Impact of food administration on lopinavir-ritonavir bioequivalence studies

European Journal of Pharmaceutical Sciences

Volumn 46, Issue 5, 2012, Pages 516-521

  Ibarra, M ^a   Fagiolino, P ^a   Vazquez M ^a   Ruiz, S ^b   Vega, M ^b   Bellocq, B ^b   Perez M ^c   Gonzalez B ^a   Goyret, A ^a  

^a UNIVERSIDAD DE LA REPÚBLICA   (Uruguay)

^b All Quimia Bioresearch Laboratory   (Uruguay)

^c Laboratorios Servimedic   (Uruguay)

Author keywords

Drug food coadministration; Lopinavir ritonavir; Sex difference in bioequivalence

Indexed keywords

LOPINAVIR PLUS RITONAVIR;

ADULT; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL ARTICLE; CONCENTRATION RESPONSE; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG FORMULATION; ECONOMIC ASPECT; ETHNICITY; FEEDING; FEMALE; GASTROINTESTINAL MOTILITY; GEOMETRY; HUMAN; MALE; NORMAL HUMAN; PRIORITY JOURNAL; SEX DIFFERENCE; SINGLE DRUG DOSE; STOMACH PH;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AREA UNDER CURVE; CROSS-OVER STUDIES; DRUG COMBINATIONS; FEMALE; FOOD-DRUG INTERACTIONS; HALF-LIFE; HIV PROTEASE INHIBITORS; HUMANS; LOPINAVIR; MALE; POSTPRANDIAL PERIOD; RITONAVIR; SEX FACTORS; THERAPEUTIC EQUIVALENCY; URUGUAY; YOUNG ADULT;

EID: 84861201859     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2012.04.004     Document Type: Article

References (12)

1. S. Agarwal, D. Pal, and A.K. Mitra Both P-gp and MRP2 mediate transport of lopinavir, a protease inhibitor Int. J. Pharm. 339 2007 139 147
2. C.T.M.M. de Kanter, E.P.H. Colbers, Q. Fillekes, A. Hoitsma, and D.M. Burger Pharmacokinetics of two generic co-formulations of lopinavir/rionavir for HIV-infected children: a pilot study of paedriatic lopimune versus the branded product in healthy adult volunteers J. Antimicrob. Chemother. 65 2010 538 542
3. E.M. Donato, L.A. Martins, P.E. Fröehlich, and A.M. Bergold Development and validation of dissolution test for lopinavir, a poorly swater-soluble drug, in soft gel capsules, based on in vivo data J. Pharm. Biomed. Anal. 47 2008 547 552
4. A.C. Freire, A.W. Basit, R. Choudhary, C.W. Piong, and H.A. Merchant Does sex matter? The influence of gender on gastrointestinal phisiology and drug delivery Inter. J. Pharm. 415 2011 15 28
5. Kaletra® (lopinavir-ritonavir) tablets and oral solution prescribing information: < http://www.rxabbott.com/pdf/kaletratabpi.pdf > [October 24th 2011].
6. C.E. Klei, Y. Chiu, W. Awni, T. Zhu, R.S. Heuser, T. Doan, J. Breitenbach, J.B. Morris, S.C. Brun, and G.J. Hanna The tablet formulation of lopinavir/ritonavir provides similar bioavailability to the soft-gelatin capsule formulation with less pharmacokinetic variability and diminished food effect J. Acquir. Inmune Defic. Syndr. 44 2007 401 410
7. C.G. Lee, M.M. Gottesman, C.O. Cardarelli, M. Ramachandra, K.T. Jeang, S.V. Ambudkar, I. Pastan, and S. Dey HIV-1 protease inhibitors are substrates for the MDR1 multidrug transporter Biochemistry 37 1998 3594 3601
8. A. Lindahl, A. Ungell, L. Knutson, and H. Lennernäs Characterization of fluids from the stomach and proximal jejunum in men and women Pharm. Res. 14 1997 497 502
9. E.R. Meaden, P.G. Hoggard, P. Newton, J.F. Tjia, D. Aldam, D. Cornforth, J. Lloyd, I. Williams, D.J. Back, and S.H. Khoo P-glycoprotein and MRP1 expression and reduced ritonavir and saquinavir accumulation in HIV-infected individuals J. Antimicrob. Chemother. 50 2002 583 588
10. R.L. Oostendorp, J.H. Beijnen, and J.H.M. Schellens The biological and clinical role of drug transporters at the intestinal barrier Cancer Treat. Rev. 35 2009 137 147
11. E.G. Schuetz, K.N. Furuya, and J.D. Schuetz Interindividual variation in expression of P-glycoprotein in normal human liver and secondary hepatic neoplasms J. Pharmacol. Exp. Ther. 275 1995 1011 1018
12. R. Verbesselt, E. Van Wijngaerden, and J. de Hoon Simultaneous determination of 8 HIV protease inhibitors in human plasma by isocratic high-performance liquid chromatography with combined use of UV and fluorescence detection: Amprenavir, indinavir, atazanavir, ritonavir, lopinavir, saquinavir, nelfinavir and M8-nelfinavir metabolite J. Chromatogr. B. 845 2007 51 60