Preparation and Drug Release in vitro of (R)-Rabeprazole Sodium Enteric-coated Pellets / 中国药师

ABSTRACT

Objective:To prepare enteric-coated pellets of ( R)-rabeprazole sodium and investigate the drug release behavior in vitro. Methods:The pellets of ( R)-rabeprazole sodium were prepared by a fluid bed coating technology, and HPMC and Eudragit L30D-55 was used as the material of isolation layer and enteric coating, respectively. The similarity of in vitro drug release was com-pared between the reference preparation and the self-prepared preparation. Similar factor ( f2 ) was used to evaluate the similarity of re-lease curves. Results:The coating formula of ( R)-rabeprazole sodium enteric-coated pellets was as follows the weight of HPMC E5 and Eudragit L30D-55 was 12. 0% and 45. 0%, respectively, and the plasticizer was 8. 0% of the weight of the polymers. The f2 of the reference preparation and the self-prepared preparation was more than 50, which indicated the release behavior was similar. Con-clusionThe release behavior of ( R)-rabeprazole sodium enteric-coated pellets is quite promising, and the preparation technology can be used in the industrial production.