Precursor phase and use thereof for preparing the magnesium salt tetrahydrate of an omeprazole enantiomer

摘要

Precursor phase of magnesium tetrahydrate salt of an omeprazole enantiomer, which has X-ray diffractogram peaks as given in the specification, is claimed. Independent claims are included for: (1) preparing the precursor phase comprising re-mashing a magnesium salt of the enantiomer in amorphous form, in a solvent/water mixture, where the solvent is water-miscible non-alcoholic organic solvents and volume ratio of the solvent to water is 95:5-30:70; (2) preparing magnesium tetrahydrate salt of an omeprazole enantiomer comprises filtrating and drying a suspension containing the precursor phase; (3) crystals of magnesium tetrahydrate salt of an omeprazole enantiomer obtained by the process; and (4) preparing magnesium salt of omeprazole enantiomer in the dihydrate form A comprises dehydration of crystals of magnesium tetrahydrate salt of an omeprazole enantiomer. ACTIVITY : ACTIVITY -Antiulcer. MECHANISM OF ACTION : None given.