FORMULATION DEVELOPMENT AND EVALUATION OF BIO-ADHESIVE CARBOPOL 974P NF POLYMER MATRIX BASED SUSTAINED RELEASE GLICLAZIDE TABLET

Abstract

The aim of the present study was to develop a sustained release bio-adhesive matrix based Gliclazide tablet to match the in-vitro and ex-vivo
experimental profile, and can be used to the treatment of Type II Diabetes Mellitus. It will be expected that single Gliclazide tablet reduce
glycosylated hemoglobin and overcoming individual large fluctuation of oral bioavailability. Eleven types of tablets were formulated by wet
granulation technique which contains 30 mg of Gliclazide and different concentrations of diverse bio-adhesive polymers which conforming to the
USP/BP monograph. The prepared tablets were evaluated for their physicochemical parameters, bio-adhesive behavior and also in-vitro release
pattern and ex-vivo residence time. Formulated F-6 tablet (300 mg) contains 30 mg Gliclazide, 90 mg Carbopol 974P NF, 155 mg Lactose, 15 mg
Povidone, 5 mg Magnesium Stearate and 5 mg Talc. Carbopol based F-6 tablets showed highest significance adherence (164.1 gm) property and also
exhibited greater than 300 minutes ex-vivo residence time. In-vitro release pattern of F-6 formulation was 44.74% (Mean Dissolution Time 52.86 hrs
which was studied for 8 hours in phosphate buffer media at pH 7.4. Different kinetic models including zero order, first order, Higuchi and Korsmeyer
pattern were applied to evaluate drug release behavior. Zero order and Korsmeyer pattern indicated most appropriate model for describing the release
profile of F-6 formulation. The drug release mechanism was consequently found to be diffusion, swelling and erosion. The results point out that
Carbopol 974P NF bio-adhesive matrix Gliclazide tablets have marked sustained release properties.