Assessment of the impact of dosing time on the pharmacokinetics/ pharmacodynamics of prednisolone

AAPS Journal

Volumn 10, Issue 2, 2008, Pages 331-341

  Xu, Jian ^a   Winkler, Julia ^a   Sabarinath, Sreedharan Nair ^a   Derendorf, Hartmut ^a  

^a UNIVERSITY OF FLORIDA HEALTH   (United States)

Author keywords

Dosing time; Pharmacokinetics Pharmacodynamics; Prednisolone; Simulation

Indexed keywords

HYDROCORTISONE; PREDNISOLONE; PREDNISONE;

ALGORITHM; AREA UNDER THE CURVE; ARTICLE; CHRONOTHERAPY; CIRCADIAN RHYTHM; COMPARTMENT MODEL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DRUG MECHANISM; DRUG RESPONSE; EVENING DOSAGE; HUMAN; HUMAN CELL; LYMPHOCYTE MIGRATION; MORNING DOSAGE; SIMULATION; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT;

ADMINISTRATION, ORAL; ALGORITHMS; CHEMOTAXIS; CHRONOTHERAPY; GLUCOCORTICOIDS; HUMANS; HYDROCORTISONE; INJECTIONS, INTRAVENOUS; LYMPHOCYTES; MODELS, BIOLOGICAL; PREDNISOLONE; PREDNISONE;

EID: 53849130272     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-008-9038-3     Document Type: Article

References (35)

1. F. Levi, and U. Schibler. Circadian rhythms: Mechanisms and therapeutic implications. Annu. Rev. Pharmacol. Toxicol. 47: 593-628 (2007).
2. L. Glass-Marmor, T. Paperna, Y. Ben-Yosef, and A. Miller. Chronotherapy using corticosteroids for multiple sclerosis relapses. J. Neurol. Neurosurg. Psychiatry. 78 (8):886-888 (2007).
3. B. Lemmer. The importance of circadian rhythms on drug response in hypertension and coronary heart disease-from mice and man. Pharmacol. Ther. 111 (3):629-651 (2006).
4. M. Baraldo, and M. Furlanut. Chronopharmacokinetics of ciclosporin and tacrolimus. Clin. Pharmacokinet. 45 (8):775-788 (2006).
5. N. G. Arvidson, B. Gudbjornsson, L. Elfman, A. C. Ryden, T. H. Totterman, and R. Hallgren. Circadian rhythm of serum interleukin-6 in rheumatoid arthritis. Ann. Rheum. Dis. 53 (8):521-524 (1994).
6. M. H. Smolensky, A. E. Reinberg, R. J. Martin, and E. Haus. Clinical chronobiology and chronotherapeutics with applications to asthma. Chronobiol. Int. 16 (5):539-563 (1999).
7. A. N. Vgontzas, E. O. Bixler, H. M. Lin, P. Prolo, G. Trakada, and G. P. Chrousos. IL-6 and its circadian secretion in humans. Neuroimmunomodulation. 12 (3):131-140 (2005).
8. N. G. Arvidson, B. Gudbjornsson, A. Larsson, and R. Hallgren. The timing of glucocorticoid administration in rheumatoid arthritis. Ann. Rheum. Dis. 56 (1):27-31 (1997).
9. L. E. Fisher, E. A. Ludwig, J. A. Wald, R. R. Sloan, E. Middleton Jr., and W. J. Jusko. Pharmacokinetics and pharmacodynamics of methylprednisolone when administered at 8 am versus 4 pm. Clin. Pharmacol. Ther. 51 (6):677-688 (1992).
10. S. Krishnaswami, G. Hochhaus, and H. Derendorf. An interactive algorithm for the assessment of cumulative cortisol suppression during inhaled corticosteroid therapy. AAPS pharmSci. 2 (3):E22 (2000).
11. M. E. Pickup. Clinical pharmacokinetics of prednisone and prednisolone. Clin. Pharmacokinet. 4 (2):111-128 (1979).
12. F. D. Boudinot, and W. J. Jusko. Dose-dependent pharmacokinetics of prednisolone in normal and adrenalectomized rats. J. Pharmacokinet. Biopharm. 14 (5):453-467 (1986).
13. F. J. Frey, B. M. Frey, A. Greither, and L. Z. Benet. Prednisolone clearance at steady state in dogs. J. pharmacol. Exp. Ther. 215 (2):287-291 (1980).
14. V. Garg, R. Blum, K. D. Wilner, and W. J. Jusko. Effect of the anti-inflammatory agent tenidap on the pharmacokinetics and pharmacodynamics of prednisolone. J. Clin. Pharmacol. 32 (3):222-230 (1992).
15. M. L. Huang, and W. J. Jusko. Nonlinear pharmacokinetics and interconversion of prednisolone and prednisone in rats. J. pharmacokinet. Biopharm. 18 (5):401-421 (1990).
16. M. E. Pickup, J. R. Lowe, P. A. Leatham, V. M. Rhind, V. Wright, and W. W. Downie. Dose dependent pharmacokinetics of prednisolone. Eur. J. Clin. Pharmacol. 12 (3):213-219 (1977).
17. J. Q. Rose, A. M. Yurchak, and W. J. Jusko. Dose dependent pharmacokinetics of prednisone and prednisolone in man. J. pharmacokinet. Biopharm. 9 (4):389-417 (1981).
18. J. Xu, J. Winkler, and H. Derendorf. A pharmacokinetic/pharmacodynamic approach to predict total prednisolone concentrations in human plasma. J. pharmacokinet. Pharmacodyn. 34 (3):355-372 (2007).
19. A. Chakraborty, W. Krzyzanski, and W. J. Jusko. Mathematical modeling of circadian cortisol concentrations using indirect response models: comparison of several methods. J. pharmacokinet. Biopharm. 27 (1):23-43 (1999).
20. S. Rohatagi, A. Bye, A. E. Mackie, and H. Derendorf. Mathematical modeling of cortisol circadian rhythm and cortisol suppression. Eur. J. Pharm. Sci. 4 (6):341-350 (1996).
21. J. G. Stark, S. Werner, S. Homrighausen, Y. Tang, M. Krieg, H. Derendorf, H. Moellmann, and G. Hochhaus. Pharmacokinetic/ pharmacodynamic modeling of total lymphocytes and selected subtypes after oral budesonide. J. pharmacokinet. Pharmacodyn. 33 (4):441-459 (2006).
22. D. E. Mager, S. X. Lin, R. A. Blum, C. D. Lates, and W. J. Jusko. Dose equivalency evaluation of major corticosteroids: Pharmacokinetics and cell trafficking and cortisol dynamics. J. clin. Pharmacol. 43 (11):1216-1227 (2003).
23. B. Meibohm, H. Derendorf, H. Mollmann, P. Frohlich, A. Tromm, M. Wagner, S. Homrighausen, M. Krieg, and G. Hochhaus. Mechanism-based PK/PD model for the lymphocytopenia induced by endogenous and exogenous corticosteroids. Int. J. clin. Pharmacol. Ther. 37 (8):367-376 (1999).
24. S. Edsbacker, M. Nilsson, and P. Larsson. A cortisol suppression dose-response comparison of budesonide in controlled ileal release capsules with prednisolone. Aliment. Pharmacol. Ther. 13 (2):219-224 (1999).
25. A. Chakraborty, R. A. Blum, S. M. Mis, D. L. Cutler, and W. J. Jusko. Pharmacokinetic and adrenal interactions of IL-10 and prednisone in healthy volunteers. J. clin. pharmacol. 39 (6):624-635 (1999).
26. S. K. Yamashita, E. A. Ludwig, E. Middleton Jr., and W. J. Jusko. Lack of pharmacokinetic and pharmacodynamic interactions between ketoconazole and prednisolone. Clin. Pharmacol. ther. 49 (5):558-570 (1991).
27. M. H. Magee, R. A. Blum, C. D. Lates, and W. J. Jusko. Pharmacokinetic/ pharmacodynamic model for prednisolone inhibition of whole blood lymphocyte proliferation. Br J. Clin. Pharmacol. 53 (5):474-484 (2002).
28. S. W. Carson, K. J. Letrent, M. Kotlyar, G. Foose, and M. E. Tancer. Lack of a fluoxetine effect on prednisolone disposition and cortisol suppression. Pharmacotherapy. 24 (4):482-487 (2004).
29. J. A. Wald, R. M. Law, E. A. Ludwig, R. R. Sloan, E. Middleton Jr., and W. J. Jusko. Evaluation of dose-related pharmacokinetics and pharmacodynamics of prednisolone in man. J. pharmacokinet. Biopharm. 20 (6):567-589 (1992).
30. Y. Hong, D. E. Mager, R. A. Blum, and W. J. Jusko. Population pharmacokinetic/pharmacodynamic modeling of systemic corticosteroid inhibition of whole blood lymphocytes: Modeling interoccasion pharmacodynamic variability. Pharm. Res. 24 (6):1088-1097 (2007).
31. J. Barth, M. Damoiseaux, H. Mollmann, K. H. Brandis, G. Hochhaus, and H. Derendorf. Pharmacokinetics and pharmacodynamics of prednisolone after intravenous and oral administration. Int. J. Clin. Pharmacol. Ther. Toxicol. 30 (9):317-324 (1992).
32. G. M. Meno-Tetang, R. A. Blum, K. E. Schwartz, and W. J. Jusko. Effects of oral prasterone (dehydroepiandrosterone) on single-dose pharmacokinetics of oral prednisone and cortisol suppression in normal women. J. Clin. Pharmacol. 41 (11):1195-1205 (2001).
33. R. Plakogiannis, and H. Cohen. Optimal low-density lipoprotein cholesterol lowering-morning versus evening statin administration. Ann. Pharmacother. 41 (1):106-110 (2007).
34. M. Cutolo, and R. H. Straub. Circadian rhythms in arthritis: Hormonal effects on the immune/inflammatory reaction. Autoimmun. Rev. 7 (3):223-228 (2008).
35. F. Buttgereit, G. Doering, A. Schaeffler, S. Witte, S. Sierakowski, E. Gromnica-Ihle, S. Jeka, K. Krueger, J. Szechinski, and R. Alten. Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): A double-blind, randomised controlled trial. Lancet. 371 (9608):205-214 (2008).