Sex related differences on valproic acid pharmacokinetics after oral single dose

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 40, Issue 4, 2013, Pages 479-486

  Ibarra, Manuel ^a   Vázquez, Marta ^a   Fagiolino, Pietro ^a   Derendorf, Hartmut ^b  

^a UNIVERSIDAD DE LA REPÚBLICA   (Uruguay)

^b UNIVERSITY OF FLORIDA   (United States)

Author keywords

Efflux transporters; Enterohepatic cycling; Pharmacokinetics; Sex differences; Valproic acid

Indexed keywords

VALPROATE SEMISODIUM; VALPROIC ACID;

ADULT; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; BODY WEIGHT; CONCENTRATION RESPONSE; CONTROLLED STUDY; DELAYED RELEASE FORMULATION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG PENETRATION; ENTEROHEPATIC CIRCULATION; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PRIORITY JOURNAL; SEX DIFFERENCE; SINGLE DRUG DOSE; ULTRAVIOLET SPECTROSCOPY;

ABSORPTION; ADMINISTRATION, ORAL; ADULT; CROSS-OVER STUDIES; FEMALE; HUMANS; MALE; SEX FACTORS; VALPROIC ACID; YOUNG ADULT;

EID: 84881185745     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-013-9323-3     Document Type: Article

References (34)

1. Depakote (divalproex sodium) package inser. North Chicago, IL: Abbott Laboratories; November 2009. www.rxabbott.com/pdf/depakote.pdf. Accessed 9 Feb 2010
2. Dutta S, Faught E, Limdi NA (2007) Valproate protein binding following rapid intravenous administration of high doses of valproic acid in patients with epilepsy. J Clin Pharm Ther 32:365-371
3. Silva MFB, Aires CCP, Luis PBM, Ruiter JPN, IJlst L, Duran M M, Wanders RJA, Tavares de Almeida I (2008) Valproic acid metabolism and its effects on mitochondrial fatty acid oxidation: a review. J Inherit Metab Dis 31:205-216
4. Pollack G, Brouwer K (1991) Physiologic and metabolic influences on enterohepatic recirculation: simulations based upon the disposition of valproic acid in the rat. J Pharmacokinet Biopharm 2:189-225
5. Dobrinska M (1989) Enterohepatic circulation of drugs. J Clin Pharmacol 29:577-580
6. Booth CL, Pollack GM, Brouwer KLR (1996) Hepatobiliary disposition of valproic acid and valproate glucuronide: use of a pharmacokinetic model to examine the rate-limiting steps and potential sites of drug interactions. Hepatology 23:771-780
7. Baltes S, Fedrowitz M, Tortós CL, Potschka H, Löscher W (2007) Valproic acid is not a substrate for P-glycoprotein or multidrug resistance proteins 1 and 2 in a number of in vitro and in vivo transport assays. J Pharmacol Exp Ther 320(1):331-343
8. Gibbs JP, Adeyeye MC, Yang Z, Shen DD (2004) Valproic acid uptake by bovine brain microvessel endothelial cells: role of active efflux transport. Epilepsy Res 58(1):53-66
9. Adkison KD, Artru AA, Powers KM, Shen DD (1994) Contribution of probenecid sensitive anion transport processes at the brain capillary endothelium and choroid plexus to the efficient efflux of valproic acid from the central nervous system. J Pharmacol Exp Ther 268:797-805
10. Scism JL, Powers KM, Artru AA, Lewis L, Shen DD (2004) Probenecid-inhibitable efflux transport of valproic acid in the brain parenchymal cells of rabbits: a microdialysis study. Brain Res 884:77-86
11. Löscher W (2002) Basic pharmacology of valproate: a review after 35 years of clinical use for the treatment of epilepsy. CNS Drugs 16:669-694
12. Ogawa K, Yumoto R, Hamada N, Nagai J, Takano M (2006) Interaction of valproic acid and carbapenem antibiotics with multidrug resistance-associated proteins in rat erythrocyte membranes. Epilepsy Res 71:76-87
13. Meibohm B, Beierle I, Derendorf H (2002) How important are gender differences in pharmacokinetics? Clin Pharmacokinet 41(5):329-342
14. Soldin OP, Mattison DR (2009) Sex differences in pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 48(3):143-157
15. Schwartz JB (2003) The influence of sex on pharmacokinetics. Clin Pharmacokinet 42(2):107-121
16. Jiang D, Bai X, Zhang Q, Lu W, Wang Y, Li L, Müller M (2009) Effects of CYP2C19 and CYP2C9 genotypes on pharmacokinetic variability of valproic acid in Chinese epileptic patients: nonlinear mixed-effect modeling. Eur J Clin Pharmacol 65:1187-1193
17. Park HM, Kang SS, Lee YB, Shin DJ, Kim ON, Lee SB, Yim DS (2002) Population pharmacokinetics of intravenous valproic acid in Korean patients. J Clin Pharm Ther 27:419-425
18. Yukawa E, To H, Ohdo S, Higuchi S, Aoyama T (1997) Population-based investigation of vaiproic acid relative clearance using nonlinear mixed effects modeling: influence of drug-drug interaction and patient characteristics. J Clin Pharmacol 37:1160-1167
19. Amini H, Javan M, Ahmadiani A (2006) Development and validation of a sensitive assay of valproic acid in human plasma by high-performance liquid chromatography without prior derivatization. J Chromatogr B Analyt Technol Biomed Life Sci 830:368-371
20. Hussein Z, Mukherjee D, Lamm J, Cavanaugh JH, Granneman GR (1994) Pharmacokinetics of valproate after multiple-dose oral and intravenous infusion administration: gastrointestinal-related diurnal variation. J Clin Pharmacol 34:754-759
21. Lindbom L, Pihlgren P, Jonsson EN (2005) PsN-Toolkit: a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed 79(3):241-257
22. Keizer RJ, van Benten M, Beijnen JH, Schellens JHM, Huitema ADR (2011) Piraña and PCluster: a modeling environment and cluster infrastructure for NONMEM. Comput Methods Programs Biomed 101(1):72-79
23. Freire AC, Basit AW, Choudhary R, Piong CW, Merchant HA (2011) Does sex matter? The influence of gender on gastrointestinal physiology and drug delivery. Inter J Pharm 415:15-28
24. Fagiolino P, González N, Vázquez M, Eiraldi R (2007) Itraconazole bioequivalence revisited: Influence of gender on highly variable drugs. The Open Drug Metab J 1:7-13
25. Galimberti CA, Mazzucchelli I, Arbasino C, Canevini MP, Fattore C, Perucca E (2006) Increased apparent oral clearance of valproic acid during intake of combined contraceptive steroids in women with epilepsy. Epilepsia 47(9):1569-1572
26. Sabers A, Buchholt JM, Uldall P, Hansen EL (2001) Lamotrigine plasma levels reduced by oral contraceptives. Epilepsy Res 47:151-154
27. Reimers A, Helde G, Brodtkorb B (2005) Ethinylestradiol, not progestogens, reduces lamotrigine serum concentrations. Epilepsia 46:1414-1417
28. Simon GL, Sherwood LG (1986) The human intestinal microflora. Digest Dis Sci 31(9):147-162
29. Dutta S, Reed RC, Cavanaugh JH (2004) Absolute bioavailability and absorption characteristics of divalproex sodium extended-release tablets in healthy volunteers. J Clin Pharmacol 44:737-742
30. Rost D, Kopplow K, Gehrke S, Mueller S, Friess H, Ittrich C, Mayer D, Stiehl A (2005) Gender-specific expression of liver organic anion transporters in rat. Eur J Clin Invest 35(10):635-643
31. Suzuki T, Zhao YL, Nadai M, Naruhashi K, Shimizu A, Takagi K, Takagi K, Hasegawa T (2006) Gender-related differences in expression and function of hepatic P-glycoprotein and multidrug resistance-associated protein (Mrp2) in rats. Life Sci 79(5):455-461
32. Wong H, Xia B, Tong V, Kumar S, Kenny JR (2012) A typical kinetics of valproic acid glucuronidation in vitro and in vivo in humans. Pharmaceut Anal Acta. doi: 10.4172/2153-2435.S11-006
33. Waxman DJ, O'Connor C (2006) Growth hormone regulation of sex-dependent liver gene expression. Mol Endocrinol 20(11):2613-2629
34. Bernardes RP, Radomski MW (1998) Growth hormone responses to continuous and intermittent exercise in females under oral contraceptive therapy. Eur J Appl Physiol 79:24-29