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Abstract

“FORMULATION, DEVELOPMENT AND EVALUATION OF BILAYER FLOATING-BIOADHESIVE TABLETS OF CINNARIZINE.”

*Ashish Arvind Mahajan, Bhushan Ashok Patil, Pallavi Shankarrao Gadhave, Shubhangi Ramesh Patil.

ABSTRACT

The aim of the present research was to develop a bilayer floating-bioadhesive drug delivery system exhibiting a unique combination of floatation and bioadhesion to prolong residence in the stomach using Cinnarizine as a model drug. In bilayer tablet formulation, the Floating sustained layer was compressed and granules of the immediate release layer was added to it then both layers were compressed using a tablet Rimek Mini Press. Granules and tablets were characterized using the official method. The immediate release layer contain Cinnarizine, Sodium starch glycolate and Dicalcium phosphate and floating sustained release layer contains different polymers, such as HPMC K15M, HPMC K100M, Carbopol 974P, Chitosan and its combinations were tried in order to get the desired sustained release profile over a period of >12h, Sodium bicarbonate and Citric acid was used as effervescent system. The in vitro drug release, buoyancy lag-time, detachment force, Swelling ability, floating behaviour, adhesion period determination carried out in 0.1 N HCl (pH 1.2) at 37 ± 0.5 0C. The optimized formulation was subjected to stability 40 0C/75% RH for 3 months according to ICH guidelines and evaluated for physical parameters, drug content, in-vitro drug release and floating behaviour. In-vivo study was performed using New Zealand Albino rabbits by X-ray imaging technique. Tablet containing 25% barium sulphate was evaluated for in-vivo floating study.

Keywords: Cinnarizine, Bilayer floating-bioadhesive tablet, Release-retarding polymers, Detachment force.


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