Development of starch-based pellets via extrusion/spheronisation

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 66, Issue 1, 2007, Pages 83-94

  Dukić, Aleksandra ^a   Mens, Raoul ^b   Adriaensens, Peter ^b   Foreman, Paul ^c   Gelan, Jan ^b   Remon, Jean Paul ^a   Vervaet, Chris ^a  

^a GHENT UNIVERSITY   (Belgium)

^b HASSELT UNIVERSITY   (Belgium)

^c NATIONAL STARCH AND CHEMICAL COMPANY   (United States)

Author keywords

Experimental design; Extrusion spheronisation; NMR; Pellets; Sorbitol; Starch

Indexed keywords

AMYLOSE; EXCIPIENT; HYDROXYPROPYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; KOLIDON 30; MANNIDEX; MANNITOL; MICROCRYSTALLINE CELLULOSE; POVIDONE; SORBIDEX; SORBITOL; STARCH; THEOPHYLLINE; UNCLASSIFIED DRUG;

ANALYSIS OF VARIANCE; ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG SOLUBILITY; EXPERIMENTAL DESIGN; FLOW MEASUREMENT; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PELLET EXTRUSION; POWDER; SCANNING ELECTRON MICROSCOPY; SPHERONIZATION; SURFACE PROPERTY; TABLET DISINTEGRATION; X RAY POWDER DIFFRACTION;

ALGORITHMS; AMYLOPECTIN; AMYLOSE; CELLULOSE; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DRUG CARRIERS; EXCIPIENTS; IMAGING, THREE-DIMENSIONAL; MAGNETIC RESONANCE SPECTROSCOPY; MICROSCOPY, ELECTRON, SCANNING; PARTICLE SIZE; PLASTICIZERS; POVIDONE; SOLUBILITY; SORBITOL; SURFACE PROPERTIES; TECHNOLOGY, PHARMACEUTICAL; THEOPHYLLINE; TIME FACTORS; X-RAY DIFFRACTION;

EID: 33947163923     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2006.08.015     Document Type: Article

References (38)

1. O'Connor R.E., and Schwartz J.B. Spheronization II: drug release from drug-diluent mixtures. Drug Dev. Ind. Pharm. 11 (1985) 1837-1857
2. Basit A.W., Newton J.M., and Lacey L.F. Formulation of ranitidine pellets by extrusion-spheronization with little or no microcrystalline cellulose. Pharm. Dev. Tech. 4 (1999) 499-505
3. Okada S., Nakahara H., and Isaka H. Adsorption of drugs on microcrystalline cellulose suspended in aqueous solutions. Chem. Pharm. Bull. 35 (1987) 761-768
4. Rivera S.L., and Ghodbane S. In vitro adsorption-desorption of famotidine on microcrystalline cellulose. Int. J. Pharm. 108 (1994) 31-38
5. Al-Nimry S.S., Assaf S.M., Jalal I.M., and Najib N.M. Adsorption of ketofifen onto some pharmaceutical excipients. Int. J. Pharm. 149 (1997) 115-121
6. Pinto J.F., Buckton G., and Newton J.M. The influence of four selected processing and formulation factors on the production of spheres by extrusion and spheronisation. Int. J. Pharm. 83 (1982) 187-196
7. Vervaet C., Baert L., and Remon J.P. Enhancement of in-vitro drug-release by using polyethylene-glycol-400 and peg-40 hydrogenated castor-oil in pellets made by extrusion/spheronisation. Int. J. Pharm. 108 (1994) 207-212
8. Souto C., Rodriguez A., Parajes S., and Martinez-Pacheco R. A comparative study of the utility of two superdisintegrants in microcrystalline cellulose pellets prepared by extrusion-spheronization. Eur. J. Pharm. Biopharm. 61 (2005) 94-99
9. Baert L., and Remon J.P. Influence of amount of granulation liquid on the drug release rate from pellets made by extrusion spheronisation. Int. J. Pharm. 95 (1993) 135-141
10. Millili G.P., and Schwartz J.B. The strength of microcrystalline cellulose pellets - the effect of granulating with water ethanol mixtures. Drug Dev. Ind. Pharm. 16 (1990) 1411-1426
11. Schroeder M., and Kleinebudde P. Structure of disintegrating pellets with regard to fractal geometry. Pharm. Res. 12 (1995) 1694-1700
12. Lindner H., and Kleinebudde P. Use of powdered cellulose for the production of pellets by extrusion/spheronisation. J. Pharm. Pharmacol. 46 (1994) 2-7
13. Alvarez L., Concheiro A., Gomez-Amoza J.L., Souto C., and Martinez-Pacheco R. Powdered cellulose as excipient for extrusion-spheronization pellets of a cohesive hydrophobic drug. Eur. J. Pharm. Biopharm. 55 (2003) 291-295
14. Kleinebudde P. Application of low substituted hydroxypropylcellulose (L-HPC) in the production of pellets using extrusion/spheronisation. Int. J. Pharm. 96 (1993) 119-128
15. Chatlapalli R., and Rohera B.D. Physical characterization of HPMC and HEC and investigation of their use as pelletization aids. Int. J. Pharm. 161 (1998) 179-193
16. Tho I., Sande S.A., and Kleinebudde P. Pectinic acid, a novel excipient for production of pellets by extrusion/spheronisation: preliminary studies. Eur. J. Pharm. Biopharm. 54 (2002) 95-99
17. Tho I., Sande S.A., and Kleinebudde P. Disintegrating pellets from a water-insoluble pectin derivative produced by extrusion/spheronisation. Eur. J. Pharm. Biopharm. 56 (2003) 371-380
18. Agrawal A.M., Howard M.A., and Neau S.H. Extruded and spheronized beads containing no microcrystalline cellulose: influence of formulation and process variables. Pharm. Dev. Tech. 9 (2004) 197-217
19. Bornhoft M., Thommes M., and Kleinebudde P. Preliminary assessment of carrageenan as excipient for extrusion/spheronisation. Eur. J. Pharm. Biopharm. 59 (2005) 127-131
20. Liew C.V., Gu L., Soh J.L.P., and Heng P.W.S. Functionality of cross-linked polyvinylpyrrolidone as a spheronization aid: a promising alternative to microcrystalline cellulose. Pharm. Res. 22 (2005) 1387-1398
21. Howard M.A., Neau S.H., and Sack J.S. PEO and MPEG in high drug load extruded and spheronised beads that are devoid of MCC. Int. J. Pharm. 307 (2006) 66-76
22. O'Connor R.E., Holinej J., and Schwartz J.B. Spheronization I: processing and evaluation of spheres prepared of commercially available excipients. Am. J. Pharm. 156 (1984) 80-87
23. Junnila R., Heinamaki J., and Yliruusi J. Effects of surface-active agent on the size, shape and hardness of microcrystalline cellulose/maize starch pellets prepared by an extrusion-spheronization technique. STP Pharma Sci. 8 (1998) 221-226
24. Junnila R., Palviainen P., Heinämäki J., Myllärinen P., Forssell P., and Yliruusi J. Waxy corn starch: a potent cofiller in pellets produced by extrusion-spheronisation. Pharm. Dev. Techn. 5 (2000) 67-76
25. Almeida Prieto S., Blanco Mendez J., and Otero Espinar F.J. Starch-dextrin mixtures as base excipients for extrusion-spheronization pellets. Eur. J. Pharm. Biopharm. 59 (2005) 511-521
26. US Patent No. 5281276.
27. Parker M.D., Rowe R.C., and Upjohn N.G. Mixer torque rheometry: a method for quantifying the consistency of wet granulations. Pharm. Tech. Int. 2 (1990) 50-62
28. Rowe R.C., and Parker M.D. Mixer torque rheometry - An update. Pharm. Tech. Eur. 6 (1994) 24-27
29. Podczeck F., and Newton J.M. A shape factor to characterize the quality of spheroids. J. Pharm. Pharmacol. 46 (1994) 82-85
30. Gaudin S., Lourdin D., Le Botlan D., Ilari J.L., and Colonna P. Plasticisation and mobility in starch-sorbitol films. J. Cereal Sci. 29 (1999) 273-284
31. Baert L., Fanara D., Debaets P., and Remon J.P. Instrumentation of a gravity feed extruder and the influence of the composition of binary and ternary mixtures on the extrusion forces. J. Pharm. Pharmacol. 43 (1991) 745-749
32. Hileman G.A., Upadrashta S.M., and Neau S.H. Drug solubility effects on predicting optimum conditions for extrusion and spheronisation of pellets. Pharm. Dev. Tech. 2 (1997) 43-52
33. Lustig-Gustafsson C., Johal H.K., Podczeck F., and Newton J.M. The influence of water content and drug solubility on the formulation of pellets by extrusion and spheronisation. Eur. J. Pharm. Sci. 8 (1999) 147-152
34. Millili GP., Wigent R.J., and Schwartz J.B. Autohesion in pharmaceutical solids. Drug Dev. Ind. Pharm. 16 (1990) 2383-2407
35. Baert L., Vermeersch H., Remon J.P., Smeyers-Verbeke J., and Massart D.L. Study of parameters important in the spheronisation process. Int. J. Pharm. 96 (1993) 225-229
36. Hellen L., Poutanen J., Yliruusi J., Merkku P., and Kristoffersson E. Changes in size and size distribution of pellets during spheronisation. Part I. Boll. Chim. Farm. 133 (1994) 80-87
37. Wan L.C.S., Heng P.W.S., and Liew C.V. Spheronization conditions on spheroid shape and size. Int. J. Pharm. 96 (1993) 59-65
38. Chopra R., Podczeck F., Newton J.M., and Alderborn G. The influence of pellet shape and film coating on the filling of pellets into hard shell capsules. Eur. J. Pharm. Biopharm. 53 (2002) 327-333