Abstract
The equipment modifications and process changes necessary to perform hot-melt particle coating in a fluid bed granulator are reviewed. A specific case is presented in which partially hydrogenated cottonseed oil is coated onto fine granules (mean particle size, 77 µm; range, 10–150 µm; one standard deviation is 10 µm) composed of a hydrophobic drug and sucrose. The major variables were product bed temperature, temperature of the wax, spray rate, and atomization air pressure. The product bed temperature was selected to give the optimum congealing rate, and the latter three variables were varied in a statistically designed experiment. The physical properties of wax-coated granules fabricated using combinations of process variables were examined. Response surface analysis was used to determine the optimum process settings in terms of dissolution, particle size, and density of the coated product. This system proved quite adequate for the production of uniformly coated granules, with the best product being obtained at the optimized conditions using 120°C atomization air and molten coating temperature, 30 g/min as the spray rate, and an atomization air pressure of 5 bar.
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REFERENCES
I. S. Hamid and C. H. Becker. J. Pharm. Sci. 59:511–514 (1970).
A. G. Cusimano and C. H. Becker. J. Pharm. Sci. 57:1104–1112 (1968).
P. M. John and C. H. Becker. J. Pharm. Sci. 57:584–589 (1968).
S. Motycka and J. G. Nairn. J. Pharm. Sci. 67:500–503 (1978).
S. P. Patel and C. I. Jarowski. J. Pharm. Sci. 64:869–872 (1975).
C. I. Igwilo and N. Pilpel. Int. J. Pharm. 15:73–85 (1983).
C. I. Irono and N. Pilpel. J. Pharm. Pharmacol. 34:480–485 (1982).
C. Igwilo and N. Pilpel. J. Pharm. Pharmacol. 39:301–302 (1987).
E. Mathiowitz and R. Langer. J. Control. Release 5:13–22 (1987).
C. R. Kowarski and F. Tiano. Pharm. Acta Helv. 50:310–312 (1975).
D. E. Fonner, Jr., J. R. Buck, and G. S. Banker. J. Pharm. Sci. 59:1587–1596 (1970).
J. B. Schwartz, J. R. Flamholz, and R. H. Press. J. Pharm. Sci. 62:1165–1170 (1973).
K. Takayama and T. Nagai. Chem. Pharm. Bull. 37:160–167 (1989).
R. M. Franz, J. A. Sytsma, B. P. Smith, and L. J. Lucisano. J. Control. Release 5:159–172 (1987).
R. M. Franz, J. E. Browne, and A. R. Lewis. In H. A. Lieberman, M. M. Rieger, and G. S. Banker (eds.), Pharmaceutical Dosage Forms: Disperse Systems, Marcel Dekker, New York, 1988, pp. 427–514.
J. Spitael and R. Kinget. Int. Conf. Powder Technol. Pharm. 1:1–11 (1978).
V. I. Gorodnichev, H. M. El-Banna, and B. V. Andreev. Pharmazie 36:270–273 (1981).
G. E. P. Box and K. B. Wilson. J. R. Stat. Soc. 13:1–45 (1951).
G. E. P. Box and N. R. Draper. Empirical Model Building and Response Surfaces, Wiley, New York, 1987.
R. H. Myers. Response Surface Methodology, Library of Congress Catalog Card No. 71-125611, 1976.
J. S. Murray. X-Stat—Statistical Experiment Design/Data Analysis/Nonlinear Optimization, Wiley, New York, 1984.
R. L. Carr. Br. Chem. Eng. 15:1541 (1970).
J. J. Motzi and N. R. Anderson. Drug Dev. Ind. Pharm. 10:225–239 (1984).
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Jozwiakowski, M.J., Jones, D.M. & Franz, R.M. Characterization of a Hot-Melt Fluid Bed Coating Process for Fine Granules. Pharm Res 7, 1119–1126 (1990). https://doi.org/10.1023/A:1015972007342
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DOI: https://doi.org/10.1023/A:1015972007342