Effect of selected direct compression excipients on the stability of acetylsalicylic acid tablets

Abstract

The effect of some direct compression excipients (Avicel® PH 101 (I), Avicel PH 101 + mannitol (II), Avicel PH 112 (III), Cellactose® (IV), and Pharmatose® DCL 40 (V)) under different storage conditions (22, 43 and 73% relative humidity, resp.) on the physico-chemical properties and dissolution rate of acetylsalicylic acid tablets was evaluated. Disintegration time, cruching strength, and friability were changed remarkably in the tablet formulations I, II, and III being humidity dependent. Formulations IV and V had no tendency to changes in physical characteristics under storage at different relative humidities for 90 days, whereas the dissolution profiles of samples I, II, and III were increased with increasing humidity. No changes in dissolution rate after storage at different humidities were observed in the lactose-based formulations IV and V. Analytical data (acetylsalicylic acid and salicylic acid content) revealed a high stability of formulations IV and V compared to the others. According to the obtained results, formulations IV and V could be suggested as excipients for high quality acetylsalicylic acid tablets.