Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets

International Journal of Pharmaceutics

Volumn 430, Issue 1-2, 2012, Pages 18-25

  Pabari, Ritesh M ^a   Ramtoola, Zebunnissa ^a  

^a ROYAL COLLEGE OF SURGEONS IN IRELAND   (Ireland)

Author keywords

Compression force; Disintegration time; Face centred central composite design; Hardness; Porosity; Tablet diameter

Indexed keywords

EXCEDRIN; IBUPROFEN; LORATADINE; NIMESULIDE; ONDANSETRON; PARACETAMOL; SELEGILINE;

ARTICLE; DRUG GRANULATION; HYDROPHOBICITY; MATHEMATICAL MODEL; PRIORITY JOURNAL; TABLET COMPRESSION; TABLET DISINTEGRATION; TABLET DISINTEGRATION TIME; TABLET FORMULATION; TABLET FRIABILITY; TABLET HARDNESS; TABLET POROSITY; TABLET PROPERTY; TABLET THICKNESS; TENSILE STRENGTH;

ADMINISTRATION, ORAL; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CALCIUM COMPOUNDS; CHEMISTRY, PHARMACEUTICAL; COMPRESSIVE STRENGTH; EXCIPIENTS; FACTOR ANALYSIS, STATISTICAL; HARDNESS; HYDROPHOBIC AND HYDROPHILIC INTERACTIONS; IBUPROFEN; KINETICS; LINEAR MODELS; MANNITOL; MODELS, CHEMICAL; PARTICLE SIZE; POROSITY; REPRODUCIBILITY OF RESULTS; SILICATES; SOLUBILITY; STARCH; TABLETS; TECHNOLOGY, PHARMACEUTICAL;

EID: 84860705683     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2012.03.021     Document Type: Article

References (29)

1. G. Abdelbary, C. Eouani, P. Prinderre, J. Joachim, J. Reynier, and P. Piccerelle Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration Int. J. Pharm. 292 2005 29 41 (Pubitemid 40255786)
2. Aubrey, C.; 2011. Orally Disintegrating technologies, technology catalysts international drug delivery and pharmaceutical research manager. Available from: < http://www.pharmatek.com/pdf/PTEKU/PTEK-U-Jul14-2011.pdf > (accessed 14.11.11.).
3. Y. Bi, H. Sunada, Y. Yonezawa, and K. Danjo Evaluation of rapidly disintegrating tablets prepared by a direct compression method Drug Dev. Ind. Pharm. 25 1999 571 581 (Pubitemid 29186288)
4. S. Corveleyn, and J.P. Remon Formulation and production of rapidly disintegrating tablets by lyophilisation using hydrochlorothiazide as a model drug Int. J. Pharm. 152 1997 215 225 (Pubitemid 27290596)
5. S.K. El-Arini, and S.D. Clas Evaluation of disintegration testing of different fast dissolving tablets using the texture analyzer Pharm. Dev. Technol. 7 2002 361 371 (Pubitemid 34983127)
6. FDA, 2008. Guidance for industry orally disintegrating tablets U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), December. Available from: < http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory/Information/ Guidances/ucm070578.pdf > (accessed 14.11.11).
7. Y. Fu, S. Yang, S.H. Jeong, S. Kimura, and K. Park Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies Crit. Rev. Ther. Drug Carrier Syst. 21 2004 433 476
8. R. Heinz, H. Wolf, H. Schuchmann, L. End, and K. Kolter Formulation and development of tablets based on Ludipress and scale-up from laboratory to production scale Drug Dev. Ind. Pharm. 26 2000 513 521 (Pubitemid 30225629)
9. F. Kiekens, A. Debunne, C. Vervaet, L. Baert, F. Vanhoutte, I. Van Assche, F. Menard, and J.P. Remon Influence of the punch diameter and curvature on the yield pressure of MCC-compacts during Heckel analysis Eur. J. Pharm. Sci. 22 2004 117 126 (Pubitemid 38668678)
10. J. Klancke Dissolution testing of orally disintegrating tablets Dissolut. Technol. 10 2003 6 9
11. Y. Kuno, M. Kojima, S. Ando, and H. Nakagami Evaluation of rapidly disintegrating tablets manufactured by phase transition of sugar alcohols J. Control. Release 105 2005 16 22 (Pubitemid 40805472)
12. Y. Kuno, M. Kojima, H. Nakagami, E. Yonemochi, and K. Terada Effect of the type of lubricant on the characteristics of orally disintegrating tablets manufactured using the phase transition of sugar alcohol Eur. J. Pharm. Biopharm. 69 2008 986 992
13. S.G. Late, and A.K. Banga Response surface methodology to optimize novel fast disintegrating tablets using β-cyclodextrin as diluent AAPS PharmSciTech 2010 1 9
14. S.G. Late, Y.Y. Yu, and A.K. Banga Effects of disintegration-promoting agent, lubricants and moisture treatment on optimized fast disintegrating tablets Int. J. Pharm. 365 2009 4 11
15. R. McLaughlin, S. Banbury, and K. Crowley Orally disintegrating tablets: the effect of recent FDA guidance on ODT technologies and applications Pharm. Technol. 2009 The industry's authoritative source supplement to the September 2009 issue
16. T. Mizumoto, Y. Masuda, T. Yamamoto, E. Yonemochi, and K. Terada Formulation design of a novel fast-disintegrating tablet Int. J. Pharm. 306 2005 83 90 (Pubitemid 41643142)
17. Y. Okuda, Y. Irisawa, K. Okimoto, T. Osawa, and S. Yamashita A new formulation for orally disintegrating tablets using a suspension spray-coating method Int. J. Pharm. 382 2009 80 87
18. PhEur, 2008. Tablets of EP, orosdispersible tablets, 6th edition.
19. Ramtoola, Z.; Pabari, R.; Kelly, J.; 2008. A method of producing fast dissolving tablets. WO Patent WO/2008/120,181.
20. M.M. Rawas-Qalaji, F. Estelle, R. Simons, and K.J. Simons Fast-disintegrating sublingual tablets: effect of epinephrine load on tablet characteristics AAPS PharmSciTech 7 2006 72 78
21. M.M. Rawas-Qalaji, F.E.R. Simons, and K.J. Simons Fast-disintegrating sublingual epinephrine tablets: effect of tablet dimensions on tablet characteristics Drug Dev. Ind. Pharm. 33 2007 523 530 (Pubitemid 46808773)
22. G. Sandri, M.C. Bonferoni, F. Ferrari, S. Rossi, and C. Caramella Differentiating factors between oral fast-dissolving technologies Am. J. Drug Deliv. 4 2006 249 262
23. S. Schiermeier, and P.C. Schmidt Fast dispersible ibuprofen tablets Eur. J. Pharm. Sci. 15 2002 295 305 (Pubitemid 34229144)
24. H. Seager Drug-delivery products and the Zydis fast-dissolving dosage form J. Pharm. Pharmacol. 50 1998 375 382 (Pubitemid 28197414)
25. M. Sugimoto, T. Maejima, S. Narisawa, K. Matsubara, and H. Yoshino Factors affecting the characteristics of rapidly disintegrating tablets in the mouth prepared by the crystalline transition of amorphous sucrose Int. J. Pharm. 296 2005 64 72 (Pubitemid 40693373)
26. B. Van Veen, K. Van der Voort Maarschalk, G. Bolhuis, K. Zuurman, and H. Frijlink Tensile strength of tablets containing two materials with a different compaction behaviour Int. J. Pharm. 203 2000 71 79 (Pubitemid 30627627)
27. Wehling, F.; Schuehle, S.; 1996. Base coated acid particles and effervescent formulation incorporating same. US Patent 5,503,846: Cima Labs, Inc. (Minneapolis, MN).
28. Wehling, F.; Schuehle, S.; Madamala, N.; 1993. Effervescent dosage form with microparticles. US Patent 5,178,878: Cima Labs, Inc. (Minneapolis, MN).
29. S. Yang, Y. Fu, S.H. Jeong, and K. Park Application of poly (acrylic acid) superporous hydrogel microparticles as a super-disintegrant in fast-disintegrating tablets J. Pharm. Pharmacol. 56 2004 429 436 (Pubitemid 38455607)