Biorelevant dissolution: Methodology and application in drug development

Dissolution Technologies

Volumn 16, Issue 3, 2009, Pages 6-12

  Wang, Qingxi ^a   Fotaki, Nikoletta ^b   Mao, Yun ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b University of Bath   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 70349496371     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT160309P6     Document Type: Article

References (26)

1. Dressman, J. B.; Amidon, G. L.; Reppas, C.; Shah, V. P. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm. Res. 1998, 15 (1), 11-22.
2. Lipka, E.; Amidon, G. L. Setting bioequivalence requirements for drug development based on preclinical data: optimizing oral drug delivery systems. J. Controlled Release 1999, 62, 41-49.
3. Jantratid, E.; Janssen, N.; Reppas, C.; Dressman, J. B. Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm. Res. 2008, 25 (7), 1663-1676.
4. Vertzoni, M.; Dressman, J.; Butler, J.; Hempenstall, J.; Reppas, C. Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds. Eur. J. Pharm. Biopharm. 2005, 60 (3), 413-417.
5. Zangenberg, N. H.; Müllertz, A.; Kristensen, H. G.; Hovgaard, L. A dynamic in vitro lipolysis model. II: Evaluation of the model. Eur. J. Pharm. Sci. 2001, 14, 237-244.
6. Garbacz, G.; Wedemeyer, R. S.; Nagel, S.; Giessmann, T.; Mönnikes, H.; Wilson, C. G.; Siegmund, W.; Weitschies, W. Irregular absorption profiles observed from diclofenac extended-release tablets can be predicted using a dissolution test apparatus that mimics in vivo physical stresses. Eur. J. Pharm. Biopharm. 2008, 70 (2), 421-428.
7. SUPAC-MR: Modified Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.
8. Dissolution Testing of Immediate Release Solid Oral Dosage Forms; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.
9. Katori, N.; Aoyagi, N.; Terao, T. Estimation of agitation intensity in the GI tract in humans and dogs based on in vitro/in vivo correlation. Pharm. Res. 1995, 12 (2), 237-243.
10. D'Arcy, D. M.; Healy, A. M.; Corrigan, O. I. Towards determining appropriate hydrodynamic conditions for in vitro in vivo correlations using computational fluid dynamics. Eur. J. Pharm. Sci. 2009, 37 (3-4), 291-299.
11. Klein, S.; Rudolph, M. W.; Skalsky, B.; Petereit, H. U.; Dressman, J. B. Use of the BioDis to generate a physiologically relevant IVIVC. J. Controlled Release 2008, 130 (3), 216-219.
12. Fotaki, N.; Reppas, C. The flow-through cell methodology in the evaluation of intralumenal drug release characteristics. Dissolution Technol. 2005, 12 (2), 17-21.
13. Fotaki, N.; Aivaliotis, A.; Butler, J.; Dressman, J.; Fischbach, M.; Hempenstall, J.; Klein, S.; Reppas, C. A comparative study of different release apparatus in generating in vitro-in vivo correlations for extended release formulations. Eur. J. Pharm. Biopharm., in press.
14. Löbenberg, R.; Krämer, J.; Shah, V. P.; Amidon, G. L.; Dressman, J. B. Dissolution testing as a prognostic tool for oral drug absorption: dissolution behavior of glibenclamide. Pharm. Res. 2000, 17 (4), 439-444.
15. Sunesen, V. H.; Pedersen, B. L.; Kristensen, H. G.; Müllertz, A. In vivo in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media. Eur. J. Pharm. Sci. 2005, 24 (4), 305-313.
16. Nicolaides, E.; Symillides, M.; Dressman, J. B.; Reppas, C. Biorelevant dissolution testing to predict the plasma profile of lipophilic drugs after oral administration. Pharm. Res. 2001, 18, 380-388.
17. Fotaki, N.; Symillides, M.; Reppas, C. Canine vs. in vitro data for predicting input profiles of L-sulpiride after oral administration. Eur. J. Pharm. Sci. 2005, 26 (3-4), 324-333.
18. Gribbon, P.; Sewing, A. High-throughput drug discovery: what can we expect from HTS? Drug Discov. Today 2005, 10 (1), 17-22.
19. Lipinski, C. A.; Lombardo, F.; Dominy, B. W.; Feeney, P. J. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv. Drug Deliv. Rev. 2001, 46 (1-3), 3-26.
20. Gould, P. L. Salt selection for basic drugs. Int. J. Pharm. 1986, 33 (1-3), 201-217.
21. Kostewicz, E. S.; Wunderlich, M.; Brauns, U.; Becker, R.; Bock, T.; Dressman, J. B. Predicting the precipitation of poorly soluble weak bases upon entry in the small intestine. J. Pharm. Pharmacol. 2003, 56 (1), 43-51.
22. Dressman, J. B.; Amidon, G. L.; Fleisher, D. Absorption potential: estimating the fraction absorbed for orally administered compounds. J. Pharm. Sci. 1985, 74 (5), 588-589.
23. Lui, C. Y.; Amidon, G. L.; Berardi, R. R.; Fleisher, D.; Youngberg, C.; Dressman, J. B. Comparison of gastrointestinal pH in dogs and humans: implications on the use of the beagle dog as a model for oral absorption in humans. J. Pharm. Sci. 1986, 75 (3), 271-274.
24. Dressman, J. B.; Yamada, K. Animal Models for Oral Drug Absorption. In Pharmaceutical Bioequivalence; Welling, P. G., Tse, F. L. S, Dighe, S. V., Eds.; Drugs in the Pharmaceutical Sciences; Marcel Dekker, Inc.: New York, 1991; Vol. 48, pp 235-266.
25. Dokoumetzidis, A.; Kalantzi, L.; Fotaki, N. Predictive models for oral drug absorption: from in silico methods to integrated dynamical models. Expert Opin. Drug Metab. Toxicol. 2007, 3 (4), 491-505.
26. Persson, E. M.; Gustafsson, A. S.; Carlsson, A. S.; Nilsson, R. G.; Knutson, L.; Forsell, P.; Hanisch, G.; Lennernaes, H.; Abrahamsson, B. The Effects of Food on the Dissolution of Poorly Soluble Drugs in Human and in Model Small Intestinal Fluids. Pharm. Res. 2005, 22 (12), 2141-2151.