Intravenous propofol emulsion compositions having...

A - Human Necessities – 61 – K

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A61K 9/107 (2006.01)

Patent

CA 2618026

The invention discloses a stable intravenous Propofol oil-in-water emulsion composition having mixed preservatives of low toxicity that is capable of withstanding accidental contamination of bacteria and fungi. The preservative system employed comprising of monoglyceryl ester of lauric acid (Monolaurin) and a member selected from (a) capric acid and/or its soluble alkaline salts or its monoglyceryl ester (Monocaprin); (b) edetate; and (c) capric acid and/or its soluble alkaline salts or its monoglyceryl ester (Monocaprin) and edetate.

La présente invention concerne une composition stable d'émulsion huile dans eau de propofol pour administration intraveineuse qui présente un mélange de conservateurs de faible toxicité et qui peut surmonter une contamination accidentelle par des bactéries ou des champignons. Le système de conservateurs utilisé comprend un ester monoglycéryl d'acide laurique (monolaurine) et un élément choisi parmi (a) de l'acide caprique et/ou des sels alcalins solubles de celui-ci ou un ester monoglycéryl de celui-ci (monocaprine), (b) de l'édétate et (c) de l'acide caprique et/ou des sels alcalins solubles de celui-ci ou un ester monoglycéryl de celui-ci (monocaprine) et de l'édétate.

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