Preparation of Sustained-Release and Enteric Coated Pellets of Pantoprazole

OBJECTIVE To prepare sustained release and enteric coated pellets of pantoprazole-Na(PAZ-Na) with Eudragit as coating material, and study the release characteristics and the micromeritics.METHODS The drug-containing pellets were prepared in the fluid bed by solution layering and then coated in subminiature fluid bed with Eudragit RS/RL and Eudragit L100-55.The formulation of coating material was determined under single-factor investigation.A HPLC method was established to determine the release characteristics of PAZ-Na in vitro.RESULTS The drug-containing sustained release and enteric coated pellets were prepared.In the first 2 h, the coated pellets released less than 10% in pH 1.2 hydrochloric acid solution, and the curve of cumulative drug release was accorded with the first grade equation in PBS(pH 6.8).The pellets showed sustained-release effect.CONCLUSION The coated pellets of PAZ-Na had a good effect of sustained-release in vitro, and the established process and formula were simple and reproducible.