T. Tabata et al., MANUFACTURING METHOD OF STABLE ENTERIC GRANULES OF A NEW ANTIULCER DRUG (LANSOPRAZOLE), Drug development and industrial pharmacy, 20(9), 1994, pp. 1661-1672
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.