Formulation and Stability Studies on Paclitaxel Self-microemulsifying Drug Delivery System

VernacularTitle:紫杉醇自微乳释药体系的处方工艺及稳定性研究
Author: Lijuan ZHOU ; Xi CHEN ; Qingfei LIU ; Yiming WANG ; Guoan LUO
Publication Type:Journal Article
Keywords: Paclitaxel; Self-microemulsifying drug delivery system; Preparation; Stability
From: Herald of Medicine 2014;(8):1063-1067
CountryChina
Language:Chinese
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.