DESIGN, CHARACTERIZATION AND EVALUATION OF POLYMORPHISM OF AMLODIPINE BESYLATE
The present work was undertaken with the aim to study the solubility of different crystal forms of Amlodipine besylate, a new class of widely used anti-hypertensive agents. It was planned to prepare crystal forms using solvents of varying polarity and by change of phase, to characterize the crystal forms using techniques like Scanning Electron Microscopy, FTIR spectroscopy, differential scanning calorimetry and X-Ray Diffractometry and to study the dissolution profile of the crystal forms. Since tablet is the most common formulation available for Amlodipine besylate, it was also planned to evaluate the impact of the differing crystal morphology on the formulation behavior of the Amlodipine besylate. These polymorphs have shown differences in their dissolution profiles. Among the polymorphs Amlo-1 and Amlo–3 were metastable polymorphs which shown much better dissolution profiles than Amlo-2, Amlo-4 and Amlo-Pure. Amlo-2 and Amlo-4 were stable polymorphs and shows slow dissolution characteristics profiles. All the obtained polymorphs have shown differences in the dissolution and disintegration patterns of the tablet.