Formulation and Evaluation of Taste Masked Orodispersible Tablets of Amlodipine Besylate by Direct Compression

The purpose of this investigation was undertaken to design a simple, rapid, cost effective and highly efficient process to fabricate intensely bitter taste of Amlodipine Besylate by complexing drug with Aminoalkyl methacrylate copolymer (Eudragit EPO) in different ratios by Hot-Melt Extrusion method. Taste masked complex were analyzed with FTIR, DSC and XRD. DCP were tested for Hardness, Thickness, Weight Variation, Drug Content, Water absorption and In vitro Dispersion Test in Simulated Salivary Fluid pH 6.8. Taste masked granules were directly compressed into tablets using Kollodion CL and Croscarmellose Sodium (Ac-Di-Sol) as superdisintegrants. Tablets of batch F6 containing mannitol and 6% wt/wt of Kollodion CL showed faster disintegration with in 24 sec and drug release (t90, 180sec) at Phosphate Buffer pH 6.8. The observed polymer interaction and reduced crystallinity may be reason for increased dissolution rate. Thus results conclusively demonstrate successful masking of taste, disintegration and dissolution of the formulated tablets.