Manufacturing Method of Stable Enteric Granules of a New Antiulcer Drug (Lansoprazole)

Abstract

In our previous studies, we clarified that enteric granules are an appropriate dosage form for lansoprazole, and we demonstrated that enteric granules could be produced when magnesium carbonate was added as an alkaline stabilizer.

These granules however were found to be some unstable under severe conditions because some of the excipients are incompatible with lansoprazole. We therefore attempted granulation not using these incompatible excipients and could obtain more stable enteric granules using a centrifugal fluid-bed granulator instead of an extruder-spheronizer. We also compared the absorption and dissolution properties of the enteric granules manufactured by these two methods.

Key Words::

• lansoprazole
• enteric granules
• magnesium carbonate
• extrusion
• CF