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Abstract: New era is
an area of novel drug delivery systems, formulation
research is oriented towards increasing safety and
efficacy of existing drug molecule through novel concept
of drug delivery. In the present investigation was under
taken with a view to develop a fast dissolving tablet of
simvastatin by directcompression with moisture
activation technique i.e., exposed in humidity chamber
75% RH at 300C for 1 hr, which offers a new range of
product having desired characterstics and intended
benefits. Fast dissolving tablets of simvastatin were
prepared by using effervescent mixture i.e., sodium
bicarbonate and citric acid, mannital, spray dried
lactose, M.S and BHT obtained tablets were subjected for
moisture activation. All the formulations were evaluated
for hardness, friability, weightvariation, mouth feel,
test for dispersibility, absorption ratio, in vitro
dispersion time and in vitro drug release studies. An
effective pleasant tasting and stable formulation F4
containing sodium bicarbonate and citric acid was found
to have hardness 3.8 Kg/cm2, in vitro dispersion time
was 10 sec, and maximum amount of drug was released with
in 5 mins, than other prepared and marketed formulation.
Introduction
Recent developments in technology have presented viable
dosage alternatives for paediatric, geriatric,
bedridden, nauseous or non compliment patients.
Traditional tablets and capsules administered with 250ml
of water may be inconvenient or impractical for such
patients. Hence fast dissolving/disintegrating tablets (FDTs)
are a perfect fit for them. FDTs dissolve or more
commonly disintegrate rapidly in the saliva with out the
aid of water. Also this dosage form offers an advantage
of convenience of administration while traveling where
there may not be an access to water. Moreover this
dosage form combines the advantage of both liquid and
tablet formulation. Simvastatin is a hypolipidemic drug.
It is a powerful lipid-lowering that can decrease low
density lipoprotein levels by upto 50%, having half life
3 hrs, it is sparingly soluble in water and bland taste
makes it an ideal candidate for fast dissolving tablets
by direct compression with moisture activation
technique, with regards to palatability. The present
investigation deals with the development of an effective
and stable FDTs of simvastatin by moisture activation
technique having adequate hardness, low dispersion time
and pleasant taste.
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