Stability and recovery of DIFICID(®) (Fidaxomicin) 200-mg crushed tablet preparations from three delivery vehicles, and administration of an aqueous dispersion via nasogastric tube.

Abstract

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.

• Authors: Anna Tousseeva, J Derek Jackson, Mark Redell, Teresa Henry, Michael Hui, Shelley Capurso, C Andrew DeRyke
• Journal: Drugs in R&D (Drugs R D) Vol. 14 Issue 4 Pg. 309-14 (Dec 2014) ISSN: 1179-6901 [Electronic] New Zealand
• PMID: 25424419 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Aminoglycosides
• Dietary Sucrose
• Pharmaceutical Vehicles
• Tablets
• Water
• Ensure formulated food
• Fidaxomicin

Topics

• Aminoglycosides (chemistry, isolation & purification)
• Dietary Sucrose
• Drug Stability
• Fidaxomicin
• Food, Formulated
• Intubation, Gastrointestinal
• Malus
• Pharmaceutical Vehicles (chemistry, isolation & purification)
• Tablets
• Water