Abstract
Fast disintegrating tablets (FDTs) dissolve or disintegrate in the mouth without the need of additional water. The aim of the present study was to formulate FDTs of Valsartan for the treatment of hypertension in children who could find difficulties in swallowing conventional solid dosage forms. The tablets were prepared by wet granulation technique. Superdisintegrants such as sodium starch glycolate (SSG) and crospovidone were optimized as 5% on the basis of least disintegration time. Different binders such as gelatin and HPMC k15m, at varying concentrations, were used along with the optimized superdisintegrant concentration. All the formulations were evaluated for content uniformity, disintegration time, friability, hardness and in vitro dissolution. In addition, the antihypertensive efficacy of optimized formulation(s) was investigated in vivo. The results of the physical parameters were found to be within the acceptable range. In vitro dissolution studies showed that increasing the concentration of superdisintegrant decreased the disintegration time, and thereby, promoted faster drug release from tablets. On the other hand, increasing binder concentration adversely hindered drug release from the tested formulations. Of interest, optimized formulation(s) of Valsartan FDTs rapidly and efficiently reduced the blood pressure in hypertensive rats. Collectively, FDTs could represent a potential drug delivery vehicle for the management of pediatric hypertension, in tandem with, alleviating the problems encountered with the administration of conventional oral solid dosage forms to children.