| 摘要 |
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. |
