In vitro release assay for liposome encapsulated vincristine

摘要

The present invention provides a novel in vitro release assay for the accurate, reproducible quantitation of vincristine sulfate release from liposomes.

主权项

1. A method of determining the in vitro release rate of vincristine from vincristine sulfate liposome injection (VSLI), the method comprising the steps of:
a. adding VSLI to an incubation solution comprising 1-butanol and phosphate buffered saline (PBS), wherein the concentration of 1-butanol after addition of the VSLI is between about 2.7% and about 2.8% (v/v); b. heating the incubation solution containing the VSLI for at least about 72 hours at about 37° C.±0.1° C.; c. removing an aliquot of the incubation solution containing the VSLI at two or more time points; d. separating the released vincristine from the VSLI by filtering each aliquot through a membrane which retains particles with D25 of 70 nm and D90 of 170 nm separate; and e. determining the amount of released vincristine in the filtrate of each aliquot removed at each time point by high performance liquid chromatography, wherein the difference in the amount of released vincristine at each time point is indicative of the release rate of vincristine from the VSLI.