title: Compatibility of epirubicin-loaded DC bead™ with different non-ionic contrast media.
abstract: OBJECTIVE
  The aim of this study was to determine the compatibility of epirubicin-loaded DC bead™ with different non-ionic contrast media over a period of seven days when stored light protected under refrigerated conditions.
  
  
  METHODS
  DC bead™ (2 ml) (Biocompatibles UK Ltd) of the bead size 70-150 µm ( = DC bead M1) or bead size 100-300 µm were loaded with 75 mg epirubicin powder formulation (Farmorubicin® dissolved in 3 ml water for injection to a concentration of 25 mg/ml) or 76 mg epirubicin injection solution (Epimedac® 2 mg/ml) within 2 h or 6 h, respectively. After removal of the excess solution, the epirubicin-loaded beads were mixed in polypropylene syringes with an equal volume (∼1.5 ml) of contrast media, i.e. Accupaque™ 300 (Nycomed Inc.), Imeron® 300 (Bracco S.p.A), Ultravist® 300 (Bayer Pharma AG), Visipaque™ 320 (GE Healthcare) and agitated in a controlled manner to get a homogenous suspension. Syringes with loaded beads in contrast media were stored protected from light under refrigeration (2-8℃). Compatibility was determined by measuring epirubicin concentrations in the suspensions in triplicate on day 0, 1, and 7. A reversed phase high-performance liquid chromatography assay with ultraviolet detection was utilized to analyze the concentration and purity of epirubicin.
  
  
  RESULTS
  Mixing of epirubicin-loaded beads with different non-ionic contrast media released 0.1-0.5% of epirubicin over a period of 24 h, irrespectively, of the DC bead™ size or type of contrast media. No further elution or degradation was observed after seven days when the admixtures were stored protected from light under refrigeration.
  
  
  CONCLUSIONS
  Compatibility of epirubicin-loaded DC bead™ with an equal volume of different contrast media in polypropylene syringes is given over a period of seven days. Due to a maximum elution of 0.1-0.5% of epirubicin from loaded DC bead™, admixtures with contrast media can be prepared in advance in centralized cytotoxic preparation units. Microbiological aspects have to be considered when determining the expiration date of the product.
authors.affiliation: Department of Pharmacy, University Medical Center Mainz, Johannes Gutenberg-University, Langenbeckstraße, Mainz, Germany.
authors.forename: Iman
authors.initials: I
authors.lastname: Sarakbi
authors.affiliation: Department of Pharmacy, University Medical Center Mainz, Johannes Gutenberg-University, Langenbeckstraße, Mainz, Germany Irene.kraemer@unimedizin-mainz.de.
authors.forename: Irene
authors.initials: I
authors.lastname: Krämer
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003287:Contrast Media / Q000032:analysis / Q000737:chemistry*; D004337:Drug Carriers / Q000032:analysis / Q000737:chemistry*; D004339:Drug Compounding; D004355:Drug Stability; D015251:Epirubicin / Q000032:analysis / Q000737:chemistry*; D008863:Microspheres; D011208:Powders; D013594:Syringes
chemical_list: D003287:Contrast Media; D004337:Drug Carriers; D011208:Powders; D015251:Epirubicin
keywords: Drug eluting beads; compatibility; contrast media; epirubicin; high-performance liquid chromatography assay