The effect of loading process on product collapse during large-scale lyophilization

Journal of Pharmaceutical Sciences

Volumn 98, Issue 3, 2009, Pages 997-1004

  Wallen, Alexis J ^a   Van Ocker, Susan H ^a   Sinacola, Jessica R ^a   Phillips, Bret R ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Crystal structure; Freeze drying; Glass transition; Lyophilization; Processing

Indexed keywords

ARTICLE; DRUG INDUSTRY; FREEZE DRYING; LARGE SCALE PRODUCTION; PRODUCT DEVELOPMENT; SURFACE PROPERTY;

EID: 62849094958     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21491     Document Type: Article

References (15)

1. Hottot A, Vessot S, Andrieu J. 2007. Freeze drying of pharmaceuticals in vials: Influence of freezing protocol and sample configuration on ice morphology and freeze-dried cake texture. Chem Eng Proc 46:666-674.
2. Searles JA, Carpenter JF, Randolph TW. 2001. The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf. J Pharm Sci 90:860-871.
3. Adams GDJ. 2003. Lyophilization of vaccines: Current trends. Methods Mol Med 87:223-243.
4. Searles JA, Carpenter JF, Randolph TW. 2001. Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine Tg0 in pharmaceutical lyophilization. J Pharm Sci 90:872-887.
5. Lu X, Pikal MJ. 2004. Freeze drying of mannitoltrehalose-sodium chloride based formulations: The impact of annealing on dry layer resistance to mass transfer and cake structure. Pharm Dev Tech 9:85-95.
6. Izutsu K, Yoshioka S, Tereo T. 1993. Decreased protein stabilizing effects of cryoprotectants due to crystallization. Pharm Res 10:1232-1237.
7. Pikal MJ. 1991. Freeze-drying of proteins II: Formulation selection. BioPharm 3:26-30.
8. Rambhalta S, Obert JP, Luthra S, Bhugra C, Pikal MJ. 2005. Cake shrinkage during freeze drying: A combined experimental and theoretical study. Pharm Dev Tech 1:33-40.
9. Wang DQ, Hey JM, Nail SL. 2004. Effect of collapse on the stability of freeze-dried recombinant factor VIII and α-amylase. J Pharm Sci 93:1253-1263.
10. Pikal MJ, Shah S, Roy ML, Putman R. 1990. The secondary drying stage of freeze drying: Drying kinetics as a function of temperature and chamber pressure. Int J Pharm 60:203-217.
11. Rambhalta S, Ramot R, Bhugra C, Pikal MJ. 2004. Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling. AAPS PharmSciTech 5:Article 58.
12. Gan KH, Crosser OK, Liapis AI, Bruttini R. 2005. Lyophilization in vials on trays: Effects of tray side. Drying Technol 23:341-363.
13. Gan KH, Bruttini R, Crosser OK, Liapis AI. 2005. Freeze-drying of pharmaceuticals in vials on trays: Effects of drying chamber wall temperature and tray side on lyophilization performance. Int J Heat Mass Transf 48:1675-1687.
14. Tsinontides SC, Rajniak P, Pham D, Hunke HA, Placek J, Reynolds SD. 2004. Freeze drying-Principles and practice for successful scale-up to manufacturing. Int J Pharm 280:1-16.
15. Kuu WY, Hardwick LM, Akers MJ. 2005. Correlation of laboratory and production freeze drying cycles. Int J Pharm 302:56-67.