Preparation and In-vitro Evaluation of Tizanidine Oral Film

Abstract

Fast-dissolving oral thin film is a novel and most advanced form of solid dosage form that dissolves or disintegrates in 1 minute when put in the mouth without water or chewing. Tizanidine hydrochloride is frequently used to treat back pain, multiple sclerosis, spastic diplegia, and specific spinal or central nervous system ailments and it was prepared as oral film for produce rapid therapeutics effect. Solvent casting was the procedure used to prepare the mouth-dissolving films. Eight formulas of the tizanidine were prepared by using different concentrations of HPMC E15 and polyvinyl alcohol (PVA). The effect of the type and concentration of the polymer was evaluated in all the formulations was evaluated for surface pH, weight uniformity, folding endurance, disintegration time, in-vitro dissolution studies. The formulation F2 was found to be an optimized formulation. It showed good results for all evaluation parameters such as weight variation 15.9±0.23 mg, surface pH 4.38, folding endurance 106, disintegration time 40 sec, and in-vitro dissolution study 100 % at the end of 4 min. From all of the observations can conclude that the formulation F2 shows better results.