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Abstract
The effect of variation in the degree of cross-linkage and extent of substitution on the disintegrant properties of sodium starch glycolate in wet granulated systems has been examined. The rates of mixing shear were evaluated for their effect on the ability of the disintegrants to function after granulation. In addition, the effect of varying the intragranular and extra-granular concentration of the disintegrants was investigated. The results indicate that increased rates of mixing shear adversely effect sodium starch glycolates. In addition, the current commercial specifications for a marketed sodium starch glycolate seem to be optimal in this segard. It also seems evident that a mixture of disintegrant within and around the granule is desirable in wet granulated systems.
Previous papers have discussed the importance of raw materials specifications in defining the fitness for use of many pharmaceutical excipients (1-6). We have recently initiated a study concerning the effect of variation of degree of cross-linkage and extent of substitution on the disintegrant action of sodium starch glycolate in direct compression systems. Further details of this study will be provided in a paper focussed on standard raw materials tests for disintegrants and their relative differences in direct compression systems (7).