Suitability of Crushed Vibegron 75 mg Tablets for Enteral Administration.

Abstract

Background Vibegron, a beta₃-adrenergic receptor agonist for overactive bladder, can be administered as an intact tablet or crushed and mixed with applesauce for patients with dysphagia. Objectives To evaluate the suitability of crushed vibegron for administration via enteral feeding tubes. Methods Vibegron 75 mg tablets were crushed, suspended in 15 mL water, and delivered through seven commonly used enteral tubes. Minimum required flush volume was assessed by flushing with 10, 20, or 30 mL water and quantifying dose delivery using high-performance liquid chromatography (HPLC). Material compatibility was assessed by holding doses in each tube for 5, 15, and 30 minutes and using HPLC to quantify dose delivery and detect impurities in vibegron and control (vibegron tablet) samples. Dosing repeatability was assessed by delivering six replicates through each tube and quantifying dose delivery. Tube occlusion was evaluated visually in all assays. Mean dose delivery through each tube was assessed using pooled data and analyzed by ANOVA. Results Delivery of > 90% was achieved in all assays, for all tubes assessed, with ≥ 20 mL flush volume; 5-, 15-, or 30-minute hold times; and delivery of 1 to 6 doses through the same tube. No additional impurities were detected in vibegron samples compared with controls. Tube occlusion was not observed. Mean dose delivery was > 95% for all tubes assessed and not significantly different between tubes (F = 1.02; P = 0.4). Conclusions Crushed vibegron tablets dispersed in 15 mL of water were delivered consistently and completely through a variety of enteral tubes with no evidence of material incompatibility or clogging.