Process for preparing a clodronate preparation

A - Human Necessities – 61 – K

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A61K 31/66 (2006.01) A61K 9/16 (2006.01)

Patent

CA 2175994

The object of the invention is a process for preparing a clodronate preparation which process is characterized in that clodronate is crystallized as disodium clodronate tetrahydrate from an aqueous solution of disodium clodronate, the resulting disodium clodronate tetrahydrate is dry granulated by compressing in such a way that the crystal structure of the disodium clodronate tetrahydrate is preserved and by crumbling and screening the mass to granules of a suitable size; the dry granulated disodium clodronate tetrahydrate is optionally mixed with suitable excipients, such as filling agents and gliding agents and, if necessary, disintegrants.

Procédé de préparation d'une préparation à clodronate. Le procédé est caractérisé en ce qu'il consiste à cristalliser le clodronate sous forme de tétrahydrate de clodronate disodique à partir d'une solution aqueuse de clodronate disodique; à granuler à sec le tétrahydrate de clodronate disodique ainsi obtenu, par compression réalisée de telle manière que la structure cristalline du tétrahydrate de clodronate disodique est préservée, puis par désagrégation et tamisage de la masse afin d'obtenir des granulés ayant les dimensions voulues; et éventuellement à mélanger le tétrahydrate de clodronate disodique granulé à sec, avec des excipients appropriés tels que des charges et des agents de glissement et, le cas échéant, des désintégrants.

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