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Formulation and development of sustained release bilayer tablet for biphasic drug release: A novel approach in management of diabetes

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Author(s): Durga Prasad Pattanayak1*, Subas Chandra Dinda 1, Ulna Laxmi Narayan2

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 7;
Start page: 2025;
Date: 2011;
Original page

Keywords: Metformin HCl | Glimepiride | Sustained release | Bilayer tablets.

ABSTRACT
The present study involves designing and develop of a bilayer tablets of glimepiride (GLP) and metformin HCl (MHCl) to offer immediate release of GLP and sustained release of MHCl. Bilayer tablets consists of two layers, i.e immediate release layer made by using superdisintegrant sodium starch glycolate and sustainedrelease layer designed as matrix formulations with polymers polyethyleneoxide and polyvinylpyrrolidone to modulate the drug release. Wet granulation method was employed to make bilayer tablets. Fourier transform infrared spectroscopy (FTIR), X-ray diffractometry (XRD) and Differential scanning calorimetry (DSC) were used for the physicochemical compatibility and stability study of the tablets. Accelerated stability studies were followed in compliance with ICH guidelines. The in-vitro release profile shows desired biphasic release behaviour. GLP was dissolved in 45 min and MHCl releases up to 12 h. FTIR, XRD and DSC data for the final formulations indicate good compatibility and stability. These tablets exhibit no change either in physical appearance or dissolution pattern after storage ataccelerated condition (40±2°C / 75±5%RH) for 6 months. Therefore, biphasic drug release pattern was successfully achieved through the formulation of bilayer tablets that are stable and capable of releasing the drug over 12 h.
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