Wound cleanser

• US 5,284,833 A
• Filed: 11/13/1992
• Issued: 02/08/1994
• Est. Priority Date: 06/24/1991
• Status: Expired due to Term

• Current Assignee: Aloe Technologies, LLC
• Original Assignee: Carrington Laboratories Incorporated
• Inventors: McAnalley, Bill H., Moore, D. Eric
• Primary Examiner(s): Wityshyn, Michael G.
• Assistant Examiner(s): Leary, Louise N.
• Application Number:
  US07/975,893
• Time in Patent Office: 452 Days
• Field of Search: 514/23, 514/54, 514/55, 514/57, 514/53, 514/21, 514/846, 514/191, 514/60, 424/543, 424/549
• US Class Current: 514/23
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Rationally designed wound cleanser that is physiologically compatible. The wound cleanser comprises a surfactant, an osmotic adjuster, a buffering agent, and water. The composition may also contain a preservative, a sudsing agent, a skin protectant, a pH adjuster, and a stabilizer.

Claims

1. A physiologically compatible aqueous wound cleanser composition which passes both Draize eye irritation test and primary dermal irritation test, said composition comprising, on a weight percent basis:

from about 0.01 to about 50 percent of a surfactant to give said composition a surface tension of below about 30 dynes/cm;

from about 0.05 to about 10 percent of an osmotic adjuster to give said composition an osmolality of from about 200 to about 320 mOs/liter;

from about 0.05 percent to about 3 percent of a buffering agent to maintain a pH in a range of from about 6 to about 7.7 in said composition; and

a sufficient amount of water necessary to establish the foregoing properties.

2. A physiologically compatible aqueous wound cleanser according to claim 1 further comprising from about 0.001 to about 1 percent of a preservative.

3. A physiologically compatible aqueous wound cleanser according to claim 2 wherein said preservative is selected from the group consisting of potassium sorbate, sodium benzoate, benzalkonium chloride, imidazolidinyl urea, glyceryl monolaurate, and thimerosal.

4. A physiologically compatible aqueous wound cleanser according to claim 2 wherein said preservative is methylparaben.

5. A physiologically compatible aqueous wound cleanser according to claim 1 further comprising from about 0.01 to about 5 percent of a sudsing agent.

6. A physiologically compatible aqueous wound cleanser according to claim 5 wherein said sudsing agent is selected for the group consisting of sodium laureth sulfate and cocoamphodiacetate.

7. A physiologically compatible aqueous wound cleanser according to claim 1 further comprising from about 0.1 to about 50 percent of a skin protectant.

8. A physiologically compatible aqueous wound cleanser according to claim 7 wherein aid skin protectant is selected from the group consisting of glycerine, allantoin and zinc acetate.

9. A physiologically compatible aqueous wound cleanser according to claim 1 further comprising a pH adjuster.

10. A physiologically compatible aqueous wound cleanser according to claim 9 wherein said pH adjuster is selected from the group consisting of hydrochloric acid, citric acid, phosphoric acid, and sodium hydroxide.

11. A physiologically compatible aqueous wound cleanser according to claim 1 further comprising from about 0.01 to about 3 percent of a stabilizer.

12. A physiologically compatible aqueous wound cleanser according to claim 11 wherein said stabilizer is a sodium salt of ethylenetriaminetetraacetic acid.

13. A physiologically compatible aqueous wound cleanser according to claim 1 wherein said surfactant is a nonionic surfactant.

14. A physiologically compatible aqueous wound cleanser according to claim 1 wherein said surfactant is selected from the group consisting of sucrose laurate, sucrose oleate, sucrose stearate, and sodium lauryl sulfate.

15. A physiologically compatible aqueous wound cleanser according to claim 1 wherein said osmotic adjuster is selected from the group consisting of mannitol, glucose, and dextrose.

16. A physiologically compatible aqueous wound cleanser according to claim 1 wherein said buffering agent is selected from the group consisting of sodium salts of phosphate, borate, and acetate.

17. A physiologically compatible aqueous wound cleanser composition comprising, on a weight percent basis:

from about 0.01 to about 40 percent of a surfactant t give said composition a surface tension of below about 30 dynes/cm;

from about 0.01 to about 5 percent of an osmotic adjuster to give said composition an osmolality of from about 250 to about 310 mOs/liter;

from about 0.01 to about 2 percent of a buffering agent to maintain a pH in a range of from about 6.8 to about 7.5 in said composition; and

a sufficient amount of water necessary to establish the foregoing properties.

18. A physiologically compatible aqueous wound cleanser according to claim 17 further comprising from about 0.01 to about 0.4 percent of a preservative.

19. A physiologically compatible aqueous wound cleanser according to claim 18 wherein said preservative is selected from the group consisting of potassium sorbate, sodium benzoate, benzalkonium chloride, imidazolidinyl urea, glyceryl monolaurate, and thimerosal.

20. A physiologically compatible aqueous wound cleanser according to claim 18 wherein said preservative is methylparaben.

21. A physiologically compatible aqueous wound cleanser according to claim 17 further comprising from about 0.02 to about 3 percent of a sudsing agent.

22. A physiologically compatible aqueous wound cleanser according to claim 21 wherein said sudsing agent is selected for the group consisting of sodium laureth sulfate and cocoamphodiacetate.

23. A physiologically compatible aqueous wound cleanser according to claim 17 further comprising from about 0.1 to about 20 percent of a skin protectant.

24. A physiologically compatible aqueous wound cleanser according to claim 23 wherein said skin protectant is selected from the group consisting of glycerine, allantoin and zinc acetate.

25. A physiologically compatible aqueous wound cleanser according to claim 17 further comprising a pH adjuster.

26. A physiologically compatible aqueous wound cleanser according to claim 25 wherein said pH adjuster is selected from the group consisting of hydrochloric acid, citric acid, phosphoric acid, and sodium hydroxide.

27. A physiologically compatible aqueous wound cleanser according to claim 17 further comprising from about 0.05 to about 2 percent of a stabilizer.

28. A physiologically compatible aqueous wound cleanser according to claim 27 wherein said stabilizer is a sodium salt of ethylenetriaminetetraacetic acid.

29. A physiologically compatible aqueous wound cleanser according to claim 17 wherein said surfactant is a nonionic surfactant.

30. A physiologically compatible aqueous wound cleanser according to claim 29 wherein said surfactant is selected from the group consisting of sucrose laurate, sucrose oleate, sucrose stearate, and sodium lauryl sulfate.

31. A physiologically compatible aqueous wound cleanser according to claim 17 wherein said osmotic adjuster is selected from the group consisting of mannitol, glucose, and dextrose.

32. A physiologically compatible aqueous wound cleanser according to claim 17 wherein said buffering agent is selected from the group consisting of sodium salts of phosphate, borate, and acetate.

33. A physiologically compatible aqueous wound cleanser composition which passes both Draize eye irritation test and primary dermal irritation test, said composition comprising, on a weight percent basis:

from about 0.25 to about 0.75 percent of a sucrose laurate;

from about 0.05 to about 0.15 percent of methylparaben;

from about 0.05 to about 0.15 percent of disodium EDTA;

from about 0.05 to about 0.15 percent of glyceryl monolaurate;

from about 2 to about 5 percent of mannitol;

from about 0.02 to about 0.08 percent of cocoamphodiacetate;

from about 0.1 to about 0.3 percent of disodium phosphate; and

a sufficient amount of water, such that said aqueous wound cleanser composition is characterized as having a surface tension of below about 30 dynes/cm, an osmolality of from about 280 jto about 296 mOs/liter, and a pH in the range of from about 7.35 to about 7.45.

34. A concentrated dry mixture suitable for reconstituting with water to form a final aqueous wound cleanser that is physiologically compatible and which passes both Draize eye irritation test and primary dermal irritation test, said essentially dry mixture comprising:

a surfactant;

an osmotic adjuster; and

a buffering agent, such that when said concentrated mixture is reconstituted with said water to give said final aqueous wound cleanser, said final aqueous wound cleanser has, on a weight percent basis, from about 0.01 to about 50 percent of said surfactant, from about 0.05 to about 10 percent of said osmotic adjuster and from about 0.05 to about 3 percent of said buffering agent, and said final aqueous wound cleanser is further characterized as having a surface tension of below about 30dynes/cm, an osmolality of from about 200 to about 320 mOs/liter, and a pH in the range of from about 6 to about 7.7.

35. A concentrated mixture according to claim 34 further comprising a sufficient amount of a preservative, such that when said concentrated mixture is reconstituted with said water, said final aqueous wound cleanser has a concentration of from about 0.001 to about 1 percent of said preservative.

36. A concentrated mixture according to claim 35 wherein said preservative is selected from the group consisting of potassium sorbate, sodium benzoate, imidazolidinyl urea, glyceryl monolaurate, thimerosal, and benzalkonium chloride.

37. A concentrated mixture according to claim 35 wherein said preservative is methylparaben.

38. A concentrated mixture according to claim 34 further comprising a sufficient amount of a sudsing agent, such that when said concentrated mixture is reconstituted with said water, said final aqueous wound cleanser has a concentration of from about 0.01 to about 5 percent of said sudsing agent.

39. A concentrated mixture according to claim 38 wherein said sudsing agent is selected from the group consisting of sodium laureth sulfate and cocoamphodiacetate.

40. A concentrated mixture according to claim 34 further comprising a sufficient amount of a protectant, such that when said concentrated mixture is reconstituted with said water, said final aqueous wound cleanser has a concentration of from about 0.1 to about 50 percent of said protectant.

41. A concentrated mixture according to claim 40 wherein said skin protectant is selected from the group consisting of glycerine, allantoin and zinc acetate.

42. A concentrated mixture according to claim 34 further comprising a pH adjuster.

43. A concentrated mixture according to claim 42 wherein said pH adjuster is selected from a group consisting of hydrochloric acid, citric acid, phosphoric acid, and sodium hydroxide.

44. A concentrated mixture according to claim 34 further comprising a sufficient amount of a stabilizer, such that when said concentrated mixture is reconstituted with said water, said final aqueous wound cleanser has a concentration of from about 0.01 to about 3 percent of said stabilizer.

45. A concentrated mixture according to claim 44 wherein said stabilizer is a sodium salt of ethylenetriaminetetraacetic acid.

46. A concentrated mixture according to claim 34 wherein said surfactant is a nonionic surfactant.

47. A concentrated mixture according to claim 46 wherein said surfactant is selected from the group consisting of sucrose laurate, sucrose, oleate, sucrose stearate, and sodium lauryl sulfate.

48. A concentrated mixture according to claim 34 wherein said osmotic adjuster is selected from the group consisting of mannitol, glucose, and dextrose.

49. A concentrated mixture according to claim 34 wherein said buffering agent is selected from the group consisting of sodium salts of phosphate, borate, and acetate.

50. A concentrated mixture according to claim 34 wherein said concentrated mixture is essentially dry.