Spray drying: Theory and pharmaceutical applications

Pharmaceutical Dosage Forms: Tablets, Third Edition: Volume 1: Unit Operations and Mechanical Properties

Volumn , Issue , 2008, Pages 227-260

  Snyder, Herm E ^a   Lechuga Ballesteros, David ^b  

^a NEKTAR THERAPEUTICS   (United States)

^b Aridis Pharmaceuticals   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 80051856079     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (90)

1. Masters K. Applications of Spray Drying. Spray Drying Handbook. 3rd ed. New York: Halsted Press, 1979: 481-516.
2. Gunsel WC, Lachman L. Comparative evaluation of tablet formulations prepared from conventionally-processed and spray-dried lactose. J Pharm Sci 1963, 52: 178-82.
3. Broadhead J, Rouan SKE, Rhodes CT. The spray drying of pharmaceuticals. Drug Dev Ind Pharm 1992; 18: 1169-206.
4. Lo WY, Law SL. Dissolution behavior of griseofulvin solid dispersions using polyethylene glycol, talc, and their combination as dispersion carriers. Drug Dev Ind Pharm 1996; 22: 231-6.
5. Jachowicz R, Nurnberg E, Hoppe R. Solid dispersions of oxazepam. Int J Pharm 1993; 99: 321-5.
6. Vidgren P, Vidgren M, Paronen P. Physical stability and inhalation behavior of mechanically micronized and spray dried disodium cromoglcate in different humidities. Acta Pharmaceutica Fennica 1989; 98: 71-8.
7. Maa Y-f, Nguyen P-A, Andya JD, et al. Effect of spray drying and subsequent processing conditions on residual moisture content and physical biochemical stability of protein inhalation powders. Pharm Res 1998; 15: 768-75.
8. Vanbever R, Ben-Jebria A, Mintzes JD, Langer R, Edwards DA. Sustained-release of insulin from insoluble inhaled particles. Drug Dev Res 1999: 48: 178-85.
9. Duddu SP, Sisk SA, Walter YH, et al. Improved lung delivery from a passive dry powder inhaler using an engineered PulmoSphere (R) powder. Pharm Res 2002; 19: 689-95.
10. Ståhl K, Claesson M, Lilliehorn P, Linden H, Backstrom K. The effect of process variables on the degradation and physical properties of spray dried insulin inteded for inhalation. Int J Pharm 2002; 233: 227-37.
11. Chan HK, Clark AR, Feeley J, et al. Physical stability of salmon calcitonin spray-dried powders for inhalation. J Pharm Sci 2004; 93: 792-804.
12. White S, Bennett DB, Cheu S, et al. EXUBERA®: Pharmaceutical development of a novel product for pulmonary delivery of insulin. Diabetes Tech Ther 2005; 7: 896-906.
13. Patton J. Breathing life into protein drugs. Nature Biotech 1998; 16: 141-3.
14. Labrude P, Rasolomanana M, Vigneron C, Thirion C, Chillot B. Protective effect of sucrose on spray drying of oxyhemoglobin. J Pharm Sci 1989; 78: 223-9.
15. Bennett DB, K. BT, Snyder HE, Platz RM, Inventors; Nektar Therapeutics, Inc., assignee. Spray drying process control of drying kinetics. US patent 20030044460, 2000.
16. Martino PD, Scoppa M, Joiris E, et al. The spray drying of acetozolamide as method to modify crystal properties and to improve compression behaviour. Int J Pharm 2001; 213: 209-21.
17. Mishra DN, Bindal M, Singh S-K, Vijaya-Kumar S-G. Spray dried excipient base: A novel technique for the formulation of orally disintegrating tablets. Chem Pharm Bull 2006; 54: 99-102.
18. Allen LV, Wang B, Davies JD. Inventors; The Board of Regents of the University of Oklahoma and Janssen assignee. Rapidly dissolving dosage form. US patent 6,066,337. July 6, 1998, 2000.
19. Hino T, Shimabayashi S, Nakai A. Silk microspheres prepared by spray-drying of an aqueous system. Pharm Pharmacol Commun 2000; 6: 335-9.
20. Tsapis N, Bennett D, Jackson B, Weitz DA, Edwards DA. Trojan particles: Large porous carriers of nanoparticles for drug delivery. Proc Natl Acad Sci USA 2002; 99: 1200-15.
21. Skalko-Basnet N, Pavelic Z, Becirevic-Lacan M. Liposomes containing drug and cyclodextrin prepared by the one-step spray-drying method. Drug Dev Ind Pharm 2000; 26: 1279-84.
22. Lo Y-l, Tsai J-C, Kuo J-H. Liposomes and disaccharides as carriers in spray-dried powderformulations of superoxide dismutase J Control Release 2004; 94: 259-72.
23. Lechuga-Ballesteros D, Charan C, Stults CLM, et al. Trileucine improves aerosol performance and stability of spray-dried powders for inhalation. J Pharm Sci 2007: 96(5): 1258-69.
24. Fäldt P, Bergenståhl B. The surface composition of spray-dried protein-lactose powders. Physiochem Eng Aspects 1993: 183-90.
25. Millqvist-Fureby A, Malmsten M, Bergenstahl B. Surface characterization of freeze-dried protein/carbohydrate mixtures. Int J Pharm 1999; 191: 103-14.
26. Vehring R, Lechuga-Ballesteros D, Foss WR. Particle formation in spray drying. J Aerosol Sci 2007, Submitted.
27. Raula J, Eerikäinen H, Kauppinen EI. Influence of the solvent composition on the aerosol synthesis of pharmaceutical polymer nanoparticles. Int J Pharm 2004; 284: 13-21.
28. Elversson J, Millqvist-Fureby A. Particle size and density in spray drying-effects of carbohydrate properties. J Pharm Sci 2005; 94: 2049-60.
29. Maa Y-F, Costantino HR, Nguyen P-A, Hsu CC. The effects of operating and formulation variables on the morphology of spray-dried protein particles. Pharm Dev Tech 1997; 2: 213-23.
30. Vanbever R, Mintzes JD, Wang J, et al. Formulation and physical characterization of large porous particles for inhalation. Pharm Res 1999; 16: 1735-42.
31. Varga CM, Snyder HE. High-magnification shadowgraphy characterization of rotary atomizer droplet production for pharmaceutical applications. Institute for liquid atomization and spraying systems conference. Toronto, Ontario, Canada; 2006.
32. Lefebvre AH. Atomization and Sprays. New York: Hemisphere Publishing Corporation, 1989.
33. Varga CM, Snyder HE. Impact of liquid viscosity on droplet sizes produced from air-assist atomizers. Institute for liquid atomization and spraying systems conference. Monterey, California, 2003.
34. Sonntag RE, Van Wylen GV. Introduction to Thermodynamics, Classical and Statistical. 2nd ed. New York: Wiley and Sons, 1982.
35. Fuchs NA. Evaporation and Droplet Growth in Gaseous Media. New York: Pergamon Press, 1959.
36. Crowe C, Sommerfeld M, Tsuji Y. Multiphase Flows with Droplets and Particles. Boca Raton, FL: CRC Press, 1998.
37. Straub JA, Chickering DE, Lovely JC, et al. Intravenous hydrophobic drug delivery: A porous particle formulation of paclitaxel (AI-850). Pharm Res 2005; 22: 347-55.
38. Shekunov BY, Chow AHL, Feeley JC, Tong HHY, York P. Aerosolisation behaviour of micronised and supercritically-processed powders. Aerosol Sci 2003; 34: 553-68.
39. Chew NY, Chan HK. Use of solid corrugated particles to enhance powder aerosol performance. Pharm Res 2001; 18: 1570-7.
40. Adler M, Unger M, Lee G. Surface composition of spray-dried particles of bovine serum albumin/trehalose/surfactant. Pharm Res. 2000; 17: 863-70.
41. Abdul-Fattah A, Lechuga-Ballesteros D, Kalonia D, Pikal MJ. The impact of drying method and formulation on the physical properties and stability of methionyl human growth hormone in the amorphous solid state. J Pharm Sci 2007; Accepted.
42. Elversson J, Millqvist-Fureby A. In situ coating-An approach for particle modification and encapsulation of proteins during spray-drying. Int J Pharm 2006; 323: 52-63.
43. Finlay WH ed. The Mechanics of Inhaled Pharmaceutical Aerosols. An Introduction. New York: Academic Press, 2001.
44. Heumann WL. Industrial Air Pollution Control Systems. New York: McGraw-Hill, 1997.
45. Clark AR, Egan M. Modelling the deposition of inhaled powdered drug aerosols. J Aerosol Sci 1994; 25: 175-86.
46. Clark AR. Medical aerosol inhalers: past, present, and future. Aerosol Sci Tech 1995; 22: 374-91.
47. Hsu CC, Wu SS, Walsh AJ. The preparation of recombinant human deoxyribonuclease powder: comparative studies of spray drying versus lyophilization and application of microwave drying. In: Strumillo C, Pakowski Z, eds. Drying '96. Vol B. Krakow, Poland: Lodz Technical University, Dep. of Process and Environmental Engineering, 1996: 1229-36.
48. Labuza TP. The effect of water activity on reaction kinetics of food deterioration. Food Tech 1980; 34: 36-41, 59.
49. Costantino HR. Excipients for use in lyophilized pharmaceutical peptide, protein, and other bioproducts. In: Pikal MJ, Costantino HR, eds. Lyophilization of Biomaterials. AAPS Press, 2004: 139-228.
50. Franks F, Hatley RHM, Mathias SF. Material science and the production of shelf-stable biologicals. Pharm Technol Int 1991; 3: 24-34.
51. Forbes RT, Davis KG, Hindle M, Clarke JG, Mass J. Water vapor sorption studies on the physical stability of a series of spray-dried protein/sugar powders for inhalation. J Pharm Sci 1998; 87: 1316-21.
52. Naini V, Byron P, Phillips EM. Physicochemical stability of crystalline sugars and their spraydried forms: dependence upon relative humidity and suitability for use in powder inhalers. Drug Dev Ind Pharm 1998; 24: 895-909.
53. Abdul-Fattah A, Kalonia DS, Pikal MJ. The challenge of drying method selection for protein pharmaceuticals: Product quality implications. J Pharm Sci 2007, Online ahead of publication.
54. Maa Y-F, Prestrelski SJ. Biopharmaceutical powders: Particle formation and formulation considerations. Curr Pharm Biotech 2000; 1: 283-302.
55. Lechuga-Ballesteros D, Miller DP, Zhang J. Residual water in amorphous solids, measurement and effects on stability. In: Levine H, ed. Progress in Amorphous Food and Pharmaceutical Systems. London: The Royal Society of Chemistry, 2002: 275-316.
56. Maa Y-F, Costantino HR, Nguyen P-A, Hsu CC. The Effect of operating and formulation variables on the morphology of spray-dried protein particles. Pharm Dev Tech 1997; 2: 213-23.
57. Mumenthaler M, Hsu CC, Pearlman R. Feasibility study on spray-drying protein pharmaceuticals: Recombinant human growth hormone and tissue-type plasminogen activator. Pharm Res 1994; 11: 12.
58. Broadhead J, Rouan SKE, Hau I, Rhodes CT. The effect of process and formulation variables on the properties of spray-dried galactosidas. J Pharm Pharmacol 1994; 64: 458-67.
59. Hageman MJ. The role of moisture in protein stability. Drug Dev Ind Pharm 1988; 14: 2047-70.
60. Ståhl K, Claesson M, Lilliehorn P, Linden H, Bäckström K. The effect of process variables on the degradation and physical properties of spray dried insulin intended for inhalation. Int J Pharm 2002; 233: 227-37.
61. Maa Y-F, Nguyen P-A, Sweeney T, Shire SJ, Hsu CC. Protein inhalation powders: Spray drying vs. Spray freeze drying. Pharm Res 1999: 16(2): 249-54.
62. Maa Y-F, Hsu CC. Effect of high shear on proteins. Biotech Bioeng 1996; 51: 458-65.
63. Maa Y-F, Hsu CC. Protein denaturation by combined effect of shear and air-liquid Interface. Biotech Bioeng 1997; 54: 503-12.
64. Maa Y-F, Nguyen P-A, Hsu SW. Spray drying of air-liquid interface sensitive recombinant human growth hormone. J Pharm Sci 1998; 87: 152-9.
65. Adler M, Lee G. Stability and surface activity of lactate dehydrogenase in spray-dried trehalose. J Pharm Sci 1999; 88: 199-208.
66. Chew NYK, Shekunov BY, Chow HHYTAHL, Savage C, Wu J, Chan H-K. Effect of amino acids on the dispersion of disodium cromoglycate powders. J Pharm Sci 2005; 94: 2289-300.
67. Li H-Y, Neill H, Innocent R, Seville P, Williamson I, Birchall JC. Enhanced dispersibility and deposition of spray-dried powders for pulmonary gene therapy. J Drug Target 2003; 11: 425-32.
68. Bosquillon C, Lombry C, Preat V, Vanbever R. Influence of formulation excipients and physical characteristics of inhalation dry powders on their aerosolization performance. J Control Release 2001; 70: 329-39.
69. Fernandez-Carballido A, Herrero-Vanrell R, T. M-MI, Pastoriza P. Biodegradable Ibuprofenloaded PLGA microspheres for intraarticular administration. Effect of Labrafil addition on release in vitro. Int J Pharm 2004; 279: 33-41.
70. Bogner RH, Wilkosz MF. Fast-dissolving tablets. US Pharmacist. 2002, http://www.uspharmacist. com/oldformat.asp?url=newlook/files/feat/fastdissolving.htm
71. Patel PB, Chaudhary A, Gupta GD. Fast Dissolving Drug Delivery Systems: An Update. 2006, http://www.pharmainfo.net/exclusive/reviews/
72. Yin SX, Franchini M, Chen J, et al. Bioavailability enhancement of a COX-2 inhibitor, BMS-347070, from a nanocrystalline dispersion prepared by spray-drying. J Pharm Sci 2005; 94: 1598-607.
73. Shama JO-H, Zhang Y, Finlay WH, Roa WH, Löbenberg R. Formulation and characterization of spray-dried powders containing nanoparticles for aerosol delivery to the lung. Int J Pharm 2004; 269: 457-67.
74. Snyder HE, Vosgber MJ, Varga CM, Inventors; Nektar Therapeutics, Inc., assignee. Spray drying methods and related compositions. US patent 20030124193, 2003.
75. Chen RC, Takahashi H, Okamoto H, Danjo K. Particle design of three-component system for sustained release using a 4-fluid nozzle spray-drying technique. Chem Pharm Bull 2006; 54: 1486-90.
76. Ozeki T, Beppu S, Mizoe T, Takashima Y, Yuasa H, Okada H. Preparation of polymeric submicron particle-containing microparticles using a 4-fluid nozzle spray drier. Pharm Res 2006; 23: 177-83.
77. Serajuddin ATM. Solid dispersion of poorly water-soluble drugs: Early promises, subsequent problems, and recent breakthroughs. J Pharm Sci 1999; 88: 1058-66.
78. Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 2000; 50: 47-60.
79. Chauhan B, Shimpi S, Paradkar A. Preparation and characterization of etoricoxib solid dispersions using lipid carriers by spray drying technique. AAPS Pharm Sci Tech 2005; 6: E405-E412.
80. Shimpi SL, Chauhan B, Mahadik KR, Paradkar A. Stabilization and improved in vivo performance of amorphous etoricoxib using Gelucire 50/13. Pharm Res 2005; 22: 1727-34.
81. Bloch D. Spray-dried solid dispersions of hydrochlorothiazide and chlorthalidone in pentaerythritol. Pharm Acta Helvetica 1983; 58: 14.
82. Corrigan O. Physicochemical properties of spray dried drugs: phenobarbitone and hydroflumethiazide. Drug Dev Ind Pharm 1983; 9: 1.
83. Ambike AA, Mahadik KR, Paradkar A. Spray-dried amorphous solid dispersions of simvastatin, a low Tg drug: in vitro and in vivo evaluations. Pharm Res 2005; 22: 990-8.
84. Mu L, Teo MM, Ning HZ, Tan CS, Feng SS. Novel powder formulations for controlled delivery of poorly soluble anticancer drug: application and investigation of TPGS and PEG in spray-dried particulate system. J Control Rel 2005; 103: 565-75.
85. Kornblum SS. Sustained-action tablets prepared by employing a spray-drying technique for granulation. J Pharm Sci 1968; 58: 125-7.
86. Gohel MC. A review of co-processed directly compressible excipients. J Pharm Pharm Sci 2005; 8: 76-93.
87. Nuguru KS, Giambattisto D, Al-Ghazawi AK. Evaluation and characterization of spray-dried mannitol as an excipient for direct copression formulations of naproxen sodium. AAPS Pharm Sci 2001; 3: Abstract available from: http://www.aapspharmsci.org/
88. Hassan H, Kata M, Ers I, Aigner Z. Preparation and investigation of inclusion complexes containing gemfibrozil and DIMEB. J Incl Phenom Macrocyclic Chem 2004; 50: 219-25.
89. Dollo G, Corre PL, Chollet M, et al. Improvement in solubility and dissolution rate of 1, 2-dithiole-3-thiones upon complexation with beta-cyclodextrin and its hydroxypropyl and sulfobutyl ether-7 derivatives. J Pharm Sci 1999; 88: 889-95.
90. Lucas P, Anderson K, Staniforth JN. Protein deposition from dry powder inhaler: Fine particle mutiplets as performance modifiers. Pharm Res 1998; 15: 562-9.