Experimental study and modeling of freeze-drying in syringe configuration. Part I: Freezing step

Drying Technology

Volumn 27, Issue 1, 2009, Pages 40-48

  Hottot, A ^a   Andrieu, J ^a   Vessot, S ^a   Shalaev, E ^b   Gatlin, L A ^b   Ricketts, S ^b  

^a UNIVERSITÉ LYON 1   (France)

^b PFIZER INC   (United States)

Author keywords

Annealing treatment; Freezing; Ice crystal morphology; Modeling; Syringe

Indexed keywords

ANNEALING; DEWATERING; FREEZING; FUNCTIONS; ICE; LOW TEMPERATURE DRYING; SUGAR (SUCROSE); SYRINGES; WATER TREATMENT; WATER VAPOR;

ANNEALING TREATMENT; EXPERIMENTAL STUDIES; GAS COOLING; ICE CRYSTAL MORPHOLOGY; ICE MORPHOLOGY; MASS TRANSFER RESISTANCES; MODELING; RADIAL POSITIONING; SUBLIMATION RATES; SUCROSE SOLUTIONS; SYRINGE; TEMPERATURE PROFILING;

MORPHOLOGY;

EID: 58449127260     PISSN: 07373937     EISSN: 15322300     Source Type: Journal    
DOI: 10.1080/07373930802565806     Document Type: Article

References (22)

1. Searles, J. A., Carpenter, J. F. and Randolph, T. (2001) The ice nucleation temperature determines the primary drying rate of lyophilization forsamples frozen on a temperature controlled shelf. Journal of Pharmaceutical Science, 90:7, pp. 860-871.
2. Chouvenc, P., Vessot, S. and Andrieu, J. (2006) Experimental study of the impact of annealing ice structure and mass transfer parameters during freeze-drying of a pharmaceutical formulation. PDA Journal of Pharmaceutical Science and Technology, 60:2, pp. 95-103.
3. Hottot, A., Vessot, S. and Andrieu, J. (2004) 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, pp. 2009-2021.
4. Liu, J., Viverette, T., Virgin, M., Anderson, M. and Dalal, P. (2005) A study of the impact of freezing on the lyophilization of a concentrated formulation with a high fill depth. Pharmaceutical Development and Technology, 10:2, pp. 261-272.
5. Petersen, A., Rau, G. and Glasmacher, B. (2006) Reduction of primary freeze-drying time by electric field induced ice nucleus formation. Heat and Mass Transfer, 42:10, pp. 929-938.
6. Nakagawa, K., Hottot, A., Vessot, S. and Andrieu, J. (2006) Influence of controlled nucleation by ultrasounds on ice morphology of frozen formulations for pharmaceutical proteins freeze-drying. Chemical Engineering and Processing, 45, pp. 783-791.
7. Searles, J. A., Carpenter, J. F. and Randolph, T. W. (2001) Annealing to optimise the primary drying rate, reduce freezing induced drying rate heterogeneity and determine Tg' in pharmaceutical lyophilization. Journal of Pharmaceutical Science, 90, pp. 872-887.
8. Mahjoub, R., Chouvenc, P., Seurin, M. J., Andrieu, J. and Briguet, A. (2006) Sucrose solution freezing studied by magnetic resonance imaging. Carbohydrate Research, 341:4, pp. 492-498.
9. Lu, X. and Pikal, M. J. (2004) Freeze-drying of mannitol-trehalose-sodium chloride-based formulations: The impact of annealing on dry layer resistance to mass transfer and cake structure. Pharmaceutical Development and Technology, 9:1, pp. 85-95.
10. Patapoff, T. and Overcashier, D. E. (2002) The importance of freezing on lyophilization cycle development. Biopharm, pp. 16-22.
11. Blond, G., Simatos, S., Catte, M., Dussap, C. G. and Gros, J. B. (1997) Modeling of the water-sucrose state diagram below 0°C. Carbohydrate Research, 298, pp. 139-145.
12. Hottot, A., Peczalski, R., Vessot, S. and Andrieu, J. (2006) Freeze-drying of pharmaceuticals in vials: Modeling of freeze-drying steps. Drying Technology, 24, pp. 561-570.
13. Moraga, N. O. and Barraza, H. G. (2003) Predicting heat conduction during solidification of a food inside a freezer due to natural convection. Journal of Food Engineering, 56:1, pp. 17-26.
14. Kowalewski, T. A. and Cybulski, A. (1996) Experimental and numerical investigations of natural convection in freezing water. International Conference on Heat Transfer with Change of Phase, Kielce. Mechanics, 61:2, pp. 7-16.
15. Strub, M., Jabbour, O., Strub, F. and Bedecarrats, J. P. (2003) Experimental study and modeling of the crystallization of a water droplet. International Journal of Refrigeration, 26:1, pp. 59-68.
16. Hottot, A., Vessot, S. and Andrieu, J. (2005) Determination of mass and heat transfer parameters during freeze-drying cycles of pharmaceutical products. PDA Journal of Pharmaceutical Sciences and Technology, 59:2, pp. 138-154.
17. Chouvenc, P., Vessot, S., Andrieu, J. and Vacus, P. (2004) Optimization of the freeze-drying cycle: A new model for pressure rise analysis. Drying Technology, 22:7, pp. 1577-1601.
18. Hottot, A., Andrieu, J., Hoang, V., Shalaev, E. Y., Gatlin, L. A. and Ricketts, S. (2008) Study and modeling of freeze drying in syringe configuration Part II: Mass and heat transfer parameters and sublimation end-point. Drying Technology
19. Williams, N. A., Lee, Y., Polli, G. P. and Jennings, T. A. (1986) The effects of cooling rate on phase transitions and associated vial breakage in frozen mannitol solutions. Journal of Parenteral Science and Technology, 40, pp. 135-141.
20. Searles, J. A. (2004) Freeze Drying/Lyophilization of Pharmaceutical and Biological Products;, pp. 109-145. Marcel Dekker, New York
21. Lunardini, V. J. (1981) Heat Transfer in Cold Climates, Van Nostrand Reinhold Company
22. McAdams, W. H. (1961) Transmission de la chaleur, Dunod, Paris