A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/107 (2006.01) A61K 31/05 (2006.01)
Patent
CA 2657090
The present invention concerns a clear pharmaceutical aqueous emulsion composition which comprises Propofol and a surfactant system and which is particularly usable for a safe administration through intravenous injection. A composition according to the invention is characterized in that said surfactant system comprises in combination at least one pharmaceutically acceptable monovalent metal salt of a fatty acid having from 5 to 23 carbon atoms, and at least one polyethylene glycol hydroxystearate. This combination allows to use a mass ratio (w/w) surfactant system / Propofol which is less than 4 and preferably less than or equal to 2.8, while obtaining such a clear composition.
L'invention concerne une composition d'émulsion pharmaceutique aqueuse et transparente qui comprend du propofol et un système tensioactif et qui convient particulièrement à une administration sûre par injection intraveineuse. La composition de l'invention se caractérise en ce que ledit système tensioactif comprend une combinaison d'au moins un sel métallique monovalent acceptable d'un acide gras possédant 5 à 23 atomes de carbone et au moins un hydroxystéarate de polyéthylène glycol. Cette combinaison permet d'utiliser un rapport massique (p/p) système tensioactif/propofol inférieur à 4 et de préférence inférieur ou égal à 2,8, tout en obtenant une composition transparente.
Broussaud Olivier
Calvet Nicolas
Comtat Sophie
Pougnas Jean-Luc
Borden Ladner Gervais Llp
Physica Pharma
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