title: Pharmacokinetics of a new subcutaneous diclofenac formulation administered to three body sites: quadriceps, gluteus, and abdomen.
abstract: OBJECTIVE
  To assess the relative bioavailability of a new subcutaneous (SC) diclofenac hydroxypropyl b-cyclodextrin (HPbCD) formulation administered to three body sites: quadriceps, gluteus, and abdomen.
  
  
  METHODS
  This was a pilot, single-dose, randomized, three-way crossover relative bioavailability study. A total of 12 healthy subjects received a single SC injection of diclofenac HPbCD 50 mg/1 mL in the quadriceps, gluteus, or abdomen.
  
  
  RESULTS
  The AUC was comparable after SC diclofenac HPbCD in the quadriceps, gluteus, and abdomen. The Cmax was comparable after SC administration in the quadriceps or abdomen, and ~ 17% higher in the gluteus. The absorption was rapid (30 minutes) after administration of the treatment at any site. The treatment was well tolerated.
  
  
  CONCLUSIONS
  The relative bioavailability of SC diclofenac HPbCD was comparable when administered to the quadriceps, gluteus, and abdomen. The new diclofenac formulation can therefore be administered subcutaneously to any of these sites without clinically significant differences. A further adequately powered study would be necessary to reveal any differences among injection sites in terms of peak plasma concentration.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Salomone
authors.forename: Cateno
authors.initials: C
authors.lastname: Piazza
authors.forename: Daniela Cristina
authors.initials: DC
authors.lastname: Vitale
authors.forename: Francesco
authors.initials: F
authors.lastname: Cardì
authors.forename: Barbara
authors.initials: B
authors.lastname: Gugliotta
authors.forename: Filippo
authors.initials: F
authors.lastname: Drago
mesh_terms: D000073738:2-Hydroxypropyl-beta-cyclodextrin; D034861:Abdominal Wall; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D006801:Humans; D007279:Injections, Subcutaneous; D018482:Muscle, Skeletal; D010865:Pilot Projects; D047392:beta-Cyclodextrins / Q000008:administration & dosage
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D047392:beta-Cyclodextrins; D004008:Diclofenac; D000073738:2-Hydroxypropyl-beta-cyclodextrin