Freeze-Drying of Pharmaceutical and Food Products

Freeze-Drying of Pharmaceutical and Food Products

Volumn , Issue , 2010, Pages 1-257

  Hua, Tse Chao ^a   Liu, Bao Lin ^a   Zhang, Hua ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84865219507     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1533/9781845697471     Document Type: Book

References (146)

1. Flosdorf E.W., Mudd S. Procedure and apparatus for preservation in "lyophile" form of serum and other biological substances. J. Immunology 1935, 29:389-425.
2. Rey L., May J.C. Freeze-diying/lyophilization of pharmaceutical and biological products 2004, Marcel Dekker Inc, New York.
3. Oetjen G.W., Haseley P. Freeze-Drying 2004, Weinheim: Wiley-VCH.
4. Hua T.C. New technology of freeze-dtying 2006, Science Press, Beijing.
5. Zhao H.G., Lin X.C. Technology of freeze-diying 1990, Huazhong Science & Technology University Press, Wuhan,China.
6. Hua T.C., Li Y.F., Liu B.L. The Principle and equipment of food's refrigeration and cold storage 1999, China Machinery Press, Beijing,China.
7. Xu C.H., Zhang S.W., Guan K.Z. Vacuum drying 2004, Chemical Industry Press, Beijing,China.
8. Gao F.C. Freeze-dried food 1998, China Light Industry Press, Beijing.
9. Lu B. New dosage form and technology of pharmaceuticals 2000, People's Medical Publishing House, Beijing.
10. Xiao H.H., Li J., Hua T.C. Research on freeze-drying of the nucleated cell of human cord blood. Chinese Journal of Cell Biology 2003, 25(6):389-393.
11. Xiao H.H., Hua T.C., LI J., Gu X.L., Wang X. Freeze-diying of mononuclear cells and whole blood of human cord blood. CryoLetters 2004, 25(2):111-120.
12. Li J., Hua T.C., Gu X.L., Xiao H.H. Morphological study of freeze-drying mononuclear cells of human cord blood. CryoLetters 2005, 26(3):193-200.
13. Hua T.C., Ren H.S. Cryobio-medical Techniques 1994, Science Press, Beijing, China.
14. Zhou G.D. Structure and Physical Properties 2000, Higher Education Press, Beijing. the second edition.
15. Ashrae Ashrae Handbook (fundamentals) 1993, New York.
16. Fennema O.R. Food Chemistry 1996, Marcel Dekker, Inc, New York. 3rd edition.
17. Kinesella L., Levine H. Glass Transitions and Water Food Structure Interactions. Advances in Food and Nutrition Research 1994, 38. Academic Press, San Diego:. J.E. Levine (Ed.).
18. Hua T.C. Cryobio-medical techniques: Study on Amorphous Solidification by fast cooling in cryobiomedical fields. in Thermophysical Studies in Biomedical Field edited 1995, 96-104. Science Press, Beijing. H.Q. Chen, C.C. Wang (Eds.).
19. Liu Z.J., HUa T.C., Chen J.M., Gao S. Effect of vitrification on freeze -diying process of pharmaceuticals. Chinese journal of pharmaceuticals 2000, 31(8):380-383.
20. Blanshard J.M.V., Lillford P.J. The Glassy State in Foods 1993, Nottingham University Press, England.
21. Zuo J.G., Hua T.C., Liu B.L., Zhou G.Y. Study of the freezing properties of solutions for freeze-drying by DSC. Chinese Journal of Cryogenics 2005, 3:48-51.
22. Hua Z.Z. Cryobio-medicine and thermophysics. Physics and Engineering 2001, 11(6):1-4.
23. Meryman H.T. Cryobiology 1966, Academic Press, New York.
24. Luyet B. On the possible biological significance of some physical changes encountered in the cooling and the rewarming of aqueous solution. Cellular injury and resistance in freezing organisms 1985, 1-20. Hokkaido University Press, Japan. E. Asahina (Ed.).
25. Wu S.Y., Yao K.M., Hua T.C. Study on cryobiological microscope system. Chinese Journal of Scientific Instrument 1988, 9(1):90-93.
26. Wu S.Y., Hua T.C. A new structure of cryomicroscope. Cryobiology 1987, 6:553-554.
27. Liu B.L., Hua T.C., Yuan S.M., Wu S.Y. A new type of cryo-microscope DSC system. Chinese Journal of Scientific Instrument 1999, 20(1):60-62.
28. Tao L.R., Hua T.C. A microscopic study of the crystallization in cryoprotectant agents. Chinese Journal of Engineering Thermophysics 2001, 22(4):481-484.
29. Tao L.R., Hua T.C. Microscopic Study of Crystal Growth in Cryopreservation Agent Solutions and Water. Annals New York Academy of Sciences 2002, 972:151-157.
30. Sun Z.Q., Hua T.C. Research on bovine embryo's cryopreservation process by cryo-microscope. Chinese Journal of Refrigeration 1987, (10):25-27.
31. Chen X.H., Hua T.C. Preliminary study on cryo-microscopic observation and preservation effect of the human leukocytes. Chinese Journal of Cryogenics 1987, 4:1-8.
32. Wang D.R., Hua T.C. Influence of unfrozen fraction to the survival of leucocytes during slow cooling. Cryobiology 1988, 25:510.
33. Hua T.C., Wang D.R. The phase diagrams of ternary solution system in cryobiology. Chinese Journal of Refrigeration 1989, 2:11-20.
34. Chen E T, Zhao L, Hua Z ZH. A cooling and temperature controlling device for cryobiology. Chinese Patent: No.91-2-15370.9.
35. Chen R.T., Hua T.C. A new cooler with very low consumption of liquid nitrogen. Cryobiology 1988, 22:549-550.
36. Chen R.T., Hua T.C. A new cryocooler for cryopreservation. Chinese Cryogenics 1989, 2:24-29.
37. Wu S.Y., Hua T.C. A new cooling technique in cryopreservation of biomaterial. Chinese Journal of Refrigeration 1987, 4:11-17.
38. Peng H Z, Hua T C, Tao LR. A programmable cooler with liquefied nitrogen vessel. Chinese Patent: ZL00-2-18101.0.
39. Peng H.Z., Hua T.C., Tao L.R. A cryocooler with internal heating and pressing liquefied nitrogen. Chinese Cryogenics 2000, 5:8-12.
40. Hua T.C., Liu B.L. Heat and mass transfer in vitrification of bio- and food Material. Heat Transfer 1998, Vol.1. Kyongju, Korea, August 23-28.
41. Ren H.S., Wei Y., Hua T.C. Theoretical predication of vitrification and devitrification tendencies for cryoprotective solutions. Cryobiology 1994, 3:47-56.
42. 2. CiyoLetters 1995, 16:157-162.
43. Cao Q., Hua T.C. Effects on rapid cooling of small samples in quenching. Annals of the New York, Academy of Sciences 1998, 858:262-269.
44. Xu J.J., Hua T.C. Comparative study on the quenching boiling of small and large samples in nitrogen. Chinese Journal of Cryogenics 1997, 4:15-18.
45. Xu J.J., Hua T.C., Liu B.L., Fu X.J. Experimental study on quenching boiling heat transfer from plate in subcooled liquid nitrogen. Chinese Journal of Cryogenics 1999, (4):174-179.
46. Hua T.C., Xu J.J. Quenching boiling in subcooled liquid nitrogen for solidification of aqueous materials. Materials Science & Engineering A 2000, 292:169-172.
47. Li Y.F., Hua T.C., Liu B.L. Research on energy saving technologies in vacuum freeze drying of foods. Chinese Journal of Cryogenics 1997, 4:51-56.
48. Su S.Q., Ding Z.H., Hua T.C. Study on the measurement of the product temperature at the moving sublimation interface during the freeze drying process. Chinese Journal of Engineering Thermophysics 2004, 25(5):852-854.
49. Su S Q, Hua T C. Method and device of the sublimation temperature during freeze drying Chinese Invention Patent: ZL 03 1 29506.1.
50. Su D.S., Wang S.L. Physical pharmaceutics 2004, Chemical Industry Press, Beijing.
51. Grazio F., Flynn K. Lyophilization closures for protein based drugs. J. Parent. Sei. Technol 1992, 46:54-61.
52. Frank F. Long-term stabilization of biologicals. Biotechnology 1994, 12:253.
53. Hancock B.C., Zografi G. Characteristics and significance of the amorphous state in pharmaceutical systems. J. Pharm. Sei 1997, 86:1-12.
54. Schmitt E.A., Law D., Zhang G. Nucleation and crystallization kinetics of hydrated amorphous lactose above glass transition temperature. J. Pharm. Sei 1999, 88:291-296.
55. Goldblith S.A., Rey L. Freeze drying and advanced food technology, London, Academic Press 1975.
56. Mujumdar A.S. Handbook of Industrial Drying 1987, Marcel Dekker Inc, USA.
57. Sandall O.C., King C.J., Wilke C.R. The relationship between transport properties and rates of freeze-drying of poultry meat. AIChE (American Institute of Chemical Engineers). Journal 1967, 13(3):428-438.
58. Heldman R., Singh R.P. Food process engineering 1981, AVI Publishing Company, USA. 2nd ed.
59. Toledo R.T. Fundamentals of food process engineering 1991, Van Nostrand Reinhold, New York. 2nd ed.
60. Sheehan P., Liapis A.I. Modeling of the primary and secondary drying stages of the freeze drying of pharmaceutical products in vials: numerical results obtained from the solution of a dynamic and spatially multi-dimensional lyophilization model for different operational policies. Biotechnology and Bioengineering 1998, 60(6):712-728.
61. Sadikoglu H., Liapis A.I. Mathematical modeling of the prime and secondary drying stages of bulk solution freeze drying in trays: Parameter estimation and model discrimination by comparison of theoretical results with experimental data. Drying Tech 1997, 15:791-810.
62. Bruttini R., Rovero G., Baldi G. Experimentation and modeling of pharmaceutical lyophilization using a pilot plant. Chemical Engineering Journal 1991, 45:B67-B77,1991.
63. 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, 31:1594-1604.
64. Li Y.F., Hua T.C. Characteristics of freeze-drying under the mass diffusion control. Chinese Journal of Refrigeration 1997, 3:23-27.
65. Sadikoglu H., Liapis A.I. Optimal control of the primary and secondary drying stages of bulk solution freeze drying in trays. Drying Tech 1998, 16(3-5):399-431.
66. Mellor J.D. Fundamentals of freeze drying 1978, Academic press, London.
67. Van Arsdel W.B., Copley M.J., Morgan A.I. Food Dehydration 1973, Avi Publishing Company, USA. 2nd ed.
68. Da D.A. Manual of vacuum design 2004, National Defense Industry Press, Beijing. the Third Edition.
69. http://www.toyo-engi.co.jp/vf_c.htm.
70. http://www.tofflon.com/system.htmce:textref.
71. Yij S.M., Bai J., Ma G.Q. Preservation and freeze-drying technology of fruits and vegetables 1999, Heilongjiang Science and Technology Press, Harbin, China.
72. Fu W.Y. Application of freeze-drying technology in instant coffee production. Chinese Journal of Packaging and Food Machinery 2000, 28(4):19-21.
73. Zeng Q.X., Xu X.L. Hazard Analysis and Critical Control Points in Food Production 2001, South China University of Technology Press, Guangzhou, China.
74. Yang J.B., Wang J., Wang B.Q. Food Safety 1999, China Light Industry Press, Beijing.
75. Certification and Accreditation Administration of the People's Republic of China. Establishment and Implementation of HACCP system for fruit and vegetable juice 2002, Intellectual Property Publishing House, Beijing, China.
76. Wu Z.Z. Application of HACCP system to the device and production of Freeze drying of kiwifruit. Bachelor's Thesis of Shanghai University of Science and Technology 2003.
77. Carpenter J.F., Crowe J.H., Crowe L.M. Stabilization of phosphofructoki-nase with sugars during freeze-drying: characterization of enhanced protection in the presence of divalent cations. Biochem. Biophys. Acta 1987, 923:109-115.
78. Arakawa T., Prestrelski S.J., Kinney W., Carpenter J.F. Factors affecting short-term and long-term stabilities of proteins. Advanced Drug Delivery Rev 1993, 10:1-28.
79. Prestrelski S.J., Tedeschi N., Arakawa T., Carpenter J.F. Dehydration- induced conformational changes in proteins and their inhibition by stabilizers. Biophys. J. 1993, 65:661-671.
80. Izutsu K., Yoshioka S., Takeda Y. The effect of additives on the stability of freeze-dried ß-galactosidase stored at elevated temperatures. Int. J. Pharm. 1991, 71:137-146.
81. Leslie S.B., Israeli E., Lighthart B., et al. Trehalose and sucrose protect both membranes and proteins in intact bacteria during drying. Appl. Environ. Microbiol. 1995, 61:3592-3597.
82. Levine H., Slade L. Another view of trehalose for drying and stabilizing biological materials. Biopharm. 1992, 5(5):36-40.
83. Allison S.D. Effects of drying methods and additives on structure and function of actin: mechanisms of dehydration-induced damage and its inhibition. Arch. Biochem. Biophy. 1998, 358:171-181.
84. Carpenter J.F., Crowe J.H. An infrared spectroscopic study of the interactions of carbohydrates with dried proteins. Biochemistry 1989, 28:3916-3922.
85. Pikal K.A., Carpenter J.F. pH changes during freezing in sodium and potassium phosphate buffer systems in the presence of glycine: effect on protein stability. Pharm. Sci 1998, l(Suppl):544.
86. Chang B.S., Reeder G., Carpenter J.F. Development of a stable freeze- dried formulation of recombinant human interleukin-1 receptor antagonist. Pharm. Res. 1996, 13:243-249.
87. Deluca P.P., Kamat M.S., Koi Da Y. Acceleration of freeze-drying cycles of aqueous solutions of lactose and sucrose with tertiary butyl alcohol. Int. Technol. Pharm. 1989, 1:439-447.
88. Wittaya-Areekul S., Nail S.L. Freeze-diying of tert-butyl alcohol/water cosolvent systems: A case report on formation of a friable freeze-dried powder of tobramycin sulfate. J. Pharm. Sei. 2002, 91:1147-1155.
89. Zuo J.G., Hua T.C. Freeze drying of organic solution. Chinese Journal of Science and Technology of Food Industry 2006, 5:203-205.
90. Kasraian K., Deluca P.P. The effect of tertiary butyl alcohol on the resistance of the dry product layer during primary drying. Pharm. Res. 1995, 12:491-495.
91. Prestrelski S.J., Pikal K.A., Arakawa T. Optimization of lyophilization conditions for recombinant human interleukin-2 by dried-state conformational analysis using Fourier-transform infrared spectroscopy. Pharm.Res. 1995, 12:1250-1259.
92. Townsend M.W., Deluca P.P. Stability of ribonuclease A in solution and the freeze-dried state. J.Pharm.Sci 1990, 79:1083-1086.
93. Izutsu K., Yoshioka S., Terao T. Decreased protein-stabilizing effects of cryoprotectants due to crystallization. Pharm.Res. 1993, 10:1232-1237.
94. Chang B.S., Randall C.S. Use of subambient thermal analysis to optimize protein lyophilization. Cryobiology 1992, 29:632-656.
95. Sarciaux J.M., Hageman K.J. Effects of bovine somatotropin (rbSt) concentration at different moisture levels on the physical stability of sucrose in freeze-dried rbSt/sucrose mixtures. J. Pharm. Sei. 1997, 86:365-371.
96. Kreilgaard L., Frokjaer S., Flink J.M., Randolph T.W., Carpenter J.F. Effects of additives on the stability of humicola lanuginosa lipase during freeze-drying and storage in the dried solid. J. Pharm. Sei. 1999, 88:281-290.
97. Liu Z.H. Thermal Analyses-Book 8 of Analytical Chemistry Manual, Chemical Industry Press, Beijing, China 2000.
98. Pyris Diamond Dsc User Manual 2002, Perkin Elmer Instruments, USA.
99. Zuo J.G., Hua T.C., Liu B.L., Zhou G.Y. Thermal analysis of tertiary butyl alcohol/sucrose/water ternary system. CryoLetters 2005, 26(5):289-296.
100. Zuo J.G., Hua T.C. Annealing characteristics of lyoprotectant solution. Acta Physico-Chimica 2005, 21(10):1175-1179.
101. Zuo J.G., Hua T.C. Cryo-microscopic and thermal analyses of freeze drying solution. Chinese Journal of Engineering Thermophysics 2006, 27(2):307-309.
102. Gao C., Zhou G.Y., XU Y., HUA T.C. Freezing characteristics of EG and glycerol aqueous solutions studied by DSC. Acta Physico-Chimica Sinica 2004, 20(2):123-128.
103. Hutchinson J.M. Studying the glass transition by DSC and TMDSC. J. Therm. Anal. Cal. 2003, 72:619-629.
104. Gao C., Zhou G.Y., Xu Y., Hua T.C. Glass transition and enthalpy relaxation behaviors of ethylene glycol and its aqueous solution with the presence of crystals. Thermo-Chimica Acta 2005, 435:37-42.
105. Gao C., Wang W.H., Hu T.J., Xu Y., Zhou G.Y., Hua T.C. Glass Transition and enthalpy relaxation behavior of ethylene glycol and it's aqueous solution with different ciystallinity. Acta Physico-Chimica Sinica 2004, 20(7):701-706.
106. Gao C., Zhou G.Y. Phenomenological study of structure relaxation of glycerol aqueous glass. Acta Physico-Chimica Sinica 2005, 21(8):909-914.
107. Gao C., Zhou G.Y., Xu Y., Hu T.J., Hua T.C. Glass transition and structure relaxation parameters of glycerol/water mixtures with high concentrations: A DSC study. Chinese Journal of Chemical Physics 2005, 18(3):457-462.
108. Zuo J.G., Hua T.C., Liu B.L., Zhou G.Y., Xu Y. Assay study on glass transition temperature of solutions in freeze-drying. Chinese Journal of Food Science 2006, 27(2):58-60.
109. Hatakeyama T., Liu Z.H. Handbook of thermal Analysis 1998, Wiley, England. lst ed.
110. Guo Y. Bio-pharmaceutical Technology 2000, China Light Industry Press, Beijing.
111. Wang P.S., Wang Y.M. Status and development of biopharmaceutical industry in the world. Chinese Journal of Fine and Specialty Chemicals 2003, (5):8-9. (6): 8-11.
112. Liu Z.J., Hua T.C. The denaturation mechanism of protein pharmaceuticals in freeze-drying process. Chinese Journal of Biochemical Pharmaceutics 2000, 21(5):263-265.
113. O'brien F.J., Harley B.A., Yannas I.V. Influence of freezing rate on pore structure in freeze-dried collagen-GAG scaffolds. Biomaterials 2004, 25(6):1077-1086.
114. Strambini G. Phosphorescence lifetime measurements indicate ice-induced partial unfolding of proteins. J. Biophys 1996, 70:971-976.
115. Townsend M.W. Use of lyoprotectants in the freeze-drying of a modal protein ribonuclease. Pda J. Pharm. Sei. Tech. 1998, 42(6):190-196.
116. Chen L.Z., Li Y.G., Bian G.Z. Protective effect of trehalose on freeze-dried products containing enzymes. Shanghai Journal of Medical Laboratory Sciences 2001, 16(3):166-167.
117. Ge Y., Liu L., Gao J.J. Protective effect of trehalose on recombinant human copper and zinc superoxide dismutase (rhCuZn-SOD). Chinese Journal of Biological Products 2003, 16(1):42-45.
118. Nail S., Liu W., Wang D.Q. Loss of protein activity during lyophilization as an interfacial phenomenon: formulation and processing effects. Freeze-Drying of Pharmaceuticals and Biologicals 2001, The Village at Breckenridge, Colorado, USA.
119. Hora M.S., Rana R.K., Wilcox C.L. Development of lyophilized formulation of interleukin. Developments in biological Standardization 1992, 74:295-306.
120. Arakawa T., Prestrelski S.J., Kenney W.C. Factors affecting short-term and long-term stabilities of proteins. Adv. Drug Deliv. Rev. 2001, 46:307-326.
121. Carpenter J.F., Prestrelski S.J., Dong A. Application of infrared spectroscopy to development of stable lyophilized protein formulations. Eur. J. Pharm. Biopharm. 1998, 45(3):231-239.
122. Qi Y.Y. Protective agent's screening and freeze-drying technology of human leukocyte interferon Acta Universitatis Medicinalis Nanjing 1997, 17(3):284-286.
123. Byeong S.C., Robert M.B., Aichun D. Physical factors affecting the storage stability of freeze- dried Interleukin-1 receptor antagonist: Glass transition and protein conformation. Archives Biochem. Biophys. 1996, 331(2):249-258.
124. Su S.Q. Parameter measurement in the freeze-drying process and freeze-drying experiment of biological pharmaceuticals. Doctoral dissertation of Shanghai University of Science and Technology 2004.
125. Ping Q.N. Modern Pharmaceutics 1999, China Medical Science and Technology Press, Beijing.
126. Bi D.Z. Pharmaceutics 1999, People's Medical Publishing House, Beijing.
127. Zhu S.S. New dosage form of pharmaceuticals 1993, People's Medical Publishing House, Beijing.
128. Gomez-Hens A., Fernandez-Romero J.M. Analytical methods for the control of liposomal delivery systems. Trends Anal Chem. 2006, 25:167-178.
129. Mozafari M.R., Mortazavi S.M. Nanoliposomes: From Fundamentals to Recent Developments 2005, Trafford Publishing Ltd, Oxford, UK.
130. Hua T.C., Li B.G., Liu Z.Z., Sun D.W. Freeze-drying of liposomes with cryopetectants and its effect on retention rate of encapsulated florafur and vitamin A. Drying Technology 2003, 21(8):1491-1505.
131. Su S.Q., Hua T.C., Ding Z.H., Hu S.G., Han L. Effects of lyoprotectants and rehydrated solutions on the encapsulation of HB-1 a liposomes. Chinese Journal of New Drugs 2004, 13(9):809-812.
132. Su S.Q., Hua T.C., Ding Z.H., Hu S.G., Han L. Vesicles size and diameter distribution of HB- I a liposomes during freeze-drying. Chinese Journal of Pharmaceuticals 2004, 35(3):154-157.
133. Liu Z.J., Hua T.C., Tao L.R., Liu B.L. The effect of cryoprotectant concentration and cooling rate on the glass transition temperature of liposome. Chinese Journal of Cryogenics 2000, 118(6):1-5.
134. Liu Z.J. Experimental study and mechanism analysis on lipofectin drug during the low temperature freeze-drying. Doctoral dissertation of Shanghai University of Science and Technology 2001.
135. Liu Z.J., Hua T.C., Li B.G. Experimental study on liposome Freeze-drying Process. Chemical Industry and Engineering Progress 2000, 19(11):69-72.
136. Liu Z.J., Hua Z.Z. The effect of the optimal freeze-drying cycle on the quality of liposome 2000.
137. Liu Z.J., Xiao H.H., Su S.Q., Hua T.C. The experimental study on the influence of freezing method on the size and encapsulation efficiency of the freeze-dried liposome pharmaceuticals. Chinese Journal of Engineering Thermophysics 2002, 23(5):599-601.
138. Lu D.Y. Medical Microbiology 1995, People's Medical Publishing House, Beijing. fourth edition.
139. Ji X.H., Zhang J.Q. Medical Immunology and Medical Microbiology 2001, Science Press, Beijing.
140. Ye Y.Y. Guidelines of pharmaceutical production 1996, Chinese Medical Science and Technology Press, Beijing.
141. Frederick J.C., Agalloco J.P. Validation of Aseptic Pharmaceutical processes 1986, Marcel Dekker, Inc, New York:.
142. China Pharmacopoeia Committee. Pharmacopoeia of the Peoples Republic of China, (2005 English Edition) 2005, People's Medical Publishing House, Beijing.
143. Chinese Biological Products Standardization Committee. Chinese Regulations of the Biological Products 2000, Chemical Industry Press, Beijing.
144. Bai H.L., Li W.C. Verified guidelines of pharmaceutical products 2003, Chemical Industry Press, Beijing.
145. China Pharmaceutical Industry Association China National Pharmaceutical Industry Corporation. The Guideline of Good Manufacture Practice for pharmaceutical products 2001, Chemical Industry Press, Beijing.
146. Frederick J., Carleton J.P. Agalloco, Validation of Pharmaceutical processes-sterile products 1999, Marcel Dekker, Inc, New York.