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

1. 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.

2. The biphasic vesicle composition of claim 1 , wherein the antioxidant is selected from the group consisting of L-methionine, D-methionine and racemic mixtures thereof.

3. The biphasic vesicle composition of claim 1 , wherein the anti-aggregant is a pharmaceutically acceptable salt of arginine.

4. The biphasic vesicle composition of claim 3 , wherein the pharmaceutically acceptable salt of arginine is L-arginine hydrochloride.

5. The biphasic vesicle composition of claim 2 , wherein the L-methionine is present in the composition in an amount of 0.1 to 5 mg/g.

6. The biphasic vesicle composition of claim 4 , wherein the L-arginine hydrochloride is present in the composition in an amount of 0.1 to 5 mg/g.