Pharmacokinetic profiles of two tablet formulations of piroxicam
Pharmacokinetic profiles of two tablet formulations of piroxicam
May 2005
C. Rasetti-Escargueila, and V. Grang?
International Journal of Pharmaceutics Volume 295, Issues 1-2 , 13 May 2005, Pages 129-134
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There is considerable interest in developing new non-steroidal anti-inflammatory drugs (NSAIDs) formulations with faster onset of analgesic action like fast dissolving tablets. An open-label, randomized, single dose, crossover study with a 18 days washout period was conducted in 16 healthy volunteers to compare the pharmacokinetic profile of 20 mg piroxicam freeze-dried tablet (Proxalyoc?, Cephalon) with that of 20 mg piroxicam capsule (Feld?ne?, Pfizer).
Tlag with previous termfreeze-dried tablet was three times shorter than with capsule (21.6 min versus 59.4 min). Mean AUC0?30 min, mean AUC0?1 h, mean plasma concentrations at 15 min, 30 min and 1 h post-dose were significantly higher with the previous termfreeze-dried tablet than with the capsule, indicating that piroxicam was more rapidly absorbed from the freeze-dried tablet with higher plasma concentrations achieved at shorter intervals after dosing. The 90% confidence intervals of the ratios of means Cmax, AUC0?t, AUC0?? and T1/2 all fell within the acceptance range of 0.8?1.25, demonstrating the bioequivalence of the two formulations.
Although the bioavailability of the two formulations was similar, the administration of piroxicam as a freeze-dried tablet gave a much faster absorption rate during the first hour after dosing than the capsule formulation. This faster absorption is an obvious advantage for the treatment of acute episodes of pain.
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