Product of Spray Dried Rice Starch (Era-Tab<sup>®</sup>) and its Utilization in Pharmaceutical Industry

Abstract

Spray dried rice starch (SDRS ) (Era-Tab ®)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