Preparation and Quality Research of Lansoprazole Enteric-coated Pellets

OBJECTIVE To prepare lansoprazole enteric-coated pellets, so as to improve the acid resistance, release and stability of lansoprazole. METHODS The lansoprazole enteric-coated pellets were prepared by powder laminar deposition technique combing the centrifugal granulator and the fluidized bed coating technology. The commercial lansoprazole enteric-coated capsules(TAKEPRON) were selected as reference formulation. The performance, release, stability and influencing factors of self-made formulation and reference formulation were investigated. The release consistency of the lansoprazole enteric-coated pellets with the reference formulation was evaluated by the similar factor comparison. RESULTS The prepared lansoprazole enteric-coated pellets were white and sphere with uniform particle size distribution, which had good roundness and strong abrasion resistance. The similarity factors with the reference formulation in the different pH media were all above 50. Under the conditions of influencing factors, the content change trend of self-made formulation was as same as reference formulation, but the change degree of related substances of self-made formulation was lower than reference formulation. CONCLUSION The prepared lansoprazole enteric-coated pellets can effectively improve the acid resistance and release rate of lansoprazole in different pH phosphate buffer solution, and achieve a release consistency with reference formulation in simulated intestinal fluid. Compared with the reference formulation, the stability of lansoprazole enteric coated pellets prepared are improved.