Abstract

INFLUENCE OF NATURAL GUMS AND SYNTHETIC POLYMERS ON THE SUSTAINED RELEASE MATRIX TABLETS OF TIZANIDINE HYDROCHLORIDE

Nayana. S. M *, Kirankumar Navade, Nethravathi.A, K. Sumana, Suresh V. Kulkarni

ABSTRACT

In recent years, plant derived polymers have evoked interest due to their diverse pharmaceutical applications such as diluents, binders, disintegrants in tablets, thickeners in oral liquids, protective colloids in suspensions, gelling agents in gels, bases in suppository and also used in cosmetics, textiles, paints and paper-making . The plant based polymers have been studied for their application in different pharmaceutical dosage forms like matrix controlled system, film coating agents, buccal films, microspheres, nanoparticles, viscous liquid formulations like ophthalmic solutions, suspensions, implants and their applicability and efficacy has been proven. These have also been utilized as viscosity enhancers, stabilizers, disintegrants, solubilizers, emulsifiers, bioadhesives and binders.[1-3] Sustained release formulation is the drug delivery system that is designed to achieve a prolonged therapeutic effect by control the drug release within the safety range over an extended period of time after administration of single dose. The objective of this research work was about Influence of Natural Gums and Synthetic Polymers on the Sustained Release Matrix Tablets of Tizanidine Hydrochloride in the management of Spasticity. Matrix tablets were prepared by direct compression method using natural polymers, and fillers like Xanthun gum, HMPC K100, and Karaya gum as matrix forming agent and excipients such as MCC, Magnesium stearate and Tlac were used. Dissolution profiles were studied in medium pH 1.2 HCl for 2 hours and pH 6.8 phosphate buffer for the remaining 10 hours. The influences of variables like polymer concentration, combination and fillers on drug release were analyzed from formulation F-1 to F- 09. The formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. Formulation (F-3) successfully sustained the release of drug up to 12 hours. The release data were fit into different kinetic models (zero-order, first-order, Higuchi’s equation and Korsmeyer ‐ Peppas equation). Tablets prepared were analyzed by using FT-IR stability studies. The mechanism of drug release from F-3 was anomalous (non Fickian) diffusion. Optimized formulation F-3 was stable after stability studies under accelerated temperature and humidity.

Keywords: Tizanidine, Xanthan gum, Karaya gum, MCC, magnesium stearate and Talc.