Color change surgical prep solution

Abstract

This invention discloses a surgical prep solution formulation, either film forming or non-film forming, that changes color upon a change in pH to indicate that the solvent has sufficiently evaporated. The major components of this surgical prep solution include: antimicrobial agents, solvents, pH adjusters, color changing pH indicators, and optionally: film forming polymers, dyes and viscosity regulators. The pH of the solution may rise or fall depending on the pH of the original solution as compared with the normal pH range of the acid mantle of the human skin or the normal pH range of a sterilizing solution. As the pH changes, the pH indicator may cause the surgical prep solution to change color. Concurrently, as the fluids evaporate, the pH indicators interact with atmospheric CO 2 , causing the solution to change color based on the pH of the solution. The solution may also be used as coating for medical devices.

1 . A composition comprising an antimicrobial agent, one or more pH adjusters, and a color-changing pH indicator, wherein the one or more pH adjusters is an acid, a base, a pH buffer or a combination thereof. 
     
     
         2 . A composition comprising an antimicrobial agent, a topically-acceptable solvent, one or more pH adjusters, and a color-changing pH indicator, wherein the one or more pH adjusters is an acid, a base, a pH buffer or a combination thereof. 
     
     
         3 . The composition according to  claim 2 , wherein the antimicrobial agent is selected from the group consisting of chlorhexidine digluconate, chlorhexidine diacetate, chlorhexidine dihydrochloride, gluconic acid, hexachlorophene, iodophors, povidone-iodine, iodine, para-chlorometaxylenol, triclosan, and mixtures thereof. 
     
     
         4 . The composition according to  claim 2 , wherein the topically-acceptable solvent comprises water, ethanol, isopropanol, acetone, or mixtures thereof. 
     
     
         5 . The composition according to  claim 2 , wherein the one or more pH adjusters are selected from the group consisting of acetic acid, boric acid, carbonic acid, chromic acid, citric acid, lactic acid, diluted hydrochloric acid, tartaric acid, propionic acid, malic acid, diluted phosphoric acid, ammonium hydroxide, ammonium carbonate, diethanolamine, ethylamine, hydrazine, methylamine, monoethanolamine, potassium hydroxide, sodium bicarbonate, sodium borate, sodium borate, sodium hydroxide, sodium phosphate dibasic, trimethylamine, trolamine, pH buffer agents and mixtures thereof. 
     
     
         6 . The composition according to  claim 2 , wherein the color-changing pH indicator is selected from the group consisting of bromophenol blue, bromothymol blue, bromocresol green, bromocresol purple, congo red, methyl orange, methyl red, methyl yellow, pentamethoxy, phenophthalein, thymophthalein, p-naphtholbenzein, 4-nitrophenol, 3-nitrophenol, o-cresolphthalein, m-cresol red, thymol blue, m-cresol purple, phenol red, and mixtures thereof. 
     
     
         7 . The composition according to  claim 2 , further comprising a film-forming polymer. 
     
     
         8 . The composition according to  claim 7 , wherein the film-forming polymer is selected from the group consisting of polyvinyl acetate, polyvinyl alcohol, methacrylic acid-ethyl acrylate copolymer, vinylpyrrolidone-vinyl acetate copolymer, polyvinyl alcohol-polyethylene glycol graft copolymer, ethyl acrylate-methyl methacrylate copolymer, acrylic polymer, polyacrylate copolymer, and mixtures thereof. 
     
     
         9 . The composition according to  claim 2 , further comprising a dye. 
     
     
         10 . The composition according to  claim 9 , wherein the dye is selected from the group consisting of Green #5, Green #8, Orange #4, Red #4, Red #17, Red #22, Red #28, Red #33, Violet #2, Yellow #8, Yellow #10, Yellow #11, Blue #1, Blue #2, Carmine, Emerald Green, Green #3, Red #3, Red #40, Yellow #5, Yellow #6, and mixtures thereof. 
     
     
         11 . The composition according to  claim 2 , further comprising a viscosity regulator. 
     
     
         12 . The composition accordingly to  claim 11 , wherein the viscosity regulator is selected from the group consisting of polyethylene glycol, polyethylene glycol derivatives, ethyl cellulose, methoxycellulose, hydroxyethylcellulose, polyvinylpyrrolidone/vinyl acetate copolymer, crosslinked pyrrolidone and mixtures thereof. 
     
     
         13 . The composition according to  claim 2 , wherein the composition undergoes a visible color change upon a change in pH. 
     
     
         14 . The composition according to  claim 13 , wherein the composition reversibly undergoes a visible color change upon change in pH. 
     
     
         15 . The composition according to  claim 13 , wherein the rate of color change is controlled by the combination of pH adjusters. 
     
     
         16 . The composition according to  claim 13 , wherein the composition undergoes a visible color change upon a change in pH from greater than about 6.5 to between about 4.5 to about 5.5. 
     
     
         17 . The composition according to  claim 13 , wherein the composition undergoes a visible color change upon a change in pH from less than about 3.0 to between about 4.0 to about 5.5. 
     
     
         18 . The composition according to  claim 13 , wherein the composition undergoes a visible color change upon a change in pH from less than about 4.5 to between about 4.5 to about 5.5. 
     
     
         19 . A method of preparing a surgical prep solution used to disinfect a pre-operative surgical site comprising combining an antimicrobial agent, one or more pH adjusters, and a color changing pH indicator to form a solution, wherein the one or more pH adjusters is an acid, a base, a pH buffer or a combination thereof. 
     
     
         20 . A method of preparing a surgical prep solution used to disinfect a pre-operative surgical site comprising combining an antimicrobial agent, a topically-acceptable solvent, one or more pH adjusters, and a color-changing pH indicator to form a solution, wherein the one or more pH adjusters is an acid, a base, a pH buffer or a combination thereof. 
     
     
         21 . A method of disinfecting comprising:
 applying a composition to a selected surface,   evaporating the composition, and   visually inspecting the residue of the composition on the selected surface for a change in color,   wherein the composition comprises an antimicrobial agent, one or more pH adjusters, and a color-changing pH indicator, and   wherein the one or more pH adjusters is an acid, a base, a pH buffer or a combination thereof.   
     
     
         22 . A method of disinfecting comprising:
 applying a composition to a selected surface,   evaporating the composition, and   visually inspecting the residue of the composition on the selected surface for a change in color,   wherein the composition comprises an antimicrobial agent, a topically-acceptable solvent, one or more pH adjusters, and a color-changing pH indicator, and   wherein the one or more pH adjusters is an acid, a base, a pH buffer or a combination thereof.   
     
     
         23 . The method according to  claim 22 , wherein the selected surface is skin. 
     
     
         24 . The method according to  claim 22 , wherein the selected surface is a medical device. 
     
     
         25 . The method according to  claim 24 , wherein the medical device is a needleless injection connector. 
     
     
         26 . The method according to  claim 22 , wherein the antimicrobial agent is an antimicrobial agent sensitive to the environmental pH. 
     
     
         27 . The method according to  claim 26 , wherein the antimicrobial agent sensitive to the environmental pH is selected from the group consisting of iodine, idophor, chlorhexidine and chlorhexidine gluconate. 
     
     
         28 . The method according to  claim 22 , further comprising preparing the composition of the applying step. 
     
     
         29 . The method according to  claim 28 , wherein the preparing step includes adding the one or more pH adjusters to the composition in situ prior to application of the composition to the skin. 
     
     
         30 . The method according to  claim 28 , wherein the preparing step includes adding the pH indicator to the composition in situ prior to application of the composition to the skin. 
     
     
         31 . A medical device comprising:
 a coating comprising one or more pH adjusters, and a color-changing pH indicator,   wherein the one or more pH adjusters is an acid, a base, a pH buffer or a combination thereof.   
     
     
         32 . The medical device according to  claim 31 , wherein the coating reversibly undergoes a visible color change upon change in pH. 
     
     
         33 . The medical device according to  claim 31 , wherein the coating further comprises an antimicrobial agent. 
     
     
         34 . The medical device according to  claim 31 , wherein the medical device is one of a needle-free connector or a needle-free valve. 
     
     
         35 . A method of disinfecting comprising:
 coating a composition of a first color to a selected surface, the coating comprising one or more pH adjusters and a color-changing pH indicator,   applying a disinfecting solution to the selected surface,   visually inspecting the coating for a change in color to a second color,   evaporating the disinfecting solution, and   visually inspecting the coating for a change in color to the first color,   wherein the one or more pH adjusters is an acid, a base, a pH buffer or a combination thereof.