Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube. Issue 4 (16th May 2014) - Moore, Kenneth T.
Abstract Purpose Because some patients have difficulty swallowing a whole tablet, we investigated the relative bioavailability of a crushed 20 mg rivaroxaban tablet and of 2 alternative crushed tablet dosing strategies. Methods Stability and nasogastric (NG) tube adsorption characteristics of a crushed rivaroxaban tablet were assessed. Then, in 55 healthy adults, relative bioavailability of rivaroxaban administered orally as a whole tablet (Reference [Whole‐Oral]), crushed tablet in applesauce suspension (Crushed‐Oral), or crushed tablet in water suspension via NG tube (Crushed‐NG) were determined. Results There were no significant changes in mean percent of non‐degraded rivaroxaban recovered over 4 hours from crushed tablet suspensions (>98.4% recovery across all suspensions and time points) or after NG tube exposure (recovery: 99.1% for silicone and 98.9% for polyvinyl chloride NG tubes). Relative bioavailability was similar between Crushed‐Oral and Reference dosing (Cmax and AUC∞ were within the 80–125% bioequivalence limits). Relative bioavailability was also similar between the Crushed‐NG and Reference dosing (AUC∞ was within bioequivalence limits; Cmax [90% CI range: 78.5–85.8%] was only slightly below the 80% lower bioequivalence limit). Conclusions A crushed rivaroxaban tablet was stable and when administered orally or via NG tube, displayed similar relative bioavailability compared to a whole tablet administered orally.