FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF OLMESARTAN MEDOXOMIL BY USING COPROCESSED EXCIPIENTS TECHIQUE
Iti Karia* and Dr. Ramesh B. Parmar
ABSTRACT
In the present work, fast dissolving tablets of Olmesartan medoxomil
were prepared using novel co-processed superdisintegrants consisting
of crospovidone and croscarmellose sodium in different ratios (1:1, 1:2
and 1:3).Olmesartanmedoxomil (OLM) is an angiotensin II receptor
blocker used for the treatment of hypertension. In present work an
attempt was made to mask the metallic taste and enhance the solubility
and dissolution rate of poorly soluble OLM by formulating it as
inclusion complexesby kneading method with β-cyclodextrins (β-CDs)
as complexing agentin 1:1 molar ratio. Effect of co-processed
superdisintegrants on pre-formulation parameters, wetting time,
disintegrating time, drug content and in-vitro release have been studied. Drug compatibility
with excipients was checked by FTIR and DSC studies. The co-processing of the
superdisintegrants was done by solvent evaporation. The values of pre-compression
parameters evaluated were within prescribed limits and indicated good free flowing property.
From the prepared inclusion complexes and co-processed excipients, fast dissolving tablets
(FDTs) were formulated. In all the formulations, hardness test indicated good mechanical
strength results ranging from 2.89 to 3.81 kg/cm2, friability is less than 1%indicated that
tablets have good mechanical resistance. Wetting time is an important criteria for
understanding the capacity of disintegrants to swell in presence of little amount of water were
found to be in the range of 7.33 to 14.66 seconds. Disintegration time was found to be in the
range of 8.33 to 20.00 seconds. Drug content was found to be in the range of 97.36 to 99.72
%. Among all the designed formulations, formulation CPI3 i.e.co-processed excipients
having ratio CSS:CP (1:3) containing 5% w/w of co-processed superdisintegrants, was found
to be promising and was displayed an in-vitro dispersion time of 8.33 seconds, which facilitates faster dispersion in mouth and wetting time of 7.33 seconds. From the present
study, it can be concluded that dissolution rate of Olmesartan medoxomil could be enhanced
by tablets containing co-processed superdisintegrants.
Keywords: Olmesartan medoxomil, fast dissolving tablets, ?-cyclodextrin, Sodium Starch Glycolate, Crosscarmellose sodium, crospovidone, co-processed excipients.
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