Preparation and in Vitro Evaluation of Zaleplon Pulsatile Release Pellets

OBJECTIVE To prepare and the optimize zaleplon pulsatile release pellets. METHODS Zaleplon pulsatile release pellets were prepared by double-layer coating method with swelling material CC-Na as the inner swelling layer and ethylcellulose aqueous dispersion as the outer controlled layer. The effects of pellets compositions and the pH values of the media on the in vitro release behavior were evaluated. The formula was optimized by Box-Behnken response surface design. RESULTS The composition of swelling layer, the coating level of swelling layer and the controlled layer had significant effect on the lag time and release rate. CONCLUSION The pellets which are optimized by Box-Behnken response surface design have an ideal pulse release.