Efecto De La Forma Quimica

Although the Tmax for ibuprofen/poloxamer was on average 20 minutes shorter than that of the standard ibuprofen formulation, this difference was not statistically significant (median 75 min vs 90 min; P = 0.1913). The power in terms of Tmax for a P-value of 0.0002 was >99% and for a P-value of 0.1913 was 31%.

The Cmax results obtained for the sodium ibuprofen formulation and the standard ibuprofen formulation were 41.47 and 31.88 μg/mL, respectively (geometric LS means). The ratio of the test/reference was 130.06% with 90% CIs of 118.86-142.32%. The Cmax obtained for the ibuprofen/poloxamer tablets was 35.22 μg/mL. The ratio of the test/reference was 110.48% with 90% CIs of 100.96-120.89%.

For overall extent of absorption, all three formulations were equivalent, with test/standard formulation ratios of both AUC0-inf and AUC0-t very close to 100%. The AUC0-t values were 117.79 μg/h/mL, 120.55 μg/h/mL and 115.28 μg/h/mL for sodium ibuprofen, ibuprofen/poloxamer and standard ibuprofen, respectively. The AUC0-inf values were 119.73 μg/h/mL, 122.75 μg/h/mL and 117.71 μg/h/mL for sodium ibuprofen, ibuprofen/poloxamer and standard ibuprofen, respectively.

Table 3 shows the ratios of the sodium ibuprofen/standard formulations and the ibuprofen/poloxamer/standard formulations for partial AUC. Throughout the first hour post dose, the partial AUCs for both the sodium ibuprofen and ibuprofen/poloxamer formulations were higher than those for the standard ibuprofen formulation, with the greatest test/standard formulation absorption ratio occurring at 20 minutes for both test formulations (Table 3). The spaghetti plots provide individual subject information per treatment, for each of the four derived pharmacokinetic parameters (Figures 2, 3, 4 and 5). In general, Cmax was found to be higher and Tmax was lower for sodium ibuprofen than ibuprofen/poloxamer or standard ibuprofen

Background

The aim of this study was to compare the pharmacokinetic properties of sodium ibuprofen and ibuprofen acid incorporating poloxamer with standard ibuprofen acid tablets.

Methods

Twenty-two healthy volunteers were enrolled into this randomised, single-dose, 3-way crossover, open-label, single-centre, pharmacokinetic study. After 14 hours' fasting, participants received a single dose of 2 × 200 mg ibuprofen acid tablets (standard ibuprofen), 2 × 256 mg ibuprofen sodium dihydrate tablets (sodium ibuprofen; each equivalent to 200 mg ibuprofen acid) and 2 × 200 mg ibuprofen acid

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