FREEZE-DRIED PANTOPRAZOLE PREPARATION AND PANTOPRAZOLE INJECTION AND METHOD OF THE PRODUCTION THEREOF

摘要

The invention relates to a method for the preparation of lyophilized pantoprazole by freeze drying of aqueous solution of pantoprazole, ethylenediamine tetraacetic acid and/or a suitable salt thereofand sodium hydroxyde and/or sodium carbonate. The preparations produced have advantageous properties and are suitable for injection solutions. The pantoprazole injection for parenteral administrationis produced by the dissolution of the pantoprazole in a suitable solvent - physiological solution. The injection set comprises the freeze dry pantoprazole and suitable solvent for parenteral administration. The pantoprazole injection has less than 130, preferably under 120 particles, invisible by naked eye, per vial, of particle size distribution equal or larger than 10 micro m. 10 claims