Prediction of food effects on the absorption of celecoxib based on biorelevant dissolution testing coupled with physiologically based pharmacokinetic modeling

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 73, Issue 1, 2009, Pages 107-114

  Shono, Yasushi ^a,b   Jantratid, Ekarat ^a   Janssen, Niels ^a   Kesisoglou, Filippos ^c   Mao, Yun ^c   Vertzoni, Maria ^d   Reppas, Christos ^d   Dressman, Jennifer B ^a  

^a GOETHE UNIVERSITY   (Germany)

^b TAKEDA PHARMACEUTICAL COMPANY LIMITED   (Japan)

^c MERCK RESEARCH LABORATORIES   (United States)

^d UNIVERSITY OF ATHENS   (Greece)

Author keywords

Celecoxib; Dissolution; Food effects; PBPK modeling; Prediction

Indexed keywords

CELECOXIB;

ADULT; ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; COMPUTER MODEL; COMPUTER PROGRAM; COMPUTER SIMULATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DISPOSITION; DRUG SOLUBILITY; FOOD; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; IN VIVO STUDY; KINETICS; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PREDICTION; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STOMACH EMPTYING;

ADULT; ANIMALS; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; FOOD-DRUG INTERACTIONS; HUMANS; INTESTINAL ABSORPTION; MILK; MODELS, BIOLOGICAL; PREDICTIVE VALUE OF TESTS; PYRAZOLES; SOLUBILITY; SULFONAMIDES;

EID: 68349150895     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2009.05.009     Document Type: Article

References (29)

1. Kaeser B., Charoin J.E., Gerber M., Oxley P., Birnboeck H., Saiedabadi N., and Banken L. Assessment of the bioequivalence of two nelfinavir tablet formulations under fed and fasted conditions in healthy subjects. Int. J. Clin. Pharmacol. Ther. 43 (2005) 154-162
2. Noble S., and Faulds D. Saquinavir: a review of its pharmacology and clinical potential in the management of HIV infection. Drugs 52 (1996) 93-112
3. Welling P.G. Effects of food on drug absorption. Annu. Rev. Nutr. 16 (1996) 383-415
4. Singh B.N. Effects of food on clinical pharmacokinetics. Clin. Pharmacokinet. 37 (1999) 213-255
5. Lentz K.A. Current methods for predicting human food effect. AAPS. J 10 (2008) 282-288
6. Fleisher D., Li C., Zhou Y., Pao L.H., and Karim A. Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications. Clin. Pharmacokinet. 36 (1999) 233-254
7. Custodio J.M., Wu C.Y., and Benet L.Z. Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption. Adv. Drug. Deliv. Rev. 60 (2008) 717-733
8. Gu C.H., Li H., Levons J., Lentz K., Gandhi R.B., Raghavan K., and Smith R.L. Predicting effect of food on extent of drug absorption based on physicochemical properties. Pharm. Res. 24 (2007) 1118-1130
9. Dressman J.B., Amidon G.L., Reppas C., and Shah V.P. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm. Res. 15 (1998) 11-22
10. Dressman J.B., and Reppas C. In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs. Eur. J. Pharm. Sci. 11 Suppl. 2 (2000) S73-S80
11. Jantratid E., Janssen N., Chokshi H., Tang K., and Dressman J.B. Designing biorelevant dissolution tests for lipid formulations: case example - lipid suspension of RZ-50. Eur. J. Pharm. Biopharm. 69 (2008) 776-785
12. Sunesen V.H., Pedersen B.L., Kristensen H.G., and Mullertz 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. 24 (2005) 305-313
13. Jantratid E., Janssen N., Reppas C., and Dressman J.B. Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm. Res. 25 (2008) 1663-1676
14. Dressman J.B., Thelen K., and Jantratid E. Towards quantitative prediction of oral drug absorption. Clin. Pharmacokinet. 47 (2008) 655-667
15. Parrott N., and Lave T. Prediction of intestinal absorption: comparative assessment of GASTROPLUS and IDEA. Eur. J. Pharm. Sci. 17 (2002) 51-61
16. Willmann S., Lippert J., and Schmitt W. From physicochemistry to absorption and distribution: predictive mechanistic modelling and computational tools. Expert. Opin. Drug. Metab. Toxicol. 1 (2005) 159-168
17. Yazdanian M., Briggs K., Jankovsky C., and Hawi A. The high solubility definition of the current FDA guidance on biopharmaceutical classification system may be too strict for acidic drugs. Pharm. Res. 21 (2004) 293-299
18. Paulson S.K., Vaughn M.B., Jessen S.M., Lawal Y., Gresk C.J., Yan B., Maziasz T.J., Cook C.S., and Karim A. Pharmacokinetics of celecoxib after oral administration in dogs and humans: effect of food and site of absorption. J. Pharmacol. Exp. Ther. 297 (2001) 638-645
19. Galia E., Nicolaides E., Horter D., Lobenberg R., Reppas C., and Dressman J.B. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm. Res. 15 (1998) 698-705
20. Vertzoni M., Dressman J., Butler J., Hempenstall J., and Reppas C. Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds. Eur. J. Pharm. Biopharm. 60 (2005) 413-417
21. Klein S. The mini paddle apparatus - a useful tool in the early developmental stage? Experiences with immediate-release dosage forms. Dissolution Technol. 13 4 (2006) 6-11
22. Kalantzi L., Page R., Nicolaides E., Digenis G., and Reppas C. In vitro methods can forecast the effects of intragastric residence on dosage form performance. Eur. J. Pharm. Sci. 33 (2008) 445-451
23. Nicolaides E., Symillides M., Dressman J.B., and Reppas C. Biorelevant dissolution testing to predict the plasma profile of lipophilic drugs after oral administration. Pharm. Res. 18 (2001) 380-388
24. Macheras P., Reppas C., and Dressman J.B. Biopharmaceutics of orally administered drugs (1995), Ellis Horwood Ltd., London
25. Pfizer, Inc. CELEBREX U.S. Physician Prescribing Information. , (cited January 16, 2009).
26. Anwar S., Fell J.T., and Dickinson P.A. An investigation of the disintegration of tablets in biorelevant media. Int. J. Pharm. 290 (2005) 121-127
27. Nicolaides E., Galia E., Efthymiopoulos C., Dressman J.B., and Reppas C. Forecasting the in vivo performance of four low solubility drugs from their in vitro dissolution data. Pharm. Res. 16 (1999) 1876-1882
28. Paulson S.K., Hribar J.D., Liu N.W., Hajdu E., Bible Jr. R.H., Piergies A., and Karim A. Metabolism and excretion of [(14)C] celecoxib in healthy male volunteers. Drug. Metab. Dispos. 28 (2000) 308-314
29. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Food-effect bioavailability and fed bioequivalence studies. , 2002 (cited February 16, 2009).