Formulation Development and Validation of Metformin hydrochloride and Gliclazide sustained release bilayer tablet.

摘要

ABSTRACT The aim of this study was to Design and Process Validate Bi-layer Tablet of Metformin Hydrochloride (MTH) and Gliclazide (GZ) effective for the treatment of Non-Insulin Dependent Diabetes Mellitus (NIDDM). For formulation of bi-layer tablet, initially both layer optimized individually. MTH and Gliclazide were formulated as sustained release layers (L1 and L2) by using various Hydrophilic polymers such as Methocel CR, HPMC K100, HPMC 15Cps and Methocel K100 LV. The effect of concentration of hydrophilic matrix (Methocel CR, HPMC 15Cps), binder (Polyvinyl Pyrollidone [PVP K90/PVP K30] on MTH and GZ drug release rate from matrix system was studied. The dissolution study of sustained release layer showed that an increasing amount of Methocel CR and HPMC or PVP K30/90 results in reduced drug release. Optimized batch of both drug formulations were used for formulation of bi-layer tablet. The rational for formulation of bi-layer tablet of these two drugs in combination was from class second generation sulphonylureas and biguanides was suitable for the treatment of NIDDM. Bi-layer tablet was suitable for preventing direct contact of these two drugs and maximize the efficacy of combination of two drugs for treatment of NIDDM. Keywords: Metformin Hydrochloride, Gliclazide, Bi-layer Tablet, Methocel CR, PVPK30/90.