Biphasic lipid-vesicle compositions and methods for treating cervical dysplasia by intravaginal delivery

A biphasic vesicle composition comprising:

• (a) a first phase comprising an oil-in-water emulsion which oil-in-water emulsion comprises oil in a water phase, wherein a sufficient amount of oil is employed to form a composition suitable for topical application, and wherein the water phase comprises interferon alpha-2b, an antioxidant and an anti-aggregant;
• and
• (b) a second phase comprising multilamellar lipid vesicles suspended in said first phase wherein said vesicles contain entrapped therein a composition comprising an oil-in-water emulsion wherein the oil-in-water emulsion comprises a water phase comprising interferon alpha-2b, an antioxidant and an anti-aggregant,
• wherein the composition comprises a therapeutically effective amount of said interferon alpha-2b, and
• wherein said anti-aggregant preserves interferon alpha-2b in the monomeric form and the anti-aggregant is arginine or a pharmaceutically acceptable salt thereof.