Product of Modified Rice Starch (Era-Gel<sup>®</sup>) and its Utilization in Pharmaceutical Industry

Abstract

Pregelatinized rice starch (Era-Gel ® ) was prepared by physical modification. The degree of pregelatinization was controlled to an appropriate level. With the addition of small amount of pregelatinized rice starch , a slightly sticky, damped mass was obtained. Pregelatinized rice starch was tested for a potential use as a tablet filler or binder in wet granulation process. Two hydrochlorothiazide formulations were compared. One formulation comprised HCTZ and PRS; the powder mixture was damped with water. The other formulation contained HCTZ, lactose as filter, corn starch as binder and also as tablet disintegrant. In the later case, the powder mixture was damped with starch paste. Both granulations were compressed on an instrumented tablet press. The tablets were evaluated for their hardness, friability, disintegration, and also dissolution. The results indicated that both formulations were comparable in all aspects. It dissolution was found to exceed the USP requirement. It was demonstrated that three components, i.e. , lactose, corn starch paste, and disintegrant could be replaced with only one single material, PRS. It was also found that PRS could perform well in acetaminophen tablet formulation which was a high-dose drug and tended to cap; however, small amount of extra binder and disintegrant were needed. It could be seen that PRS had a great potential use in wet granulation process.