Co-processed MCC-Eudragit® e excipients for extrusion-spheronization

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 79, Issue 3, 2011, Pages 658-663

  Goyanes, Alvaro ^a   Souto, Consuelo ^a   Martínez Pacheco, Ramón ^a  

^a UNIVERSITY OF SANTIAGO DE COMPOSTELA   (Spain)

Author keywords

Co processed excipient; Eudragit E; Extrusion spheronization; Hydrochlorothiazide; Microcrystalline cellulose; Pellet

Indexed keywords

EUDRAGIT; EXCIPIENT; HYDROCHLOROTHIAZIDE; MICROCRYSTALLINE CELLULOSE; SORBITOL;

ARTICLE; CONTROLLED STUDY; DRUG FORMULATION; DRUG MIXTURE; DRUG RELEASE; DRUG SOLUBILITY; INFRARED SPECTROSCOPY; PELLET EXTRUSION; SCANNING ELECTRON MICROSCOPY; SPHERONIZATION; TABLET COMPRESSION; TABLET DISINTEGRATION; TABLET FRIABILITY; TABLET POROSITY; X RAY POWDER DIFFRACTION;

CELLULOSE; COMPRESSIVE STRENGTH; DRUG COMPOUNDING; EXCIPIENTS; HYDROCHLOROTHIAZIDE; METHACRYLATES; MICROSCOPY, ELECTRON, SCANNING; PARTICLE SIZE; POWDER DIFFRACTION; SOLUBILITY; SPECTROPHOTOMETRY, INFRARED; SURFACE PROPERTIES; X-RAY DIFFRACTION;

EID: 80053939620     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2011.07.013     Document Type: Article

References (32)

1. K.E. Fielden, J.M. Newton, and R.C. Rowe A comparison of the extrusion and spheronization behavior of wet powder masses processed by a ram extruder and a cylinder extruder Int. J. Pharm. 81 1992 225 233
2. R.D. Shah, M. Kabadi, D.G. Pope, and L.L. Augsburger Physicomechanical characterization of the extrusion-spheronization process. Part 2. Rheological determinants for successful extrusion and spheronization Pharm. Res. 12 1995 496 507
3. J.F. Pinto, G. Buckton, and J.M. Newton The influence of four selected processing and formulation factors on the production of spheres by extrusion and spheronization Int. J. Pharm. 83 1992 187 196
4. R.E. O'Connor, and J.B. Schwartz Drug release mechanism from a microcrystalline cellulose pellet system Pharm. Res. 10 1993 356 361 (Pubitemid 23080598)
5. K.R. Zimm, J.B. Schwartz, and R.E. O'Connor Drug release from a multiparticulate pellet system Pharm. Dev. Technol. 1 1996 37 42 (Pubitemid 28259195)
6. G.P. Millili, and J.B. Schwartz The strength of microcrystalline cellulose pellets - the effect of granulating with water ethanol mixtures Drug Dev. Ind. Pharm. 16 1990 1411 1426 (Pubitemid 20170831)
7. C. Souto, A. Rodriguez, S. Parajes, and R. Martínez-Pacheco 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 (Pubitemid 41096693)
8. A. Goyanes, C. Souto, and R. Martínez-Pacheco A comparison of chitosan-silica and sodium starch glycolate as disintegrants for spheronized extruded microcrystalline cellulose pellets Drug Dev. Ind. Pharm. 37 2011 825 831
9. C. Vervaet, L. Baert, and J.P. Remon 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 (Pubitemid 24223175)
10. A. Goyanes, C. Souto, and R. Martínez-Pacheco Control of drug release by incorporation of sorbitol or mannitol in microcrystalline-cellulose- based pellets prepared by extrusion-spheronization Pharm. Dev. Technol. 15 2010 626 635
11. V.R. Sinha, R. Kumria, and M.K. Agrawal Influence of formulation and excipient variables on the pellet properties prepared by extrusion spheronization Curr. Drug Deliv. 2 2005 1 8 (Pubitemid 40590916)
12. A. Dukic-Ott, M. Thommes, J.P. Remon, P. Kleinebudde, and C. Vervaet Production of pellets via extrusion-spheronisation without the incorporation of microcrystalline cellulose: a critical review Eur. J. Pharm. Biopharm. 71 2009 38 46
13. H. Lindner, and P. Kleinebudde Use of powdered cellulose for the production of pellets by extrusion spheronization J. Pharm. Pharmacol. 46 1994 2 7 (Pubitemid 24047047)
14. L. Alvarez, A. Concheiro, J.L. Gomez-Amoza, C. Souto, and R. Martinez-Pacheco Powdered cellulose as excipient for extrusion-spheronization pellets of a cohesive hydrophobic drug Eur. J. Pharm. Biopharm. 55 2003 291 295 (Pubitemid 36564854)
15. M. Schroder, and P. Kleinebudde Influence of formulation parameters on dissolution of propyphenazone pellets Eur. J. Pharm. Biopharm. 41 1995 382 387 (Pubitemid 26037092)
16. I. Tho, S.A. Sande, and P. Kleinebudde Disintegrating pellets from a water-insoluble pectin derivative produced by extrusion/spheronisation Eur. J. Pharm. Biopharm. 56 2003 371 380 (Pubitemid 37346510)
17. M. Thommes, and P. Kleinebudde Use of kappa-carrageenan as alternative pelletisation aid to microcrystalline cellulose in extrusion/spheronisation. Part I. Influence of type and fraction of filler Eur. J. Pharm. Biopharm. 63 2006 59 67
18. A. Dukic-Ott, J.P. Remon, P. Foreman, and C. Vervaet Immediate release of poorly soluble drugs from starch-based pellets prepared via extrusion/spheronisation Eur J. Pharm. Biopharm. 67 2007 715 724 (Pubitemid 47576617)
19. P. Verheyen, K.J. Steffens, and P. Kleinebudde Use of crospovidone as pelletization aid as alternative to microcrystalline cellulose: effects on pellet properties Drug Dev. Ind. Pharm. 35 2009 1325 1332
20. M.A. Howard, S.H. Neau, and M.J. Sack PEO and MPEG in high drug load extruded and spheronized beads that are devoid of MCC Int. J. Pharm. 307 2006 66 76 (Pubitemid 41773253)
21. P. Gupta, S.K. Nachaegari, and A.K. Bansal Improved excipient functionality by coprocessing A. Katdare, M.V. Chaubal, Excipient Development for Pharmaceutical Biotechnology,and Drug Delivery Systems 2006 Informa Healthcare New York 109 126
22. R.C. Rowe, P.J. Sheskey, and S.C. Owen Handbook of Pharmaceutical Excipients 2006 Pharmaceutical Press and American Pharmacists Association London
23. J.A.B. Funck, J.B. Schwartz, W.J. Reilly, and E.S. Ghali Binder effectiveness for beads with high drug levels Drug Dev. Ind. Pharm. 17 1991 1143 1156
24. G.A. Hileman, S.R. Goskonda, A.J. Spalitto, and S.M. Upadrashta A factorial approach to high-dose product development by an extrusion spheronization process Drug Dev. Ind. Pharm. 19 1993 483 491 (Pubitemid 23063380)
25. JRS PHARMA, Prosolv ODT. < http://www.jrs.de/Pharma/wDeutsch/ produktinfo/productinfo-prosolv-odt.shtml >, 2001 (accessed July 2011).
26. JRS PHARMA, Prosolv EASYtab. < http://www.jrs.de/Pharma/wEnglisch/ produktinfo/productinfo-prosolv-easytab.shtml >, 2011 (accessed July, 2011).
27. H.P. Deppeler Hydrochlorothiazide K. Florey, Analytical Profiles of Drug Substances 1981 Academic Press New York 405 441
28. H.E. Exner, and E. Linck Image analysis for characterization of size-distribution and shape-distribution of lead powders Powder Met. Int. 9 1977 131 133 (Pubitemid 8547197)
29. L. Svarovsky Powder Testing Guide: Methods of measuring the physical properties of bulk powders 1987 Elsevier Applied Science London
30. F.M. Fayed, and L. Otten Handbook of Powder Science and Technology 1984 Van Nostrand Reinhold New York
31. K.A. Khan, and C.T. Rhodes Effect of compaction pressure on dissolution efficiency of some direct compression systems Pharm. Acta Helv. 47 1972 594 607
32. R. Carr Chemical Engineering 1965 McGraw-Hill New York