title: 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.affiliation: Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA, anna.tousseeva@gmail.com.
authors.forename: Anna
authors.initials: A
authors.lastname: Tousseeva
authors.forename: J Derek
authors.initials: JD
authors.lastname: Jackson
authors.forename: Mark
authors.initials: M
authors.lastname: Redell
authors.forename: Teresa
authors.initials: T
authors.lastname: Henry
authors.forename: Michael
authors.initials: M
authors.lastname: Hui
authors.forename: Shelley
authors.initials: S
authors.lastname: Capurso
authors.forename: C Andrew
authors.initials: CA
authors.lastname: DeRyke
mesh_terms: D000617:Aminoglycosides / Q000737:chemistry* / Q000302:isolation & purification*; D019422:Dietary Sucrose; D004355:Drug Stability; D000077732:Fidaxomicin; D005526:Food, Formulated; D007441:Intubation, Gastrointestinal; D027845:Malus; D014677:Pharmaceutical Vehicles / Q000737:chemistry* / Q000302:isolation & purification*; D013607:Tablets; D014867:Water
chemical_list: D000617:Aminoglycosides; D019422:Dietary Sucrose; D014677:Pharmaceutical Vehicles; D013607:Tablets; D014867:Water; C082131:Ensure formulated food; D000077732:Fidaxomicin