Controlled ice nucleation in the field of freeze-drying: Fundamentals and technology review

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 85, Issue 2, 2013, Pages 214-222

  Geidobler, R ^a   Winter, G ^a  

^a UNIVERSITY OF MUNICH   (Germany)

Author keywords

Controlled nucleation; Freeze drying; Ice nucleation; Lyophilization

Indexed keywords

ATTENTION; FREEZE DRYING; SCALE UP; CHEMISTRY; CONTROLLED NUCLEATION; FREEZE-DRYING; ICE NUCLEATION; METHODOLOGY; PHARMACEUTICS; REVIEW; TEMPERATURE; PROCEDURES;

ICE; WATER;

CONTROLLED NUCLEATION; FREEZE-DRYING; ICE NUCLEATION; LYOPHILIZATION;

FREEZE DRYING; ICE; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; WATER;

EID: 84899775084     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2013.04.014     Document Type: Article

References (56)

1. J.A. Searles, J.F. Carpenter, and T.W. Randolph The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf Journal of Pharmaceutical Sciences 90 7 2001 860 871
2. M. Akers, and et al. Glycine crystallization during freezing: the effects of salt form, pH, and ionic strength Pharmaceutical Research 12 10 1995 1457 1461
3. E.B. Moore, and V. Molinero Structural transformation in supercooled water controls the crystallization rate of ice Nature 479 7374 2011 506 508
4. J.C. Kasper, and W. Friess The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals European Journal of Pharmaceutics and Biopharmaceutics 78 2 2011 248 263
5. M. Matsumoto, S. Saito, and I. Ohmine Molecular dynamics simulation of the ice nucleation and growth process leading to water freezing Nature 416 6879 2002 409 413
6. M. Burke, and et al. Freezing and injury in plants Annual Review of Plant Physiology 27 1 1976 507 528
7. C.S. Lindenmeyer, and et al. Rate of growth of ice crystals in supercooled water Journal of Chemical Physics 27 3 1957 822
8. T.W. Patapoff, and D.E. Overcashier The importance of freezing on lyophilization cycle development Biopharm 15 3 2002 16 21
9. S. Rambhatla, and et al. Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling AAPS PharmSciTech 5 4 2004 54 62
10. H. Kumano, and et al. Study on latent heat of fusion of ice in aqueous solutions International Journal of Refrigeration 30 2 2007 267 273
11. A.A. Shibkov, and et al. Morphology diagram of nonequilibrium patterns of ice crystals growing in supercooled water Physica A: Statistical Mechanics and its Applications 319 2003 65 79
12. B. Luyet, and G. Rapatz Patterns of ice formation in some aqueous solutions Biodynamica 8 156 1958 1 68
13. F.T.A. Franks Freeze-Drying of Pharmaceuticals and Biopharmaceuticals 2007 RSC Publishing Cambridge
14. M. Kramer, B. Sennhenn, and G. Lee Freeze-drying using vacuum-induced surface freezing Journal of Pharmaceutical Sciences 91 2 2002 433 443
15. A.K. Konstantinidis, and et al. Controlled nucleation in freeze-drying: effects on pore size in the dried product layer, mass transfer resistance, and primary drying rate Journal of Pharmaceutical Sciences 2011 pp. n/a-n/a
16. J. Brower, Presentation: ice fog induced nucleation, in: CPPR Conference on Freeze Drying of Pharmaceuticals and Biologicals, Breckenridge, 2012.
17. J.C.P. Kaltenegger, R. Lee, F. DeMarco, and E. Renzi Neuartiges Verfahren zur Steuerung der Eiskeimbildung Technopharm 2 6 2012 420 424
18. K. Nakagawa, and et al. Influence of controlled nucleation by ultrasounds on ice morphology of frozen formulations for pharmaceutical proteins freeze-drying Chemical Engineering and Processing: Process Intensification 45 9 2006 783 791
19. P. Chakravarty, and et al. Ice fog as a means to induce uniform ice nucleation during lyophilization BioPharm International 25 1 2012 33 38
20. W. Wang Lyophilization and development of solid protein pharmaceuticals International Journal of Pharmaceutics 203 1-2 2000 1 60
21. J.A. Searles, J.F. Carpenter, and T.W. Randolph Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T g ′ in pharmaceutical lyophilization Journal of Pharmaceutical Sciences 90 7 2001 872 887
22. 2O Archives of Biochemistry and Biophysics 81 2 1959 319 329
23. M.C. Heller, J.F. Carpenter, and T.W. Randolph Manipulation of lyophilization-induced phase separation: implications for pharmaceutical proteins Biotechnology Progress 13 5 1997 590 596
24. K.-I. Izutsu, and et al. Effect of salts and sugars on phase separation of polyvinylpyrrolidone[ndash]dextran solutions induced by freeze-concentration Journal of the Chemical Society, Faraday Transactions 94 3 1998 411 417
25. O.R. Fennema, W.D. Powrie, E.H. Marth, Low Temperature Preservation of Foods and Living Matter, Marcel Dekker, Inc., 1973.
26. M.L. Roy, and M.J. Pikal Process control in freeze drying: determination of the end point of sublimation drying by an electronic moisture sensor PDA Journal of Pharmaceutical Science and Technology 43 2 1989 60 66
27. A. Hottot, S. Vessot, and J. Andrieu A direct characterization method of the ice morphology. Relationship between mean crystals size and primary drying times of freeze-drying processes Drying Technology 22 8 2004 2009 2021
28. A. Hottot, S. Vessot, and J. Andrieu Freeze drying of pharmaceuticals in vials: Influence of freezing protocol and sample configuration on ice morphology and freeze-dried cake texture Chemical Engineering and Processing: Process Intensification 46 7 2007 666 674
29. M.J. Pikal, and et al. The secondary drying stage of freeze drying: drying kinetics as a function of temperature and chamber pressure International Journal of Pharmaceutics 60 3 1990 203 207
30. X. Tang, and M. Pikal Design of freeze-drying processes for pharmaceuticals: practical advice Pharmaceutical Research 21 2 2004 191 200
31. J. Liu, and et al. 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 2005 261 272
32. S. Patel, C. Bhugra, and M. Pikal Reduced pressure ice fog technique for controlled ice nucleation during freeze-drying AAPS PharmSciTech 10 4 2009 1406 1411
33. S. Passot, and et al. Effect of controlled ice nucleation on primary drying stage and protein recovery in vials cooled in a modified freeze-dryer Journal of Biomechanical Engineering 131 7 2009 074511
34. I.R. Last, and K.A. Prebble Suitability of near-infrared methods for the determination of moisture in a freeze-dried injection product containing different amounts of the active ingredient Journal of Pharmaceutical and Biomedical Analysis 11 11-12 1993 1071 1076
35. T. Rowe, A technique for the nucleation of ice, in: International Symposium on Biological Product Freeze-Drying and Formulation, Geneva, Switzerland, 1990.
36. T.N. Thompson, Personal Communication: The FreezeBooster Technique, 2012.
37. L. Weija, Controlled Nucleation During Freezing Step of Freeze Drying Cycle Using Pressure Differential Ice Fog Distribution, Patent US2012/02722544 A1, 2012.
38. R. Geidobler, S. Mannschedel, and G. Winter A new approach to achieve controlled ice nucleation of supercooled solutions during the freezing step in freeze-drying Journal of Pharmaceutical Sciences 101 12 2012 4409 4413
39. P.P. Fernández, and et al. High-pressure shift freezing versus high-pressure assisted freezing: effects on the microstructure of a food model Food Hydrocolloids 20 4 2006 510 522
40. P.D. Sanz, and et al. Freezing processes in high-pressure domains International Journal of Refrigeration 20 5 1997 301 307
41. M.T. Kalichevsky, D. Knorr, and P.J. Lillford Potential food applications of high-pressure effects on ice-water transitions Trends in Food Science & Technology 6 8 1995 253 259
42. T.H. Gasteyer, et al., Lyophilization System and Method, Patent US20070186437A1, 2007.
43. T.H. Gasteyer, et al., Method of Inducing Nucleation of a Material, Patent US20070186567A1, 2007.
44. R. Bursac, R. Sever, and B. Hunek A practical method for resolving the nucleation problem in lyophilization BioProcess International 7 9 2009 66 72
45. R. Hickling Nucleation of freezing by cavity collapse and its relation to cavitation damage Nature 206 4987 1965 915 917
46. K. Ohsaka, and E.H. Trinh Dynamic nucleation of ice induced by a single stable cavitation bubble Applied Physics Letters 73 1 1998 129 131
47. T. Inada, and et al. Active control of phase change from supercooled water to ice by ultrasonic vibration 1. Control of freezing temperature International Journal of Heat and Mass Transfer 44 23 2001 4523 4531
48. R. Chow, and et al. The sonocrystallisation of ice in sucrose solutions: primary and secondary nucleation Ultrasonics 41 8 2003 595 604
49. W. Rau Eiskeimbildung durch Dielektrische Polarisation Zeitschrift fur Naturforschung 6 1951 649 657
50. T. Hozumi, and et al. Effects of electrode materials on freezing of supercooled water in electric freeze control International Journal of Refrigeration 26 5 2003 537 542
51. A. Petersen, G. Rau, and B. Glasmacher Reduction of primary freeze-drying time by electric field induced ice nucleus formation Heat and Mass Transfer 42 10 2006 929 938
52. A. Petersen, and et al. A new approach for freezing of aqueous solutions under active control of the nucleation temperature Cryobiology 53 2 2006 248 257
53. S. Jiang, and S.L. Nail Effect of process conditions on recovery of protein activity after freezing and freeze-drying European Journal of Pharmaceutics and Biopharmaceutics 45 3 1998 249 257
54. Y.G. Zhou, H. Theodore, Nigel J. Grinter, Alan T. Cheng, Yeu-Chuan Simon Ho, Robert R. Sever, Method and System for Nucleation Control in a Controlled Rate Freezer (CRF), Patent US 20120102982A1, 2012.
55. W.-Y. Kuu, Mark J. Doty, William S. Hurst, Christine L. Rebbeck, Optimization of Nucleation and Crystallization for Lyophilization Using Gap Freezing, in: B. Healthcare (Ed.), Patent US 20120192448A1, US, 2012.
56. H.-G. Hof, Gefriertrocknungsanlage, European Patent EP0777092B1, 1998.