申请人:Athukuri Venkata Subbarao
公开号:US20110300218A1
公开(公告)日:2011-12-08
Provided herein are solid state forms of ranolazine salts. Also provided is a stable amorphous form of ranolazine hydrochloride having a water content of less than about 0.5% by weight. Further provided are amorphous co-precipitates of ranolazine or a pharmaceutically acceptable salt thereof with povidone. Processes for the preparation of ranolazine forms, pharmaceutical compositions, and methods of treating thereof are also included. The solid state forms of ranolazine salts are useful for preparing ranolazine in high purity.
本文提供了盐酸拉诺拉嗪的固态形式。还提供了一种稳定的无定形形式的盐酸拉诺拉嗪,其水含量低于约0.5%的重量。此外,还提供了拉诺拉嗪或其药学上可接受的盐与聚乙烯吡咯烷酮的无定形共沉淀物。还包括制备拉诺拉嗪形式的过程、制药组合物和治疗方法。拉诺拉嗪盐的固态形式可用于高纯度制备拉诺拉嗪。