Antimicrobial compositions and methods for using the same

• US 5,661,170 A
• Filed: 06/12/1996
• Issued: 08/26/1997
• Est. Priority Date: 03/21/1994
• Status: Expired due to Term

• Current Assignee: Pacific World Corporation (PWC Holding Corp.)
• Original Assignee: Woodward Laboratories, Inc.
• Inventors: Chodosh, Daniel Frank
• Primary Examiner(s): KRASS, FREDERICK F
• Application Number:
  US08/662,906
• Time in Patent Office: 440 Days
• Field of Search: 514/390, 514/599, 514/975, 514/642, 514/643, 514/383, 514/384, 424/54
• US Class Current: 514/390
• 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 33/12 Quaternary ammonium compounds
• CPC Class Codes: A01N 47/36 containing the group >N—CO—N< directly attached to at least one heterocyclic ring; Thio analogues thereof
• CPC Class Codes: A61K 31/14 Quaternary ammonium compounds, e.g. edrophonium, choline betaines A61K31/205
• CPC Class Codes: A61K 31/415 1,2-Diazoles

Abstract

Antimicrobial compositions useful in the treatment of microbial infections and as general cleansers are provided along with methods for their administration. The antimicrobial compositions are aqueous based and preferably contain a quaternary ammonium compound as a antimicrobial agent. The antimicrobial compositions also preferably contain a surfactant such as a cationic, nonionic, or amphoteric surfactant or mixtures thereof. A keratolytic agent, such as allantoin, is also preferably blended into the antimicrobial compositions. The antimicrobial compositions are ideally suited for subcutaneous, cutaneous, or mucosal membrane administration.

Claims

1. A method for cleansing an animal, comprising administering to the area to be cleansed an antimicrobial composition comprising:

(a) benzalkonium chloride, as an antimicrobial agent, present in an amount of from 0.05-5 weight percent of said antimicrobial composition;

(b) allantoin, present in an amount of about 0.05-5 weight percent of said antimicrobial composition;

(c) about 0.1-20 weight percent surfactant, which is not the same as the antimicrobial agent, comprising at least one nonionic, cationic or amphoteric surfactant; and

(d) at least about 60 weight percent water.

2. The method of claim 1 wherein said antimicrobial composition is in the form of a cleanser or scrub.

3. The method of claim 1 wherein said antimicrobial composition is administered to the skin of a human.

6. The method of claim 1 wherein the benzalkonium chloride is percent in an amount of from about 0.1 to about 2.5 weight percent, and the allantoin is present in an amount of from about 0.25 to about 2.5 weight percent, both based on the antimicrobial composition.

7. The method of claim 6 wherein the surfactant comprises an amphoteric surfactant in an amount of from about 0.5 to about 8 weight percent, and a cationic surfactant in an amount of from about 0.05 to about 5 weight percent, of the antimicrobial composition.

8. The method of claim 6 wherein said antimicrobial composition is administered to the skin of a human.

4. A method for preventing the onset of a microbial infection, comprising administering to an area to be treated an antimicrobial composition comprising:

(a) benzalkonium chloride, as an antimicrobial agent, present in an amount of from 0.05-5 weight percent of said antimicrobial composition;

(b) allantoin, present in an amount of about 0.05-5 weight percent of said antimicrobial composition;

(c) about 0.1-20 weight percent surfactant, which is not the same as the antimicrobial agent, comprising at least one nonionic, cationic or amphoteric surfactant; and

(d) at least about 60 weight percent water.

5. The method of claim 4 wherein said antimicrobial composition is administered to the skin of a human.

9. The method of claim 4 wherein the benzalkonium chloride is present in an amount of from about 0.1 to about 2.5 weight percent, and the allantoin is present in an amount of from about 0.25 to about 2.5 weight percent, both based on the antimicrobial composition.

10. The method of claim 9 wherein the surfactant comprises an amphoteric surfactant in an amount of from about 0.5 to about 8 weight percent, and a cationic surfactant in an amount of from about 0.05 to about 5 weight percent, of the antimicrobial composition.

11. The method of claim 9 wherein said antimicrobial composition is administered to the skin of a human.

12. A method for cleaning an animal, comprising administering to the area to be cleansed an antimicrobial composition comprising:

(a) benzalkonium chloride, as an antimicrobial agent, present in an amount of from 0.13-2 weight percent of said antimicrobial composition;

(b) allantoin, present in an amount of about 00.5-2.5 weight percent of said antimicrobial composition;

(c) from about 1 to about 6 weight percent of an amphoteric surfactant;

(d) from about 1 to about 6 weight percent of a non-ionic surfactant;

(e) from about 0.5 to about 2.5 weight percent of a cationic surfactant;

(f) from about 0.5 to about 8 weight percent propylene glycol; and

(g) at least about 60 weight percent water.

13. A method for cleansing an animal, comprising administering to the area to be cleansed an antimicrobial composition comprising:

(a) at least one antimicrobial agent comprising at least one quaternary ammonium compound present in an amount of from 0.05-5 weight percent of said antimicrobial composition;

(b) allantoin, present in an amount of about 0.05-5 weight percent of said antimicrobial composition;

(c) about 0.1-20 weight percent surfactant, which is not the same as the antimicrobial agent, comprising at least one nonionic, cationic or amphoteric surfactant; and

(d) at least about 60 weight percent water.

14. The method of claim 13 wherein said antimicrobial composition is administered to the skin of a human.

15. The method of claim 13 wherein said surfactant comprises an amphoteric surfactant present in an amount of from about 0.5-8 weight percent of said antimicrobial composition.

16. The method of claim 13 wherein said surfactant comprises a cationic surfactant present in an amount of from about 0.05 to about weight percent of said antimicrobial composition.

17. A method for cleansing an animal, comprising administering to the area to be cleansed an antimicrobial composition consisting essentially of:

(a) at least one antimicrobial agent comprising at least one quaternary ammonium compound present in an amount of from 0.05-5 weight percent of said antimicrobial composition;

(b) allantoin, present in an amount of about 0.05-5weight percent of said antimicrobial composition;

(c) about 0.1-20 weight percent surfactant, which is not the same as the antimicrobial agent, comprising at least one nonionic, cationic or amphoteric surfactant;

(d) at least one preservative, which is not the same as the antimicrobial agent,

(e) optionally up to 15 weight percent proplene glycol; and

(f) at least about 60 weight percent water.

18. A method for preventing the onset of a microbial infection, comprising administering to an area to be treated an antimicrobial composition comprising:

(a) at least one antimicrobial agent comprising at least one quaternary ammonium compound present in an amount of from 0.05-5 weight percent of said antimicrobial composition;

(b) allantoin, present in an amount of about 0.05-5 weight percent of said antimicrobial composition;

(c) about 0.1-20 weight percent surfactant, which is not the same as the antimicrobial agent, comprising at least one nonionic, cationic or amphoteric surfactant; and

(d) at least about 60 weight percent water.

19. The method of claim 18 wherein said antimicrobial composition is administered to the skin of a human.

20. The method of claim 18 wherein the surfactant comprises an amphoteric surfactant in an amount of from about 0.5 to about 8 weight percent, and a cationic surfactant in an amount of from about 0.05 to about 5 weight percent, of the antimicrobial composition.

21. An aqueous antimicrobial pharmaceutical composition for topical or mucous membrane administration of an antimicrobial agent, consisting essentially of:

(a) at least one antimicrobial agent comprising at least one quaternary ammonium compound present in a therapeutically effective, non-toxic quantity of from about 0.05 to about 5 weight percent of the antimicrobial composition;

(b) allantoin, present in an amount of about 0.05-5 weight percent of the antimicrobial composition;

(c) at least one surfactant, which is not the same as said antimicrobial agent, comprising at least one nonionic, cationic or amphoteric surfactant, said surfactant being present in an amount of 0.1-20 weight percent of the antimicrobial composition;

(d) a preservative, which is not the same as said antimicrobial agent; and

(e) at least 80 weight percent water.

22. The antimicrobial composition of claim 21 wherein the water is present in an amount of at least about 85 weight percent.

23. The antimicrobial composition of claim 21 wherein the surfactant comprises a cationic surfactant, said cationic surfactant being present in an amount of from about 0.05 to about 5 weight percent of said antimicrobial composition.

24. The antimicrobial composition of claim 21 wherein the surfactant comprises an amphoteric surfactant, said amphoteric surfactant being present in an amount of from about 0.5 to about 8 weight percent of said antimicrobial composition.

25. The antimicrobial composition of claim 21 further comprising from 0.25-12 weight percent propylene glycol.

26. The antimicrobial composition of claim 21 wherein the quaternary ammonium compound comprises benzalkonium chloride.

27. The antimicrobial composition of claim 26 wherein the benzalkonium chloride is present in an amount of from about 0.10 to about 5 weight percent.

28. The antimicrobial composition of claim 27 wherein the surfactant comprises a cationic surfactant, said cationic surfactant being present in an amount of from about 0.05 to about 5 weight percent of the antimicrobial composition.

29. The antimicrobial composition of claim 27 wherein the surfactant comprises a nonionic surfactant, said nonionic surfactant being present in an amount of from about 0.5 to about 8 weight percent of the antimicrobial composition.

30. The antimicrobial composition of claim 27 wherein the surfactant comprises an amphoteric surfactant, said amphoteric surfactant being present in an amount of from about 0.5 to about 8 weight percent of the antimicrobial composition.

31. The antimicrobial composition of claim 27 wherein the composition is in the form of a cleanser, a scrub, a vaginal douche, a perianal wipe, a colosotomy wipe, a toothpaste, a mouthwash, or a gel.

32. The antimicrobial composition of claim 26 wherein the benzalkonium chloride is present in an amount of from about 0.1 to about 2.5 weight percent, and the allantoin is present in an amount of from about 0.25 to about 2.5 weight percent, both based on the antimicrobial composition.

33. The antimicrobial composition of claim 32 wherein the surfactant comprises an amphoteric surfactant in an amount of from about 0.5 to about 8 weight percent, and a cationic surfactant in an amount of from about 0.05 to about 5 weight percent, of the antimicrobial composition.

34. The antimicrobial composition of claim 33 wherein the surfactant further comprises a nonionic surfactant in an amount of from about 0.5 to about 8 weight percent of the antimicrobial composition.

35. The antimicrobial composition of claim 32 further comprising propylene glycol in an amount up to about 15 weight percent of the antimicrobial composition.

36. The antimicrobial composition of claim 32 further comprising an additional antimicrobial agent selected from the group consisting of tolnaftate, naftifine hydrochloride, terbinafine hydrochloride, ciclopirox olamine, haloprogin, an imidazole, and a triazole.

37. An aqueous antimicrobial pharmaceutical composition for topical or mucous membrane administration of an antimicrobial agent, consisting essentially of:

(a) at least one quaternary ammonium compound comprising benzalkonium chloride in an amount of from 0.1 to 2.5 weight percent of the antimicrobial composition;

(b) allantoin, present in an amount of from about 0.05 to 5 weight percent of the antimicrobial composition;

(c) at least one surfactant comprising at least one nonionic, cationic or amphoteric surfactant, said surfactant being present in an amount of from about 0.1 to 20 weight percent of the antimicrobial composition and which is not the same as the quaternary ammonium compound;

(d) a preservative, which is not the same as the quaternary ammonium compound; and

(e) at least 80 weight percent water.

38. The antimicrobial composition of claim 37 wherein the water is present in an amount of at least about 85 weight percent.

39. The antimicrobial composition of claim 37 wherein the benzalkonium chloride is present in an amount of from 0.13 to 2.0 weight percent of the antimicrobial composition.

40. An aqueous antimicrobial pharmaceutical composition for topical or mucous membrane administration of an antimicrobial agent, consisting essentially of:

(a) at least of quaternary ammonium compound comprising benzalkonium chloride in an amount of from 0.1 to 2.5 weight percent of the antimicrobial composition;

(b) allanation, present in an amount of from about 0.05 to 0.5 weight percent of the antimicrobial composition;

(c) at least one surfactant comprising at least one nonionic, cationic or atmospheric surfactant, said surfactant being present in an amount of from about 0.1 to 20 weight percent of the antimicrobial composition and which is not the same as the quaternary ammonium compound;

(d) propylene glycol present in an amount of from about 0.25 to 12.0 weight percent of the antimicrobial composition;

(e) a preservative, which is not the same as the quaternary ammonium compound; and

(f) at least 80 weight percent water.

41. The antimicrobial composition of claim 40 wherein the water is present in an amount of at least about 85 weight percent.

42. The antimicrobial composition of claim 40 wherein the benzalkonium chloride is present in an amount of from 0.13 to 2.0 weight percent of the antimicrobial composition.