title: Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Global Clinical Pharmacology, Janssen Research and Development, LLC, Titusville, NJ, USA.
authors.forename: Kenneth T
authors.initials: KT
authors.lastname: Moore
authors.affiliation: Janssen Research and Development, LLC, Raritan, NJ, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Krook
authors.affiliation: Global Clinical Pharmacology, Janssen Research and Development, LLC, Titusville, NJ, USA.
authors.forename: Seema
authors.initials: S
authors.lastname: Vaidyanathan
authors.affiliation: Janssen Research and Development, LLC, Raritan, NJ, USA.
authors.forename: Troy C
authors.initials: TC
authors.lastname: Sarich
authors.affiliation: Janssen Research and Development, LLC, Raritan, NJ, USA.
authors.forename: C V
authors.initials: CV
authors.lastname: Damaraju
authors.affiliation: Janssen Scientific Affairs, LLC, Raritan, NJ, USA.
authors.forename: Larry E
authors.identifier: 0000-0003-0909-9839
authors.initials: LE
authors.lastname: Fields
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D004339:Drug Compounding; D016903:Drug Monitoring; D004355:Drug Stability; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics*; D005260:Female; D006207:Half-Life; D064368:Healthy Volunteers; D006801:Humans; D007441:Intubation, Gastrointestinal; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics*; D013607:Tablets; D055815:Young Adult
chemical_list: D065427:Factor Xa Inhibitors; D013607:Tablets; D000069552:Rivaroxaban
keywords: bioavailability; factor Xa inhibitor; nasogastric tube; pharmacokinetics; rivaroxaban