Formulation and evaluation of Risperidone orally disintegrating tablets

Abstract

Most people have difficulty swallowing, particularly the geriatric or pediatric population. Tablets have many advantages such as cost-effectiveness, compactness, least variability of contents of all oral dosage forms. Oral Disintegrating Tablets (ODT) are dissolving tablets that are solid oral dosage forms that break down into a swallowable form without additional water. There are many properties such as it should break down without additional water, easily transportable. Chemicals such as Mannitol, Sorbitol, Propyl paraben, Methyl paraben, Crospovidone, etc. are used for manufacturing ODTs. The formulation steps for the tablet are sieving, dry mixing, lubrication, and compression. ODTs are evaluated for friability, thickness, hardness and weight variation. Formulation-I contained 2mg Risperidone,121.60mg Mannitol anhydrous, 11.20mg sodium starch glycollate, 0.80mg methylparaben, 0.20mg propylparaben, 1.40mg Aspartame, 0.7mg Sunset yellow, 1.40mg Strawberry flavour, and 0.70mg Magnesium stearate. Each formulation from F-II to F-VII were made by changing the composition compared to F-I. Using a pH 1.2 buffer, Risperidone calibration curves were analyzed using HPLC. There were straight-line relationships for Risperidone standard solution in Media at a concentration of 0-10 μg/ml. Physico-chemical parameters such as Loose Bulk Density (LBD), Angle of Repose, Tapped Bulk Density (TBD), Drug content (%) and Compressibility index (%) were analyzed for FI- F-VII. The cumulative percentage drug release of F-I is 96.50, F-II is 99.65, F-III is 99.82, F-IV is 98.56, F-V is 98.25, F-VI is 99.73 and F-VII is 99.82. F-I - F-VII formulations were compared to marketed sample (ZISPER MD 2mg). Stability Data of Risperidone F-VII Orally disintegrating Tablets at two different temperatures were carried out.