Rapid freeze-drying cycle optimization using computer programs developed based on heat and mass transfer models and facilitated by tunable diode laser absorption spectroscopy (TDLAS)

Journal of Pharmaceutical Sciences

Volumn 98, Issue 9, 2009, Pages 3469-3482

  Kuu, Wei Y ^a   Nail, Steven L ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Absorption spectroscopy; Algorithm; Freeze drying lyophilization; Mathematical model; Nonlinear regression

Indexed keywords

MANNITOL;

ABSORPTION SPECTROSCOPY; ANALYTIC METHOD; ARTICLE; COMPUTER PROGRAM; DRUG FORMULATION; FREEZE DRYING; HEAT TRANSFER; MATHEMATICAL MODEL; PROCESS OPTIMIZATION; TEMPERATURE DEPENDENCE; TUNABLE DIODE LASER ABSORPTION SPECTROSCOPY; VALIDITY;

EID: 68949114041     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21813     Document Type: Article

References (17)

1. Tang X, Pikal MJ. 2004. Design of freeze-drying process for pharmaceuticals: Practical advice. Pharm Res 21:191-200. (Pubitemid 38221965)
2. Pikal MJ. 1985. Use of laboratory data in freeze drying process design: Heat and product resistance parameters and the compute simulation of freeze drying. J Parenteral Sci Tech 39:115-138.
3. Milton N, Pikal MJ, Roy ML, Nail SL. 1997. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization. PDA J Pharm Sci Technol 51:7-16. (Pubitemid 27443530)
4. Chouvenc P, Vessot S, Andrieu J, Vacus P. 2004. Optimization of the freeze-drying cycle: A new model for pressure rise analysis. Drying Technol 22:1577-1601. (Pubitemid 39364957)
5. Chouvenc P, Vessot S, Andrieu J, Vacus P. 2005. Optimization of the freeze-drying cycle: Adaption of the pressure rise analysis model to noninstantaneous isolation valves. PDA J Pharm Sci Technol 59:298-309. (Pubitemid 41611873)
6. Tang X, Nail SL, Pikal MJ. 2005. Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer. Pharm Res 22:685-699. (Pubitemid 40603267)
7. Chang B, Fischer NL. 1995. Development of an efficient single-step freeze-drying cycle for protein formulations. Pharm Res 12:831-837.
8. Pikal MJ, Roy ML, Shah S. 1984. Mass and heat transfer in vial freeze-drying of pharmaceuticals: Role of the vial. J Pharm Sci 73:1224-1237. (Pubitemid 14030708)
9. Kuu WY, Hardwick L, Akers MJ. 2006. Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles. Int J Pharm 313:99-113.
10. Kuu WY, Nail SL, Hardwick LM. 2007. Determination of shelf heat transfer coefficients along the shelf flow path of a freeze dryer using the shelf fluid temperature perturbation approach. Pharm Dev Technol 12: 485-494.
11. Kuu WY, Nail SL, Sacha GA. 2008. Rapid determination of vial heat transfer parameters using tunable diode laser absorption spectroscopy (TDLAS) in response to step-changes in pressure setpoint during freeze-drying. J Pharm Sci 98:1136-1154.
12. Pikal MJ, Shah S, Senior D, Lang JE. 1983. Physical chemistry of freeze drying: Measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. J Pharm Sci 72:635-650.
13. Kuester JL, Mize JH. 1973. Optimization techniques with FORTRAN. New York: McGraw-Hill. p. 251-271.
14. Gieseler H, Kessler WJ, Finson M, Davis SJ, Mulhall PA, Bons V, Debo DJ, Pikal MJ. 2007. Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurements during freeze drying. J Pharm Sci 96:1776-1793. (Pubitemid 47122955)
15. Schneid S, Gieseler H, Kessler W, Pikal MJ. 2008. Non-invasive product temperature determination during primary drying using tunable diode laser absorption spectroscopy. J Pharm Sci. Published online in Wiley InterScience (www.interscience.wiley.com). 10.1002/jps.21522, 1-13.
16. OMEGA Engineering, One Omega Drive, Box 4047, Stamford, CT 06907-10047 http://www.omega.com.
17. Cannon AJ, Trappler EH. 2000. The influence of lyophilization on polymorphic behavior of mannitol. PDA J Pharm Sci Technol 54:3-22.