METHOD FOR ISOLATING PHARMACEUTICALLY EXPLOITABLE ETIDRONATE DISODIUM

The invention relates to a method for isolating etidronate disodium. According to said method, a liquid-liquid dispersion consisting of an aqueous-organic phase and an aqueous phase containing the etidronate disodium salt is set to a temperature of between 0 °C and 30 °C and is intensively mixed; a coarse-grained fraction is subsequently precipitated out of the liquid-liquid dispersion and in a second, delayed step, a fine-grained fraction is precipitated out of the organic phase. The invention also relates to a novel solid form of etidronate disodium that can be obtained using this method. The invention provides a method for producing etidronate disodium with a particle size in the region of 0.2 to 1.0 mm, good flowability and a high bulk density, coupled with properties that can be pharmaceutically exploited to advantage. Pronalazak se odnosi na postupak za izolovanje dinatrijumetidronata, pri čemu se a) tečnost-tečnost disperzija sastavljena iz - jedne vodeno-organske i - jedne vodene faze koja sadrži dinatrijumetidronat postavi na temperaturu od 0В°C do 30В°C i intenzivno meša, b) zatim se iz tečno-tečno disperzije istaloži krupnozrna frakcija, c) u drugom produženom koraku iz organske faze istaloži frakcija finog zrna, kao i novi oblik čvrstog tela ninatrijumetidronata, koji može da se dobije ovim postupkom. Pripremljen je postupak za dobijanje dinatrijumetidronata sa veličinom zrna u području od 0,2 do 1,0 mm, sa dobrom sposobnošću sipanja, odnosno visokom nasipnom gustinom i sa tim vezano visokom farmaceutskom primenljivošću.[The invention relates to a method for isolating etidronate disodium. According to said method, a liquid-liquid dispersion consisting of an aqueous-organic phase and an aqueous phase containing the etidronate disodium salt is set to a temperature of between 0 В°C and 30 В°C and is intensively mixed; a coarse-grained fraction is subsequently precipitated out of the liquid-liquid dispersion and in a second, delayed step, a fine-grained fraction is precipitated out of the organic phase. The invention also relates to a novel solid form of etidronate disodium that can be obtained using this method. The invention provides a method for producing etidronate disodium with a particle size in the region of 0.2 to 1.0 mm, good flowability and a high bulk density, coupled with properties that can be pharmaceutically exploited to advantage.