DESIGN AND EVALUATION OF VALSARTAN FAST DISSOLVING TABLETS BY DIRECT COMPRESSION METHOD

Article history Valsartan is an angiotensin II type 1 receptor antagonist indicated in the treatment of hypertension and mild to moderate heart failure of ischamatic or cardiomyopatheic origin. The bioavailability of valsartan is 23% indicating extensive first pass metabolism in liver. In the present research work an attempt has been made to prepare fast dissolving tablets of valsartan by using direct compression technique using sodium starch glycolate, croscarmellose sodium, kyronT-314 and crospovidone are used as a superdisintegrants. The prepared tablets were evaluated for pre and post-compressional parameters. The values of pre-compression parameters evaluated were within prescribed limits and indicated good free flowing property. All the post compression parameters are evaluated were prescribed limits and results were within IP acceptable limits. The drug content uniformity was in between 97.90 to 99.90 %, water absorption ration were found between 51 to 80% and wetting time between 13 to 61 sec. Rapid disintegration within several minutes was observed in all the formulations. The in-vitro disintegration time of fast dissolving tablets were found to be 17 to 71 sec. which is in the range of fulfilling the official requirements. By the addition of superdisintegrants the disintegration time increased significantly (P<0.05) tablets prepared.IR spectral analysis the pure drug characteristic absorption bands of formulations absorption bands have shown all most same range. As there is no variation and shift in the position of characteristic absorption bands it can be justified there is no interaction between drug and polymer. The DSC results shows that there was no drug interaction with the formulation additives of the tablet, drug. After three month the tablets were again analyzed for the hardness, friability and disintegration time. Short term stability studies on the formulations indicated that there are no significant changes in hardness, friability and dispersion time (p<0.05). The above results concluded that, although differences existed between the superdisintegrants, the fast dissolving Valsartan tablets could be prepared by using any of the superdisintegrants used. Among all the formulation DCP4 (6 % CP) were found to be promising and showed a disintegration time of 17 sec, 50 % of drug released in 7.52 min, and 90 % of drug released in 12.60 min.