Biphasic lipid-vesicle composition and method for treating cervical dysplasia by intravaginal delivery

Abstract

A biphasic lipid vesicle composition for treating cervical displasia by intravaginal delivery. The composition includes a suspension of lipid-bilayer vesicles having entrapped therein, an oil-in-water emulsion, human interferon alpha-2b and L-methionine, the composition having an interferon alpha-2b specific activity of between about 1-10 MIU (million international units) per gram composition, and between 0.01 to 0.5 weight percent L-methionine. In the treatment method, the composition is administered at a dose of between about 1-20 MIU interferon alpha-2b, and this dose is administered at least 3 days/week, for a period of at least 4 weeks.

1 - 11 . (canceled) 
     
     
         12 . A method for treating cervical dysplasia in a subject in need thereof comprising administering intravaginally to said subject a therapeutically effective amount of a biphasic vesicle composition comprising:
 (a) a first phase comprising an oil-in-water emulsion which itself comprises oil, water, interferon alpha-2b and methionine; 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 which itself comprises oil, water, interferon alpha-2b and methionine,
 wherein each phase comprises an amount sufficient of methionine to stabilize said interferon alpha-2b against oxidation, and 
 further wherein each phase contains a therapeutically effective aggregate amount of said interferon alpha-2b. 
   
     
     
         13 . The method according to  claim 12 , wherein said oil-in water emulsion is comprised of oil droplets having a size of from about 0.1 μm to 1 μm. 
     
     
         14 . The method according to  claim 12 , wherein said methionine is present in a concentration of from 0.01 to 0.5 weight percent. 
     
     
         15 . The method according to  claim 12 , wherein at least 30% of said interferon alpha-2b and said methionine is entrapped within said vesicles as part of said oil-in-water emulsion. 
     
     
         16 . The method according to  claim 13 , wherein at least 30% of said interferon alpha-2b and said methionine is entrapped within said vesicles as part of said oil-in-water emulsion. 
     
     
         17 . The method according to  claim 14 , wherein at least 30% of said interferon alpha-2b and said methionine is entrapped within said vesicles as part of said oil-in-water emulsion. 
     
     
         18 . The method according to  claim 12 , wherein said multilamellar vesicle comprises from about 2 to about 4 weight percent cholesterol. 
     
     
         19 . The method according to  claim 12 , wherein said step of administering intravaginally to said subject a biphasic vesicle composition is repeated until said subject is no longer in need of treatment for cervical dysplasia.