Formulation and In-Vitro Evaluation of Taste Masked Fast Disintegrating Tablets of Labetalol Hydrochloride by Wet Granulation Technique

Abstract

Labetalol Hydrochloride is a β-blocker generally indicated for the treatment of hypertension, and it is extensively metabolized due to the hepatic metabolism. In the present work, an attempt was made to mask the taste by Solid Dispersion technique, with a formulation into Fast Disintegrating dosage form, using superdisintegrants such as Cross carmellose sodium (CCS), crospovidone (CP) and sodium starch glycolate (SSG). The complexes of Labetalol hydrochloride with HP-β-CD (1:3 ratio) were prepared by Co-precipitation method. Using the drug HP-β-CD complex, Fast Disintegrating tablets were prepared by Wet granulation Technique and evaluated for hardness, friability, weight variation, thickness, disintegrating time (DT), In-vitro dispersion time and  dissolution rate. The results of Direct compression optimized formulation WG9 (Sodium Starch Glycolate 15mg and Starch paste 18mg) has shown the % Drug release of  99.97%, In-vitro Dispersion time of 16 Secs respectively.

Keywords: Solid dispersions, fast disintegrating tablets, Labetalol, Crospovidone, Croscarmellose sodium and Sodium starch glycolate.