Process for preparing clodronate preparations

摘要

In the present invention there is disclosed a process for preparing clodronate preparations, which preparation process comprises crystallization of disodium clodronate tetrahydrate from an aqueous solution of disodium clodronate either (a) by addition of a fully or partially water miscible organic solvent to the aqueous solution of disodium clodronate in which disodium clodronate is practically insoluble, whereby initial temperature ranging from 30 to 120 degC is successively reduced to a temperature in the range of 0 to 20 degC, or (b) by evaporation of dissolved disodium clodronate aqueous solution optionally in the presence of a water miscible or partially miscible organic solvent and also in the presence of an organic solvent being practically immiscible with water in a two-phase system at a temperature ranging from 20 to 100 degC, - resulting disodium clodronate tetrahydrate is then granulated in dry state by moulding between rollers at pressure ranging from 3 to 9 MPa at a temperature ranging from 40 to 50 degC so that the crystal structure of the disodium clodronate tetrahydrate remains maintained and further the mass is separated and sieved to granules of suitable size - the dry granulated disodium clodronate tetrahydrate is then optionally mixed with suitable excipients, such as filling agents, sliding matters and if necessary with decomposing agents.