Formulation and Evaluation of Orodispersible Tablet of Domperidone

Abstract

The aim of the present study was to develop and evaluate orodispersible tablets of domperidone by
direct compression method. Sodium starch glycolate ( SCG ), Kollidone CLSF and sodium bicarbonate were used as
disintegrants to achieve the desired disintegration time required for orodispersible tablets. To mask the bitter taste of
drug, impart sweetness and to offer a better feeling in mouth, saccharin sodium, aspartame, citric acid, menthol and
lemon flavor were also added. Mannitol and lactose were used as sugar based multifunctional diluents. The prepared
tablets were evaluated for their physical (hardness, friability, weight variation), organoleptic (taste, mouth-feel, color)
and functional (disintegration time) properties and for the drug content. The excipients were used in various
concentrations in order to optimize the desired properties. SCG and Kollidone CLSF, used in 5.5% and 4%
respectively, gave satisfactory disintegration time using BP instrument and within the mouth. Combination of
saccharin sodium (1.5%) and aspartame (3%) along with mannitol (40%) and other excipients effectively masked the
bitterness and provided satisfactory sweetness level. Incorporation of 0.05% menthol provided excellent mouth
feeling as assessed by a panel of volunteers. Hardness and friability values were also optimized in the formulations to
produce tablets of acceptable physical stability and mechanical strength. Weight variation and drug content of all
formulations fully complied with the official specifications.