2001
DOI: 10.1590/s0100-879x2001001100017
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Limited-sampling strategy models for estimating the pharmacokinetic parameters of 4-methylaminoantipyrine, an active metabolite of dipyrone

Abstract: Bioanalytical data from a bioequivalence study were used to develop limited-sampling strategy (LSS) models for estimating the area under the plasma concentration versus time curve (AUC) and the peak plasma concentration (C max ) of 4-methylaminoantipyrine (MAA), an active metabolite of dipyrone. Twelve healthy adult male volunteers received single 600 mg oral doses of dipyrone in two formulations at a 7-day interval in a randomized, crossover protocol. Plasma concentrations of MAA (N = 336), measured by HPLC, … Show more

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Cited by 15 publications
(10 citation statements)
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References 12 publications
(12 reference statements)
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“…The results for T max were consistent with the results (range 1-2) reported by Levy M et al and Volz M et al 3,9 . The mean (SD) t 1/2 was 6.99±1.23 hours for the test formulation and 6.79±2.74 hours for the reference formulation which was slightly longer than the t 1/2 (4.4 ± 2.8 h) reported by Suarez-Kurtz G et al 2 .…”
Section: Resultscontrasting
confidence: 49%
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“…The results for T max were consistent with the results (range 1-2) reported by Levy M et al and Volz M et al 3,9 . The mean (SD) t 1/2 was 6.99±1.23 hours for the test formulation and 6.79±2.74 hours for the reference formulation which was slightly longer than the t 1/2 (4.4 ± 2.8 h) reported by Suarez-Kurtz G et al 2 .…”
Section: Resultscontrasting
confidence: 49%
“…Because the analgesic effect of dipyrone correlates with the time course of 4-methyl aminoantipyrine concentrations in serum 2,7 , pharmacokinetic parameters pertaining to this active metabolite are appropriate for assessing the bioequivalence of dipyrone formulations. Most of a dose is excreted in the urine as metabolites.…”
Section: Dhaneshwar Shepmentioning
confidence: 99%
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“…Jackknife validation of the limited sampling strategy equations was performed using sas 9.1 (SAS Inc., Cary, NC, USA) [16]. For jackknife validation, the regression equation for the prediction of AUC 0–12 was derived in a subset of patients (28 patients) including concentrations at n fixed time points.…”
Section: Methodsmentioning
confidence: 99%
“…As the first active metabolite of metamizole, 4‐MAA reaches its peak plasma concentration within 1 to 2 hours and is further metabolized in the liver to both a second active metabolite, 4‐aminoantipyrine (4‐AA), via N‐demethylation, and a first inactive metabolite, 4‐formylaminoantipyrine (4‐FAA), via C‐oxidation . Up to now, hepatic metabolism of 4‐MAA was known to be mediated by the cytochrome P450 (CYP) 3A4 system .…”
Section: Hepatic Metabolism Of Metamizolementioning
confidence: 99%