FORMULATION AND EVALUATION OF FAST DISSOLVING TABLET CONTAINING AMLODIPINE BESYLATE SOLID DISPERSION Research Article

The purpose of the present investigation was to increase the solubility and dissolution rate of amlodipine besylate by the preparation of its solid dispersion with PEG 4000, PVP K-30 using kneading process. Drug polymer interactions were investigated using differential scanning calorimetry (DSC) and fourier transform infrared spectroscopy (FTIR). Surface morphology of solid dispersion particles was determined by SEM study. Dissolution rate of solid dispersion was determined in PBS 6.8. The obtained results showed that dispersion of the drug in the polymer considerably enhanced the dissolution rate. The drug-to-carrier ratio was the controlling factor for dissolution improvement. FTIR spectra revealed no chemical incompatibility between the drug and PVP K-30, PEG 4000. As indicated from DSC data, amlodipine besylate was in the amorphous form, which explains the better dissolution rate of the drug from its solid dispersions. For the preparation of amlodipine besylate fast dissolving tablets, solid dispersion in the ratio of 1:2:2 with PVP K-30 and PEG 4000 was used with various superdisintegrants(croscarmellose sodium, microcrystalline cellulose and crospovidone). Dissolution profile of optimized mouth dissolving tablet was compared with the marketed formulation of amlodipine besylate(amdepin®) and the results obtained were better than the marketed formulation. Thus it justified the potential of solid dispersion technique in enhancing the bioavailability of drug.