Injectable sodium acetylsalicylate composition and method

A - Human Necessities – 61 – K

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A61K 31/60 (2006.01) A61K 9/14 (2006.01) C07C 69/86 (2006.01)

Patent

CA 2336789

An injectable composition of sodium acetylsalicylate is provided having very high purity and which is extremely stable and having pharmaceutical acceptability for use as a subdermal injectable medication. The anhydrous sodium acetylsalicylate is formed by removing water vapor from the dihydrate form of the sodium acetylsalicylate at the same rate as that of its formation. The shelf life of such sodium acetylsalicylate is at least about 2-3 years, exhibiting between 97 % and 100 % purity after three years at room temperature. A method of making the anhydrous sodium acetylsalicylate injectable aspirin composition is also provided.

L'invention concerne une composition injectable d'acétylsalicylate de sodium présentant une très grande pureté, qui est extrêmement stable et est acceptable d'un point de vue pharmaceutique pour être utilisée comme médicament injectable de façon sous-cutanée. L'acétylsalicylate de sodium anhydre est formé par élimination de vapeur d'eau de la forme dihydrate de l'acétylsalicylate de sodium à la même vitesse que celle à laquelle elle se forme. La durée de conservation d'un tel acétylsalicylate de sodium est d'au moins environ 2-3 ans, le produit présentant entre 97 % et 100 % de pureté après 3 ans à température ambiante. L'invention concerne également un procédé de fabrication de la composition d'aspirine injectable d'acétylsalicylate de sodium anhydre.

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