| To study the formulation and technology of iloperidone and investigate its stability. Using the dissolution of tablets as the evaluati on standard, the formulation was optimized via single factor tests. The differential scanning calorimeter (DSC) and powder X-ray diffractometry (PXRD) were used to identify the state of the drug existence in the product. The stability research of tablets were performed by influencing factor test, accelerated test and long-term observation test, using property, dissolution, content and relevant substance as index.The optimized formulation was as follows:lactose monohydrate52.3%, macrocrystalline cellulose (MCC)26.15%, hydroxypropylmethylcellulose (HPMC)6.5%, crospovidone (PVPP)11%(interior addition8%and exterior addition3%), magnesium stearate (MS)0.5%, colloidal silicon dioxide0.3%. Iloperidone existed in the product at amorphous forms or solvates from DSC and PXRD. The tablets were stable in influencing factor test, accelerated test and long-term observation test.The dissolution of prepared Iloperidone tablets using solid dispersion technology was significantly improved and similar to market products. The tablets should be stored in dark and cool condition. |
