Author(s): RasettiEscargueil C, Grang V
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Abstract 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.
This article was published in Int J Pharm
and referenced in Journal of Bioequivalence & Bioavailability