METHOD FOR PRODUCING MAGNESIUM SALT OF ESOMEPRAZOLE IN STABLE FORM

摘要

1. A method of obtaining a purified magnesium salt of esomeprazole, comprising the following stages:! obtaining the starting magnesium salt of esomeprazole,! contacting the specified magnesium salt of esomeprazole with a precipitant comprising an aqueous component to a maximum content, which is determined by the saturation with water in the precipitant, and! the allocation of purified magnesium salts of esomeprazole formed in the contacting stage. ! 2. The method according to claim 1, where the specified source of magnesium salt of esomeprazole is in the first polymorphic form, which at the specified stage of contacting is converted into a second polymorphic salt of the magnesium salt of esomeprazole, which differs from the specified first polymorphic form. ! 3. The method according to claim 1 or 2, wherein said first polymorphic form of the esomeprazole magnesium salt is determined by at least one form selected from an amorphous form, a crystalline form, an anhydrous form, a hydrate, a solvate and mixed forms, and wherein said obtained second polymorphic The esomeprazole magnesium salt form is esomeprazole magnesium salt dihydrate. ! 4. A method for producing esomeprazole magnesium salt dihydrate comprising the following steps:! obtaining the starting magnesium salt of esomeprazole,! contacting the specified magnesium salt of esomeprazole with a precipitant, including an aqueous solution, to a maximum content, which is determined by the saturation with water in the precipitant, and! the allocation of the dihydrate of the magnesium salt of esomeprazole formed at the contacting stage. ! 5. The method according to claim 4, where the specified source of magnesium salt of esomeprazole is in amorphous form or in the form of dihydrate, which on the specified