PREPARATION OF SUBLINGUAL TABLET OF FELODIPIN

Abstract

This study was conducted to prepare orally disintegrating tablets containing the solid dispersion system of felodipin by wet granulation method. The solid dispersion system of felodipin was prepared by solvent evaporation method. We investigated the effects of water-body polymers used as carriers, including PVP K30, HP β - cyclodextrin, PEG 6000 and the ratio of the active substance Lutrol F127 on the solubility of felodipin from the solid dispersion system. We studied the effect of the type and rate of super-disintegration excipients, including crosscarmellose sodium, sodium starch glyconate, L-HPC and the rate of filled excipients including lactose, manitol on the rate of felodipin release and disintegration time of tablets. We evaluated the solubility of felodipin from tablet in pH 6.5 phosphate buffer with 0.5% sodium lauryl sulfate and photometric measurement at 362 nm. This study selected the optimal formulation of sublingual tablets containing solid dispersion system with the ratio of felodipin : PVP K30 : Lutrol F127 as 1 : 3 : 1, disintegrant excipients sodium starch glyconate 7% and filler excipients, including 28.7 mg lactose and 23.0 mg manitol. The dosage form was dissolved with 87.52% of felodipin after 5 minutes and completely dissolved in 48 seconds.