Abstract
IMPROVEMENT OF AQUEOUS SOLUBILITY AND DISSOLUTION RATE OF SIMVASTATIN THROUGH VARIOUS SOLID DISPERSION TECHNIQUES

M. Vijaya Laxmi*, Sana Sulthana, Shashikumar Yadav, Srinu Naik and Vijaya Kuchana

ABSTRACT

The present work dealt with Improvement of Aqueous Solubility of Poorly Soluble drug -Simvastatin (SIM) through various Solid dispersion techniques such as Solvent evaporation method, Fusion or melting method and Solvent melt method at different drug: carrier ratios. Simvastatin, a BCS Class II drug, exhibits low solubility and high permeability. Consequently, its dissolution rate becomes the rate-limiting step for drug absorption. This study aimed to improve the solubility and dissolution rate of Simvastatin by increasing its solubility and dissolution characteristics through solid dispersion technique using polyethylene glycol (PEG 4000) as hydrophilic carrier. The prepared solid dispersions were characterized by FTIR-Spectroscopy, differential scanning calorimetry, X-ray powder diffraction, and dissolution studies. The solid dispersion prepared by solvent melt method in 1:6 (Drug: Carrier) ratio –SM4SD3 shown better dissolution. The optimized solid dispersion (SM4SD3) was formulated into Fast disintegrating tablets (F1-F10) by direct compression method using various superdisintegrants such as sodium starch glycolate, crospovidone and Croscarmellose sodium. The prepared FDTs were evaluated for its pre and post compression parameters. The drug excipient compatibility studies carried out by FTIR revealed no interaction between the components in the solid dispersion, while the XRD and DSC studies revealed a reduction in the crystallinity of the solid dispersions. In vitro dissolution studies showed Improve dissolution of Fast disintegrating tablets incorporated with high concentration of Croscarmellose sodium (F10) as it rapidly promotes disintegration and dissolution.

Keywords: Simvastatin, Solubility, Solid dispersions (SD), Polyethylene glycol, Binary systems, Bioavailability, Superdisintegrants.


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