Abstract

DESIGN AND DEVELOPMENT OF BILAYERED TABLETS OF AMLODIPINE BESYLATE AND METOPROLOL SUCCINATE

Dr.B.Venkateswara Reddy, K.Navaneetha, K.Venkata Ramana Reddy, P.Poli Reddy

Abstract

The present work aims to develop a bilayer dosage form containing one immediate release drug amlodipine besylate and another extended release drug metoprolol succinate. The immediate release layer was prepared by using micro crystalline cellulose, sodium starch glycolate, crosspovidone and dicalcium phosphate. The sustain release layer was prepared by using HPMC K15, Sodium CMC, Carbopol. FTIR studies for the drug and polymers shows that they are compatible. The optimized formulations from both layers are used to prepare the bilayer tablet. The prepared tablets are evaluated for various properties. Release of Metoprolol Succinate from the tablets formulated by employing Carbopol and PEO showed that the drug release was as per within the USP limits. So formulation M7 is concluded as optimized formulation for sustained release. Amlodipine besylate from the tablets formulated by employing dicalcium phosphate, MCC and sodium starch glycolate showed that the drug release was as per within the USP limits. So formulation A8 is concluded as optimized formulation for immediate release. And for further study batch A8 and M7 were used for tableting a bilayered formulation which is subjected to post compression and In-Vitro dissolution studies by HPLC. The release kinetics of optimized formula (A8M7) showed nonfickian transport and followed Higuchi model. Thus it can be concluded that the combination therapy uses lower doses of drug to reduce the patient’s blood pressure.

Keywords: Amlodipine besylate; Metoprolol succinate; Immediate release; Extended release; Bilayered formulation; Non-fickian transport; Higuchi model