FORMULATION AND DEVELOPMENT OF FLOATING DRUG DELIVERY OF ITOPRIDE HCL

Abstract

The aim of current research was to formulate floating tablets of Itopride hydrochloride using an effervescent approach for gastroretentive drug delivery system, as it is gastroprokinetic drug, the site of action is stomach and as the drug pH ranges from 3.5 to 5.5. It was formulated as hydrodynamic balanced tablet using sodium bicarbonate and citric acid as gas generating agent, HPMC as hydrophilic polymer and Xanthan gum as drug release retarding agent with an objective to control the drug release and restrict the region of drug release to stomach. Tablets were prepared by direct compression method. Drug Excipient compatibility study was confirmed by FTIR & DSC studies. Floating  tablets were prepared  by direct compression  using  3² factorial design using different polymers as independent variables in which HPMC K4M, Xanthan gum were used for maintaining drug release and dependent variables  as % drug release, floating lag time & swelling index. The floating tablet formulations were evaluated for physical characterization, assay, swelling index, inâ€vitro drug release, hardness, friability, weight variation.  The formulations were investigated for % drug release, floating lag time by in-vitro dissolution study. Formulation was optimized on basis of acceptable tablet properties and in vitro drug release. Formulation F1 was selected on basis of factorial design dependent variable i.e. % drug release, floating lag time & swelling index.