Effect of freeze-dryer design on drying rate of an amorphous protein-formulation determined with a gravimetric technique

Pharmaceutical Development and Technology

Volumn 13, Issue 6, 2008, Pages 463-472

  Gieseler, Henning ^a   Lee, Geoffrey ^a,b  

^a UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^b Division of Pharmaceutics   (Germany)

Author keywords

Drying rate; Freeze drying; Lyophilization; Vial heat transfer coefficient

Indexed keywords

BOVINE SERUM ALBUMIN; SUCROSE;

ARTICLE; CALCULATION; CONTAINER; CORRELATION ANALYSIS; DENSITY; DRUG FORMULATION; DRYING RATE; EQUIPMENT; EQUIPMENT DESIGN; FREEZE DRYER; FREEZE DRYING; GRAVIMETRY; HEAT TRANSFER; HEAT TRANSFER COEFFICIENT; MATHEMATICAL MODEL; MEASUREMENT; PARAMETER; PRIORITY JOURNAL; SHELF PACKING DENSITY; TECHNIQUE; TEMPERATURE DEPENDENCE;

ALGORITHMS; CALORIMETRY, DIFFERENTIAL SCANNING; FREEZE DRYING; PROTEINS; SERUM ALBUMIN, BOVINE; SUCROSE; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; THERMODYNAMICS; THERMOGRAVIMETRY; TRANSITION TEMPERATURE; VACUUM; WATER;

EID: 54949102798     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.1080/10837450802309638     Document Type: Article

References (20)

1. Rambhatla S, Pikal MJ. Heat and mass transfer scale-up issues during freeze-drying I: Atypical radiation and the edge vial effect. AAPS Pharm. Sci. Tech. 2003;4(2):111-120.
2. Rambhatla S, Tchessalov S, Pikal MJ. Heat and mass transfer scale-up issues during freeze-drying, III: Control and characterization of dryer differences via operational qualification tests. AAPS Pharm. Sci. Tech. 2006;7(2)Article 39.
3. Roth C, Winter G, Lee G. Continuous measurement of drying rate of crystalline and amorphous systems during freeze-drying using an in situ microbalance technique. J. Pharm. Sci. 2001;90(9):1345-1355.
4. Gieseler H, Lee G. Effects of vial packing density on momentary drying rate during freeze-drying of carbohydrates or a model protein measured using a microbalance technique. Pharm. Res. 2008;25(2):302-312.
5. Tang X, Pikal MJ. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm. Res. 2004;21(2):191-200.
6. Tang X, Nail SL, Pikal MJ. Freeze-drying process design by manometric temperature measurement: design of a smart freeze-dryer. Pharm. Res. 2005;22(4)685-700.
7. Hill VL, Craig DQM, Feely LC. The effects of experimental parameters and calibration on MTDSC data. Int. J. Pharm. 1999;21-32.
8. Placek J. Heat transfer limitations, their reduction and control. Proceed. 2001, Freeze-Drying Pharm Biologic, Breckenridge.
9. Pikal MJ, Shah S. The collapse temperature in freeze-drying: dependence on measurement methodology and rate of water removal from the glassy phase. Int. J. Pharmaceut. 1990;62:165-186.
10. Hancock BC, Zografi G. The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids. Pharm. Res. 1994;11(4):471-477.
11. Wang W. Lyophilization and development of solid protein pharmaceuticals. Int. J. Pharmaceut. 2000;203:1-60.
12. Biliaderis C, Swan R, Arvanitoyannis I. Physiochemical properties of commercial starch hydrolyzates in the frozen state. Food Chem. 1999;64(4):537-546.
13. Pikal MJ. Use of laboratory data in freeze-drying process design: heat and mass transfer coefficients and the computer simulation of freeze-drying. J. Parent. Sci. Technol. 1985;39(3):115-138.
14. Pikal MJ. Freeze-drying. Encyclopedia of Pharmaceutical Technology. New York: Marcel Dekker; 2002:1299-1326.
15. Kuu W, Hardwick L, Ackes M. Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles. Int. J. Pharm. 2006;313:99-113.
16. Rambhatla S, Pikal MJ. Heat and mass transfer scale-up issues during freeze-drying I: Atypical radiation and the edge vial effect. AAPS Pharm. Sci. Tech. 2003;4(2)111-120.
17. Tang XC, Nail SL, Pikal MJ. Evaluation of manometric temperature measurement (MTM), a process analytical technology tool in freeze-drying, Part III: Heat and mass transfer measurement. AAPS Pharm. Sci. Tech. 2006;7(4)Article 97.
18. Schneid S, Gieseler H, Kessler W, Pikal MJ. The determination of position dependent vial heat transfer coefficient: A comparision of tunable diode laser absorption spectroscopy and gravimetric measurements. 2006, Proc. CCPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Patenkirchen, Germany.
19. Searls JA. Heterogeneity phenomena in pharmaceutical lyophilization. PhD Thesis, University of Colorado, Boulder, CO; 2000.
20. Gieseler H, Kessler WJ, Finson M, Davis SJ, Mulhall PA, Bons V, Debo DJ, Pikal MJ. Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurement during freeze drying. J. Pharm. Sci. 2007;96(7):1776-1793.