Effect of super-disintegrants combination on physical properties and release profile of orally disintegrating tablets of fluoxetine HCl

The effect of superdisintegrants combination (croscarmellose sodium, CCS, and sodium starch glycolate, SSG) at different ratios was studied on the physical characteristics, disintegration time and in vitro fluoxetine HCl release profiles. Fluoxetine HCl formulation containing combination of SSG and CCS (1:1) was selected as the best and optimized formulation if it compared to other formulations due to its hardness (7 Kp), friability (0.16%), drug content uniformity (99.12%), wetting time (21.54 s), water absorption ratio (106.19%), and rapid disintegrating time (in vitro 11.99 and in vivo 21.4 s). Good correlation (R² = 0.896) was observed between them, which indicates successful formulation was achieved for an orally disintegrating tablet of fast disintegration time in the oral cavity for human volunteers. The tablets disintegration time was increased with the increase in the total level of the superdisintegrants combination from 2-8% of CCS and SSG. Moreover, the disintegration time decreased with the increase in the level of CCS within formulations.