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ORIGINAL ARTICLE
Year : 2010  |  Volume : 1  |  Issue : 2  |  Page : 199-206

Formulation and evaluation of S-(-)-Amlodipine besylate and nebivolol hydrochloride tablets


1 Jeevanjyoti Pharmaceutical, Aurangabad, Maharastra, India
2 Kamla Nehru College of Pharmacy, Aurangabad, Maharastra, India
3 Government College of Pharmacy, Aurangabad, Maharastra, India
4 Mulana Azad College of Arts and Science, Aurangabad, Maharastra, India

Correspondence Address:
S A Shaikh
Jeevanjyoti Pharmaceutical, Aurangabad, Maharastra
India
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Source of Support: None, Conflict of Interest: None


PMID: 22247846

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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.


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