The effect of aging on the dissolution of wet granulated tablets containing super disintegrants

Abstract The effect of aging at various storage conditions on the dissolution efficiency of tablets containing three ‘super disintegrants’ (croscarmellose sodium, crospovidone, and sodium starch glycolate) was investigated utilizing wet granulated tablets. The super disintegrants were incorporated via three methods: extragranularly, intragranularly, or distributed equally between the two phases. The solubility of the tablets was varied by using lactose, dibasic calcium phosphate, or naproxen as the main tablet component. The granulation moisture content was varied to investigate its impact on tablet dissolution after aging. The results indicated that aging decreased the dissolution efficiency of super disintegrants in wet granulated tablets. Generally, the formulations that initially exhibited the fastest dissolution showed the largest decreases in dissolution after storage. Croscarmellose sodium was affected to a greater extent after storage than crospovidone or sodium starch glycolate. Tablets that contained lactose were more affected by storage at the various conditions than were tablets that contained naproxen or dibasic calcium phosphate. Tablet dissolution after aging was unaffected by both the mode of super disintegrant incorporation and the granulation moisture content. No significant correlation was observed between changes in tablet hardness and alterations in dissolution rate after storage. Monitoring tablet dimensions showed that there was no substantial swelling in tablets after aging at elevated humidity and temperature, except for a slight increase in thickness for tablets that contained crospovidone.