Pharmaceutical compositions containing an omega-3 fatty acid...

A - Human Necessities – 61 – K

Patent

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A61K 38/13 (2006.01) A61K 9/107 (2006.01) A61K 9/48 (2006.01) A61K 31/20 (2006.01) A61K 31/202 (2006.01) A61K 31/232 (2006.01) A61K 35/12 (2006.01) A61K 45/06 (2006.01) A61P 39/00 (2006.01)

Patent

CA 2313024

Self-emulsifying microemulsion or emulsion preconcentrate pharmaceutical compositions containing an omega-3 fatty acid oil such as a fish oil and a poorly water soluble therapeutic agent such as cyclosporin are formulated for administration, particularly oral administration to a human. The preconcentrates, which are substantially free of or contain only minor amounts of a hydrophilic solvent system, contain a pharmaceutically effective amount of an omega-3 fatty acid oil; a therapeutically effective amount of a poorly water soluble therapeutic agent that is substantially soluble in the omega-3 fatty acid oil; and a surfactant system comprising at least one surfactant. Microemulsions or emulsions formed by diluting the self-emulsifying preconcentrate with an aqueous solution are also provided.

L'invention concerne des compositions pharmaceutiques d'un préconcentré de microémulsion ou émulsion auto-émulsifiant contenant une huile d'acide gras oméga-3 (telle qu'une huile de poisson) et un agent thérapeutique peu soluble dans l'eau (tel que la cyclosporine). Ces compositions pharmaceutiques sont préparées en vue de leur administration à l'homme, en particulier par voie orale. Lesdits préconcentrés, sensiblement dépourvus d'un système de solvants hydrophiles ou ne contenant que de faibles quantités desdits solvants, contiennent une quantité pharmaceutiquement effective d'une huile d'acide gras oméga-3, une quantité thérapeutiquement effective d'un agent thérapeutique peu soluble dans l'eau mais sensiblement soluble dans l'huile d'acide gras oméga-3, et une solution de tensioactifs comprenant au moins un tensioactif. L'invention concerne en outre des microémulsions ou émulsions formées par dilution du préconcentré auto-émulsifiant avec une solution aqueuse.

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