Ebastine is a 2nd generation H1 receptor
antagonist that is mainly indicated for allergic rhinitis
and chronic idiopathic urticaria. In allergic conditions
the patient become panic and will have difficulty to
swallow tablet with a glassful of water. In such cases
Orodispersive tablets will be a good solution for patient
compliance and efficient dose regimen. Ebastine tablets
are available in different strength i.e. 10 mg and 20 mg.
The main objective of this project work was to developed
and designed an Orodispersive tablets (ODTs)
containing Ebastine 20 mg, using “Natural Super
Disintegrants’’ by molecular dispersion technique
including various pharmaceutical excipients with
different strengths to enhance patient compliance and
therapeutic value as compare with the available market
brands. Orodispersive Tablets of Ebastine were
formulated by molecular dispersion technique and using
Natural Superdisintegrants such as Agar and Guar gum
and other excipients like gelatin, sodium lauryl sulphate,
microcrystalline cellulose, sweetening agent as Sodium
saccharine, talc and magnesium stearate as lubricants,
clove oil and lemon flavor as flavoring agent. Drug -
excipients compatibility tests performed before start the
formulation. The selection and the rejection of excipients
for experimental formulation was considered after
getting the result of drug excipients compatibility study.
The flowability of the powder mixtures were evaluated
using Carr's index, Angle of Repose and the Hausner’s
ratio. The tablets were evaluated according to the
standards prescribed by British Pharmacopoeia like
weight variation, thickness, hardness, friability,
disintegration time, a simulated wetting test and in-vitro
dissolution. Prepared tablets after Optimization showed
disintegration time less than 30 seconds and drug
dissolution of about 75% within 30 minutes. The
prepared tablets of optimized batch tested for stability
40 degree Celsius and 75% RH for 3 months and were
found to be stable. Prepared Orodispersive tablets of
Ebastine 20 mg from optimized batch were found
bioequivalent under fasting and fed conditions with the
available market products. The determination and
evaluation were made for the most effective type and
optimal amount of “Natural Super Disintegrants’’ for
the manufacture of Orodispersive Tablets by molecular
dispersion & direct compression technique.