Formulation and Development of Fast Disintegrating Azelnidipine Tablets: Functionality of Superdisintegrants

Azelnidipine, a calcium channel blocker, is used for hypertension and angina pectoris. Azelnidipine fast-disintegrating tablets (FDT) have been prepared by kneading method. In the present study cyclodextrins (?CD and HP?CD) and surfactants (Kolliphor HS15) were tried to enhance the solubility and dissolution rate of Azelnidipine. The individual main effects and combined (interaction) effects of cyclodextrins and surfactants on the solubility and dissolution rate of Azelnidipine was evaluated in a series of 22 factorial experiments.) The hardness, friability, drug content and disintegration time, in vitro release and stability parameter has been studied. Hardness of the tablets was in the range 6.0 –7.5 kg/sq.cm. Percent weight loss in the friability test was less than 0.85% with all the formulations. The disintegration time was in the range 1 –3.5 min. with all the tablets prepared. Drug content of the tablets was within 100 ± 2% of the labeled claim. The dissolution efficiency was also increased from 4.56% for formulation E1 to 41.54 % and 36.59 % respectively for formulations E4 and E8. The formulation did not show any change in disintegration time and drug content after stability period. It was concluded that fast disintegrating Azelnidipine tablets can be prepared by kneading method using super disintegrants.