Abstract

Over the past 38 years, as the expense and complications involved in marketing new drug entities have increased, with concomitant recognition of the therapeutic advantages of novel drug delivery, greater attention has been focused on development of a modified release drug delivery systems. A mucoadhesive controlled release device can improve the effectiveness of drug by helping to maintain a drug concentration between the effective and toxic level, inhibiting the dilution of drug in the body fluid and allowing targeting and localizing of a drug at a specific site. The objective of the present study is to formulate the mucoadhesive Bilayer tablets of Metformin Hydrochloride and Glyburide .The mucoadhesive sustained release layer was formulated with Metformin Hydhochoide, along with Na-CMC and HPMC in combination as mucoadhesive polymers with ethyl cellulose as insoluble polymer to maintain the integrity of tablets. The immediate release layer was formulated with Sodium Starch Glycolate as super disintegrants. The bilayer tablets were formulated using wet granulation technique for mucoadhesive layer and direct compression for immediate release layer. All the physicochemical properties of the tablets were evaluated. The exvivo technique use to study the mucoadhesive strength and duration of the tablets against bovine intestine. From the study it found that the Formulation F2 with Na-CMC: HPMC in ratio 4:1 in mucoadhesive layer shows release of 89.17% of Metformin Hydrochloride in 12 hrs and 4% Sodium starch glycolate shows maximum release of 98.07% of Glyburide in first 10 minutes. The drug release follows the Higuchi release model and n value showed anomalous release profile. The swelling index increases with increase in the concentration of anionic polymers and its combination with non-ionic polymers. Increase in the swelling index leads to increase in mucoadhesion of the tablets. The mucoadhesion strength was found to be maximum for F2 formulation (0.287 N) and the tablet adhere to the membrane for more than 10 hrs. Effective mucoadhesive bilayer tablets were formulated using HPMC, Na CMC to deliver the drug for more than 10 hrs at the targeted site.

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