title: Pharmacokinetic properties of low-dose SoluMatrix meloxicam in healthy adults.
abstract: SoluMatrix® meloxicam has been developed using SoluMatrix Fine Particle Technology™ to produce a meloxicam drug product with enhanced absorption properties to enable treatment at lower doses than available oral meloxicam drug products. This follows recognition of serious dose-dependent adverse events (AEs) associated with nonsteroidal anti-inflammatory drugs, including meloxicam. This study investigated the pharmacokinetic (PK) properties of SoluMatrix meloxicam 5-mg (fasting conditions) and 10-mg capsules (fasting and fed conditions) and compared SoluMatrix meloxicam 10-mg capsules with meloxicam 15-mg tablets under fasting conditions. This four-period crossover study randomized 28 healthy adult participants to receive single doses of SoluMatrix meloxicam 5-mg capsules (fasting) and 10-mg capsules (fasting or fed) and meloxicam tablets 15 mg (fasting). Meloxicam plasma concentrations were assessed through 96 h postdose. Safety was assessed. Twenty-five participants (89.3 %) completed the study. Under fasting conditions, SoluMatrix meloxicam 10 mg [1252.8 (254.22) ng/mL] produced similar meloxicam mean (standard deviation (SD)) maximum plasma concentrations vs meloxicam 15-mg tablets [1288.8 (424.40) ng/mL]. The overall mean (SD) systemic meloxicam exposure was 33 % lower for SoluMatrix meloxicam 10 mg [29,173.01 (11,042.09) ng*h/mL] vs meloxicam 15-mg tablets [40,875.6 (11,733.47) ng*h/mL]. The median time to maximum plasma meloxicam levels occurred earlier following SoluMatrix meloxicam 5 mg (2.0 h) and 10 mg (2.0 h) administration vs meloxicam 15-mg tablets (4.0 h). Few study-medication-related AEs were reported. SoluMatrix meloxicam 10 mg was more rapidly absorbed and associated with a lower overall exposure compared with meloxicam 15-mg tablets in this study in healthy adults under fasting conditions.
authors.affiliation: PAREXEL International, Baltimore, MD, USA.
authors.forename: Azra
authors.initials: A
authors.lastname: Hussaini
authors.affiliation: Iroko Pharmaceuticals LLC, One Kew Place, 150 Rouse Boulevard, Philadelphia, PA, 19112, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Solorio
authors.affiliation: Iroko Pharmaceuticals LLC, One Kew Place, 150 Rouse Boulevard, Philadelphia, PA, 19112, USA. cyoung@iroko.com.
authors.forename: Clarence
authors.initials: C
authors.lastname: Young
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000493:pharmacokinetics*; D019540:Area Under Curve; D018592:Cross-Over Studies; D004339:Drug Compounding; D005215:Fasting; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D000077239:Meloxicam; D008875:Middle Aged; D061214:Patient Safety; D012995:Solubility; D013607:Tablets; D013843:Thiazines / Q000493:pharmacokinetics*; D013844:Thiazoles / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam
keywords: Healthy volunteers; Meloxicam; Pharmacokinetics; SoluMatrix