Formulation and Evaluation of Gliclazide Immediate Release and Metformin Sustain Release Bilayer Tablet
The aim of the present work is to formulate and evaluate a bilayer tablet BT of Metformin HCl as Sustained release and Gliclazide as Immediate release IR . The polymer used in sustained release is HMPC K100M and the super disintegrant used in immediate release in proportion of Gum Karaya and Croscarmellose sodium by Direct compression method. The Preformulation studied, Bulk density, Tapped density, Housner’s ratio, Carr’s index, Angle of repose and UV of Metformin HCl and Gliclazide is performed. In this study, a bilayer tablet containing gliclazide in IRL and metformin in SRL was made using the direct compression method, with the goal of making the formulations IRL as small as possible. Will release gliclazide as soon as possible to combat postprandial hyperglycaemic level, followed by steady state plasma glucose management by Metformin with a long term release. The hardness of the different formulations ranged from 7.5 8.5 kg cm. All the formulations exhibited less than 1 friability. The drug content analysis of Metformin and Gliclazide in all formulations was found within the I P limits ±5 which indicate that the drug was uniformly distributed in the tablets. The in vitro dissolution study was performed for layer I Metformin up to 12 hrs after every 1hour intervals and for layer II Gliclazide up to 40 min after every 5 min interval . The bilayer tablet contributing initial loading dose and dissolves rapidly, the remainder of the drug in the extended release was constant rate till the end of the dissolution process. The DSC and I.R spectra proved that there was no interaction between the polymer excipients and Metformin, Gliclazide. The stability study of Formulation F4 showed after three months that there was no degradation and the drug was stable under accelerated and real time stability conditions.
Bilayer tablet, Immediate release layer, Sustain release layer
Gajanan Ramasane | Sujit Kakade | Ashok Bhosale