Pharmacokinetic profiles of two tablet formulations of piroxicam.

Author(s): Rasetti-Escargueil C, Grange V

Affiliation(s): Therapharm Recherches, 60 rue Carnot, 92100 Boulogne-Billancourt, France.

Publication date & source: 2005-05-13, Int J Pharm., 295(1-2):129-34.

Publication type: Clinical Trial; Randomized Controlled Trial

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 (Feldene, Pfizer). T(lag) with freeze-dried tablet was three times shorter than with capsule (21.6 min versus 59.4 min). Mean AUC(0-30 min), mean AUC(0-1 h), mean plasma concentrations at 15 min, 30 min and 1 h post-dose were significantly higher with the freeze-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 C(max), AUC(0-t), AUC(0-infinity) and T(1/2) 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.