DEVELOPMENT AND EVALUATION OF RAMOSETRON HYDROCHLORIDE MOUTH DISSOLVING THIN FILM FOR ENHANCED THERAPEUTIC EFFICACY AND PALATABILITY

Abstract

Objective: Many people have difficulties in swallowing traditional dosage forms such as tablets and capsules. The goal of this study was to develop the mouth-dissolving thin film of Ramosetron HCl (RH) for quick onset of action in the treatment of vomiting and irritable bowel syndrome, with the added benefit of disguising the bitter taste of RH. Methods: The solvent-casting approach was employed to formulate mouth dissolving thin film. The effect of variable concentrations and different grades of hydrophilic polymer HPMC (E5, E15 and E50), and plasticizers like glycerol and PEG 400 on disintegration time, drug release, thickness, tensile strength, percent elongation, folding endurance, and on appearance were studied. The optimized batch was kept for stability study at40±2 °C/75±5% RH for 30 d. Results: The formed films were transparent with a smooth surface texture. The thickness, weight variation, drug content and pH of the surface were within acceptable limits. Tensile strength and folding endurance values demonstrated adequate mechanical strength. In 45 seconds, the formulation F6 comprising HPMC E5 (150 mg) and HPMC E15 (150 mg) with PEG 400 (0.4 ml) disintegrated. The F6 formulation released 98.78±0.96 %drug in 8 min and considered as optimal formulation. The taste masking of drug was evaluated by a taste perception study using volunteers. The optimized batch was found to be stable at 40±2 °C/75±5% RH for 30 d. Conclusion: The concentration of hydrophilic polymers and plasticizers had a significant effect on the formulation and assessment characteristics of thin film. Mannitol assisted in masking the bitter taste of RH.