Sublimation kinetics and sublimation end-point times during freeze-drying of pharmaceutical active principle with organic co-solvent formulations

Chemical Engineering Research and Design

Volumn 87, Issue 7, 2009, Pages 899-907

  Daoussi, Rim ^a   Vessot, Séverine ^a   Andrieu, Julien ^a   Monnier, Olivier ^b  

^a UNIVERSITÉ LYON 1   (France)

^b SANOFI   (France)

Author keywords

Drying kinetics; Freeze drying; Organic co solvent; Sublimation end point

Indexed keywords

ACTIVE PRINCIPLES; AQUEOUS SOLVENTS; CONTACT DRYERS; COSOLVENT; DRYING KINETICS; DRYING PARAMETERS; END POINTS; FREEZE-DRYING; FREEZE-DRYING PROCESS; FULL FACTORIAL DESIGN; GAS PRESSURES; GLASS TRANSITION TEMPERATURE; INCREASING FUNCTIONS; MAXIMUM VALUES; MICROBALANCE; OPERATING CONDITION; ORGANIC CO-SOLVENT; ORGANIC MEDIUM; PRESSURE AND TEMPERATURE; SIGNIFICANT IMPACTS; SOLVENT CONCENTRATION; SUBLIMATION RATES; TERT BUTANOL; TOTAL GAS PRESSURE;

ALCOHOLS; DEWATERING; GASES; GLASS TRANSITION; LOW TEMPERATURE DRYING; ORGANIC POLYMERS; ORGANIC SOLVENTS; POINT CONTACTS; SUBLIMATION;

CURING;

EID: 66149087285     PISSN: 02638762     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cherd.2008.09.007     Document Type: Review

References (15)

1. Chouvenc P., Vessot S., Andrieu J., and Vacus P. Optimization of the freeze-drying cycle: a new model for pressure rise analysis. Drying Technology 22 7 (2004) 1577-1601
2. Daoussi, R. Vessot, S. Andrieu, J. and Monnier, O., 2007, Lyophilisation d'un produit pharmaceutique en milieu non aqueux, Impact des conditions de la congélation et de la formulation sur les taux résiduels de solvant et l'humidité et sur le temps de séchage, Congrès SFGP 2007 St-Etienne, CD ROM (6pp).
3. Daoussi, R., 2008, Etude expérimentale et optimisation du procédé de lyophilisation d'un principe actif pharmaceutique en milieu organique, Thesis, University of Lyon I.
4. Hottot A., Vessot S., and Andrieu J. A direct characterization method of the ice morphology: relationship between mean ice crystals size and primary drying times of freeze drying processes. Drying Technology 22 8 (2004) 2009-2021
5. Hottot A., Peczalski R., Vessot S., and Andrieu J. Freeze-drying of pharmaceutical proteins in vials. Modelling of freezing and sublimation steps. Drying Technology 60 2 (2006) 95-103
6. Hottot A., Vessot S., and Andrieu J. Sublimation kinetics during freeze-drying of pharmaceutical protein formulation. Drying Technology 25 5 (2007) 753-758
7. Hottot A., Vessot S., and Andrieu J. Freeze-drying of pharmaceuticals in vials: Influence of freezing protocol and sample configuration on ice morphology and freeze-dried cake texture. Chemical Engineering and Processing 46 (2007) 666-674
8. Kasraian K., and Deluca P. Thermal analysis of the tertiary butyl-alcohol-water system and its implications on freeze-drying. Pharmaceutical Research 12 12 (1994) 484-490
9. Pikal M., Shah S., Senior D., and Lang J. Physical chemistry of freeze-drying: measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. Journal of Pharmaceutical Sciences 72 (1983) 635-650
10. Pikal M. Freeze-drying of proteins: process, formulation and stability. In: Cleland J., and Langer R. (Eds). Formulation and Delivery of Proteins and Peptides (1994), ACS, Washington 120-133
11. Nakagawa K., Hottot A., Vessot S., and Andrieu J. Influence of controlled nucleation by ultrasounds on ice morphology of frozen formulations for pharmaceutical proteins freeze-drying. Chemical Engineering and Processing 45 (2006) 783-791
12. Nail S., and Gatlin L. Freeze drying: principles and practice. In: Avis A., Lieberman A., and Lachman L. (Eds). Pharmaceutical Dosage Forms vol. 2 (1993), Marcel Dekker, New York 163-333
13. Roth C., Winter G., and Lee G. Continuous measurement of drying rate of crystalline and amorphous systems during freeze-drying using an in situ microbalance technique. Journal of Pharmaceutical Sciences 90 9 (2001) 1345-1355
14. Wittaya-Areekul S. Freeze-drying from nonaqueous solution. Mahidol University Journal of Pharmaceutical Sciences 26 1-4 (1999) 33-43
15. Xiang J. Investigation of freeze-drying sublimation rates using a freeze-drying microbalance technique. International Journal of Pharmaceutics 279 (2004) 95-105