Preparations for topical skin use and treatment

Abstract

Topical preparations for release of an active agent to the skin are provided. The preparations have an internal phase dispersed within an external phase. The internal phase includes a hydrophilic carrier and an enzyme active agent. The external phase comprises a silicone matrix.

1 . A topical preparation adapted to be applied to the skin comprising: 
 an internal phase; and an external phase; wherein said internal phase comprises droplets dispersed within said external phase; said internal phase comprises at least one hydrophilic carrier, at least one hydrophilic component containing water and at least one active agent comprising an enzyme; said internal phase is an aqueous phase emulsion in said external phase; and said external phase comprises a silicone matrix.    
     
     
         2 . The topical preparation as claimed in  claim 1  wherein said at least one active agent is hydrophilic, and wherein said at least one active agent may be released from said silicone matrix.  
     
     
         3 . The topical preparation as claimed in  claim 1  wherein said droplets are from about 0.1 μm to about 2000 μm in diameter.  
     
     
         4 . The topical preparation as claimed in  claim 3  wherein said droplets are from about 0.1 μm to about 1000 μm in diameter.  
     
     
         5 . The topical preparation as claimed in  claim 3  wherein said droplets are from about 0.1 μm to about 500 μm in diameter.  
     
     
         6 . The topical preparation as claimed in  claim 3  wherein said droplets are from about 0.1 μm to about 200 μm in diameter.  
     
     
         7 . The topical preparation as claimed in  claim 3  wherein said droplets are from about 0.1 μm to about 100 μm in diameter.  
     
     
         8 . The topical preparation as claimed in  claim 3  wherein said droplets are from about 0.1 μm to about 50 μm in diameter.  
     
     
         9 . The topical preparation as claimed in  claim 3  wherein said droplets are from about 0.1 μm to about 10 μm in diameter.  
     
     
         10 . The topical preparation as claimed in  claim 3  wherein said droplets are from about 0.1 μm to about 5 μm in diameter.  
     
     
         11 . The topical preparation as claimed in  claim 1  wherein said at least one hydrophilic carrier is selected from propylene glycol, polyethylene glycol, poloxamer, glycerin, alcohol, polyhydric alcohol, and water, and combinations thereof.  
     
     
         12 . The topical preparation as claimed in  claim 1  wherein said at least one hydrophilic carrier comprises polypropylene glycol.  
     
     
         13 . The topical preparation as claimed in  claim 1  wherein said at least one hydrophilic carrier comprises up to about 50% by weight of said topical preparation.  
     
     
         14 . The topical preparation as claimed in  claim 1  wherein said preparation is occlusive to fluids.  
     
     
         15 . The topical preparation as claimed in  claim 1  wherein said at least one hydrophilic component containing water comprises from about 5% to about 40% by weight of said topical preparation.  
     
     
         16 . The topical preparation as claimed in  claim 1  wherein said at least one hydrophilic component containing water comprises from about 10% to about 35% by weight of said topical preparation.  
     
     
         17 . The topical preparation as claimed in  claim 1  wherein said at least one hydrophilic component containing water comprises from about 15% to about 35% by weight of said topical preparation.  
     
     
         18 . The topical preparation as claimed in  claim 1  wherein said at least one hydrophilic component containing water comprises a water-thickening agent.  
     
     
         19 . The topical preparation as claimed in  claim 1  wherein said silicone matrix is selected from high molecular weight polydimethylsiloxanes, loosely or lightly cross-linked silicone elastomers, fillerless elastomers, cellular elastomers, silicone rubbers, silicone pressure sensitive adhesives, and combinations thereof.  
     
     
         20 . The topical preparation as claimed in  claim 1  wherein said external phase further comprises a silicone-based surfactant.  
     
     
         21 . The topical preparation as claimed in  claim 1  wherein said internal phase and said external phase are selected such that said topical preparation comprises a topical dressing, and wherein said topical dressing comprises a patch.  
     
     
         22 . The topical preparation as claimed in  claim 21  wherein said patch is up to about 25 μm thick.  
     
     
         23 . The topical preparation as claimed in  claim 21  wherein said external phase comprises a loosely or lightly cross-linked silicone elastomer.  
     
     
         24 . The topical preparation as claimed in  claim 1  wherein said internal phase and said external phase are selected such that said topical preparation comprises a topical dressing, and wherein said topical dressing comprises a spread on film.  
     
     
         25 . The topical preparation as claimed in  claim 24  wherein said external phase comprises a silicone rubber.  
     
     
         26 . The topical preparation as claimed in  claim 24  wherein said spread on film polymerizes in situ when applied to skin.  
     
     
         27 . The topical preparation as claimed in  claim 1  wherein said internal phase and said external phase are selected such that said topical preparation comprises an ointment.  
     
     
         28 . The topical preparation as claimed in  claim 27  wherein said external phase comprises at least one silicone elastomer and at least one silicone surfactant.  
     
     
         29 . The topical preparation as claimed in  claim 27  wherein said ointment polymerizes in situ when applied to skin.  
     
     
         30 . A topical preparation adapted to be applied to the skin comprising: 
 an internal phase; and an external phase; wherein said internal phase comprises droplets dispersed within said external phase; said internal phase comprises at least one hydrophilic carrier, at least one hydrophilic component containing water and at least one active agent comprising at least one enzyme selected from hydrolases, cutinases, oxidases, transferases, reductases, hemicellulases, esterases, isomerases, pectinases, lactases, peroxidases, laccases, catalases, polypeptides, antibodies, peptides, hormones, cytokines, and growth factors, and combinations thereof; said internal phase is an aqueous phase emulsion in said external phase; and said external phase comprises a silicone matrix.    
     
     
         31 . The topical preparation as claimed in  claim 30  wherein said at least one active agent comprises at least one hydrolase enzyme.  
     
     
         32 . The topical preparation as claimed in  claim 31  wherein said hydrolase enzyme is selected from lipases and proteases.  
     
     
         33 . The topical preparation as claimed in  claim 32  wherein said protease comprises a subtilisin protease.  
     
     
         34 . The topical preparation as claimed in  claim 33  wherein said subtilisin protease comprises LG12.  
     
     
         35 . The topical preparation as claimed in  claim 32  wherein said hydrolase enzyme comprises Protease A or Protease B.  
     
     
         36 . The topical preparation as claimed in  claim 31  wherein said hydrolase enzyme comprises a lipase, and wherein said lipase in said silicone matrix comprises from about 0.0001% to about 0.2% by weight of said silicone matrix.  
     
     
         37 . The topical preparation as claimed in  claim 31  wherein said hydrolase enzyme comprises a protease, and wherein said protease concentration is about 0.1 mg/g to about 5.0 mg/g of said topical preparation.  
     
     
         38 . The topical preparation as claimed in  claim 31  wherein said hydrolase enzyme comprises LG12 protease.  
     
     
         39 . The topical preparation as claimed in  claim 30  wherein said at least one hydrophilic component is selected from polyvinyl alcohol and polyvinylpyrrolidone and combinations thereof.  
     
     
         40 . The topical preparation as claimed in  claim 30  wherein said at least one hydrophilic component comprises up to about 50% by weight of said internal phase.  
     
     
         41 . The topical preparation as claimed in  claim 30  wherein said at least one hydrophilic component comprises up to about 35% by weight of said internal phase.  
     
     
         42 . The topical preparation as claimed in  claim 30  wherein said internal phase and said external phase are selected such that said topical preparation comprises a topical dressing, and wherein said topical dressing comprises a patch.  
     
     
         43 . The topical preparation as claimed in  claim 42  wherein said patch is up to about 25 μm thick.  
     
     
         44 . The topical preparation as claimed in  claim 42  wherein said external phase comprises a loosely or lightly cross-linked silicone elastomer.  
     
     
         45 . The topical preparation as claimed in  claim 30  wherein said internal phase and said external phase are selected such that said topical preparation comprises a topical dressing, and wherein said topical dressing comprises a spread on film.  
     
     
         46 . The topical preparation as claimed in  claim 45  wherein said external phase comprises a silicone rubber.  
     
     
         47 . The topical preparation as claimed in  claim 45  wherein said spread on film polymerizes in situ when applied to skin  
     
     
         48 . The topical preparation as claimed in  claim 30  wherein said internal phase and said external phase are selected such that said topical preparation comprises an ointment.  
     
     
         49 . The topical preparation as claimed in  claim 48  wherein said external phase comprises at least one silicone elastomer and at least one silicone surfactant.  
     
     
         50 . The topical preparation as claimed in  claim 48  wherein said ointment polymerizes in situ when applied to skin.