Parenteral cisplatin emulsion

A - Human Necessities – 61 – K

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A61K 33/24 (2006.01) A61K 9/107 (2006.01) A61P 35/00 (2006.01)

Patent

CA 2379815

Sterile pharmaceutical cisplatin compositions as oil-in-water emulsion having low toxicity for parenteral administration are described. The compositions essentially consist of oil-in-water emulsion with cisplatin in oily phase. The process of making these synergistic compositions has been described. Cisplatin is dispersed in oily phase and emulsified with aqueous phase using emulsifier. Edetate specified in the composition is in a quantity sufficient to stabilise and prevent discolouration of the product on autoclaving.

L'invention concerne des compositions pharmaceutiques stériles de cisplatine pouvant se présenter sous la forme d'émulsions huile/eau de faible toxicité, destinées à être administrées par voie parentérale. Ces compositions sont essentiellement constituées d'une émulsion huile/eau renfermant de la cisplatine en phase huileuse. Cette invention concerne également le procédé d'élaboration de ces compositions synergiques, qui consiste notamment à disperser la cisplatine en phase huileuse et à émulsionner celle-ci à l'aide d'un émulsifiant en phase aqueuse. Enfin, l'édétate utilisé dans cette composition est présent en quantité suffisante pour stabiliser et prévenir toute décoloration du produit, une fois celui-ci stérilisé à l'autoclave.

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