Abstract

FORMULATION AND EVALUATION OF SIMVASTATIN ORODISPERSIBLE TABLETS

Mahmoud Mahyoob Alburyhi*, Abdalwali Ahmed Saif, Maged Alwan Noman and Shada Hassan Yassin

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Abstract

Simvastatin is a lipid lowering drug which is used to lower the risk of cardiovascular disease and manage abnormal lipid levels by inhibiting the endogenous production of cholesterol. Simvastatin is practically insoluble in water and undergoes extensive first-pass metabolism in the liver, thus the oral bioavailability is very low (5%). The main objective of this study is to develop Orodispersible tablets of Simvastatin to overcome the two mentioned problems. Seven formulations were prepared by direct compression method using β-cyclodextrin as polymer and croscarmellose sodium, crospovidone and sodium starch glycolate as superdisintegrants and mannitol, microcrystalline cellulose and lactose as diluents in different ratios. Orodispersible tablets of Simvastatin were formulated and formulations were evaluated for thickness uniformity, diameter, hardness, weight variation, friability, disintegration time and in-vitro dissolution studies. Formulation F7 was selected as the best formulation based on disintegration time and in-vitro dissolution studies when compared to Orodispersible tablets of Simvastatin formulations. The co-administration of β-cyclodextrin with Simvastatin improved the oral bioavailability of Simvastatin.

Keywords: Simvastatin, Orodispersible tablets, Superdisintegrants, Dissolution, Formulation, Evaluation.