Preliminary bioequivalence of an oral integrating film formulation containing meloxicam with a suspension formulation in beagle dogs
Autor: | Jae-Yeon Lee, Lee Soo-Han, Chun-Woong Park, Jong-Shik Park, Sungmin Kim, Jae-Cheol Choi, Kim Young-Ah |
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Rok vydání: | 2020 |
Předmět: |
Male
medicine.medical_specialty 040301 veterinary sciences Urology Administration Oral 02 engineering and technology Absorption (skin) Bioequivalence Meloxicam Beagle 0403 veterinary science 020210 optoelectronics & photonics Dogs Pharmacokinetics 0202 electrical engineering electronic engineering information engineering medicine Animals Suspension (vehicle) Pharmacology Cross-Over Studies General Veterinary business.industry 04 agricultural and veterinary sciences Crossover study Therapeutic Equivalency Area Under Curve Geometric mean business medicine.drug Tablets |
Zdroj: | Journal of veterinary pharmacology and therapeuticsREFERENCES. 44(3) |
ISSN: | 1365-2885 |
Popis: | 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. |
Databáze: | OpenAIRE |
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