METHOD FOR ISOLATING PHARMACEUTICALLY EXPLOITABLE ETIDRONATE DISODIUM SALT

1. A method for isolating etidronate disodium, characterized in that a) a liquid-liquid dispersion, consisting of - an aqueous-organic and - an aqueous phase comprising the etidronate disodium salt is adjusted to a temperature of 0 degree C to 30 degree C and intensively stirred, b) then a coarse gr...

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Hauptverfasser: RATHE, HARALD, SCHMIDT, BARBARA, GRAWE, DETLEF
Format: Patent
Sprache:eng ; rus
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Zusammenfassung:1. A method for isolating etidronate disodium, characterized in that a) a liquid-liquid dispersion, consisting of - an aqueous-organic and - an aqueous phase comprising the etidronate disodium salt is adjusted to a temperature of 0 degree C to 30 degree C and intensively stirred, b) then a coarse grain fraction is precipitated from the liquid-liquid dispersion, c) in a second, delayed step a fine grain fraction is precipitated from the organic phase. 2. The method as claimed in claim 1, characterized in that the liquid-liquid dispersion has a total water content of 25 to 35% by volume. 3. The method as claimed in claim 1 or 2, characterized in that the liquid-liquid dispersion has a total etidronate disodium salt content of 10 to 100 g/kg of dispersion. 4. The process as claimed in one of claims 1 to 3, characterized in that d) the fine grain fraction is separated from the coarse grain fraction by classification and fed back into the method. 5. The method as claimed in claim 4, characterized in that e) the coarse grain fraction according to step d) is filtered and dried by means of drying in a moving bed up to a final temperature of 85 degree C to 100 degree C. 6. The method as claimed in one of claims 1 to 5, characterized in that the liquid-liquid dispersion is preferably adjusted to between 5 degree C and 10 degree C. 7. The method as claimed in one of claims 1 to 6, characterized in that the aqueous-organic phase is an isopropanol/water phase. 8. The method as claimed in one of claims 1 to 7, characterized in that, for the liquid-liquid dispersion, an aqueous solution of etidronate disodium is added to a solvent consisting of isopropanol/water. 9. Etidronate disodium, obtainable by the method as claimed in one of claims 1 to 8. 10. Etidronate disodium, whose solid form is characterized by an X-ray powder diffractogram according to figure 1. 11. Etidronate disodium, whose solid form is characterised by an IR spectrum according to figure 2. В изобретении описывается способ выделения динатриевой соли этидроната, заключающийся в том, что а) используют жидкостно-жидкую дисперсию, которая состоит из водно-органической фазы и водной, содержащей динатриевую соль этидроната фазы, и температуру которой поддерживают в интервале от 0 до 30°С и которую интенсивно перемешивают, б) затем из этой жидкостно-жидкостной дисперсии осаждают крупнозернистую фракцию и в) через небольшой промежуток времени на второй, завершающей стадии из органической фазы осаждают мелкозерни