Abstract

FORMULATION AND EVALUATION OF BI LAYER FLOATING TABLETS OF AMLODIPINE BESYLATE AND METFORMIN HYDROCHLORIDE

Meghana. S *, S.Srilatha.

ABSTRACT

The main aim of present study is to formulate and evaluate bilayer tablets of Metformin Hydrochloride and Amlodipine Besylate as fixed dose combination tablets for effective treatment of type II diabetes mellitus and for hypertension. Preformulation studies including drug excipient compatibility were conducted for both drugs. Different formulations of sustained release, floating Metformin Hcl tablets were prepared by using hydrophilic polymers like HPMC K4m etc., were evaluated. Amlodipine immediate release formulations were prepared using crosspovidone, croscarmellose sodium and sodium starch glycolate as superdisintegrants and were evaluated. Based on the in vitro dissolution data F3 and F6 were selected as the best formulations from Metformin and Amlodipine formulations respectively. From the bilayer tablet Amlodipine layer disintegrated in 60 sec, Metformin layer started floating after 5 min and gave total floating time 18-24 hrs with good swelling index, good post compression parameters. In vitro dissolution study of bilayer tablet was done in USP type II along with UV spectrophotometer gave cumulative % drug release of Amlodipine as 98.75% at 60 min and 99.32 % of Metformin at 12 hrs. From the study it was found that, HPMC K4m shows good sustained release for 12 hrs. Among the disintegrants used sodium carboxy methyl cellulose showed good disintegration of Amlodipine layer.

Keywords: Amlodipine Besylate, Metformin Hydrochloride, sodium starch glycolate, HPMC K4M, dissolution studies, sustained release.