Rapimelts of Venlafaxine Hydrochloride- An Approach to Formulation and In-vitro Evaluation

Abstract

The present research workwas designed to manufacture venlafaxine hydrochloride rapimelts using different super disintegrants by direct compression method. The superdisintegrants used were sodium starch glycolate Primogel croscarmellose sodium Ac-Di-Sol and crospovidone Polyplasdone XL10 in varying concentrations of 2-5. In total nine formulations of venlafaxine hydrochloride rapimelts were prepared. The preformulation studies were conducted for the prepared blends and were found satisfactory. The formulated tablets of venlafaxine hydrochloride were evaluated for parameters like friability hardness disintegration time wetting time water absorption ratio disintegration time drug content and drug release. All the evaluated parameters were found within the limits. Amongst therapimelts prepared R-IX containing 5 of crospovidone showed 100 of drug release within 20 min and was optimized as the best formulation. The rapimelts of optimized formulation was subjected for accelerated stability studies as per ICH guidelines for a period of 180 days and then evaluated for hardness wetting time water absorption ratio and in vitro dispersion time. No significant changes in the evaluated parameters indicate that the formulation was found functionally stable.