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

1. A method for treating human papilloma virus (HPV) in a patient, which method comprises administering to said, patient a therapeutically effective amount of a biphasic vesicle composition comprising;

a) a first phase comprising an oil-in-water emulsion which itself comprises oil in water, wherein a sufficient amount of oil is employed to form a composition suitable for topical application, and wherein the water 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 water phase comprises 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 so as to enhance the shelf-life of said composition and the anti-aggregant is arginine or a pharmaceutically acceptable salt thereof.

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

3. The method of claim 2 , wherein the antioxidant is L-methionine and is present in an amount of from 0.1 to 5 mg/g.

4. The method of claim 1 , wherein the anti-aggregant is a pharmaceutically acceptable salt of arginine.

5. The method of claim 4 , wherein the pharmaceutically acceptable salt of arginine is L-arginine hydrochloride.

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