Solvent/cosolvent free microemulsion and emulsion...

A - Human Necessities – 61 – K

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A61K 9/107 (2006.01) A61K 9/48 (2006.01)

Patent

CA 2331640

Self-emulsifying microemulsion or emulsion preconcentrate pharmaceutical compositions capable of forming an oil-in-water microemulsion or emulsion upon dilution with an aqueous solution are disclosed. The preconcentrate contains a therapeutically effective amount of a poorly water soluble therapeutic agent; a pharmaceutically effective amount of a low HLB oil component; and a surfactant system consisting essentially of at least one surfactant having an HLB of from about 10 to 20 and is substantially free or contains only minor amounts of a hydrophilic solvent system. Microemulsions or emulsions formed by diluting the self-emulsifying preconcentrate with an aqueous solution are also provided.

On décrit des compositions pharmaceutiques de microémulsion ou d'émulsion auto-émulsionnante qui sont capables de former une microémulsion ou une émulsion huile-dans-eau lorsqu'elles se diluent avec une solution aqueuse. Le préconcentré contient une quantité thérapeutiquement efficace d'un agent thérapeutique faiblement soluble dans l'eau; une quantité pharmaceutiquement efficace d'un constituant huile à faible rapport hydrophile-lipophile; et un système de tensioactifs contenant essentiellement au moins un tensioactif dont le rapport hydrophile-lipophile est compris entre 10 et 20 et qui est sensiblement dépourvu d'un système de solvant hydrophile ou qui n'en contient qu'une faible quantité. On décrit également des microémulsions ou des émulsions qui sont formées au moyen de la dilution du préconcentré auto-émulsionnant avec une solution aqueuse.

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