Formulation and Stability Studies of Fast Disintegrating Tablets of Amlodipine Besylate

Abstract:

Introduction: Among tablets, fast dissolving technology has gained considerable popularity due to their rapid onset of action. Amlodipine besylate (ADB) is a longacting calcium channel blocker that is used in the treatment of angina and hypertension which are life-threatening conditions and require immediate relief. Currently, no fast dissolving tablet dosage form of ADB is commercially available. Methods: A total of seven fast disintegrating tablets of Amlodipine besylate (ADB) have been prepared by direct compression method employing various excipients (Disintegrants and binders) in different concentrations. Pre-compression and post-compression studies were performed along with the storage in the stability chambers under real (30±2ºC / 65±5% RH) and accelerated conditions (40±2ºC / 75±5% RH) for six months. The assay of ADB was performed using a validated UV spectrometric method at 361 nm. Results: The release of ADB from tablets has been found to be very fast with almost more than 85% drug released within 15 min. The release of drug from all the tablet formulations followed Higuchi model. Conclusion: The use of sodium bicarbonate as super disintegrant has greatly promoted the rapid release of the active drug. The binder has been shown to affect the tensile strength of the tablets. The stability studies for six months in aluminum blister packaging indicated no significant change in concentration in the majority of the formulations. This study provides basic groundwork related to the formulation of fast disintegrating tablets of ADB.

Key words: Amlodipine besylate, Direct compression, Drug release, Fast disintegrating tablets, Model dependent and independent methods, Pre-compression and postcompression studies.