Amorphous Esomeprazole Hydrate

Abstract

The present invention relates to a novel amorphous form of esomeprazole hydrate, to a process for its preparation and to a pharmaceutical composition containing it. Thus, tetrahydrofuran and water are added to esomeprazole potassium salt at 25-30 C, cooled to 20 C and then the pH is adjusted to 7.5-8.0 with acetic acid. The reaction mass is cooled to 5 C, stirred for 2 to 3 hours at 0-5 C, filtered the mass, washed with chilled mixture of water and tetrahydrofuran (2:1), and again washed with water. The wet cake is dried at 30-35 C under vacuum to reach the moisture content to 25-30%. The solid is again dried in rotovapour at 25-30 C under nitrogen atmosphere to give amorphous esomeprazole hydrate.

Dependencies are inferred from the claim text.