Preparation and Evaluation of Risperidone Oro-dispersible Tablets

摘要

The demand for Orodispersible tablets (ODTs) has been growing during the last decade especially for elderly and children who have swallowing difficulties. Risperidone is an atypical antipsychotic drug which is extensively metabolized due to the hepatic metabolism. Although the formulation of Risperidone into oro-dispersible dosage form will improve the release and bioavailability, the bitter taste of the drug will be a great problem. In the current work, the aim was masking the taste by complexation technique, with a formulation into oro-dispersible tablets by sublimation and lypholization. The inclusion complex of Risperidone with 2HP-β- CD (1:1 molar ratio) was prepared by solvent evaporation method. Phase solubility showed stability constant 39.13M-1. The prepared complex was evaluated for taste masking and characterized by using Infrared, differential scanning calorimetry, X-ray diffraction, scanning electron microscope and in-vitro drug release. Risperidone ODTs were successfully prepared by either of sublimation method using camphor as subliming or lypholization technique which involved addition of disintegration accelerators. The prepared tablets were evaluated for weight variation, friability, hardness, in-vitro disintegration, wetting time, drug content and in-vitro dissolution. The formulations R15 prepared by lypholization using 1% of tween 20 as disintegration accelerator is a promising novel formula for Risperidone where 100% of the labeled dose was dissoluted within 3 minutes.