Abstract

FORMULATION DESIGN AND OPTIMIZATION OF MOUTH DISSOLVING TABLETS OF TELMISARTAN USING SOLID DISPERSION TECHNIQUE

*Ananda Chaudhary, Mukesh Sangra, Sandeep Kumar

Abstract

The purpose of this research was to formulate mouth dissolving tablet of Telmisartan for rapid action, beneficial for patients having difficulties in swallowing and in conditions where access to water is difficult. Telmisartan is an antihypertensive drug used for the treatment of hypertension. The crucial aspect in the formulation of mouthdissolving tablets is to mask the bitter taste and to minimize the disintegration time while maintaining a good mechanical strength of the tablet. Solid dispersion was prepared to increase the solubility and dissolution rate of Telmisartan with Poloxamer188 (PXM188) by using fusion method. Drug polymer interactions were investigated using differential scanning calorimetry (DSC), x-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR). For the preparation of Telmisartan mouth dissolving tablets, its 1:3 solid dispersions with PXM188 was used with various synthetic superdisintegrants (Croscarmellose sodium, SSG). In an attempt to construct a statistical model for the prediction of wetting time, disintegration time and percentage friability, a 32 full factorial design was used to optimize the influence of the amounts of superdisintegrants. The results indicate that the optimized tablet formulation provides a DT 45 sec, WT 65 sec, cumulative percentage drug release 96.23% and acceptable friability (0.82%). Stability studies of optimized formulation revealed that formulation is stable.

Keywords: Telmisartan, PXM188, solid dispersion, Fusion method, Mouth dissolving tablets, factorial design.