Abstract
Amlodipine besylate is a recognized drug for hypertension therefore development of an ODT of Amlodipine besylate and to evaluate the effect of various superdisintegrants on its disintegration time and release profile was the prime objective of this research work. Tablets were prepared by direct compression technique using three different superdisintegrants. Sodium starch glycolate, Croscarmellose sodium and Crosspovidone XL-10 were used as superdisintegrants in combinations to achieve optimum release profile, disintegration time and hardness. Direct compression process was selected for this formulation of ODT tablets, because porous nature is more in direct compression blend than wet granulation blend, so it will give faster disintegration. Microcrystalline cellulose was used as diluent and mannitol, mint flavor and sodium saccharin were used to enhance the organoleptic properties of tablets. The tablets were evaluated for weight variation, hardness, friability, in-vitro disintegration time and drug release characteristics. Hardness and friability data indicated good mechanical strength around 3 kg/cm2 for all the batches. The results of in-vitro disintegration time indicated that the tablets dispersed rapidly in mouth within 60s. Dissolution study revealed release rate of drug from the tablets was comparable with marketed tablet formulation of Amlodipine besylate. It was concluded that superdisintegrants addition technique is a useful method for preparing orally disintegrating tablets by direct compression method.
