Antimicrobial composition containing parachlorometaxylenol (PCMX)

• US 6,413,921 B1
• Filed: 08/01/2000
• Issued: 07/02/2002
• Est. Priority Date: 08/01/2000
• Status: Expired due to Term

• Current Assignee: CareFusion 2200 Inc (Becton, Dickinson & Co)
• Original Assignee: Allegiance Corporation (Cardinal Health, Inc.)
• Inventors: Childers, David, Jeng, David
• Primary Examiner(s): OGDEN JR, NECHOLUS
• Application Number:
  US09/630,678
• Time in Patent Office: 700 Days
• Field of Search: 510/130, 510/131, 510/137, 510/159, 510/383, 510/405, 510/428, 510/433, 510/488, 424/400, 424/401, 424/404, 424/405
• US Class Current: 510/131
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 25/30 characterised by the surfactants
• CPC Class Codes: A01N 31/08 Oxygen or sulfur directly attached to an aromatic ring system
• CPC Class Codes: A61K 2800/75 Anti-irritant
• CPC Class Codes: A61K 8/02 characterised by special physical form
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 8/347 Phenols
• CPC Class Codes: A61K 8/361 Carboxylic acids having more than seven carbon atoms in an unbroken chain; Salts or anhydrides thereof
• CPC Class Codes: A61K 8/44 Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
• CPC Class Codes: A61K 8/463 containing sulfuric acid derivatives, e.g. sodium lauryl sulfate
• CPC Class Codes: A61K 8/466 containing sulfonic acid derivatives; Salts
• CPC Class Codes: A61K 8/8182 Copolymers of vinyl-pyrrolidones. Compositions of derivatives of such polymers
• CPC Class Codes: A61K 8/86 Polyethers
• CPC Class Codes: A61K 8/922 of vegetable origin
• CPC Class Codes: A61Q 17/005 Antimicrobial preparations
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 19/10 Washing or bathing preparations

Abstract

The present invention provides an antimicrobial composition for disinfection of a skin surface in preparation for surgery. The antimicrobial composition comprises parachlorometaxylenol (PCMX) and an anionic surfactant composition which exhibits both a high degree of antimicrobial efficacy and low skin irritability properties. In a preferred embodiment, the composition comprises an anionic surfactant composition comprising a surfactant having a hydrophobic portion consisting of a linear alkyl and a hydrophilic portion having ethoxylation termination with a sulfonate anionic group, and a sarcosine surfactant. A preferred surfactant composition further comprises a foaming anionic surfactant, such as sodium lauryl sulfate. The antimicrobial composition can be used in skin disinfecting formulations, such as scrub formulations and pre-operative skin disinfecting formulations. In one embodiment, the composition comprises about 3.3% parachlorometaxylenol. The composition can be used as a surgical scrub formulation or in various pre-surgical skin disinfecting products, including sponges, swabs and topical application devices.

Claims

1. An antimicrobial composition for disinfecting a skin surface comprising:

a) parachlorometaxylenol in an amount of about 3% to about 4% by weight;

b) an anionic surfactant composition consisting essentially of sodium C_12-15 pareth-15 sulfonate, sarcosine surfactant, and sodium lauryl sulfate; and

c) an emollient.

2. The antimicrobial composition of claim 1, wherein parachlorometaxylenol is present in an amount of about 3.3% by weight of the composition.

3. The antimicrobial composition of claim 1, wherein the sarcosine surfactant is selected from the group consisting of sodium lauroyl sarcosinate, sodium cocoyl sarcosinate, and combinations thereof.

4. The antimicrobial composition of claim 3 wherein the sarcosine surfactant is sodium lauroyl sarcosinate.

5. The antimicrobial composition of claim 1 wherein the emollient is a vegetable fatty acid.

6. The antimicrobial composition of claim 5 wherein the vegetable fatty acid contains a phospholipid having linoleic acid.

7. The antimicrobial composition of claim 6 wherein the vegetable fatty acid is soya acid.

8. The antimicrobial composition of claim 1 further comprising a viscosity enhancer.

9. The antimicrobial composition of claim 8 wherein the viscosity enhancer is a polyethylene glycol glucoside.

13. A surgical scrub formulation comprising the antimicrobial composition of claim 1.

14. A pre-surgical scrub formulation comprising the antimicrobial composition of claim 1.

15. A topical application device comprising the antimicrobial composition of claim 1.

16. The topical application device of claim 15 wherein said device is a sponge, sponge stick, scrub brush, swab or fluid dispensing device.

21. A method of topically disinfecting skin comprising applying to the skin surface to be disinfected a topical application device containing the antimicrobial composition of claim 1.

10. An antimicrobial composition for disinfection of a skin surface consisting essentially of:

a) parachlorometaxylenol in an amount from about 3% to about 4% by weight;

b) sodium C_12-15 pareth-15 sulfonate;

c) sodium lauroyl sarcosinate;

d) sodium lauryl sulfate;

e) an emollient;

f) a solvent system comprising water and a phenolic-compatible solvent; and

g) a viscosity enhancer.

11. The antimicrobial composition of claim 10 further comprising an additional ingredient selected from the group consisting of a preservative, a buffer system, an opacifier and combinations thereof.

12. An antimicrobial composition consisting essentially of:

a) parachlorometaxylenol in an amount of about 3.3% by weight;

b) sodium C12-15 pareth-15 sulfonate in an amount of about 6.3% by weight;

c) sodium lauroyl sarcosinate in an amount of about 3.0% by weight;

d) sodium lauryl sulfate in an amount of about 1.05% by weight;

e) soy acid in an amount of about 0.3% by weight;

f) propylene glycol in an amount of about 9.0% by weight;

g) PEG-120 methyl glucose dioleate in an amount of about 3.0% by weight;

h) water in an amount of about 72.47% by weight;

i) phenoxyethanol in an amount of about 1.0% by weight;

j) citric acid in an amount of about 0.26% by weight;

k) sodium hydroxide in an amount of about 0.02% by weight;

l) styrene/PVP co-polymer in an amount of about 0.3% by weight.

17. A method of disinfecting skin comprising applying to the skin surface to be disinfected an antiseptically effective amount of an antimicrobial composition comprising:

a) parachlorometaxylenol in an amount of about 3% to about 4% by weight; and

b) an anionic surfactant composition consisting essentially of sodium C_12-15 pareth-15 sulfonate, sarcosine surfactant, and sodium lauryl sulfate; and

c) an emollient.

18. The method of claim 17 wherein the sarcosine surfactant is selected from the group consisting of sodium lauroyl sarcosinate, sodium cocoyl sarcosinate and combinations thereof.

19. The method of claim 18 wherein the sarcosine surfactant is sodium lauroyl sarcosinate.

20. The method of claim 17 wherein parachlorometaxylenol is present in an amount of about 3.3% by weight.