Preliminary bioequivalence of an oral integrating film formulation containing meloxicam with a suspension formulation in beagle dogs.

The oral disintegrating film (ODF) has advantages over suspension and tablet. These include convenience of administration, patient compliance, and accurate dosing. We evaluated the bioequivalence between the ODF and the meloxicam suspension by using a crossover design with a 3-week washout period. Six healthy male beagle dogs were randomized to receive both formulations of meloxicam, 2 mg. Plasma meloxicam concentrations were measured at the same times. From the start until maximum concentration, the initial absorption of the ODF meloxicam formulation was more rapid (2.08 ± 1.56 hr) as compared to the suspension (3.33 ± 1.03 hr). Mean elimination half-lives were 28.77 ± 4.01 and 32.85 ± 9.79 hr for the ODF and the suspension, respectively. Bioequivalence of the ODF was confirmed, based on the relative ratios of geometric mean concentrations (and 90% confidence intervals within the range of 80%-125%) for a maximum concentration of 101.05% (88.59-115.25), for the area under the plasma concentration-time curve (AUC) to the last sampling time of 96.07% (87.06-115.25), and for AUC to infinity of 92.65% (86.76-98.94). The meloxicam ODF may be used as an alternative to suspension formulations in the treatment of inflammatory joint diseases and painful musculoskeletal disorders.