Modeling of freezing step during freeze-drying of drugs in vials

A mathematical model that simulates temperature profiles during freezing process of standard pharmaceutical formulations (mannitol and BSA based) was set up in two‐dimensional axsymmetric space, and the ice crystal mean sizes were semi empirically estimated from the resulting temperature profiles. W...

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Vydané v:	AIChE journal Ročník 53; číslo 5; s. 1362 - 1372
Hlavní autori:	Nakagawa, Kyuya, Hottot, Aurélie, Vessot, Séverine, Andrieu, Julien
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.05.2007 Wiley Subscription Services American Institute of Chemical Engineers Wiley
Predmet:	Applied sciences Chemical and Process Engineering Chemical engineering Chemical Sciences Drugs Engineering Sciences Exact sciences and technology Freeze drying Freezing freezing modeling Heat and mass transfer. Packings, plates Ice ice crystal morphology Mass transfer Mathematical models nucleation temperature Sublimation Temperature Water vapor Temperature distribution Freeze drying Cooling nucleation temperature Sublimation ice crystal morphology Permeability Water vapor Modeling Freezing Mass transfer freeze-drying freezing modeling Mathematical model Crystal morphology Drying
ISSN:	0001-1541, 1547-5905
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Popis
Shrnutí:	A mathematical model that simulates temperature profiles during freezing process of standard pharmaceutical formulations (mannitol and BSA based) was set up in two‐dimensional axsymmetric space, and the ice crystal mean sizes were semi empirically estimated from the resulting temperature profiles. Water vapor mass transfer permeability values during sublimation step were also estimated from ice phase morphological parameters. All these numerical data were compared with experimental data, and a quite good agreement was observed that confirmed the adequacy of the present model calculations. It was confirmed that, for a given formulation, the mass transfer parameters during freeze‐drying were strongly dependent on morphological textural parameters, and consequently, on the nucleation temperatures that fix the ice phase morphology. The influence of freezing rate was also predicted from the simulations, proving that an increase of cooling rates led to slower primary drying rates. © 2007 American Institute of Chemical Engineers AIChE J, 2007
Bibliografia:	ark:/67375/WNG-6RQVPQN8-3 istex:5195C0A842BB86D34ED46C9208BE5CE11CE06214 ArticleID:AIC11147 Japan Society for the Promotion of Science SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 14 ObjectType-Article-2 content type line 23
ISSN:	0001-1541 1547-5905
DOI:	10.1002/aic.11147