Formulation and Stability Studies on Paclitaxel Self-microemulsifying Drug Delivery System / 医药导报

ABSTRACT

Objective To study the preparation and stability of paclitaxel self-microemulsifying drug delivery system ( PTX-SMEDDS) . Methods The formulation of the PTX-SMEDDS was optimized by monitoring the appearance, particle size, concentration, relative substance, and bacterial endotoxin. Influence of different pH and different dosage of activated carbon on PTX-SMEDDS was investigated. Subsequently it was subjected to stability studies. Results The PTX-SMEDDS was a translucent diluted-yellow solution with a mean diameter of 19. 6 nm. High speed centrifugal test indicated PTX-SMEDDS was stable. The result of the influential factor tests showed PTX-SMEDDS was unstable to high temperature and light. In the accelerated tests for 6 months, the quality of PTX-SMEDDS was stable. The samples should be sealed and stored at low temperature and shady place. Conclusion Easily prepared and stable formulation of PTX-SMEDDS is achieved, and further investigation is warranted to develop self-microemulsifying drug delivery system for injection.