Tinted antiseptic solutions having improved stability

Abstract

An antiseptic solution including, a cationic antiseptic agent, a film forming polymer, an anionic tinting agent, and a solvent, wherein the cationic antiseptic agent, the film forming polymer and the anionic tinting agent each remain solubilized within the solution for greater than about 1 hour at 25° C. and 60% relative humidity. The antiseptic agent is preferably octenidine dihydrochloride or chlorhexadine gluconate. The film forming polymer is preferably an acrylate polymer. The solvent is preferably ethanol, isopropanol, and n-propanol. When a drape is adhered to a dried surgical film via the antiseptic solution, the force required to peel the drape from the surgical film is at least about 105 g/25 mm.

What is claimed is: 
     
       1. An antiseptic solution comprising:
 about 0.0001% w/v to about 2.0% w/v of a cationic antiseptic agent, wherein the cationic antiseptic agent comprises a cationic surfactant and one selected from the group consisting of a biguanide or a bis-(dihydropyridinyl)-decane derivative; 
 about 0.1% w/v to about 5% w/v of a film forming polymer comprising an acrylate polymer; 
 about 0.01% to about 0.15% w/v of an anionic tinting agent; and 
 a solvent, 
 wherein the polymer is selected from the group consisting of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate and methyl 2-methyl-2-propenoate and 2-propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with 2-propenoic acid and N-(1,1,3,3tetramethylbutyl)-2-propenamide, and 
 the cationic antiseptic agent, the film forming polymer, and the anionic tinting agent each remain solubilized within the solution for about 1 hour or more at 25° C. and 60% relative humidity. 
 
     
     
       2. The antiseptic solution of  claim 1 , wherein the cationic antiseptic agent, the film forming polymer, and the anionic tinting agent each remain solubilized for about 24 hours or more at 25° C. and 60% relative humidity. 
     
     
       3. The antiseptic solution of  claim 1 , wherein the cationic antiseptic agent, the film forming polymer, and the anionic tinting agent each remain solubilized for about 1 month or more at 25° C. and 60% relative humidity. 
     
     
       4. The antiseptic solution of  claim 1 , wherein the cationic antiseptic agent, the film forming polymer, and the anionic tinting agent each remain solubilized for at 3 month or more at 25° C. and 60% relative humidity. 
     
     
       5. The antiseptic solution of  claim 1 , wherein the antiseptic agent comprises an octenidine salt or chlorhexadine salt. 
     
     
       6. The antiseptic solution of  claim 1 , wherein the antiseptic agent comprises octenidine dihydrochloride or clorhexadine gluconate. 
     
     
       7. The antiseptic solution of  claim 1 , wherein the anionic tinting agent comprises an agent selected from the group consisting of Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Yellow No. 8, Orange No. 4, and combinations thereof. 
     
     
       8. The antiseptic solution of  claim 1 , wherein the solvent comprises an alcoholic solvent. 
     
     
       9. The antiseptic solution of  claim 8 , wherein the solvent comprises an alcoholic solvent selected from the group consisting of ethanol, isopropanol, and n-propanol. 
     
     
       10. The antiseptic solution of  claim 8 , wherein the concentration of the solvent is about 50 to about 80% v/v. 
     
     
       11. The antiseptic solution of  claim 1 , further comprising a plasticizer. 
     
     
       12. The antiseptic solution of  claim 11 , wherein the plasticizer comprises triethyl citrate or dibutyl sebacate. 
     
     
       13. The antiseptic solution of  claim 11 , wherein the concentration of the plasticizer is about 0.05% to about 2% w/v. 
     
     
       14. A method of disinfecting a surface comprising applying the antiseptic solution of  claim 1  to the surface. 
     
     
       15. The method of  claim 14 , wherein the surface is human skin. 
     
     
       16. A method of adhering a drape to a surface, the method comprising:
 applying the antiseptic solution of  claim 1  to the surface; 
 allowing the antiseptic solution to dry, thereby producing a tacky film; and 
 contacting the drape with the tacky film such that the drape is adhered to the surface via the tacky film. 
 
     
     
       17. The method of  claim 16 , wherein the surface is human skin. 
     
     
       18. The method of  claim 16 , wherein the force required to peel the drape from the surface is about 105 g/25 mm or more. 
     
     
       19. An antiseptic applicator comprising the antiseptic solution of  claim 1  contained therein. 
     
     
       20. An antiseptic solution comprising:
 about 0.0001% w/v to about 2.0% w/v of a cationic antiseptic agent, wherein the cationic antiseptic agent comprises a cationic surfactant and one selected from the group consisting of a biguanide or a bis-(dihydropyridinyl)-decane derivative;   about 70% v/v of an alcoholic solvent comprising isopropanol;   a film forming polymer selected from octylacrylamide polymers, carboxyacrylate polymers, and polymers having dimethylaminoethyl methacrylate, butyl methacrylate, or methyl methacrylate side groups; and   an anionic tinting agent,   wherein the cationic antiseptic agent, the film forming polymer, and the anionic tinting agent each remain solubilized within the antiseptic solution for about 1 month or more at 25° C. and 60% relative humidity, and   wherein when a drape is adhered to a dried surgical film via the antiseptic solution, the force required to peel the drape from the surgical film is about 105 g/25 mm or more.   
     
     
       21. The antiseptic solution of  claim 20 , wherein the concentration of the film forming polymer in the antiseptic solution is about 0.1% w/v to about 5% w/v. 
     
     
       22. The antiseptic solution of  claim 20 , wherein the cationic antiseptic agent, the film forming polymer, and the anionic tinting agent each remain solubilized within the antiseptic solution for about 3 months or more at 25° C. and 60% relative humidity. 
     
     
       23. The antiseptic solution of  claim 20 , wherein the anionic tinting agent comprises an agent selected from the group consisting of Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 4, Yellow No. 5, Yellow No. 6, Yellow No. 8, Orange No. 4, and combinations thereof. 
     
     
       24. The antiseptic solution of  claim 20 , wherein the antiseptic solution further comprises a plasticizer. 
     
     
       25. The antiseptic solution of  claim 24 , wherein the plasticizer comprises an ester of an organic acid. 
     
     
       26. The antiseptic solution of  claim 24 , wherein the concentration of the plasticizer in the antiseptic solution is about 0.05% to about 2% w/v. 
     
     
       27. The antiseptic solution of  claim 20 , wherein the concentration of the anionic tinting agent in the antiseptic solution is about 0.01% to about 0. 15% w/v.