Behavior of Pregelatinized Starch during Granulation and Its Influence on Tablet Properties.

Abstract

Using pregelatinized starch as a binder, fluidized-bed granulation and agitation granulation were attempted to investigate the behavior of starch and to examine its relationship with the resultant tablet properties (hardness and disintegration). The amounts of soluble starch before and after granulation were measured. Also, hardness and the disintegration time of the resultant tablets were measured. In fluidized-bed granulation, the soluble starch content did not change noticeably during granulation, thus exerting no influence on tablet properties. On the other hand, in agitation granulation, the soluble starch content increased, so that the disintegration time of the resultant tablets was prolonged. This may be because the soluble starch increased during agitation granulation due to a large shearing force and inhibited water penetration into the tablet and/or because some changes occurred in the swelling properties of the pregelatinized starch.Therefore, when pregelatinized starch is used as a binder, the fluidized-bed method is recommended to consistently obtain satisfactory tablet properties.