Antiseptic skin prep composition
View Patent ↗The disclosed antiseptic composition has improved stability, flow control and tinting ability is provided. The antiseptic composition comprises a cationic antiseptic, an anionic tinting agent, a polymer that serves as a stabilizer and preferably a viscosity builder, an alcohol-based solvent and optionally a plasticizer and viscosity builder.
1. An antiseptic skin prep composition comprising:
(a) cationic excipient consisting only of a cationic antiseptic agent;
(b) anionic colorant;
(c) a non-ionic polyvinyl pyrrolidone polymer or copolymer; and
(d) C 1 -C 4 alcohol-based solvent,
wherein the antiseptic skin prep composition exhibits no visible precipitation when stored in a sealed inert barrier container having an internal diameter of 4.5 cm at 23 deg C. for at least 17 days.
2. The antiseptic skin prep composition as claimed in claim 1 , wherein the cationic antiseptic agent is present in the range of 0.1-2.5% by weight of the antiseptic skin prep composition.
3. The antiseptic skin prep composition of claim 1 , wherein the anionic colorant is present in the range of 0.01-0.1% by weight of the antiseptic skin prep composition.
4. The antiseptic skin prep composition of claim 1 , wherein the non-ionic polyvinyl pyrrolidone polymer or copolymer is present in the range of 0.1 to 10% by weight of the antiseptic skin prep composition.
5. The antiseptic skin prep composition of claim 1 , wherein the concentration of anionic colorant to non-ionic polyvinyl pyrrolidone polymer or copolymer is in the ratio 1:1 to 1:1000.
6. The antiseptic skin prep composition of claim 1 , comprising at least 60% by weight of a lower alcohol.
7. The antiseptic skin prep composition of claim 1 , wherein the cationic antiseptic agent is selected from a group of chlorhexidine salts, polyhexamethylene biguanide salts, octenidine salts, alexidine salts, benzethonium salts, and combinations thereof.
8. The antiseptic skin prep composition of claim 1 , wherein the anionic colorant is selected from a group of anionic dyes including FD & C Red No. 3, FD&C Yellow No. 6, FD&C Blue No. 1, D&C Yellow 10, Brilliant Blue, D&C green and Carmoisine.
9. The antiseptic skin prep composition of claim 1 , wherein the non-ionic polyvinyl pyrrolidone polymer or copolymer is selected from a group of polyvinyl pyrrolidone, copolymers of polyvinyl pyrrolidone and vinyl acetate, copolymer of polyvinyl pyrrolidone and butene, or combinations thereof.
10. The antiseptic skin prep composition of claim 1 , wherein the non-ionic polyvinyl pyrrolidone polymer is polyvinyl pyrrolidone.
11. The antiseptic skin prep composition of claim 1 , wherein the weight average molecular weight of the non-ionic polyvinyl pyrrolidone polymer or copolymer is 100,000-3,000,000 g/mol.
12. The antiseptic skin prep composition of claim 1 , wherein the C 1 -C 4 alcohol-based solvent is selected from a group of isopropyl alcohol, ethanol, n-propanol or combinations thereof.
13. An antiseptic skin prep solution of claim 1 , characterized by a viscosity of 1 to 100 cp when measured using a Brookfield DV2T viscometer, spindle LV-02 at 23 C.
14. The antiseptic skin prep composition of claim 1 , further comprising a plasticizer.
15. The antiseptic skin prep composition of claim 14 , wherein the plasticizer is glycerol.
16. The antiseptic skin prep composition of claim 1 , characterized as stable without any visible precipitate for at least 6 months at a temperature of 40 deg C.
17. A kit comprising:
an antiseptic skin prep composition of claim 1 , and
gauze, foam, or prepping solution dispenser.
18. A kit comprising,
a cationic excipient consisting only of a cationic antiseptic agent and non-ionic polyvinyl pyrrolidone polymer or copolymer provided as a solution; and
an anionic colorant provided separate from the solution,
wherein the solution and the anionic colorant are mixed just prior to use and remain stable without precipitation for at least 5 mins at 23 deg C.
19. A process of preparing an antiseptic skin prep composition of claim 1 , the method comprising:
mixing until dissolved the following:
an anionic colorant;
a cationic antiseptic agent;
a non-ionic, polyvinyl pyrrolidone polymer or copolymer;
a C 1 -C 4 alcohol; and
water.
20. The antiseptic skin prep composition of claim 1 , wherein the non-ionic, polyvinyl pyrrolidone polymer or copolymer prevents or postpones precipitation of a complex between the cationic antiseptic agent and the anionic colorant for at least 17 days at 23 deg C.