Forms of dexlansoprazole and processes for the preparation thereof

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.

主权项

1. A Form APO-I dexlansoprazole propylene glycolate hydrate having a Powder X-Ray Diffraction (PXRD) diffractogram comprising peaks, in terms of degrees 2θ, at approximately 5.6, 7.6, 9.8, 11.3, 17.0, 18.2 and 28.4.