[EN] FORMS OF DEXLANSOPRAZOLE AND PROCESSES FOR THE PREPARATION THEREOF<br/>[FR] FORMES DE DEXLANSOPRAZOLE ET PROCÉDÉS DE PRÉPARATION ASSOCIÉS
申请人:APOTEX PHARMACHEM INC
公开号:WO2011020189A1
公开(公告)日:2011-02-24
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.
提供的是右旋兰索拉唑丙二醇酸盐水合物。还提供了其多晶形式。右旋兰索拉唑丙二醇酸盐水合物可能是丙二醇组分在(R)绝对构型和(S)绝对构型近似相等的比例下存在,或者主要存在于(R)绝对构型或(S)绝对构型。还提供了右旋兰索拉唑的盐。特别地,提供了结晶的右旋兰索拉唑异丙胺盐和结晶的右旋兰索拉唑叔丁基胺盐MTBE溶剂化物。还提供了包含右旋兰索拉唑丙二醇酸盐水合物的制药配方。此外,还提供了制备右旋兰索拉唑丙二醇酸盐水合物的过程。