Abstract

FORMULATION AND IN- VITRO EVALUATION OF TIZANIDINE HCL FLOATING TABLET

Sagar Patel*, Dr. K.R. Patel, Dr. M.R. Patel, Dr. A.D. Patel

Abstract

The present study was carried out with an objective to prepare and optimized floating tablet of Tizanidine HCl using combination of natural and synthetic polymer. Tizanidine HCl is use as muscle relaxant to treat spasm, cramping and tightness of muscle. Drug is maximum absorbed from stomach and least absorbed from the lower part of GIT having short biological half life 2.5 hr. It is prefer to take 2-3 times a day therefore overcome dosing frequency by preparing floating tablet of Tizanidine HCl that provide sustained drug release and better patient’s compliance. The present research work describes the affect of the combined ratio of xanthan gum and HPMC K100M and different diluents. The polymer to copolymer ratio (X1) and different diluent (X2) were selected as independent variables, while time required for 50% drug release (t50), time required for 90% drug release (t90), drug release at 12 hr (Q12), floating lag time, diffusion exponent (n), release rate constant (k) were selected as a dependent variables. Tablets were prepared by direct compression method & evaluated for pre-compression and post-compression parameters. Dissolution data were fitted to various models to ascertain kinetic of drug release. Regression analysis and analysis of variance were performed for dependent variables. All the batches were evaluated for the pre-compression and post-compression parameters and results of all batches complies within the limits. All formulations showed good floating lag time and total floating time more than 24 hr. Optimized batch (S6) showed 99.53% drug release at the end of 24 hrs and similarity factor (f2= 75.59) and dissimilarity factor (f1= 4.80) with theoretical release profile of Tizanidine HCl. Optimized formulation followed by anamolous non Fickian diffusion follow dominantly with zero order release and found to be stable after 28 days at accelerated condition. It was showed that polymer: copolymer ratio and different diluents had a significant effect on drug release rate and floating lag time. Finally it was concluded that drug release rate retarded with increasing in polymer: copolymer ratio due to the higher the viscosity of HPMC K 100M compare to xanthan gum and also retard drug release in order of MCC>lactose>DCP.

Keywords: Tizanidine HCl, Floating tablet, Xanthan Gum, HPMC K100M, 32 full factorial design.