Formulation Optimization and Evaluation of Immediate Release Tablet of Telmisartan

Abstract

Telmisartan is an angiotensin-II receptor antagonist used in the treatment of hypertension. The goal of this research work was to develop the formulation as immediate release tablet of telmisartan by using the superdisintegrants by design of experiments. The FTIR study revealed that there was no interaction between drug and polymer and combination can be safely prepared. Tablets were prepared by using direct compression method. Tablets were evaluated for hardness, thickness, weight variation, disintegration time, drug content, friability and in vitro drug release. All the physical parameters were in acceptable limit of pharmacopoeial specification. A Central Composite Design (CCD) was selected to optimize the formulation B6 which showed the in-vitro drug release 97.16% at 30 min. The two factors croscarmellose sodium and microcrystalline cellulose were varied as required by the experimental design. A composition was selected as optimized formulation (N1), which was compared with the conventional tablet (10% MCC) formulation, while difference (F1) factor and similarity (F2) factor found to be 6.96 and 60.5 respectively. The optimized formulation (N1) was showed in-vitro drug release of 97.74% at the end of 30 minutes, while disintegration time of the tablet was showed 19 sec comparison to other formulations. Further the drug release of immediate release tablets was compared with the drug release profile of conventional tablet which was prepared by using 10% micro crystalline cellulose (MCC) as disintegrating agent.