Taste Masked Formulation of Montelukast Sodium for the Pediatric Population and its Evaluation

The purpose of this study was to mask the metallic taste of montelukast sodium by complexation with beta-cyclodextrin and to incorporate the drug in a dispersible tablet for the pediatric population. The kneading method was applied to form the complex. The drug-beta-cyclodextrin (1:1) ratio was optimized by applying human panel method for taste evaluation and Oneway ANOVA for drug release. The complex was mixed with other excipients to form a dispersible tablet. Results from an evaluation by a panel of nine human volunteers demonstrated that the dispersible tablets with taste masking complex improved the taste significantly. In conclusion, beta-cyclodextrin can effectively mask the metallic taste of the active pharmaceutical ingredient and does not affect the drug release.