Influence pellets of process parameters on sustained-release theophylline coated with aqueous polymer dispersions and organic solvent- based polymer solutions

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 43, Issue 2, 1997, Pages 149-157

  Lorck, Claudio Alexander ^a   Grunenberg, Petra Christine ^a   Jünger, Herbert ^a   Laicher, Arním ^a  

^a ASTELLAS PHARMA INC   (Japan)

Author keywords

Coating process parameters; Curing; Multiple dose units; Pellet core properties; Sustained release

Indexed keywords

ETHYL CELLULOSE; EUDRAGIT; EUDRAGIT RS; ORGANIC SOLVENT; PALATINOL; PHTHALIC ACID DIBUTYL ESTER; POLYMER; SURELEASE X; THEOPHYLLINE; UNCLASSIFIED DRUG;

ARTICLE; DISSOLUTION; FILM COATING; HUMIDITY; PARTICLE SIZE; PELLET EXTRUSION; SUSTAINED RELEASE PREPARATION; TEMPERATURE;

EID: 0031402167     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0939-6411(96)00035-5     Document Type: Review

References (27)

1. N. Follnier, E. Doelker. Biopharmaceutical comparison of oral multiple-unit and single-unit sustained-release dosage forms. S.T.P. Pharma Sci. 2 (1992) 141-158.
2. L. Hellen, J. Poutanen, J. Yliruusi, P. Merkku, E. Kristoffersson. Changes in size and size distribution of pellets during spheronization. Part I, Boll. Chim. Farmaceutico 133 (1994) 80-87.
3. L. Hellen, J. Poutanen, J. Yliruusi, P. Merkku, E. Kristoffersson. Changes in shape and shape distribution, surface morphology and density of pellets during spheronization. Part II, Boll. Chim. Farm. 133 (1994) 88 94.
4. P. Holm, T. Schaefer, HG. Kristensen. Pelletization by controlled wet granulation in a high-shear mixer. S.T.P. Pharma Sci. 3 (1993) 286-293.
5. A. Laicher, C.A. Lorck, P.C. Grunenberg, H. Klemm, F. Stanislaus. Aqueous coating of pellets to sustained-release dosage forms in a fluid-bed coater. Pharm. Ind. 55 (1993) 1113-1116.
6. A. Laicher, C.A. Lorck, J. Tobin, F. Stanislaus. Process optimization of pellet coating and drying using fluid-bed production units. Pharm. Tech. Eur. 9 (1994) 41-48.
7. R.M. Iyer, L.L. Augsburger, D.M. Parikh. Evaluation of drug layering and coating: effect of process mode and binder level. Drug Dev. Ind. Pharm. 19 (1993) 981-998.
8. P. Holm, J. Holm, P.-O. Lang. A comparison of two fluid-bed systems - enteric coating of pellets. Acta Pharm. Nord 3 (1991) 235-241.
9. P.B. Deasy. Microencapsulation of drugs by pan and air suspension techniques. Crit. Rev. Ther. Drug Carrier Syst. 8 (1991) 39-89.
10. A.G. Ozturk, S.S. Ozturk, B.O. Palsson, T.A. Wheathley, J.B. Dressman. Mechanism of release from pellets coated with an ethylcellulose-based film. J. Control. Release 14 (1990) 203-213.
11. G. Ragnarsson, M.O. Johansson. Coated drug cores in multiple unit preparations: influence of particle size. Drug Dev. Ind. Pharm. 14 (1988) 2285 2297.
12. R. Wesdyk, Y.M. Joshi, N.B. Jain, K. Morris, A. Newman. The effect of size and mass on the film thickness of beads coated in fluidized bed equipment. Int. J. Pharm. 65 (1990) 67-76.
13. R. Wesdyk, Y.M. Joshi, J. De Vincentis, A.W. Newman, N.B. Jain. Factors affecting differences in film thickness of beads coated in fluidized bed units. Int. J. Pharm. 93 (1993) 101-109.
14. N.H. Shah, L. Zhang, A. Railkar, I. Trivedi, C.I. Patel, M.H. Infeld, A.W. Malick, L.K. Wong. Factors affecting the kinetics and mechanism of release of cliazapril from beadlets coated with aqueous and nonaqueous ethylcellulose-based coating. Pharm. Tech. 10 (1994) 140-149.
15. R. Bodmeier, O. Paeratakul. The effect of curing on drug release and morphological properties of ethylcellulose pseudolatex-coated beads. Drug Dev. Ind. Pharm. 20 (1994) 1517-1533.
16. D. Hutchings, B. Kuzmak, A. Sakr. Processing considerations for an EC latex coating system: influence of curing time and temperature. Pharm. Res. 11 (1994) 1474-1478.
17. K. Amighi, A. Moës. Influence of plasticizer concentration and storage conditions on the drug release rate from Eudragit® RS 30D film-coated sustained-release theophylline pellets. Eur. J. Pharm. Biopharm. 42 (1996) 29-35.
18. K. Amighi, A. Moës. Evaluation of thermal and film forming properties of acrylic aqueous polymer dispersion blends: application to the formulation of sustained-release film coated theophylline pellets. Drug Dev. Ind. Pharm. 21 (1995) 2355-2369.
19. Anwendungstechniches Merkblatt, Rhöm Pharma, Weiterstadt, Germany (1992).
20. C. Vecchio, F. Fabiani, A. Gazzaniga. Use of colloidal silica as a separating agent in film-forming processes performed with aqueous dispersion of acrylic resins. Drug Dev. Ind. Pharm. 21 (1995) 1781-1787.
21. Surelease Colorcon, Königstein/Ts., Germany (1990).
22. D.M. Jones. Factors to consider in fluid-bed processing. Pharm. Tech. 9 (1985) 50-62.
23. P.C. Schmidt, F. Niemann, The Miniwid coaler. III. Effect of application temperature on the dissolution profile of sustained-release Theophylline pellets coated with Eudragit RS 30 D. Drug Dev. Ind. Pharm. 19 (1993) 1603-1612.
24. L.E. Appel, G.M. Zentner. Use of modified ethylcellulose lattices for microporous coating of osmotic tablets. Pharm. Res. 8 (1991) 600-603.
25. B.C. Lippold, H. Förster. Entwicklung Herstellung und in-vitro-Testung von peroralen Depotarzneiformen mit konstanter Wirkstoffliberation am Beispiel des Theophyllins. Pharm. Ind. 44 (1982) 735-740.
26. S.C. Porter. Controlled-release film coatings based on ethylcellulose. Drug Dev. Ind. Pharm. 15 (1989) 1495-1521.
27. P. Sheen, P.J. Sabol, G.J. Alcorn, K.M. Feld. Aqueous film coating studies of sustained release nicotinic acid pellets: an in-vitro evaluation. Drug Dev. Ind. Pharm. 18 (1992) 851-860.