@article{SHAIKH_2016, title={FORMULATION AND DEVELOPMENT OF S-(-)-AMLODIPINE BESYLATE TABLETS TO IMPROVE THE DISSOLUTION PROFILE}, volume={1}, url={https://asiapharmaceutics.info/index.php/ajp/article/view/752}, DOI={10.22377/ajp.v1i1.752}, abstractNote={<p>The object ive of the present study was to develop a tablet formulat ion of S- ( - ) - amlodipine besylate<br />chiral separation drug, L-Type Calcium channel blocker for better management of hypertension and also<br />suitable in the treatment diabetic hypertension patients, while reducing or avoiding undesirable adverse<br />effects, such as headache and edema, dizziness, flushing, palpitation, fatigue, nausea, abdominal pain<br />and somnolence which are often associated with administration of a racemic mixture of amlodipine. The<br />R (+) enantiomer lacks or has a lower level of antihypertensive activity.<br />I n the present study S- ( - ) - amlodipine besylate 5.0 mg tablets have been formulated and developed<br />using wet granulation and direct compression techniques respectively, to provide a safe, highly effective<br />method for treating severe hypertension while reducing undesirable adverse effects. Pre and post formulation<br />parameters were studied for the formulated batches. The study was also carried out to design<br />a suitable dissolution medium for S-(-)- amlodipine besylate. S-(-)- amlodipine besylate had maximum<br />solubility in pH 1.2 and thus the most suitable media for S-(-)- amlodipine besylate dissolution studies.<br />The dissolution profile of the formulated formulation was compared with the marketed preparation. The<br />results indicated improved dissolution profile of formulation (WMS3). The RSD below 2% indicated insignificant<br />batch-to-batch variation. The accelerated stability study of the optimized formulation was performed<br />as per the ICH guidelines. The results indicated no change in optical rotation of S-(-)- amlodipine<br />besylate.</p>}, number={1}, journal={Asian Journal of Pharmaceutics (AJP)}, author={SHAIKH, S. A.}, year={2016}, month={Sep.} }