Formulation and In-vitro Evaluation of Fast disintegrating Tablets using Sertraline Hydrochloride as a model Drug

The present study was aimed towards the formulation and invitro evaluation of rapidly disintegrating Sertraline hydrochloride, a new antidepressant as a model drug. Fast disintegrating tablets of sertraline hydrochloride was formulated using 5% and 10% concentration of superdisintegrants like Crospovidone, Croscarmellose sodium, Prgelatinized starch, low-substituted hydroxy propyl cellulose (L-HPC) and Sodium starch glycolate. A novel diluent (a combination of mannitol and silicified microcrystalline cellulose(SMCC)) in the ratio 70:30 was used in the study. All the formulations were prepared by direct compression method (Rimek II minipress) using 9.5mm flat-faced punches. Prepared tablet were evaluated for thickness, hardness, friability, uniformity of weight, disintegration time, wetting time, drug content and dissolution study. Disintegration time, wetting time and in vitro drug release were taken as the basis to optimize the best fast disintegrating formulation. Formulations containing crospovidone and croscarmellose sodium displayed shortest disintegration and wetting time and maximum dissolution compared to other disintegrants. Optimized formulations (S2and S4) were subjected to stability studies for thirty days which showed stability with regards to release pattern. Overall results suggests that a 10% disintegrant concentration is suitable for the preparation of sertraline hydrochloride fast disintegrating tablets and the tablets containing disintegrants Crospovidone (S2) and croscarmellose sodium (S4) are the best.