Formulation and in vitro Evaluation of Mouth Dissolving Tablets of Labetalol HCI by Sublimation Method

The objective of this research was to formulate fast dissolving tablets of Labetalol HCl that disintegrate in the oral cavity upon contact with saliva and there by improve therapeutic efficacy. Fast dissolving tablets of Labetalol HCl were prepared by direct compression method by using sublimation method. Seven formulations were prepared and evaluated for hardness, thickness, friability, weight variation, drug content, in vitro disintegration time, in vitro dispersion time, wetting time, water absorption ratio and in vitro dissolution studies. FTIR and DSC studies revealed that there was no chemical interaction between the drug and the excipients. Formulation S5 were found to be the best on the basis of wetting time, in vitro disintegration time and in vitro drug release. The formulation S5 containing Crospovidone as superdisintegrant and ammonium bicarbonate as subliming agent were found to be the optimized combinations. Stability studies were carried out for S5 at 400C±20C/75%±5% RH for 60 days. The results of stability studies indicated no significant changes with respect to physicochemical properties, in vitro disintegration time, wetting time and in vitro drug release.