Doxorubicin-loaded drug-eluting beads (DC Bead®) for use in transarterial chemoembolization: a stability assessment.
OBJECTIVE
Evaluation of doxorubicin stability over time when stored into the DC Bead embolic agent, in various containers, which are used for the delivery of the doxorubicin-loaded beads to the patients for up to 14 days under refrigerated conditions.


METHODS
The doxorubicin was loaded through the ionic exchange mechanism into the calibrated polyvinyl alcohol-based hydrogel beads (DC Bead), with the loading process carried out either in the original DC Bead glass vials or within a polypropylene plastic syringe. The loaded samples were eluted at given time points and the extracted doxorubicin was analysed by high-performance liquid chromatography for concentration and chromatographic area response purity.


RESULTS
The variance on the doxorubicin concentration of the samples stored in the syringes under refrigerated conditions was less than 10% over the 14 days period. The chromatographic purity of doxorubicin eluted from the DC Bead in their primary glass vial packaging was measured at 99.7%. The dissolution test showed that the elution rate and amount recovered from samples stored in vials were statistically similar between Day 0 and Day 14. The chromatographic purity of the doxorubicin loaded into DC Bead in presence of non-ionic contrast medium was >99.0% for 7 days under refrigerated conditions.


CONCLUSIONS
Doxorubicin-loaded DC Bead® are shown to have adequate physicochemical stability over a period of 14 days when stored in syringes or vials under refrigerated conditions for up to 14 days. The admixtures of doxorubicin-loaded beads with contrast medium are stable for up to 7 days under refrigerated conditions.
Pharmacy Department, CHU Mont-Godinne, Yvoir & Drug Stability Research Group, Brussels, Belgium.
Jean-Daniel
JD
Hecq
Andrew L
AL
Lewis
Danielle
D
Vanbeckbergen
Alexandre
A
Athanosopoulos
Laurence
L
Galanti
Jacques
J
Jamart
Peter
P
Czuczman
Ting
T
Chung
D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000737:chemistry* / Q000627:therapeutic use; D016461:Chemoembolization, Therapeutic; D002851:Chromatography, High Pressure Liquid; D003287:Contrast Media / Q000737:chemistry; D004317:Doxorubicin / Q000008:administration & dosage / Q000737:chemistry* / Q000627:therapeutic use; D004337:Drug Carriers / Q000008:administration & dosage / Q000737:chemistry* / Q000627:therapeutic use; D004339:Drug Compounding; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005898:Glass / Q000737:chemistry; D007472:Iohexol / Q000737:chemistry; D007700:Kinetics; D008863:Microspheres; D011126:Polypropylenes / Q000737:chemistry; D011142:Polyvinyl Alcohol / Q000737:chemistry; D012034:Refrigeration; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet; D013594:Syringes
D000903:Antibiotics, Antineoplastic; D003287:Contrast Media; D004337:Drug Carriers; D011126:Polypropylenes; D007472:Iohexol; D004317:Doxorubicin; D011142:Polyvinyl Alcohol