Process to prepare pharmaceutical compositions containing...

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/58 (2006.01) A61K 9/08 (2006.01) A61K 9/19 (2006.01) A61K 47/02 (2006.01) A61K 47/18 (2006.01)

Patent

CA 2152262

The invention elates to a process for preparing a pharmaceutical preparation having neuromuscular blocking activity in a vial by dissolving vecuroniumbromide or an analogue thereof in water saturated with carbondioxide or an organic solvent, filling the solution thus obtained into the vial to provide therein the required unit dosage form of vecuronium bromide or an analogue thereof, removing the solvent, i.e. water or organic solvent in the vial by lyophilization or evaporation, and hermetically closing the vial. The invention also relates to a method of preparing an aqueous injection solution starting from said vial by dissolving the contents of the vial either in an amino acid solution of sufficient concentration so as to obtain a final physiological pH or in a pharmaceutically acceptable buffer system of pH 7 to 7.4.

L'invention concerne un procédé d'obtention d'une préparation pharmaceutique présentant une activité de blocage neuromusculaire, dans un flacon, consistant à dissoudre du bromure de vécuronium ou un analogue de celui-ci dans de l'eau saturée d'oxyde de carbone ou d'un solvant organique, à remplir le flacon de la solution ainsi obtenue de manière qu'il contienne la forme galénique unitaire requise de bromure de vécuronium ou d'un analogue de celui-ci, à extraire le solvant, c'est-à-dire de l'eau ou un solvant organique se trouvant dans le flacon par lyophilisation ou évaporation, et à fermer hermétiquement ledit flacon. L'invention concerne étalement un procédé de préparation d'une solution d'injection aqueuse à partir dudit flacon, consistant à dissoudre les contenus du flacon soit dans une solution d'acides aminés de concentration suffisante pour obtenir un pH physiologique final, soit dans un système tampon pharmaceutiquement acceptable d'un pH compris entre 7 et 7,4.

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