Development of potential novel cushioning agents for the compaction of coated multi-particulates by co-processing micronized lactose with polymers

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 79, Issue 2, 2011, Pages 406-415

  Lin, Xiao ^a   Chyi, Chin Wun ^b   Ruan, Ke Feng ^a   Feng, Yi ^a   Heng, Paul Wan Sia ^b  

^a SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

^b NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

Author keywords

[No Author keywords available]

Indexed keywords

CHLORPHENIRAMINE MALEATE; HYDROXYPROPYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; METHYLCELLULOSE; PHARMATOSE DCL 11; POVIDONE; UNCLASSIFIED DRUG;

ARTICLE; COMPRESSION; DRUG COATING; DRUG RELEASE; PHYSICAL CHEMISTRY; PRESSURE; SPRAY DRYING; TABLET;

EID: 80054999460     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2011.03.024     Document Type: Article

References (38)

1. R. Bodmeier, Tableting of coated pellets, Eur. J. Pharm. Biopharm. 43 (1997) 1-8. (Pubitemid 28298804)
2. T. Yao, M. Yamada, H. Yamahara, M. Yoshida, Tableting of coated particles II. Influence of particle size of pharmaceutical additives on protection of coating membrane from mechanical damage during compression process, Chem. Pharm. Bull. 46 (1998) 826-830. (Pubitemid 28257484)
3. A. Dashevsky, K. Kolter, R. Bodmeier, Compression of beads coated with various aqueous polymer dispersions, Int. J. Pharm. 279 (2004) 19-26. (Pubitemid 38968638)
4. Y.S. Habib, L.L. Augsburger, R.F. Shangraw, Production of inert cushioning beads: effect of excipients on the physicomechanical properties of freeze-dried beads containing microcrystalline cellulose produced by extrusion-spheronization, Int. J. Pharm. 233 (2002) 67-83. (Pubitemid 34230420)
5. A. Debunne, C. Vervaet, D. Mangelings, J.P. Remon, Compaction of entericcoated beads: influence of formulation and process parameters on tablet properties and in vivo evaluation, Eur. J. Pharm. Sci. 22 (2004) 305-314. (Pubitemid 38758018)
6. G.J. Vergote, F. Kiekens, C. Vervaet, J.P. Remon, Wax beads as cushioning agents during the compression of coated diltiazem beads, Eur. J. Pharm. Sci. 17 (2002) 145-151. (Pubitemid 35248268)
7. F. Zhou, C. Vervaet, M. Schelkens, R. Lefebvre, J.P. Remon, Bioavailability of ibuprofen from matrix beads based on the combination of waxes and starch derivatives, Int. J. Pharm. 168 (1998) 79-84. (Pubitemid 28293666)
8. M. Celik, L. Maganti, Formulation and compaction of microspheres, Drug Dev. Ind. Pharm. 20 (1994) 3151-3173. (Pubitemid 24353484)
9. F. Nicklasson, G. Alderborn, Modulation of the tableting behaviour of microcrystalline cellulose beads by the incorporation of polyethylene glycol, Eur. J. Pharm. Sci. 9 (1999) 57-65. (Pubitemid 29430193)
10. J.J. Torrado, L.L. Augsburger, Effect of different excipients on the tableting of coated particles, Int. J. Pharm. 106 (1994) 149-155. (Pubitemid 24136533)
11. M.E. Aulton, A.M. Dyer, K.A. Khan, The strength and compaction of millispheres, Drug Dev. Ind. Pharm. 20 (1994) 3069-3104. (Pubitemid 24353481)
12. F. Nicklasson, B. Johansson, G. Alderborn, Occurrence of fragmentation during compression of beads prepared from a 4 to 1 mixture of dicalcium phosphate dehydrate and microcrystalline cellulose, Eur. J. Pharm. Sci. 7 (1999) 221-229. (Pubitemid 29015739)
13. J. Wakelin, H. Virgin, E. Crystal, Development and comparison of two X-ray methods for determining the crystallinity of cotton cellulose, J. Appl. Phys. 30 (1959) 1654-1662.
14. J.T. Fell, J.M. Newton, Determination of tablet strength by the diametralcompression test, J. Pharm. Sci. 59 (1970) 688-691.
15. B.V. Veen, G.K. Bolhuis, Y.S. Wu, K. Zuurman, H.W. Frijlink, Compaction mechanism and tablet strength of unlubricated and lubricated (silicified) microcrystalline cellulose, Eur. J. Pharm. Biopharm. 59 (2005) 133-138. (Pubitemid 39573445)
16. P.J. Denny, Compaction equations: a comparison of the Heckel and Kawakita equations, Powder Technol. 127 (2002) 162-172.
17. J.M. Sonnergaard, Quantification of the compatibility of pharmaceutical powders, Eur. J. Pharm. Biopharm. 63 (2006) 270-277.
18. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms, FDA Center for Drug Evaluation and Research, Rockville, MD, 1997.
19. V.P. Shah, Y. Tsong, P. Sathe, J.-P. Liu, In vitro dissolution profile comparisonstatistics and analysis of the similarity factor, f2, Pharm. Res. 15 (1998) 889- 896. (Pubitemid 28307831)
20. F.O. Costa, J.J.S. Sousa, A.A.C.C. Pais, S.J. Formosinho, Comparison of dissolution profiles of ibuprofen pellets, J. Control. Release 89 (2003) 199-212. (Pubitemid 36507015)
21. A.E.K. Lundqvist, F. Podczeck, M. Newton, Compaction of, and drug release from, coated drug pellets mixed with other pellets, Eur. J. Pharm. Biopharm. 46 (1998) 369-379. (Pubitemid 29057686)
22. A. Debunne, C. Vervaet, J.P. Remon, Development and in vitro evaluation of an enteric-coated multiparticulate drug delivery system for the administration of piroxicam to dogs, Eur. J. Pharm. Biopharm. 54 (2002) 343-348. (Pubitemid 35341836)
23. H. Vromans, A.H. De Boer, G.K. Bolhuis, C.F. Lerk, K.D. Kussendrager, H. Bosch, Studies on tableting properties of lactose. Part 2. Consolidation and compaction of different types of crystalline lactose, Pharm. Weekbl. Sci. 7 (1985) 186-193. (Pubitemid 15225081)
24. K.M. Picker, "Soft tableting": a new concept to tablet pressure-sensitive materials, Pharm. Dev. Technol. 9 (2004) 107-121. (Pubitemid 38250231)
25. W. Schmid, K.M. Picker-Freyer, Tableting and tablet properties of alginates: characterisation and potential for soft tableting, Eur. J. Pharm. Biopharm. 72 (2008) 165-172.
26. T. Sebhatu, G. Alderborn, Relationships between the effective interparticulate contact area and the tensile strength of tablets of amorphous and crystalline lactose of varying particle size, Eur. J. Pharm. Sci. 8 (1999) 235-242. (Pubitemid 29325015)
27. H. Yuasa, T. Ozeki, H. Takahashi, Y. Kanaya, M. Ueno, Application of the solid dispersion method to the controlled release of medicine. 6. Release mechanism of a slightly water soluble medicine and interaction between flurbiprofen and hydroxypropyl cellulose in solid dispersion, Chem. Pharm. Bull. 42 (1994) 354-358. (Pubitemid 24119658)
28. K. Yamashita, T. Nakate, K. Okimoto, A. Ohike, Y. Tokunaga, R. Ibuki, K. Higaki, T. Kimura, Establishment of new preparation method for solid dispersion formulation of tacrolimus, Int. J. Pharm. 267 (2003) 79-91. (Pubitemid 37352952)
29. N. Kohri, Y. Yamayoshi, H. Xin, K. Iseki, N. Sato, S. Todo, K. Miyazaki, Improving the oral bioavailability of albendazole in rabbits by the solid dispersion techniques, J. Pharm. Pharmacol. 51 (1999) 159-164. (Pubitemid 29131308)
30. O.C. Chidavaenzi, G. Buckton, F. Koosha, The effect of co-spray drying with polyethylene glycol 4000 on the crystallinity and physical form of lactose, Int. J. Pharm. 216 (2001) 43-49. (Pubitemid 32232093)
31. S. Garnier, S. Petit, F. Mallet, M.N. Petit, D. Lemarchand, S. Coste, J. Lefebvre, G. Coquerel, Influence of ageing, grinding and preheating on the thermal behaviour of alpha-lactose monohydrate, Int. J. Pharm. 361 (2008) 131-140.
32. V.-P. Lehto, M. Tenho, K. Vaha-Heikkila, P. Harjunen, M. Paallysaho, J. Valisaari, P. Niemela, K. Jarvinen, The comparison of seven different methods to quantify the amorphous content of spray dried lactose, Powder Technol. 167 (2006) 85- 93. (Pubitemid 44308634)
33. L.S. Taylor, G. Zografi, Sugar-polymer hydrogen bond interactions in lyophilized amorphous mixtures, J. Pharm. Sci. 87 (1998) 1615-1621. (Pubitemid 28559651)
34. J. Broadhead, S.K. Edmond Rouan, C.T. Rhodes, The spray drying of pharmaceuticals, Drug Dev. Ind. Pharm. 18 (1992) 1169-1206.
35. G. Alderborn, G. Frenning, Mechanical strength of tablets, in: L.L. Augsburger, S.W. Hoag (Eds.), Pharmaceutical Dosage Forms: Tablets, Third Edition. Manufacture and Process Control, Informa Healthcare, New York, USA, vol. 3, 2008, pp. 225-232.
36. G.P. Millili, 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)
37. A. Tunón, J. Gråsjö, G. Alderborn, Effect of intragranular porosity on compression behaviour of and drug release from reservoir pellets, Eur. J. Pharm. Sci. 19 (2003) 333-344. (Pubitemid 36957930)
38. C. Schwartzbach, K. Masters, Performance of spray dryer with integrated filter and fluid bed, Dry. Technol. 19 (2001) 1909-1923. (Pubitemid 33073136)