Clear propofol compositions

Details Clear propofol compositions Clear propofol compositions

A - Human Necessities

61

K

A61K 31/05 (2006.01) A61K 47/14 (2006.01) A61K 47/22 (2006.01) A61P 23/00 (2006.01) A61P 23/02 (2006.01)

Patent

CA 2432549

The present invention relates to a stable clear sterile aqueous composition of Propofol suitable for parenteral administration and a process for making the same. The composition comprises Propofol, TPGS and water. The composition of present invention gives clear product suitable for parenteral administration overcoming the disadvantages of emulsion formulation. The ratio of propofol to TPGS is at least 1: 10 (by wt.) and the content of TPGS is from 1 to 20% w/v in the composition. The composition is rendered sterile by end autoclaving.

L'invention concerne d'une part une composition aqueuse, stérile, incolore, et stable à base de propofol convenant à l'administration parentérale, et d'autre part le procédé de préparation de cette composition. Cette composition comprend du propofol, du TPGS et de l'eau. Par ailleurs, cette composition permet d'obtenir un produit incolore qui convient à l'administration parentérale et qui ne présente pas les inconvénients des formulations en émulsion. Le rapport entre le propofol et le TPGS est d'au moins 1: 10 (en poids), la teneur du TPGS étant comprise entre 1 et 20 % w/v dans la composition. Cette composition est stérilisée en autoclave.

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