Stability and Recovery of DIFICID® (Fidaxomicin) 200-mg Crushed Tablet Preparations from Three Delivery Vehicles, and Administration of an Aqueous Dispersion via Nasogastric Tube

Fidaxomicin is approved for the treatment of adults with Clostridium difficile-associated diarrhea, many of whom have difficulty swallowing an intact tablet. The study objective was to evaluate the stability and recovery of crushed DIFICID(®) (fidaxomicin) 200-mg tablets dispersed in water, applesauce, or Ensure(®) brand liquid nutritional supplement, and to determine the recovery of fidaxomicin from the administration of an aqueous dispersion of a crushed DIFICID(®) tablet through a nasogastric (NG) tube. DIFICID(®) tablets were crushed and dispersed in water, applesauce, or Ensure(®). The stability and recovery of fidaxomicin were evaluated over 24 h in these vehicles. In a separate experiment, the ability to recover a full dose of fidaxomicin when administering as an aqueous dispersion through an NG tube was assessed. When DIFICID(®) tablets were crushed and dispersed in water, the active ingredient, fidaxomicin, was stable for up to 2 h at room temperature. Additionally, it was stable for up to 24 h in dispersions with applesauce or Ensure(®). Recovery of fidaxomicin after crushing and dispersing in any of the three vehicles studied ranged from 95 to 108 %, which is within the normal range of individual tablet variability. When crushed, dispersed in water, and administered through an NG tube, the average recovery of fidaxomicin was 96 %. Stability and recovery of fidaxomicin were confirmed when DIFICID(®) tablets were crushed and dispersed in water, applesauce, or Ensure(®). In addition, administration of an aqueous dispersion of a crushed tablet through an NG tube is supported by acceptable recovery of fidaxomicin.