176 Evaluation of Meloxicam Plasma Concentrations Using a Microneedle Patch for Drug Delivery

Abstract

To evaluate meloxicam plasma concentrations using a microneedle patch, 12 pigs (initial BW = 2.5 ± 0.53 kg) were stratified into of 4 treatment groups. Treatment groups were: 1) pigs (n = 2) received 0.5 mg/kg meloxicam via oral drench (oral); 2) pigs (n = 2) received a patch with no meloxicam (placebo); 3) pigs (n = 4) received microneedle patch dosed at 2.5 mg/kg (low dose); and 4) pigs (n = 4) received 2 microneedle patches dosed at 5 mg/kg (high dose). Blood was collected for plasma analysis at 0, 2, 4, 8, 12, 24, 48, 72, 96, and 168 hours. Microneedle patches were adhered on the pinna of the ear after blood collection at 0 hour. Statistical analyses were performed using the MIXED procedure of SAS 9.4, assessing effects of treatment, time, and treatment × time interaction. Statistical significance was determined at P ≤ 0.05, with tendencies at 0.05 < P ≥ 0.1. There was a treatment × time interaction (P < 0.0001), with the oral treatment group having greater meloxicam plasma concentrations at 2, 4, and 8 hours than placebo, low dose, and high dose treatment groups (P < 0.0001), but there were no differences for 24, 48, 72, 96, and 168 hours (P > 0.1). The oral treatment group tended to have greater meloxicam plasma concentrations at 12 hours compared with placebo (P = 0.09), low dose (P = 0.054), and high dose (P = 0.054) treatment groups. There were no differences between placebo, low dose, and high dose treatment groups for any blood collection timepoint (P > 0.1). Meloxicam concentrations in plasma were detectable but low for both the low dose treatment group (0.21 ng/mL) and high dose treatment group (1.14 ng/mL). Research is continuing to determine the ideal meloxicam dosage needed on the patch to deliver desired plasma concentrations.