title: Bioequivalence in dogs of a meloxicam formulation administered as a transmucosal oral mist with an orally administered pioneer suspension product.
abstract: A mucosal mist formulation of meloxicam, administered as a spray into the mouth (test article), was compared for bioequivalence to a pioneer meloxicam suspension for oral administration (reference article). Pharmacokinetic profiles and average bioequivalence were investigated in 20 dogs. The study design comprised a two-period, two-sequence, two-treatment cross-over design, with maximum concentration (C(max)) and area under plasma concentration-time curve to last sampling time (AUC(last)) used as pivotal bioequivalence variables. Bioequivalence of the products was confirmed, based on relative ratios of geometric mean concentrations (and 90% confidence intervals within the range 0.80-1.25) for C(max) of 101.9 (97.99-106.0) and for AUC(last) of 97.24 (94.44-100.1). The initial absorption of meloxicam was more rapid for the test article, despite virtually identical C(max) values for the two products. Mean elimination half-lives were 29.6 h (test article) and 30.0 h (reference article). The meloxicam plasma concentration-time profiles were considered in relation to published data on the inhibition of the cyclooxygenase-1 (COX-1) and COX-2 isoenzymes by meloxicam.
authors.affiliation: Royal Veterinary College, Hawkshead Campus, Hatfield, Herts, UK.
authors.forename: P
authors.initials: P
authors.lastname: Lees
authors.forename: Z
authors.initials: Z
authors.lastname: Cheng
authors.forename: T J
authors.initials: TJ
authors.lastname: Keefe
authors.forename: E
authors.initials: E
authors.lastname: Weich
authors.forename: J
authors.initials: J
authors.lastname: Bryd
authors.forename: R
authors.initials: R
authors.lastname: Cedergren
authors.forename: E
authors.initials: E
authors.lastname: Cozzi
mesh_terms: D000284:Administration, Oral; D000336:Aerosols / Q000008:administration & dosage; D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D004285:Dogs / Q000378:metabolism; D005260:Female; D000077239:Meloxicam; D013810:Therapeutic Equivalency; D013843:Thiazines / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013844:Thiazoles / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
chemical_list: D000336:Aerosols; D000894:Anti-Inflammatory Agents, Non-Steroidal; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam