Compatibility and stability of the novel anticancer agent ES-285 x HCl formulated with 2-hydroxypropyl-beta-cyclodextrin in infusion devices.
ES-285 x HCl is a novel marine-derived anticancer agent isolated from the clam Spisula polynyma. The compound is pharmaceutically formulated as a lyophilised product containing 25 or 50 mg ES-285 x HCl and 500 or 1000 mg 2-hydroxypropyl-beta-cyclodextrin per dosage unit and requires reconstitution with sterile water for injection before intravenous administration. The aim of this study was to determine the stability and compatibility of ES-285 x HCl in infusion devices. ES-285 x HCl was shown to be stable at concentrations of 10-1400 microg/ml after dilution in 5% dextrose in water and compatible with PE infusion containers and PE and silicone tubing. No sorption on- or into the administration set was observed at concentrations equal to or above 20 microg/ml. In conclusion, ES-285 x HCl infusion solutions can be administered without stability or sorption problems using a PE infusion container and PE or silicone tubing in concentrations equal or above 20 microg/ml in 3-hour or 24-hour infusion administration schedules.
Den Brok
M W J
MW
Slotervaart Hospital/The Netherlands Cancer Institute, Department of Pharmacy & Pharmacology, Amsterdam, The Netherlands. apmbk@slz.nl
Nuijen
B
B
García
J L
JL
Miranda
E
E
Calvo
P
P
Manada
C
C
Beijnen
J H
JH
D000073738:2-Hydroxypropyl-beta-cyclodextrin; D000473:Alkanes / Q000737:chemistry*; D000970:Antineoplastic Agents / Q000737:chemistry*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D007262:Infusions, Intravenous; D008055:Lipids / Q000737:chemistry*; D012995:Solubility; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet; D047392:beta-Cyclodextrins / Q000737:chemistry*
D000473:Alkanes; D000970:Antineoplastic Agents; D008055:Lipids; D012996:Solutions; D047392:beta-Cyclodextrins; D000073738:2-Hydroxypropyl-beta-cyclodextrin; C408363:spisulosine