Drying of pharmaceutical productsdrying of pharmaceutical products

Transport Phenomena in Particulate Systems

Volumn , Issue , 2012, Pages 148-171

  de Oliveira, Wanderley P ^a   de Freitas, Luis Alexandre P ^a   Freire, José Teixeira ^b  

^a UNIVERSITY OF SÃO PAULO   (Brazil)

^b FEDERAL UNIVERSITY OF SÃO CARLOS   (Brazil)

Author keywords

Fluid bed drying; Medicinal plants; Sorption isotherms; Spouted bed; Spray drying

Indexed keywords

EID: 84884429903     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.2174/978160805227111201010148     Document Type: Chapter

References (104)

1. A.S. Rankell, H.A. Lieberman, and R.F. Schiffman, "Drying", in The theory and practice of industrial pharmacy, L. Lachman, H.A. Lieberman, and J. Kanig, Eds., 3rd ed., Philadelphia: Lea & Fabiger, 1986, PP. 47- 65.
2. C. Strumillo, I. Zbicinski, and X.D. Lio, "Effect of particle structure on quality retention of bioproducts during thermal drying", Dry. Technol., vol. 14, PP. 1921-1946, 1996.
3. T.P. Labuza, "Effects of dehydration and storage", Food Technol., vol. 27, PP. 20-26, 1973.
4. J. Adamiec, W. Kaminski, A.S. Markowski, and C. Strumillo, "Drying of biotechnological products", in Handbook of industrial drying, A.S. Mujumdar, Ed., 3rd ed., Boca Raton: CRC/Taylor & Francis, 2006, PP. 905- 929.
5. S. Byrn, R. Pfeiffer, M. Ganey, C. Hoiberg, and G. Poochikian, "Pharmaceutical solids: strategic approach to regulatory considerations", Pharmaceutical Res., vol. 12, PP. 945-954, 1995.
6. F.J. Muzio, T. Shinbrot, and B.J. Glasser, "Powder technology in the pharmaceutical industry: the need to catch up fast", Powder Technol., vol. 124, PP. 1-7, 2002.
7. R.N. Marreto, L.A.P. Freitas, and J.T. Freire, "Drying of pharmaceuticals: The applicability of spouted beds", Dry. Technol., vol. 24, PP. 327-338, 2007.
8. R.B. Keey, Drying of loose and particulate solids materials. New York:Hemisphere Publ. Co.,1992.
9. A.T. Florence and D. Attwood, Physicochemical principles of pharmacy, 4th ed., London: Pharmaceutical Press, 2006.
10. J.I. Wells, Pharmaceutical preformulation. West Sussex: Ellis Horwood Ltd., 1988. 168 Transport Phenomena In Particulate Systems Oliveira et al.
11. H.G. Brittain and E.F. Fiese, "Effects of pharmaceutical processing on drug polymorphs and solvates", in Polymorphism in pharmaceutical solids. H.G. Brittain, Ed., New York: Marcel Dekker, 1999, PP. 331-362.
12. A. Abdul-Fattah, D.S. Kalonia, and M.J. Pikal, "The challenge of drying method selection for protein pharmaceuticals: product quality implications", J. Pharm. Sci., vol. 96, PP. 1886-1916, 2007.
13. M. Ameri and Y.F. Maa, "Spray-drying of biopharmaceuticals: Stability and process considerations", Dry. Technol., vol. 24, PP. 763-768, 2006.
14. M. Guerreiro, C. Albet, A. Palomer, and A. Guglietta, "Drying in pharmaceutical and biotechnological industries", Food Sci. Technol. Int., vol. 9, PP. 237-243, 2003.
15. Z. Pakowiski and A.S. Mujumdar, "Drying of pharmaceuticals", in Handbook of industrial drying, A.S. Mujumdar, Ed., 3rd ed., Boca Raton: CRC/Taylor & Francis, 2006, PP. 689-712.
16. A.S. Mujumdar and A.S. Menon, "Drying of solids: Principles classification and selection of dryers", in Handbook of industrial drying, A.S. Mujumdar, Ed., 2nd ed., New York: Marcel Dekker, 1995, PP. 1-39.
17. K.G.V. Scoik, M. Zoglio, and J.T. Carstensen, "Drying", in Pharmaceutical dosage forms: Tablets, Vol. 2, H.A. Lieberman, L. Lachman, and J.B. Schwartz, Eds., 2nd ed., New York: Marcel Dekker Inc., 1990, PP. 73-105.
18. A.S. Mujumdar, "Classification and Selection of Industrial Dryers", in Mujumdar's practical guide to industrial drying, S. Devahastin, Ed., Quebec: Energex Co., 2000, PP. 23-36.
19. A. Lekhal, K.P. Girard, M.A. Brown, S. Kiang, J.G. Khinast, and B.J. Glasser, "The effect of agitated drying on the morphology of L-threonine (needle-like) crystals", Int. J. Pharm., vol. 270, PP. 263-277.
20. D.J. Burnett, F. Thielmann, T. Sokoloski, and J. Brum, "Investigating the moisture induced crystallization kinetics of spray-dried lactose", Int. J. Pharm., vol. 313, PP. 23-28, 2006.
21. B.R. Bhandari and T. Howes, "Implication of glass transition for the drying and stability of dried foods", J. Food Eng., vol. 40, PP. 71-79, 1999.
22. D.Q.M. Craig, P.G. Royall, V.L. Kett, and M.L. Hopton, "The relevance of amorphous state to pharmaceutical dosage forms: Glassy drugs and freeze dried systems", Int. J. Pharm., vol. 179, PP. 179-207, 1999.
23. L.A. Tacon and L.A.P. Freitas, "Paste residence time in a spouted bed dryer. III: Effect of paste properties and quality interactions", Dry. Technol. vol. 25, PP. 841-852, 2007.
24. A.S. Mujumdar and S. Devahastin, "Fundamental principles of drying", in Mujumdar's practical guide to industrial drying, S. Devahastin, Ed., Quebec: Energex Co., 2000, PP. 1-22.
25. G.W. Moyers and C.G. Baldwin, "Psychrometry, evaporative cooling, and solids drying", in Perry's chemical engineers' handbook, R.H. Perry, D.W. Green, and J.O. Maloney, Eds., 7th ed., New York: McGraw-Hill, 1997, PP. 12.1-12.90.
26. D.C. Shallcross, Handbook of psychrometric charts - humidity diagrams for engineers, London: Chapman & Hall, 1997.
27. Souza, C.R.F. "Standardized dried extracts of Brazilian medicinal plants: assessment of technical and economical feasibility of the spouted bed drying", Doctor Thesis, Faculty of Pharmaceuticals Science of State University of Sao Paulo, Ribeirão Preto-SP, Brazil, 2007 (In Portuguese).
28. F.P. Collares, J.R.D. Finzer, and T.G. Kieckbusch, "Glass transition control of the detachment of food pastes dried over glass plates", J. Food Eng., vol. 61, PP. 261-267, 2004.
29. J. Hardy, J. Scher, and S. Banon, "Water activity and hydration of dairy powders", Lait, vol. 82, PP. 441-452, 2002.
30. M. Mathlouthi and B. Rogé, "Water vapour sorption isotherms and the caking of food powders", Food Chem., vol. 82, PP. 61-71, 2003.
31. N.M. Carvalho and J. Nakagawa, Seeds: Science, technology and production, 4th ed., Jaboticabal: FUNEP, 1980 (in Portuguese).
32. S. Arnosti Jr., J.T. Freire, D.J.M. Sartori, and M.A.S. Barrozo, "Equilibrium moisture content of Brachiaria brizantha", Seed Sci. Technol., vol. 27, PP. 273-282, 1999.
33. S. Lahsasni, M. Kouhila, M. Mahrouz, and N. Kechaou, "Experimental study and modelling of adsorption and desorption isotherms of prickly pear peel (Opuntia ficus indica)", J. Food Eng., vol. 55, PP. 201-207, 2002.
34. M. Chaplin, "Water activity," in Water structure and Science. [Online]. Available: www.lsbu.ac.uk/water/activity. [Accessed: April. 06, 2009].
35. R.F. Bott, "Influence of the production process, storage conditions and physical and chemical properties on the stability of standardized dried extracts of medicinal plants", Doctor Thesis, Faculty of Pharmaceuticals Science of State University of Sao Paulo, Ribeirão Preto-SP, 2008 (in Portuguese).
36. H. Abramovic and C. Klofutar, "Water adsorption isotherms of some gellan gum samples", J. Food Eng., vol. 77, PP. 514-520., 2006.
37. T.J. Laaksonen, Y.H. Roos, and T.P. Labuza, "Comparisons of the use of desiccators with or without vacuum for water sorption and glass transition studies", Int. J. Food Prop., vol. 4, PP. 545-563, 2001.
38. T.P. Labuza, Moisture sorption: practical aspects of isotherm measurement and use. St. Paul: American Association of Cereal Chemists, 1984.
39. W. Schar and M. Ruegg, "The evaluation of G.A.B. constants from water vapor sorption data", LWT- Food Sci. Technol., vol. 18, PP. 225-229, 1985.
40. C.R. Oswin, "The kinetics of package life III. Isotherm", J. Soc. Chem. Ind.-L, vol. 65, PP. 419-421, 1946.
41. S. Jaya, M. Sudhagar, and H. Das, "Stickiness of food powders and related physico-chemical properties of food components", J. Food Sci. Technol., vol. 39, PP. 1-7, 2002.
42. K.K.W. Chu and A.H.L. Chow, "Impact of carbohydrate constituents on moisture sorption of herbal extracts", Pharmaceutical Res., vol. 17, PP. 1133-1137, 2000.
43. J.C. Callahan, G.W. Cleary, M. Elefant, L. Kaplan, T. Kensler, and R.A. Nash, "Equilibrium moisture content of pharmaceutical excipients", Drug Dev. Ind. Pharm., vol. 8, PP. 355-369, 1982.
44. L.G. Sweeney, Z. Wang, R. Loenberg, J.P. Wang, C. Lange, and W.H. Finlay, "Spray-freeze-dried liposomal ciprofloxacin powder for inhaled aerosol drug delivery", Int. J. Pharm., vol. 305, PP. 180-185. 2005.
45. D. Kunii and O. Levenspiel. Fluidization engineering, 2nd ed., Newton: Butterworth-Heinemann, 1991.
46. J.A. Seitz, S.P. Mehta, and J.L. Yeager, "Tablet Coating", in The theory and practice of industrial pharmacy, L. Lachman, H.A. Lieberman, and J. Kanig Eds., 3rd ed., Philadelphia: Lea & Fabiger, 1986, PP. 346-373.
47. S. Sethia and E. Squillante, "Solid dispersions: Revival with greater possibilities and applications in oral drug delivery", Critical Reviews in Therapeutic Drug Carrier Systems, vol. 20, PP. 215-247, 2003.
48. K. Dewettinck and A. Huyghebaert, "Fluidized bed coating in food technology", Trends Food Sci. Technol., vol. 10, PP. 163-168, 1999.
49. K. Jono, H. Ichikawa, M. Miyamoto, and Y. Fukumori, "A review of particulate design for pharmaceutical powders and their production by spouted bed coating", Powder Technol., vol. 113, PP. 269-277, 2000.
50. F.P. Runha, D.S. Cordeiro, C.A.M. Pereira, J. Vilegas, and W.P. Oliveira, "Production of dry extracts of medicinal Brazilian plants by spouted bed process: Development of the process and evaluation of thermal degradation during the drying operation", Food Bioprod. Process., vol. 79, PP. 160-168, 2001.
51. S. Hovmand, "Fluidized bed drying," in Handbook of industrial drying, A.S. Mujumdar, Ed., 1st ed., New York: Marcel Dekker, 1987, PP. 165-225.
52. R.S. Pagliarussi, J.K. Bastos, and L.A.P. Freitas, "Fluid bed drying of guaraná (Paullinia cupana HBK.) extracts: effect of process factors on caffeine content", AAPS Pharm. Sci. Tech., vol. 7, PP. E1-E7, Article 54, 2006.
53. S.C.S. Rocha, "Tablet coating", in Special topics on drying, J.T. Freire and D.J.M. Sartori, Eds., vol. 1, São Carlos: UFSCar, 1992, PP.295-330 (in Portuguese).
54. Oliveira, W.P. and Freire, J.T., "Technological aspects of the particle coating processes", in Special topics on drying, J.T. Freire and D.J.M. Sartori, Eds., vol. 1, São Carlos: UFSCar, 1992, PP. 253-294 (in Portuguese).
55. H.V.A. Oliveira, M.P.G. Peixoto, and L.A.P. Freitas, "Study on the efficiency of hard gelatin capsules coating in a spouted bed", Dry. Technol., vol. 23, PP. 2039-2053, 2005.
56. G.Z. Martins, C.R.F. Souza, J.S. Shankar, and W.P. Oliveira, "Effect of process variables on fluiddynamics and adhesion efficiency during spouted bed coating of hard gelatine capsules", Chem. Eng. Process., vol. 47, PP. 2238-2246, 2008.
57. R. Pissinati and W.P. Oliveira, "Enteric coating of soft gelatin capsules by spouted bed: effect of operating conditions on coating efficiency and on product quality", Eur. J. Pharm. Biopharm., vol. 55, PP. 313-321, 2003.
58. G.M. Walker, C.R. Holland, M.M.N. Ahmad, and D.Q.M. Craig, "Influence of process parameters on fluidized hotmelt granulation and tablet pressing of pharmaceutical powders", Chem. Eng. Sci., vol. 60, PP. 3867-3877, 2005.
59. G.B. Borini, T.C. Andrade, and L.A.P. Freitas, "Hot melt granulation of coarse pharmaceutical powders in a spouted bed", Powder Technol., vol. 189, PP. 520-527, 2009.
60. S. Shelukar, J. Ho, J. Zega, E. Roland, N. Yeh, D. Quiram, A. Nole, A. Katdare, and S. Reynolds, "Identification and characterization of factors controlling tablet coating uniformity in a wurster coating process", Powder Technol., vol. 110, PP. 29-36, 2000.
61. Glatt, GmbH, Fluid Bed Coating. [Online]. Available at: http://www.glatt.com/e/01_technologien/01_04_08.htm. [Accessed: May. 28, 2009].
62. M.I. Ré and J.T. Freire, "Drying of pharmacological extracts", in Proc. of XV Brazilian Congress of Particulate Systems (ENEMP), Uberlândia-MG, Brazil, vol. 1, 1987, PP. 399-406 (in Portuguese).
63. A.J.P. Santinho, N.L. Pereira, O. Freitas, and J.H. Collet, "Influence of formulation on the physicochemical properties of casein microparticles", Int. J. Pharm., vol. 186, PP. 191-198, 1999.
64. I.K. Shuhama, M.L. Aguiar, W.P. Oliveira, and L.A.P. Freitas, "Experimental production of annatto powders in spouted bed dryer", J. Food Eng., vol. 59, PP. 93-97, 2003.
65. M.M. Baracat, A.N. Nakagawa, L.A.P. Freitas, and O. Freitas, "Microcapsule processing in a spouted bed", Can. J. Chem. Eng., vol. 82, PP. 134-141, 2004.
66. D.S. Cordeiro and W.P. Oliveira, "Technical aspects of the production of dried extract of Maytenus ilicifolia leaves by jet spouted bed drying", Int. J. Pharm., vol. 299, PP. 115-126, 2005.
67. C.R.F. Souza, "A comparative study of the production of dried extract of Bauhinia forficata Link by the Spraydryer and the spouted bed processes", Master Thesis, Faculty of Pharmaceuticals Science of State University of Sao Paulo, Ribeirão Preto-SP, Brazil, 2003 (in Portuguese).
68. W.P. Oliveira, R.F. Bott, and C.R.F. Souza, "Manufacture of standardized dried extracts from medicinal Brazilian plants", Dry. Technol., vol. 24, PP. 523-533. 2006.
69. C.R.F. Souza, M.W. Donida, S.C.S. Rocha, and W.P. Oliveira, "The role of colloidal silicon dioxide in the enhancement of the drying of herbal preparations in suspended state", Chem. Eng. Commun., vol. 196, PP. 391- 405, 2009.
70. C.R.F. Souza, I.A. Schiavetto, F.C.F. Thomazini, and W.P. Oliveira, "Processing of Rosmarinus officinalis L. extract on spray and spouted bed dryers", Braz. J. Chem. Eng., vol. 25, PP. 56-69, 2008.
71. K. Masters, Spray Drying Handbook, 5th ed., New York: Longman John Wiley, 1991.
72. I. Filková and A.S. Mujumdar, "Industrial Spray Drying Systems, in Handbook of industrial drying, A.S. Mujumdar, Ed., 2nd edition, vol. 1, New York: Marcel Dekker, 1995, PP. 263-308.
73. F.B. Marquele, K.M. Straciere, M.J.V. Fonseca, and L.A.P. Freitas, "Spray-dried propolis extract. I: Physicochemical and antioxidant properties", Die Pharmazie, vol. 61, PP. 325-330, 2006.
74. C.R.F. Souza and W.P. Oliveira, "Powder properties and system behavior during spray drying of Bauhinia forficata Link extract", Dry. Technol., vol. 24, PP. 735-749, 2006.
75. I.L. Nunes and A.Z. Mercadante, "Encapsulation of lycopene using spray-drying and molecular inclusion processes", Braz. Arch. Biol. Techn., vol. 50, PP. 893-900, 2007.
76. A.C. Oliveira, T.S. Moretti, C. Boschini, O. Freitas, L.A.P. Freitas, and C. Favaro-Trindade, "Microencapsulation of B-lactis (Bl 01) and L-acidophilus (LAC 4) by complex coacervation followed by spouted bed drying", Dry. Technol., vol. 25, PP. 1687-1693, 2007.
77. H. Yoshi, T.L. Neoh, T. Furuta, and M. Okawara, "Encapsulation of protein by spray-drying and crystal transformation method," Dry. Technol., vol. 26, PP. 1308-1312, 2008.
78. T.A.G. Langrish, "New engineered particles from spray dryers: Research needs in spray drying," Dry. Technol., vol. 25, PP. 981-993, 2007.
79. S. Vaidya, R. Bhosale, and R.S. Singhal, "Microencapsulation of cinnamon oleoresin by spray drying using different wall materials", Dry. Technol., vol. 24, PP. 983-992, 200.
80. M.I. Ré, "Formulating drug delivery systems by spray drying", Dry. Technol., vol. 24, PP. 433-446, 2006.
81. C. Yu, W. Wang, H. Yao, and H. Liu, "Preparation of phospholipid microcapsule by spray drying", Dry. Technol., vol. 25, PP. 695-702, 2007.
82. J.O.H. Sham, Y. Zhang, W.H. Finlay, W.H. Roa, and R. Lobenberg, "Formulation and characterization of spraydried powders containing nanoparticles for aerosol delivery to the lung", Int. J. Pharm., 2004, 269, 457-467.
83. G.K. Braga and W.P. Oliveira, "Manufacturing drug loaded chitosan microspheres by spray drying: development, characterization and potential use in dentistry," Dry. Technol., vol. 25, PP. 303-310, 2007.
84. A.I. Liapis and R. Bruttini, "Freeze Drying," in Handbook of industrial drying, A.S. Mujumdar, Ed., 2nd ed., New York: Marcel Dekker, 1987, PP. 309-343.
85. V. Tattini Jr, D.F. Parra, and R.N.M. Pitombo, "Influence of cooling rate on the physical, chemical and structural behavior during lyophilization of bovine albumin," Revista Brasileira de Ciências Farmacêuticas, vol. 42, PP. 127-136 2006, (in Portuguese).
86. L.G. Marques, A.M. Silveira, and J.T. Freire, "Freeze-drying characteristics of tropical fruits," Dry. Technol., vol. 24, PP. 457-463, 2006.
87. J.I. Lombrana and J. Izkara, "Experimental estimation of effective transport coefficients in freeze drying for simulation and optimization purpose", Dry. Technol., vol. 14, PP. 743-763, 1996.
88. Aspen Process Manual - Drying, [Online]. Available: http://internet.processmanual.com/ipmcontent/ DR.htm, [Accessed: April. 01, 2009].
89. L.F.T. Alonso and K.J. Park, "Dryer selection methods", Ciência e Tecnologia de Alimentos, vol. 25, PP. 208- 216, 2005 (in Portuguese).
90. S.R. Georgetti, R. Casagrande, C.R.F. Souza, W.P. Oliveira, and M.J.V. Fonseca, "Spray-drying of the soybean extract: effects on chemical properties and antioxidant activity", LWT - Food Sci. Technol., vol. 41, PP. 1521- 1527, 2008.
91. H. Remili, P. Boussard, and M. Devleeschouwer, "Microbiological quality of spray-dried pharmaceutical plants extracts", Eur. J. Pharm. Sci., vol 1, PP. 265-268, 1994.
92. ANVISA, Ministry of Health, Resolution on phytotherapic products NR 48, Poder Executivo, Brasília-DF, Brazil, 2004 (in Portuguese).
93. ANVISA, Ministry of Health, Resolution on GMP of pharmaceutical products NR 210, Poder Executivo, Brasília-DF, Brazil, 2003 (in Portuguese).
94. Eudralex. "The Rules Governing Medicinal Products in the European Union, v. 4 - Guidelines for good manufacturing practices for medicinal products for human and veterinary use" [Online]. Available: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/eudralex_en.htm, [Accessed: April. 01, 2009].
95. ANVISA, Ministry of Health, Resolution on phytotherapic products NR 17, Poder Executivo, Brasília-DF, Brazil, 2000 (in Portuguese).
96. J.P. Benoit, H. Marchais, H. Rolland, and V. Vande-Velde, "Biodegradable microspheres: advances in production technology," in Microencapsulation methods and industrial applications, S. Benita, Ed., New York: Marcel Dekker, 1996, PP. 35-72.
97. K.E. Avis, A.J. Shukla, and R.K. Chang, Pharmaceutical unit operations: coating, Boca Raton: Interpharm/CRC, 1999.
98. F. Shahidi and X.Q. Han, "Encapsulation of food ingredients", Crit. Rev. Food Sci., vol. 33, PP. 501-547, 1993.
99. H. Ichikawa and Y. Fukumori, "Microagglomeration of pulverized pharmaceutical powder using the Wurster process I. Preparation of highly drug-incorporated, subsieve-sized core particles for subsequent microencapsulation by film coating", Int. J. Pharm., vol. 180, PP. 195-210, 1999.
100. M.I. Ré, "Microencapsulation by spray drying", Dry. Technol., vol. 16, PP. 1195-1236, 1998.
101. R. Jalil and J.R. Nixon, "Biodegradable poly (lactide acid) and poly (lactide-co-glycolide) microcapsules: problems associated with preparative techniques and release properties", J. Microencap., vol. 7, PP. 297-325, 1990.
102. K. Park and Y. Yeo, "Microencapsulation technology," in Encyclopedia of pharmaceutical technology. 3rd ed., vol. 3, New York: Informa Healthcare, 2006, PP. 2315-2327.
103. E. Allemann, J. Leroux, and R.Gurny, "Polymeric nano and microparticles for the oral delivery of peptides and peptidomimetics", Adv. Drug Deliver. Rev., vol. 34, PP. 171-189, 1998.
104. P. Johansen, Y. Men, H.P., Merkle, and B. Gander, "Revisiting PLA/PLGA microspheres an analysis of their potential in parenteral vaccination", Eur. J. Pharm. Biopharm., vol. 50, PP. 29-146, 2000.