Preparation of Lansoprazole Enteric-coated Pellet Capsules / 中国药房

ABSTRACT

OBJECTIVE:To prepare lansoprazole enteric-coated pellet capsules(LECPC).METHODS:The lansoprazole enteric-coated pellets were prepared using fluid-bed coating technology through blank pellets being coated with main component layer,insulating layer and enteric layer in order.Enteric-coated pellets were encapsulated into hard gelatin capsules to obtain LECPC.Drug-loading rate and drug release in artificial intestinal fluid and artificial gastric fluid of 3 batches were investigated.RESULTS:The prepared pellets assumed complete round shape,lustrous appearance and coating well with mean drug-loading rate above 96%.The release of 3 batches in artificial intestinal fluid within 45 minutes were greater than (94.3?0.76) % while were smaller than (6.2?1.6)% in artificial gastric fluid within 2 hours.CONCLUSION:The prepared capsule is feasible in technology,reproducible and reliable in quality.It represents satisfactory release in vitro and property of resisting acid.