Spray-drying and supercritical fluid particle generation techniques

Inhalation Aerosols: Physical and Biological Basis for Therapy

Volumn , Issue , 2006, Pages 307-346

  Van Oort, Michiel M ^a   Sacchetti, Mark ^a  

^a GLAXOSMITHKLINE   (United States)

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EID: 85123026983     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (121)

1. Briggs A. A new freeze drying technique for processing biological materials. Int Symp Freeze-Drying Biol Prod 1976; 36:251-260.
2. Rogers TL, Hu J, Yu Z, Johnson KP, Williams RO. A novel particle engineering technology: spray freezing into liquid. Int J Pharm 2002; 242:93-100.
3. Rogers TL, Johnston KP, Williams RO III. Physical stability of micronized powders produced by spray-freeze drying into liquid (SFL) to enhance the dissolution of an insoluble drug. Pharm Dev Technol 2003; 8(2):187-197.
4. Rogers TL, Nelsen AC, Sarkari M, Young N, Johnston KP, Williams RO III. Enhanced aqueous dissolution of a poorly water soluble drug by novel particle engineering technology: spray-freezing into liquid with atmospheric freeze-drying. Pharm Res 2003; 20(3):485-493.
5. Sonner C, Maa YF, Lee G. Spray-freeze-drying for protein powder preparation: particle characterization and a case study with trypsinogen stability. J Pharm Sci 2002; 91(10):2122-2139.
6. Maa Y, Nguyen P, Sweeney T, Shire SJ, Hsu CC. Protein inhalation powders: spray drying vs spray freeze drying. Pharm Res 1999; 16(2):249-254.
7. Mumenthaler M, Leuenberger H. Atmospheric spray freeze drying: a suitable alternative in freeze drying technology. Int J Pharma 1991; 72(2):97-110.
8. Takenaka H, Kawashima Y, Chikamatsu Y, Ando Y. Mechanical properties, dissolution behavior and stability to oxidation of L-ascorbylmonostearate microcapsules prepared by a spray-drying polycondensation technique. Chem Pharm Bull 1982; 30:2189-2195.
9. Masters K. Spray Drying Handbook. New York: Longman, 1991.
10. Koushik K, Kompella U. Particle and device engineering for inhalation drug delivery. Drug Delivery Technol 2004; 4:40-50.
11. Clarke MJ, Peart J. New developments in dry powder inhaler technology. Am Pharm Rev 2001; 4(3):37-45.
12. Newman S. Dry powder inhalers for optimal drug delivery. Exp Opin Biol Ther 2004; 4:23-33.
13. Edwards DA, Dunbar D. Bioengineering of therapeutic aerosols. Annu Rev Biomed Eng 2002; 4:93-107.
14. Taylor G, Gumbleton M. Aerosols for macromolecule delivery. Am J Drug Delivery 2004; 2(3):143.
15. Daugherty AL, Mrsny RJ. Emerging technologies that overcome biological barriers for therapeutic protein delivery. Exp Opin Biol Ther 2003; 7:1071.
16. Okamoto H, Todo H, Iida K, Danjo K. Dry powders for pulmonary delivery of peptides and proteins. Kona 2002; 20:71-83.
17. Patton JS, Platz RM. Pulmonary delivery of peptides and proteins for systemic action. Adv Drug Del Rev 1992; 8:179-196.
18. Niven RW. Delivery of biotherapeutics by inhalation aerosols. Pharm Technol 1993; 17:72-82.
19. Wall DA. Pulmonary absorption of peptides and proteins. Drug Delivery 1995; 2:1-20.
20. Broadhead J, Edmond RSK, Rhodes CT. The spray drying of pharmaceuticals. Drug Dev Ind Pharm 1992; 18:1169-1206.
21. Louey M, Garcia-Contreras L. Controlled release products for respiratory delivery. Am Pharm Rev 2004; 7(4):82-87.
22. Sakagami M, Byron P. Respirable microspheres for inhalation. Clin Pharmacokinet 2005; 44(3):263-277.
23. Lefebvre AH. Atomization and Sprays. Bristol, PA: Taylor & Francis, 1989.
24. Dombrowski N, Munday G. Spray drying. In: Blakebrough N, ed. Biochemical and Bioengineering Science. New York: Academic Press, 1968:209-320.
25. Whitby KT, Lundgren DA, Peterson CM. Homogeneous aerosol generators. Int J Air Wat Poll 1965; 9:263-277.
26. Philipson K. On the production of monodisperse particles with a spinning disk. J Aerosol Sci 1973; 4:51-57.
27. Davies CN, Cheah PKP. Spinning generators of homogeneous aerosols. J Aerosol Sci 1984; 15:719-739.
28. Byron PR, Hickey AJ. Spinning disk generation and drying of monodisperse solid aerosols with output concentrations sufficient for single-breath inhalation studies. J Pharm Sci 1987; 76:60-64.
29. Lefebvre AH, Wang XF, Martin C. Spray characteristics of aerated-liquid pressure atomizers. AIAA J Propulsion Power 1988; 4:293-298.
30. Kelly AJ. The electrostatic atomization of hydrocarbons. Proceedings of the 2nd International Conference on Liquid Atomization and Spray Systems. Madison, WI, 1982:57-65.
31. Fell JT, Newton JM. The characterization of the form of lactose in spray dried lactose. Pharm Acta Helv 1970; 45:520-522.
32. Fell JT, Newton JM. The production and properties of spray dried lactose. Parts 1, 2 and 3. Pharm Acta Helv 1971; 46:226-235, 425-430, 441-447.
33. Kauzmann W. The nature of the glassy state and the behavior of liquids at low temperatures. Chem Rev 1948; 43:219-256.
34. Boyer RF. The relation of transition temperatures to chemical structure in high polymers. Rubber Chem Technol 1963; 36:1303-1421.
35. Adachi K, Suga H, Seki S. The glassy crystalline state - a nonequilibrium state of plastic crystals. Bull Chem Soc Jpn 1970; 43:1916.
36. Sakka S, MacKenzie JD. Relation between apparent glass transition temperature and liquid temperature for inorganic glasses. J Non-Cryst Solids 1971; 6:145-162.
37. Summers MP. Glass formation in barbiturates and solid dispersion systems of barbiturates with citric acid. J Pharm Sci 1978; 67:1606-1610.
38. Fukuoka E, Makita M, Yamamura S. Glassy state of pharmaceuticals. III. Thermal properties and stability of pharmaceuticals and their binary glass systems. Chem Pharm Bull 1989; 39:1047-1050.
39. Fukuoka E, Makita M, Nakamura Y. Glassy state of pharmaceuticals. V. Relaxation during cooling and heating of glass by differential scanning calorimetry. Chem Pharm Bull 1991; 39:2087-2090.
40. Leith D. Cyclones. In: Fayed ME, Otten L, eds. Handbook of Powder Science and Technology. New York: Van Nostrand Reinhold, 1984:730-753.
41. Iinoya K, Hisakuni H, Sue E, Fuyuki T, Yamada Y. Air cyclone classifier for submicron size. Proceedings of the 2nd World Congress on Particle Technology, Japan; September 19-22, 1990:120-126.
42. Katz J. Electrostatic precipitator application and concepts. In: Fayed ME, Otten L, eds. Handbook of Powder Science and Technology. New York: Van Nostrand Reinhold, 1984:754-769.
43. Dunbar C. Porous Particles for Inhalation: The Science Behind Their Improved Dispersibility, Proceedings of Respiratory Drug Delivery X, Book 1, 2006:307-313.
44. Ranz WE, Marshall WR. Evaporation from drops. Parts I and II. Chem Eng Prog 1952; 48:141-146, 173-180.
45. Duffle JA, Marshall WR. Factors influencing the properties of spray dried materials. Parts I and II. Chem Eng Prog 1953; 49:417-423, 480-486.
46. Crosby EJ, Marshall WR. Effects of drying conditions on the properties of spray dried particles. Chem Eng Prog 1958; 54:56-63.
47. Charlesworth DH, Marshall WR. Evaporation from drops containing dissolved solids. AIChE J 1960; 6:9-23.
48. Frossling N. Gerlands Beitr Geophysik 1938; 52:170.
49. Alexander K, King CJ. Factors governing surface morphology of spray-dried amorphous substances. Drying Tech 1985; 3:321-348.
50. Bruno TJ, Ely JF. Supercritical Fluid Technology: Reviews in Modern Theory and Applications. Boca Raton: CRC Press, 1991.
51. Kiran E, Brennecke JF. Supercritical fluid engineering science: fundamentals and applications. ACS Symp Series 1993; 514.
52. Johnson JM, Penniger L. Supercritical fluid science and technology. ACS Symp Series 1989; 406.
53. Tom JW, Debenedetti PG. Particle formation with supercritical fluids-a review. J Aerosol Sci 1991; 22:555-584.
54. York P, Kompella UB, Shekunov B, Drugs and the Pharmaceutical Sciences #138: Supercritical Fluid Technology for Drug Product Development. New York: Marcel Dekker, 2004.
55. Clifford T. Fundamentals of Supercritical Fluids. Oxford: Oxford University Press, 1999.
56. Gopalan A, Wai C, Jacobs HJ. Supercritical carbon dioxide: separations and processes. ACS Symposium Series 860, Washington, D.C., 2003.
57. Kiran E, Brennecke JF. Supercritical Fluid Engineering Science. Washington, D.C.: American Chemical Society, 1992.
58. Rizvi SSH. Supercritical Fluid Processing of Food and Biomaterials. London: Blackie Academic, 1994.
59. Bright F, McNally MEP. Supercritical Fluid Technology. Washington, D.C.: American Chemical Society, 1992.
60. Penninger JML, Radosz M, McHugh MA, Krukonis VJ, Supercritical Fluid Technology. Amsterdam: Elsevier, 1985.
61. Arai Y, Sako T, Takebayashi Y. Supercritical Fluids. Berlin: Springer-Verlag, 2002.
62. Kiran E, Levelt SJMH, Supercritical Fluids-Fundamentals for Applications. Kluwer Academic Publishers, Dordrecht 1994.
63. Kiran E, Debenedetti PG, Peters CJ, Supercritical Fluids-Fundamentals for Applications. Dordrecht: Kluwer Academic Publishers, 2000.
64. Smith RD. Supercritical fluid molecular spray thin films and fine powders. U.S. Patent 4,734,451, March 1988.
65. Smith RD. Supercritical fluid molecular spray film deposition and powder formation. U.S. Patent 4,582,731, April 1986.
66. Krukonis V. Supercritical fluid nucleation of difficult to comminute solids. Paper 140f, AIChE meeting, San Francisco, November 1984.
67. Loth H, Hemgesberg E. Properties and dissolution of drugs micronized by crystallization from supercritical gases. Int J Pharm 1986; 32:265.
68. Mohamed RS, Debenedetti PG, Prud'homme RK. Effects of process conditions on crystals obtained from supercritical mixtures. AIChE J 1989; 35:325.
69. Chang CJ, Randolph AD. Precipitation of microsize organic particles from supercritical fluids. AIChE J 1989; 35:1876.
70. Debenedetti PG, Sang YS-D. Formation of biologically active protein powders and polymeric micro-fibers with supercritical anti-solvents. Am Assoc Aerosol Res 1993; 11:D3.
71. Yeo S-D, Lim G-B, Debenedetti PG, Bernstein H. Formation of microparticulate protein powders using a supercritical fluid antisolvent. Biotechnol Bioeng 1993; 41:341-346.
72. Gallagher-Wetmore P, Coffey MP, Krukonis V. Application of supercritical fluids in recrystallization: nucleation and gas anti-solvent (GAS) techniques. Respiratory Drug Delivery, IV. Richmond, VA, 1994.
73. Hanna M, York P. Patent WO 96/00610.
74. Tservistas M, Levy MS, LoYim MYA, et al. The formulation of plasmid DNA loaded pharmaceutical powders using supercritical fluid technology. Biotechnol Bioeng 2001; 72(1):12-23.
75. Huang, ETS, Change, H, Liang CD, Sievers RE. Fine particle pharmaceutical manufacturing using dense carbon dioxide mixed with aqueous or alcoholic solutions. ACS Symposium Series 860, Washington, D.C., 2003:324-338.
76. Sievers RE, Huang ETS, Villa JA, Engling G, Brauer PR. Micronization of water soluble and alcohol soluble pharmaceuticals and model compounds with a low-temperature Bubble Dryer. J Supercritical Fluids 2003; 26:9-16.
77. Sievers RE, and Karst U. U.S. Patent 5639441 (1997).
78. Sievers RE. European Patent 0677332 B1 (2002)
79. Clark A, York P. SCF-Pulmonary Pharmaceuticals: The Uncoated Truth, Proceeding of Respiratory Drug Delivery X, Book 1, 2006:317-324.
80. Willeke K, Baron PA. Aerosol Measurement: Principles, Techniques and Applications. New York: Van Nostrand Reinhold, 1993.
81. Allen T. Particle Size Measurement. New York: Chapman and Hall, 1990.
82. Leschonski K, Rothele S, Menzel U. A special feeder for diffraction pattern analysis of dry powders. Part Charact 1984; 1:161-166.
83. Visser J. Adhesion of colloidal particles. In: Matijevic E, ed. Surface and Colloid Science, Vol. 8. New York: Wiley, 1976:3-84.
84. Rietema K. The Dynamics of Fine Powders. New York: Elsevier, 1991.
85. Meloy TP. Particulate characterization: future approaches. In: Fayed ME, Otten L, eds. Handbook of Powder Science and Technology. New York: Van Nostrand Reinhold; 1984:69-98.
86. Reid K, Martin AT, Clark JM. Particle shape discrimination using the aerosol shape analysis system (ASAS). J Aerosol Sci 1992; 23:5325-S328.
87. Meakin P. Fractal aggregates. Adv Colloid Interface Sci 1988; 28:249-331.
88. Kaye BH. A Random Walk Through Fractal Dimensions. Weinheim; VCH Publishers, 1989.
89. Reist PC, Hsieh M-T, Lawless PA. Fractal characterization of the structure of aerosol agglomerates grown at reduced pressure. Aerosol Sci Technol 1989; 11:91-99.
90. Hickey AJ, Concessio NM. Flow properties of selected pharmaceutical powders from a vibrating spatula. Part Part Syst Charact 1994; 11:457-462.
91. Kaye BH. A new approach to powder rheology. Pharm Technol 1994; 18:116-126.
92. Amal R, Raper JA, Waite TD. A factal structure model of aggregates. Proceedings of the 2nd World Congress on Particle Technology, Japan, September 19-22, 1990:564-571.
93. Leith D. Drag on nonspherical objects. Aerosol Sci Technol 1987; 6:153-161.
94. Johnson DL, Leith D, Reist PC. Drag on-non-spherical, orthotropic aerosol particles. J Aerosol Sci 1987; 18:87-97.
95. Lee C-T, Leith D. Drag force on agglomerated spheres in creeping flow. J Aerosol Sci 1989; 20:503-513.
96. Reist PC. Aerosol Science and Technology. New York: McGraw-Hill, 1993.
97. Geldart D. Types of fluidization. Powder Technol 1973; 7:285-292.
98. Geldart D. Gas Fluidization Technology. New York: Wiley, 1986.
99. Boehme G, Krupp H, Rabenhorst H, Sandstede G. Adhesion measurements involving small particles. Trans Instn Chem Eng 1962; 40:252-259.
100. Zimon AD. Adhesion of Dust and Powder, 2nd ed. New York: Consultants Bureau, 1982.
101. Mullins ME, Michaels LP, Menon V, Locke B, Ranade MB. Effect of geometry on particle adhesion. Aerosol Sci Technol 1992; 17:105-118.
102. Pietsch W. Size Enlargement by Agglomeration. New York: Wiley, 1991.
103. Okuda S, Fujibayashi Y. Dispersion of fine particles using high velocity air flow. Proceedings of the 2nd World Congress on Particle Technology, Japan, September 19-22, 1990:40-47.
104. Yamada Y, Murata H. Performance of powder dispersion by air annular jet. Proceedings of the 2nd World Congress on Particle Technology, Japan, September 19-22, 1990:48-54.
105. Yamamoto H. Relationship between adhesive force of fine particles and their dispersibility in gas. Proceedings of the 2nd World Congress on Particle Technology, Japan, September 19-22, 1990:167-173.
106. Buckton G, Darcy P. Assessment of disorder in crystalline powders-a review of analytical techniques and their application. Int J Pharm 1999; 179:141-158
107. Pikal MJ, Lukes AL, Lang JE, Gaines K. Quantitative crystallinity determinations for 0-lactam antibiotics by solution calorimetry: correlations with stability. J Pharm Sci 1978; 67:767-773.
108. Saleki-Gerhardt A, Ahlneck C, Zografi G. Assessment of disorder in crystalline solids. Int J Pharm 1994; 101:237-247.
109. Buckton G, Darcy P, Mackellar A. The use of isothermal microcalorimetry in the study of small degrees of amorphous content of powders. Int J Pharm 1995; 117:253-256.
110. Fukuoka E, Makita M, Yamamura S. Some physicochemical properties of glassy indomethacin. Chem Pharm Bull 1986; 34:4314-4321.
111. Suga H, Seki S. Thermodynamic investigation on glassy states of pure simple compounds. J Non-Cryst Solids 1974; 16:171-194.
112. Takeda K, Yamamuro O, Suga H. Calorimetric study on structural relaxation of 1-pentene in vapor-deposited and liquid-quenched glassy states. J Phys Chem 1995; 99:1602-1607.
113. Ahlneck C, Zografi G. The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state. Int J Pharm 1990; 62:87-95.
114. Levoguer CL, Booth J. Polymorphism in Spray Dried Lactose, Surface Measurement Systems Application Notes.
115. Mackin L, Zanon R, Park JM, Foster K, Opalenik H, Demonte M. Quantification of low levels (<10%) of amorphous content in micronised active batches using dynamic vapour sorption and isothermal microcalorimetry. Int J Pharm 2002; 231(2):227-236.
116. Buckton G, Darcy P. The use of gravimetric studies to assess the degree of crystallinity of predominantly crystalline powders. Int J Pharm 1995; 123:265.
117. Forbes RT, Davis KG. Water vapor sorption studies on the physical stability of a series of spray-dried protein/sugar powders for inhalation. J Pharm Sci 1998; 87:1316.
118. Shamblin SL, Hancock BC, Zografi G. Water vapor sorption by peptides, proteins and their formulations. Eur J Pharm Biopharm 1998; 45:239.
119. Burnett D, Thielmann F, Booth J. Determining the critical relative humidity for moisture induced phase transitions. Int J Pharm 2004; 287:123.
120. Hancock B, Zografi G.Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci 1997; 86:1-12.
121. Yu L. Amorphous pharmaceutical solids: preparation, characterization and stabilization. J Adv Drug Delivery Rev 2001; 48(1):27-42.