Interaction between fed gastric media (Ensure Plus®) and different hypromellose based caffeine controlled release tablets: Comparison and mechanistic study of caffeine release in fed and fasted media versus water using the USP dissolution apparatus 3

International Journal of Pharmaceutics

Volumn 461, Issue 1-2, 2014, Pages 419-426

  Franek, Frans ^a   Holm, Per ^b   Larsen, Frank ^b   Steffansen, Bente ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b H LUNDBECK A S   (Denmark)

Author keywords

FaSSIF; FeSSIF; Food effects; HPMC; Texture analysis

Indexed keywords

CAFFEINE; ENSURE; ENSURE PLUS; HYDROXYPROPYLMETHYLCELLULOSE; UNCLASSIFIED DRUG; WATER; DELAYED RELEASE FORMULATION; EXCIPIENT; TABLET; VITAMIN K GROUP;

ARTICLE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DISSOLUTION; DRUG EXPOSURE; DRUG RELEASE; FOOD AND DRUG ADMINISTRATION; IN VITRO STUDY; MATRIX TABLET; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; STOMACH; TABLET THICKNESS; VELOCITY; VISCOSITY; CHEMICAL PHENOMENA; CHEMISTRY; COMPARATIVE STUDY; DELAYED RELEASE FORMULATION; MEDICINAL CHEMISTRY; PROCEDURES; SOLUBILITY; TABLET;

CAFFEINE; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; EXCIPIENTS; HYDROPHOBIC AND HYDROPHILIC INTERACTIONS; HYPROMELLOSE DERIVATIVES; SOLUBILITY; TABLETS; VISCOSITY; VITAMIN K; WATER;

EID: 84891590365     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2013.12.003     Document Type: Article

References (35)

1. B. Abrahamsson, T. Albery, A. Eriksson, I. Gustafsson, and M. Sjöberg Food effects on tablet disintegration Eur. J. Pharm. Sci. 22 2004 165 172 (Pubitemid 38668681)
2. D.A. Alderman A review of cellulose ethers in hydrophilic matrices for oral controlled-release dosage forms Int. J. Pharm. Tech. Prod. Mfr. 5 1984 1 9 (Pubitemid 15105124)
3. S. Baumgartner, M. Pavli, and J. Kristl Effect of calcium ions on the gelling and drug release characteristics of xanthan matrix tablets Eur. J. Pharm. Biopharm. 69 2008 698 707
4. R. Bettini, P.L. Catellani, P. Santi, G. Massimo, N.A. Peppas, and P. Colombo Translocation of drug particles in HPMC matrix gel layer: effect of drug solubility and influence on release rate J. Control. Release 70 2001 383 391 (Pubitemid 32155461)
5. L.W.S. Cheong, P.W.S. Heng, and L.F. Wong Relationship between polymer viscosity and drug release from a matrix system Pharm. Res. 9 1992 1510 1514
6. P. Colombo, R. Bettini, P. Santi, A. De Ascentiis, and N.A. Peppas Analysis of the swelling and release mechanisms from drug delivery systems with emphasis on drug solubility and water transport J. Control. Release 39 1996 231 237 (Pubitemid 26194222)
7. P. Colombo, R. Bettini, and N.A. Peppas Observation of swelling process and diffusion front position during swelling in hydroxypropyl methyl cellulose (HPMC) matrices containing a soluble drug J. Control. Release 61 1999 83 91 (Pubitemid 29406082)
8. S. Conti, L. Maggi, L. Segale, E. Ochoa Machiste, U. Conte, P. Grenier, and G. Vergnault Matrices containing NaCMC and HPMC: 2. Swelling and release mechanism study Int. J. Pharm. 333 2007 143 151 (Pubitemid 46283282)
9. J.A. Dean Lange's Handbook of Chemistry 1985 McGraw Hill Book Co. New York, NY
10. N. Fotaki, M. Symillides, and C. Reppas In vitro versus canine data for predicting input profiles of isosorbide-5-mononitrate from oral extended release products on a confidence interval basis Eur. J. Pharm. Sci. 24 2005 115 122 (Pubitemid 40051294)
11. E. Galia, E. Nicolaides, D. Hörter, R. Löbenberg, C. Reppas, and J.B. Dressman Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs Pharm. Res. 15 1998 698 705 (Pubitemid 28275645)
12. P. Gao, J.W. Skoug, P.R. Nixon, T. Robert Ju, N.L. Stemm, and K.C. Sung Swelling of hydroxypropyl methylcellulose matrix tablets. 2. Mechanistic study of the influence of formulation variables on matrix performance and drug release J. Pharm. Sci. 85 1996 732 740 (Pubitemid 26234678)
13. S. Jamzad, L. Tutunji, and R. Fassihi Analysis of macromolecular changes and drug release from hydrophilic matrix systems Int. J. Pharm. 292 2005 75 85 (Pubitemid 40255790)
14. M. Kamba, Y. Seta, A. Kusai, M. Ikeda, and K. Nishimura A unique dosage form to evaluate the mechanical destructive force in the gastrointestinal tract Int. J. Pharm. 208 2000 61 70
15. N. Kavanagh, and O.I. Corrigan Swelling and erosion properties of hydroxypropyl methylcellulose (hypromellose) matrices - influence of agitation rate and dissolution medium composition Int. J. Pharm. 279 2004 141 152 (Pubitemid 38968649)
16. U. Klancar, B. Markun, S. Baumgartner, and I. Legen A novel beads-based dissolution method for the in vitro evaluation of extended release HPMC matrix tablets and the correlation with the in vivo data AAPS J. 15 2013 267 277
17. S. Klein Biorelevant dissolution test methods for modified release dosage forms. PhD Thesis 2005 Johann Wolfgang Goethe-Universität Germany
18. S. Klein Predicting food effects on drug release from extended-release oral dosage forms containing a narrow therapeutic index drug Dissol. Technol. 16 2009 28 40
19. S. Klein, M. Rudolph, B. Skalsky, H. Petereit, and J. Dressman Use of the BioDis to generate a physiologically relevant IVIVC J. Control. Release 130 2008 216 219
20. S. Klein, J.B. Dressman, J. Butler, J.M. Hempenstall, and C. Reppas Media to simulate the postprandial stomach. I. Matching the physicochemical characteristics of standard breakfasts J. Pharm. Pharmacol. 56 2004 605 610 (Pubitemid 38607651)
21. F. Langenbucher Letters to the Editor: Linearization of dissolution rate curves by the Weibull distribution J. Pharm. Pharmacol. 24 1972 979 981
22. P.I. Lee, and C.J. Kim Probing the mechanisms of drug release from hydrogels J. Control. Release 16 1991 229 236
23. C.L. Li, L.G. Martini, J.L. Ford, and M. Roberts The use of hypromellose in oral drug delivery J. Pharm. Pharmacol. 57 2005 533 546 (Pubitemid 40562392)
24. K. Mitchell, J.L. Ford, D.J. Armstrong, P.N.C. Elliott, C. Rostron, and J.E. Hogan The influence of additives on the cloud point, disintegration and dissolution of hydroxypropyl methylcellulose gels and matrix tablets Int. J. Pharm. 66 1990 233 242
25. R.V. Nellore, G.S. Rekhi, A.S. Hussain, L.G. Tillman, and L.L. Augsburger Development of metoprolol tartrate extended release matrix tablet formulations for regulatory policy consideration J. Control. Release 50 1998 247 256 (Pubitemid 28044119)
26. T.D. Reynolds, S.H. Gehrke, A.S. Hussain, and L.S. Shenouda Polymer erosion and drug release characterization of hydroxypropyl hethylcellulose matrices J. Pharm. Sci. 87 1998 1115 1123 (Pubitemid 28452113)
27. M.A. Solinis, Y. de la Cruz, R.M. Hernandez, A.R. Gascon, B. Calvo, and J.L. Pedraz Release of ketoprofen enantiomers from HPMC K100M matrices - diffusion studies Int. J. Pharm. 239 2002 61 68 (Pubitemid 34615795)
28. K.C. Sung, P.R. Nixon, J.W. Skoug, T.R. Ju, P. Gao, E.M. Topp, and M.V. Patel Effect of formulation variables on drug and polymer release from HPMC-based matrix tablets Int. J. Pharm. 142 1996 53 60 (Pubitemid 26343829)
29. F. Tajarobi, S. Abrahmsen-Alami, M. Hansen, and A. Larsson The impact of dose and solubility of additives on the release from HPMC matrix tablets-identifying critical conditions Pharm. Res. 26 2009 1496 1503
30. S. Turner, C. Federici, M. Hite, and R. Fassihi Formulation development and human in vitro-in vivo correlation for a novel, monolithic controlled-release matrix system of high load and highly water-soluble drug niacin Drug Dev. Ind. Pharm. 30 2004 797 807 (Pubitemid 39362865)
31. M.J. Vazquez, B. Perez-Marcos, J.L. Gomez-Amoza, R.i. Pacheco, C. Souto, and A. Concheiro Influence of technological variables on release of drugs from hydrophilic matrices Drug Dev. Ind. Pharm. 18 1992 1355 1375
32. L.S.C. Wan, P.W.S. Heng, and L.F. Wong The effect of hydroxypropyl methylcellulose on water penetration into a matrix system Int. J. Pharm. 73 1991 111 116
33. L.S.C. Wan, P.W.S. Heng, and L.F. Wong Relationship between swelling and drug release in a hydrophilic matrix Drug Dev. Ind. Pharm. 19 1993 1201 1210 (Pubitemid 23130427)
34. W. Weitschies, R.S. Wedemeyer, O. Kosch, K. Fach, S. Nagel, E. Söderlind, L. Trahms, B. Abrahamsson, and H. Mönnikes Impact of the intragastric location of extended release tablets on food interactions J. Control. Release 108 2005 375 385 (Pubitemid 41608669)
35. H.D. Williams, K.P. Nott, D.A. Barrett, R. Ward, I.J. Hardy, and C.D. Melia Drug release from HPMC matrices in milk and fat-rich emulsions J. Pharm. Sci. 100 2011 4823 4835