%0 Journal Article
%T FORMULATION AND EVALUATION OF S-(-)-AMLODIPINE BESYLATE AND NEBIVOLOL HYDROCHLORIDE TABLETS
%A Shaikh S.A
%A Shaikh S.S
%A Shahi S.R.
%A Shookur M.A.
%J Journal of Advanced Pharmaceutical Technology & Research
%D 2010
%I Medknow Publications
%X The objective of the present study was to develop a tablet formulation of S-(-)- amlodipine besylate chiral separation drug and nebivolol hydrochloride for better management of hypertension, while reducing or avoiding undesirable adverse effects, which are often associated with administration of a racemic mixture of amlodipine. The composition containing the optically pure S-(-)- isomer of amlodipine 2.5 mg has calcium channel blocking activity and, nebivolol hydrochloride 5 mg has beta-receptor blocking activity.The study was also carried out to design a suitable dissolution medium for S-(-) - amlodipine besylate and nebivolol hydrochloride. Amlodipine besylate and nebivolol hydrochloride had maximum solubility in pH 1.2 and thus pH 1.2 was selected as the most suitable media for S-(-) - amlodipine besylate and nebivolol hydrochloride dissolution studies. The RSD below 2% indicated insignificant batch-to-batch variation. The accelerated stability study of the optimized formulation was performed as the ICH guidelines. The results indicated no change in optical rotation of S-(-) - amlodipine besylate. Hence, combination of two drugs can be formulated into the tablet by wet granulation technique having satisfactory release profile.
%K Tablet
%K S-(-) - amlodipine besylate
%K nebivolol hydrochloride
%K combination therapy
%K dissolution
%K wet granulation.
%U http://www.japtr.org/Manuscripts/Formulation%20and%20Evaluation%20of%20S-(-)-Amlodipine%20Besylate%20and%20Nebivolol%20Hydrochloride%20Tablets.pdf