title: Formulation and evaluation of s-(-)-amlodipine besylate and nebivolol hydrochloride tablets.
abstract: 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.
authors.affiliation: Jeevanjyoti Pharmaceutical, Aurangabad, Maharastra, India.
authors.forename: S A
authors.initials: SA
authors.lastname: Shaikh
authors.forename: S S
authors.initials: SS
authors.lastname: Shaikh
authors.forename: S R
authors.initials: SR
authors.lastname: Shahi
authors.forename: M A
authors.initials: MA
authors.lastname: Shookur
authors.forename: L K
authors.initials: LK
authors.lastname: Reddy
authors.forename: A N
authors.initials: AN
authors.lastname: Padalkar
authors.forename: Mahesh
authors.initials: M
authors.lastname: Thube