Formulation Design of Novel Fast Dissolving Tablets Using Low and High Compressible Saccharides

In the present work, fast dissolving tablets of granisetron HCl were prepared using low compressible (mannitol) and high compressible saccharides (sorbitol 5-15% w/w) along with crospovidone, croscarmellose sodium and L-HPC as super-disintegrants in different ratios(2-8% w/w) In case of sorbitol, the presence of interlocking crystals that are generated using specific manufacturing conditions enables strong binding and result in a more robust tablet at low compression forces. In addition, mannitol provides the required dispersibility and mouth feel for a successful FDT formulation. Exhibits significantly low friability, even at a low compression force. In addition contributing to the robustness of the tablets, the sorbitol also imparts a sweet taste and unique textured to the mannitol, thereby improving the ODT formulations mouthfeel. The low level of sorbitol required to obtain an added functionality, mannitol does not affect its pharmacopoeial uniformity to USP-NF standards, thus offering an advantage with respect to the regulatory requirements. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity and in vitro dispersion time. Based on in vitro dispersion time (approximately 12-23 sec), three formulations were selected and tested for in vitro drug release pattern (in pH 6.8 phosphate buffer). Short-term stability (at 40o/ 75% RH for 3 months) and drug-excipient interaction (IR spectroscopy). Among the three promising formulations, the formulation containing 8% w/w of crospovidone and 15% w/w of sorbitol, emerged as the overall best formulation (t50% 3 min) based on the in vitro drug release characteristics compared to conventional commercial tablet formulation (t50% 19.0 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in vitro dispersion time (p<0.05).