Formulation and evaluation of bilayered tablets of sustained release metformin HCl and gliclazide

Abstract

The aim of the present work is to formulate and evaluate a bilayered tablet (BT) ofMetformin HCl as Sustained release and Gliclazide as Immediate release (IR). The polymer usedin sustained release is HMPC K100M and the super disintegrate used in immediate release inproportion of Gum Karaka & Croscarmellose sodium by direct compression method. In thisstudy, a bilayered tablet containing Gliclazide in IRL and Metformin in SRL was made using thewet granulation method, with the goal of making the formulations IRL as small as possible, Willrelease Gliclazide as soon as possible to combat postprandial hyperglycemic level, followed bysteady-state plasma glucose management by Metformin with along-termrelease. The hardnessof the different formulations ranged from 7.5-8.5 kg/cm. All the formulations exhibited less than1% friability. The drug content analysis of Metformin and Gliclazide in all formulations wasfound within the IP limits (±5%) which indicate that the drug was uniformly distributed in thetablets. The inviter dissolution study was performed for layer I (Metformin) up to 12 hrs (afterevery 1hour intervals) and for layer II (Gliclazide) up to 40 min (after every 5 min interval). Thebilayered tablet contributing initial loading dose and dissolves rapidly, the remainder of the drugin the extended release was constant rate till the end of the dissolution process. The I.R spectraprovedthattherewasno interactionbetweenthepolymer,Excipients andMetformin,Gliclazide.