Kevin W. Kells;Kaarina Milnes;Cameron L. McPhail;Fan Wang
发明人:
Fan Wang,Kevin W. Kells,Kaarina Milnes,Cameron L. McPhail
申请号:
US13391327
公开号:
US20130065927A1
申请日:
2010.08.19
申请国别(地区):
US
年份:
2013
代理人:
摘要:
Provided is dexlansoprazole propylene glycolate hydrate. Polymorphic forms thereof are also provided. The dexlansoprazole propylene glycolate hydrate maybe such that the propylene glycol component is present in approximately equal proportions of (R) absolute configuration and (S) absolute configuration, or present in predominantly (R) absolute configuration, or predominantly (S) absolute configuration. Salts of dexlansoprazole are also provided. In particular, crystalline dexlansoprazole isopropylammonium salt and crystalline MTBE solvate of dexlansoprazole t-butylammonium salt are provided. Pharmaceutical formulations comprising dexlansoprazole propylene glycolate hydrate are also provided. Furthermore, processes for preparation of dexlansoprazole propylene glycolate hydrate are provided.