Abstract

PREPARATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS USING SPHERICALLY CRYSTALLINE FLUVASTATIN SODIUM

Trivedi Dhruvin Rakeshkumar*, Dr. Anand K. Patel, Dr Anil S. Solanki and Dr. Vishnu M. Patel

ABSTRACT

To prepare and evaluate sustained release matrix tablets of spherically crystalline fluvastatin sodium to enhance micromeritics of fluvastatin sodium by CRYSTALLO-CO-AGGLOMERATION (CCA) technique along with using HYD ROXYPROPYL METHYL CELLULOSE (HPMC) and xanthan gum as rate retarding polymer. To prepare directly compressible matrix tablets of fluvastatin sodium spherical agglomerates. The prepared spherical agglomerates were evaluated in terms of %yeild, drug content, dissolution studies, Differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), X-ray diffraction (XRD) studies, Scanning electron microscopy (SEM). The prepared Optimized fluvastatin sodiumspherical agglomerates tablets were evaluated for weight variation, Hardness, thickness, Friability, Drug content, dissolution study, swelling index, kinetic modeling and stability etc. The FTIR and DSC indicate drug poymer compactibility. The XRD revealed a characteristic decrease in crystallinity. SEM study showed that the crystal possess a good spherical shape with regular surface. The evaluation of spherical agglomerates prepared tablets even after stability showed no significant change in tablet properties and sustain release tablets prepared by spherical agglomerats showed effective sustain release over period of time.On the basis of these evaluation parameters it was concluded that optimized Sustain release matrix tablets made by spherically crystalline fluvastatin sodium in which F7 sustained drug release for 12 hrs and release 99.26% of drug.

Keywords: Spherical crystallization, % yeild, DSC, XRD, SEM, bulk density, tapered density, bulkiness, angle of repose, Hausner's ratio, etc.