The Study Of Iloperidone Tablet

Schizophrenia is a disease with the highest incidence of mental illness, which haschronic progressive course and has the tendency to relapse. It is a huge challenge to lookfor the safe and effective antipsychotic drugs. The focus of antipsychotic drugs is theatypical antipsychotics in the current researches. Iloperidone, an atypical antipsychoticdrug that was approved by FDA on May6,2009, is a dual-retardant of5-HT2and D2receptors for treating schizophrenia. Now it has not been approved to produce withinChina. Iloperidone is an insoluble drug. The key of the study is that whether thedissolution behavior of iloperidone tablet we prepared is similar to original product, andwhether the tablets can be produced industrially.This study was focused on the preparation and quality control of the iloperidonetablets, providing the experimental basis for industrialized production of iloperidonetablets. Firstly, according to the dissolution curve of the listed products in the four kinds ofdissolution medium, the formulation and process were screened with the index of thedrug’s dissolution of15min in0.1mol·L-1HCl. Based on the above study, the optimalformulation was determined. These results showed that the dissolution curve ofiloperidone tablets prepared by the optimal formulation was similar with that of the listedproducts.Secondly, the preparation’s quality control was studied via UV spectrometry for thecontent determination and the dissolubility test. According to the prescription andpreparation process parameters of the pilot production, we produced three batches ofproducts that be used to study the stability. These results of the affected factor test,speed-up test and long-term test showed that the preparation indexes, such as content,content uniformity, dissolution and related indicators, were unchanged obviously in thetest process, indicating that the preparation has good stability.In the study, the prescription and pilot production process parameters weredetermined, providing a basis for the industrialized production.