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.

中文翻译：

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含有美洛昔康的口服整合膜制剂与混悬剂在比格犬中的初步生物等效性

口腔崩解膜（ODF）优于混悬剂和片剂。这些包括给药的便利性、患者的依从性和准确的剂量。我们通过使用具有 3 周洗脱期的交叉设计评估了 ODF 和美洛昔康悬浮液之间的生物等效性。六只健康的雄性比格犬随机接受美洛昔康的两种配方，2 毫克。同时测量血浆美洛昔康浓度。从开始到最大浓度，ODF 美洛昔康制剂的初始吸收比悬浮液（3.33 ± 1.03 小时）更快（2.08 ± 1.56 小时）。ODF 和悬浮液的平均消除半衰期分别为 28.77 ± 4.01 和 32.85 ± 9.79 小时。ODF 的生物等效性得到证实，基于几何平均浓度的相对比率（以及 80%–125% 范围内的 90% 置信区间），最大浓度为 101.05% (88.59–115.25)，血浆浓度-时间曲线下面积 (AUC ) 到最后一次采样时间为 96.07% (87.06–115.25)，AUC 到无穷大 92.65% (86.76–98.94)。美洛昔康 ODF 可用作治疗炎性关节疾病和疼痛性肌肉骨骼疾病的混悬剂的替代品。