Jun-Ichi Kikuta

Effect of Mixing Time on the Lubricating Properties of Magnesium Stearate and the Final Characteristics of the Compressed Tablets

AbstractThe effect of mixing time on hardness, disintegration time and ejection force in tablettlng of magnesium stearate and lactose granules was studied. The hardness of the tablets decreased with an increase in mixing time of the blends, as previously reported. A semilogarithmic plot of the hardness versus mixing time gave a straight line having a turning point. At the early phase of mixing the hardness was decreasing with a large first-order rate and then continued to decrease with another small first-order rate. The change in disintegration time or ejection force versus mixing time was basically the same as that in the hardness. This type of plot was applicable to the mixing magnesium stearate with not only granular but also powdered materials.

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

AbstractIn 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.