Evaluation of Novel co-processed excipient for fast disintegration of aspirin tablet formulations

Abstract

Co-processing is a technique that ensures sub-particulate interaction of individual excipients leading to overall functionality of the resulting excipient. The aim of this study is to co-process Cyperus esculentus starch with mannitol by fusion and evaluate its effect on tablet disintegration and in vitro dissolution. Co-processed excipients were prepared from Cyperus esculentus starch and mannitol by fusion in ratios of 1:1, 1:2 and 2:1 (CM1, CM2, and CM3 respectively) and evaluated for flow and swelling properties. The excipients were incorporated into Aspirin tablet formulations at 5 %w/w by direct compression (FM1, FM2, FM3 respectively). Similar tablets were prepared using sodium starch glycolate (FSG) and the formulations were assessed for hardness, friability, wetting time, disintegration
time and in vitro dissolution profile. All the prepared excipients possessed excellent flow with Carr’s index between 17.31 and 20.78 and Hausner ratio between 1.21 and 1.26. CM3 had the highest swelling profile (1.491) while CM2 had the lowest (1.321). Formulation FM1 had the highest tensile strength (14.12 N/cm² ) but slower wetting time (34.33 sec) compared to FM3 with tensile strength of 11.32 N/cm² and wetting time of 9.00 sec. Disintegration time of CM3 (4.26 min) was comparable to that of FSG (4.01 min); their dissolution profile was also found to be similar. Coprocessing Cyperus esculentus starch and mannitol by fusion (2:1) influenced tablet  disintegration and in vitro dissolution and has potential to be used in manufacture of fast dissolving tablet formulations.

Keywords: Co-processing; Cyperus esculentus starch; Mannitol; Disintegration; Dissolution