Evaluation of Soy Polysaccharide as a Disintegrating Agent Part I: Direct Compression

Abstract

Soy polysaccharide, a group of high molecular weight polysaccharides obtained from soy beans, was evaluated as a disintegrant in tablets made by direct compression using lactose and dicalcium phosphate dihydrate as fillers. A cross-linked sodium carboxy-methyl cellulose and corn starch were used as control disintegrants. Parameters studied were compressibility, friability and disintegration times. Dissolution studies were conducted on tablets containing hydrochlorothiazide as a model drug of low water solubility. Soy polysacchardie performs well as a disintegrating agent in direct compression formulations with results paralleling those of cross-linked CMC at the 2% level and superior to corn starch at the 8% level. Dissolution rates of the drug from tablets were rapid, particularly at the 5% level and were not adversely affected by aging at room temperatures.