MANUFACTURING METHOD OF STABLE ENTERIC GRANULES OF A NEW ANTIULCER DRUG (LANSOPRAZOLE)

In our previous studies, we clarified that enteric granules are an app ropriate dosage form for lansoprazole, and we demonstrated that enteri c granules could be produced when magnesium carbonate was added as an alkaline stabilizer. These granules however were found to be some unst able under severe conditions because some of the excipients are incomp atible with lansoprazole. We therefore attempted granulation not using these incompatible excipients and could obtain more stable enteric gr anules using a centrifugal fluid-bed granulator instead of an extruder -spheronizer. We also compared the absorption and dissolution properti es of the enteric granules manufactured by these two methods.