Preparation and quality evaluation of paclitaxel self-microemulsifying drug delivery system / 中国药学杂志

ABSTRACT

OBJECTIVE: To prepare paclitaxel self-microemulsifying drug delivery system (PTX-SMEDDS) and evaluate its quality. METHODS: The equilibrium solubility of paclitaxel in different compositions of oil, emulsifiers and assistant emulsifiers was investigated. The optimal Km was determined and PTX-SMEDDS was prepared by using the method of titration to establish the pseudo-tern, injury phase diagram. The appearance, morphology, size distribution, concentration and stability of PTX-SMEDDS were determined. RESULTS: PTX-SMEDDS prepared with EL-35, lecithin and anhydrous ethanol at the ratio of 416, containing 6% DOC-Na and 7.5% of MCT, was a uniform and stable colloidal system displaying as a translucent diluted-yellow solution. PTX-SMEDDS under elec-from microscopy consisted of small spherical drops with a mean diameter of 19.4 nm. The appearance, pH, concentration and particle size of SMEDDS were stable after it was diluted with sodium chloride injection and glucose injection by 10-fold or 50-fold, respectively. CONCLUSION: The PTX-SMEDDS is easy to prepare and its quality is stable, which provieds some information for the development of new paclitaxel formulations.