INCLUSION COMPOUNDS OF SALTS OF AMINO ACIDS OF BENCIMIDAZOLE DERIVATIVES WITH CYCLODEXTRINS, THEIR PREPARATION AND PHARMACEUTICAL FORMULATIONS BASED ON SUCH COMPOUNDS.

摘要

Stable inclusion complex of an amino acid salt of a benzimidazole derivative and of a cyclodextrin, obtainable by the procedure comprising the steps of: a. dissolve the amino acid in water or in an ethanol: water mixture; b. add the benzimidazole derivative to this solution; c. mix the solution at high speed for 1 to 10 minutes; d. adding a cyclodextrin to the solution obtained in step C while maintaining vigorous stirring for 0.5 to 24 hours; and. Prepare the final stable inclusion complex by a method selected from spray drying, lyophilization, evaporation of the solvent under reduced pressure, by deposition on inert nuclei or by a granulation process, to obtain tablets or pellets by extrusion-spheronization.