pharmaceutics 313, pp99-113, 26, 2006