Abstract

FORMULATION AND EVALUATION AND STABILITY STUDIES OF BILAYER TABLETS OF METFORMIN AND LINAGLIPTIN

Ch. Sai Babu*

Abstract

The present study was to establish Bi-layer tablets of Metformin HCl and Linagliptin of which Metformin HCl as sustained release and Linagliptin as immediate release layer. Sustained layer were prepared by wet granulation method using Eudragit’s as polymers, immediate release layer were prepared by direct compression method using super disintegrants such as cross carmellose sodium and sodium starch glycollate. The tablets were evaluated for Bulk density, Tapped density, Compressibility index, Hausner ratio, and Angle of repose. All the values were found within limits of standard. In vitro release studies were carried out by USP type 2 paddle apparatus. The results showed that Eudragit’s in sustained layer can control the release of drug. The in vitro release profile of drug from sustained release layer could be expressed by higuchi’s equation as pilot show high linearity R2 =0.9911and diffusion was the dominant mechanism of drug release. The formulation (F6) having immediate release layer produces immediate effect 94.53 ± 0.30 within 45 minutes followed by sustained release effect 95.77 ± 0.37 up to 8 hours. The present study concluded that Bilayer tablets of Lingaptin and Metformin HCl can be a better alternative to conventional dosage form for providing sustained drug delivery.

Keywords: Bilayer tablet, linagliptin, Metformin HCl, Sustained Release, immediate release Higuchi equation.