Formulation and Evaluation of Amlodipine Besylate tablet by Direct Compression Method
Background: Amlodipine is an antihypertensive agent usually used in all types of hypertension. The drug belongs to Calcium Channel Blockers. It inhibits the calcium influx through the cell membrane. Apart from hypertension, the drug is also beneficial in other heart ailments.
Objective: The purpose of the study is to formulate and evaluate Amolodipine Besylate prepared by direct compression method.
Methodology: Non-active ingredients were blended with the active and tablets were formulated using direct compression technique. The manufacturing formula contain Amlodipine besylate 10mg, microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, cross carmellose. For evaluation in process and finished product tests were conducted. The tests include weight variation test, thickness test, hardness test, disintegration and as well as assay using UV spectrophotometer.
Result and Conclusion: The results of the newly formulated drug were found to be within the pharmacoepeial limits. Weight variation, disintegration test, thichkness test, hardness test, friability tests and assay all showed results in compliance with the BP/USP. Hence, concluded that amlodipine formulated via direct compression technique showed similar results to those formulated via granulation technique.
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