The nonsteady state modeling of freeze drying: In-process product temperature and moisture content mapping and pharmaceutical product quality applications

Pharmaceutical Development and Technology

Volumn 10, Issue 1, 2005, Pages 17-32

  Pikal, M J ^a   Cardon, S ^a   Bhugra, Chandan ^a   Jameel, F ^a   Rambhatla, S ^a   Mascarenhas, W J ^b   Akay, H U ^b  

^a UNIVERSITY OF CONNECTICUT   (United States)

^b Technalysis Inc   (United States)

Author keywords

Freeze drying; Heat and mass transfer in freeze drying; Lyophilization process; Non steady state modeling of lyophilization; Temperature and moisture distribution in freeze drying

Indexed keywords

ARTICLE; CALCULATION; DRUG FORMULATION; DRUG MANUFACTURE; ENERGY CONSERVATION; FREEZE DRYING; GLASS TRANSITION TEMPERATURE; MATHEMATICAL ANALYSIS; MOISTURE; MOLECULAR WEIGHT; PRIORITY JOURNAL; QUALITY CONTROL; TEMPERATURE; THEORETICAL MODEL; VALIDATION PROCESS; WATER VAPOR;

EID: 14644437110     PISSN: 10837450     EISSN: None     Source Type: Journal    
DOI: 10.1081/PDT-200035869     Document Type: Article

References (15)

1. Pikal, M.J. Freeze drying. In Encyclopedia of Pharmaceutical Technology, 6; Swarbick, J., Boylan, J., Eds.; Marcel Dekker, 2001. See also, the Dekker web site, www.Dekker.com. The DOI number is, 10.1081/E-EPT-100001712, pages 1299-1326.
2. Pikal, M.J. Use of laboratory data in freeze drying process design: heat and mass transfer coefficients and the computer simulation of freeze-drying. J. Parenter. Drug Assoc. 1985, 39 (No. 3), 115-138.
3. Millman, M.J.; Liapis, A.I.; Marchello, J.M. An analysis of the lyophilization process using a sorption-sublimation model and various operational policies. AICHE J. 1985, 3, 1594-1604.
4. Mascarenhas, W.J.; Akay, H.U.; Pikal, M.J. A computational model for finite element analysis of the freeze-drying process. Comput. Methods Appl. Mech. Eng. 1997, 148, 105-124.
5. Milton, N.; Pikal, M.J.; Roy, M.L.; Nail, S.L. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization. PDA J. Pharm. Sci. Technol. 1997, 5, 7-16.
6. Tang, X.; Pikal, M.J. Evaluation of manometric temperature measurement (MTM) in freeze drying. Part II: measurement of dry layer resistance, (under review).
7. Pikal, M.J.; Roy, M.L.; Shah, S. Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial. J. Pharm. Sci. 1984, 73, 1224-1237.
8. Pikal, M.J.; Lang, J.E.; Shah, S. Desolvation kinetics of cefamandole sodium methanolate: the effect of water vapor. Int. J. Pharm. 1983, 17, 237-262.
9. Zografi, G.; Kontny, M.J. The interaction of water with cellulose-and starch derived pharmaceutical excipients. Pharm. Res. 1986, 187-194.
10. Pikal, M.J.; Shah, S.; Roy, M.L.; Putman, R. The secondary drying stage of freeze drying: drying kinetics as a function of temperature and chamber pressure. Int. J. Pharm. 1990, 60, 203-217.
11. Pikal, M.J.; Shah, S. Intravial distribution of moisture during the secondary drying stage of freeze drying. PDA J. Pharm. Sci. Technol. 1997, 51, 17-24.
12. Pikal, M.J.; Shah, S.; Senior, D.; Lang, J.E. Physical chemistry of freeze-drying: measurement of sublimation rates for frozen aqueous solutions by a micro balance technique. J. Pharm. Sci. 1983, 72, 635-650.
13. Saleki-Gerhardt, A.; Zografi, G. Non-isothermal and isothermal crystallization of sucrose from the amorphous state. Pharm. Res. 1994, 11, 1166-1173.
14. Hatley, R.H.M.; van den Berg, C.; Franks, F. The unfrozen water content of maximally freeze concentrated carbohydrate solutions: validity of the methods used for its determinaton. Cryo-Lett. 1991, 12, 113-124.
15. Hatley, R.H.M.; Mant, A. Determination of the unfrozen water content of maximally freeze-concentrated carbohydrate solutions. Int. J. Biol. Macromol. 1993, 15, 227-232.