Conditional examinations for pulverization of lansoprazole orally disintegrating tablets

Abstract

Lansoprazole orally disintegrating tablets are produced as a spastab-type formulation containing enteric-coated granules. We examined the acidoresistance of these enteric-coated granules following pulverization of lansoprazole orally disintegrating tablets. One branded and five generic tablets were pulverized by tapping, grinding, or mechanical milling. The enteric-coated granules of the branded and generic tablets pulverized via tapping, mild mechanical milling at low speed for 5 s, and slightly mild mechanical milling at high speed for 5 s retained acidoresistance. Moreover, acidoresistance was maintained during storage for one week following pulverization, except for one kind of generic tablets. The granules from the branded tablets also maintained acidoresistance for one week following severe mechanical milling at low speed for 30 s. Grinding and very severe mechanical milling at high speed for 30 s damaged the acidoresistance of all tablets. The results of the present study reveal the pulverization conditions under which the enteric-coated granules for the branded and generic tablets tested retain their acidoresistance.