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Product of Modified Rice Starch (Era-Gel (R)) and Its Utilization in Pharmaceutical Industry

Pregelatinized rice starch (Era-Gel (R)) 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.

Product of Spray Dried Rice Starch (Era-Tab (R)) and Its Utilization in Pharmaceutical Industry

Spray dried rice starch (SDRS) (Era-Tab (R))was prepared by spray drying of rice starch at a suitable condition. Scanning electron microscope revealed that particle of SDRS was spherical and made up entirely agglomerates of rice starch grains. Tablet properties of SDRS were studied and compared with those of three commercially available direct compression fillers. Hardness, friability, and disintegration of the tablets were evaluated. It was found that SDRS was inferior to only one of them. Segregation tendency of direct compression formulation containing SDRS as a major component was tested. A blend of propranolol hydrochloride and SDRS was tableted on an rotary tablet press. Dissolution and drug content were evaluated. The results indicated that segregation did not occur over a two-hour period. To demonstrate the uniform distribution of low-dose drug, a mixture of SDRS and chlorpheniramine maleate were prepared at 4% of the drug. The tablets were assayed for the content uniformity and found to be excellent. Since direct compression process avoided the use of heat and moisture which were normally employed in wet granulation process, aspirin which was a heat and moisture sensitive drug was formulated with the use of SDRS. The tablets obtained were found to be satisfactory. Therefore, it was concluded that it could be employed successfully as a filler in direct compression tableting

Effect of Nano Silicon Dioxide on Tablet Properties of Rice Starch

Starch-colloidal silicon dioxide mixtures (Era-Tab SP® ) was prepared by co-spray drying and dry mixing methods and the flow ability and tablet properties of both methods were compared in particular with spray dried rice starch (SNR) alone. In co-spray drying, various percentages of rice starch and colloidal silicon dioxide blends were suspended in distilled water and subjected to spray dryer. The dry mixing method was obtained by blending of the colloidal silicon dioxide and spray dried rice starch at various percentages. It was found that co-spray drying of starch-colloidal silicon dioxide mixtures improved flow ability by reducing of the frictional forces between the granules greater than the dry mixing method. SEM micrographs presented the depositions of colloidal silicon dioxide on the surface of agglomerated starch granules obtained from both methods. The addition of colloidal silicon dioxide increased the tensile strength of the compressed tablet especially via the co-spray drying method by increasing the interaction of hydrogen bonding inside the tablet. Moreover, the co-spray drying method also reduced the friability and the disintegration time of the tablets better than the dry mixing method.

About Associate Professor Dr. Saiyavit Varavinit