US2007104798A1PendingUtilityA1

Synergistic antimicrobial preparations containing chlorite and hydrogen peroxide

Assignee: S K PHARMACEUTICALS INCPriority: Oct 4, 1999Filed: Dec 4, 2006Published: May 10, 2007

Est. expiryOct 4, 2019(expired)· nominal 20-yr term from priority

A61P 31/12A61P 31/00A61P 31/10A61P 27/04A61P 27/02A61P 31/04A61K 31/728A61K 33/40A61P 17/06A61P 17/02A61P 17/00A61K 33/14A61K 33/20A61K 9/0048A61L 12/124A01N 59/00A61K 33/00A61L 12/10A61K 9/0014A61K 33/22

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References

Claims

Abstract

An anti-microbial preservative for use in ophthalmic and dermatologic products. The preservative includes from about 0.005 wt. % to about 0.20 wt. % chlorite compound and from about 0.005 wt. % to about 0.05 wt. % peroxy compound. Additionally, the preservative does not generate chlorine dioxide within the pH range of 5.0-8.8. Also included are an antimicrobial ophthalmic and dermatologic compositions for direct application onto an eye or skin of a living being including from about 0.005 wt. % to about 0.20 wt. % chlorite compound and from about 0.005 wt. % to about 0.05 wt. % peroxy compound. Also included are methods for treating dryness of the eyes and skin disorders (e.g., wounds, burns, infections, ulcerations, psoriasis, etc.) and for disinfecting and cleansing contact lenses while in place upon an eye by applying the composition to the eye or to the contact lens.

Claims

exact text as granted — not AI-modified

1 . An anti-microbial preservative for use in an ophthalmic product, the preservative comprising from about 0.005 wt. % to about 0.20 wt. % chlorite compound and from about 0.005 wt. % to about 0.05 wt. % peroxy compound, wherein the preservative does not generate chlorine dioxide, and wherein the preservative is at a pH range between about 6.0 and about 8.8.

2 . The preservative of claim 1 wherein the chlorite compound is a metal chlorite.

3 . The preservative of claim 2 wherein the metal is sodium.

4 . The preservative of claim 2 wherein the metal is selected from the group consisting of potassium, calcium, and magnesium.

5 . The preservative of claim 1 wherein the peroxy compound is hydrogen peroxide.

6 . The preservative of claim 1 wherein the ophthalmic product is an artificial tear solution.

7 . The preservative of claim 1 wherein the ophthalmic product is a contact lens disinfecting solution.

8 . The preservative of claim 1 wherein the ophthalmic product is a contact lens cleaning solution.

9 . The preservative of claim 8 wherein the cleaning solution is directly applied to a contact lens in place on an eye of a living being.

10 . An antimicrobial ophthalmic composition for direct application onto an eye of a living being, the composition comprising from about 0.005 wt. % to about 0.20 wt. % chlorite compound and from about 0.005 wt. % to about 0.05 wt. % peroxy compound, wherein the composition does not generate chlorine dioxide, and wherein the composition is at a pH range between about 6.0 and 8.8.

11 . The antimicrobial ophthalmic composition of claim 10 wherein the chlorite compound is a metal chlorite.

12 . The antimicrobial ophthalmic composition of claim 11 wherein the metal is sodium.

13 . The antimicrobial ophthalmic composition of claim 11 wherein the metal is selected from the group consisting of potassium, calcium, and magnesium.

14 . The antimicrobial ophthalmic composition of claim 10 wherein the peroxy compound is hydrogen peroxide.

15 . The antimicrobial ophthalmic composition of claim 10 additionally comprising a lubricant chosen from the group consisting of non-ionic polymeric lubricants, anionic polymeric lubricants, and combinations thereof.

16 . The antimicrobial ophthalmic composition of claim 15 additionally comprising a block polymer based surfactant.

17 . The antimicrobial ophthalmic composition of claim 15 wherein the ophthalmic composition additionally comprises:

lubricant
0.05 wt. % to 0.3 wt. %;

boric acid
0.15 wt. % to 0.3 wt. %;

sodium chloride
0.50 wt. % to 0.8 wt. %;

surfactant
0.05 wt. % to 0.3 wt. %;

HCl or NaOH
to adjust pH; and

purified water
Q.S. to volume.

18 . The antimicrobial ophthalmic composition of claim 17 additionally comprising from about 0.001 wt. % to about 0.50 wt. % of sodium hyaluronate.

19 . The antimicrobial ophthalmic composition of claim 15 wherein the ophthalmic composition additionally comprises:

lubricant
0.05 wt. % to 0.30 wt. %;

sodium phosphate monobasic
0.10 wt. % to 0.25 wt. %;

sodium phosphate dibasic
0.10 wt. % to 0.40 wt. %;

sodium chloride
0.50 wt. % to 0.80 wt. %;

surfactant
0.05 wt. % to 0.30 wt. %;

HCl or NaOH
to adjust pH; and

purified water
Q.S. to volume.

20 . The antimicrobial ophthalmic composition of claim 19 additionally comprising from about 0.001 wt. % to about 0.50 wt. % sodium hyaluronate.

21 . The antimicrobial ophthalmic composition of claim 10 wherein the composition is applied onto an eye for treating dryness of the eye.

22 . The antimicrobial ophthalmic composition of claim 10 wherein the composition is applied onto an eye for treating an infection of an eye.

23 . The antimicrobial ophthalmic composition of claim 22 wherein the infection is caused by bacterial keratitis.

24 . The antimicrobial ophthalmic composition of claim 22 wherein the infection is caused by a virus.

25 . The antimicrobial ophthalmic composition of claim 22 wherein the infection is caused by a fungus.

26 . The antimicrobial ophthalmic composition of claim 10 wherein the composition is applied onto an eye for cleansing a contact lens in place on the eye.

27 . A method of treating dryness of a eye of a living being, the method comprising applying an antimicrobial ophthalmic composition onto the eye, the composition comprising from about 0.005 wt. % to about 0.20 wt. % chlorite compound and from about 0.005 wt. % to about 0.05 wt. % peroxy compound, wherein the composition does not generate chlorine dioxide, and wherein the composition is at a pH range between about 6.0 and 8.8.

28 . The method of claim 27 wherein the chlorite compound of the ophthalmic composition is a metal chlorite.

29 . The method of claim 28 wherein the metal is sodium.

30 . The method of claim 28 wherein the metal is selected from the group consisting of potassium, calcium, and magnesium.

31 . The method of claim 27 wherein the peroxy compound of the ophthalmic composition is hydrogen peroxide.

32 . The method of claim 27 wherein the ophthalmic composition additionally comprises a lubricant chosen from the group consisting of non-ionic polymeric lubricants, anionic polymeric lubricants, and combinations thereof.

33 . The method of claim 32 wherein the ophthalmic composition additionally comprises a block polymer based surfactant.

34 . The method of claim 33 wherein the ophthalmic composition additionally comprises:

lubricant
0.05 wt. % to 0.3 wt. %;

boric acid
0.15 wt. % to 0.3 wt. %;

sodium chloride
0.50 wt. % to 0.8 wt. %;

surfactant
0.05 wt. % to 0.3 wt. %;

HCl or NaOH
to adjust pH; and

Purified water
Q.S. to volume.

35 . The method of claim 34 wherein the ophthalmic composition additionally comprises from about 0.001 wt. % to about 0.50 wt. % sodium hyaluronate.

36 . The method of claim 33 wherein the ophthalmic composition additionally comprises:

lubricant
0.05 wt. % to 0.30 wt. %;

sodium phosphate monobasic
0.10 wt. % to 0.25 wt. %;

sodium phosphate dibasic
0.10 wt. % to 0.40 wt. %;

sodium chloride
0.50 wt. % to 0.80 wt. %;

surfactant
0.05 wt. % to 0.30 wt. %;

HCl or NaOH
to adjust pH; and

purified water
Q.S. to volume.

37 . The method of claim 36 wherein the ophthalmic composition additionally comprises from about 0.001 wt. % to about 0.50 wt. % sodium hyaluronate.

38 . A method of cleansing a contact lens in place upon an eye of a living being, the method comprising applying an antimicrobial ophthalmic composition onto the lens, the composition comprising from about 0.005 wt. % to about 0.20 wt. % chlorite compound and from about 0.005 wt. % to about 0.05 wt. % peroxy compound, wherein the composition does not generate chlorine dioxide, and wherein the composition is at a pH range between about 6.0 and 8.8.

39 . The method of claim 38 wherein the chlorite compound of the ophthalmic composition is a metal chlorite.

40 . The method of claim 39 wherein the metal is sodium.

41 . The method of claim 39 wherein the metal is selected from the group consisting of potassium, calcium, and magnesium.

42 . The method of claim 38 wherein the peroxy compound of the ophthalmic composition is hydrogen peroxide.

43 . The method of claim 38 wherein the ophthalmic composition additionally comprises a lubricant chosen from the group consisting of non-ionic polymeric lubricants, anionic polymeric lubricants, and combinations thereof.

44 . The method of claim 38 wherein the ophthalmic composition additionally comprises a sustained delivery component which limits the rate at which the chlorite and hydrogen peroxide become available for generation of oxygen.

45 . The method of claim 44 wherein the sustained delivery component is a polymeric matrix.

46 . The method of claim 44 wherein the sustained delivery component is a liposome.

47 . The method of claim 44 wherein the sustained delivery component is an ointment.

48 . The method of claim 44 wherein the sustained delivery component is selected from the group consisting of a cellulose ester, hydroxymethylpropyl cellulose, methylhydroxylethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, a salt of a cellulose ester, cellulose acetate, hydroxyproylmethyl cellulose phthalate, methacrylic acid-ethyl acetate copolymer, polyvinylpyrrolidone, polyvinyl alcohol, hyaluronic acid, a phospholipid, phospholipids having a neutral charge, phospholipids having a negative charge, dipalmytoyl phosphatidyl choline, dipalmytoyl phosphatidyl serine, and sodium salts thereof.

49 . The method of claim 44 wherein the sustained delivery component comprises 1 percent to 20 percent by weight of the preparation.

50 . The method of claim 47 wherein the ophthalmic composition comprises:

sodium chlorite
0.005 wt. % to 0.200 wt. %;

hydrogen peroxide
0.005 wt. % to 0.050 wt. %;

HPMC
0.05 wt. % to 0.20 wt. %;

sodium phosphate
0.01 wt. % to 0.30 wt. %;

monobasic monohydrate

HCl or NaOH
to adjust to pH 7.4

purified water
Q.S. to volume.

51 . The method of claim 38 wherein the ophthalmic composition additionally comprises a block polymer based surfactant.

52 . The method of claim 51 wherein the ophthalmic composition additionally comprises:

lubricant
0.05 wt. % to 0.30 wt. %;

boric acid
0.15 wt. % to 0.30 wt. %;

sodium chloride
0.50 wt. % to 0.80 wt. %;

surfactant
0.05 wt. % to 0.30 wt. %;

HCl or NaOH
to adjust pH; and

purified water
Q.S. to volume.

53 . The method of claim 52 wherein the ophthalmic composition additionally comprises from about 0.001 wt. % to about 0.50 wt. % sodium hyaluronate.

54 . The method of claim 51 wherein the ophthalmic composition additionally comprises:

lubricant
0.05 wt. % to 0.30 wt. %;

sodium phosphate monobasic
0.10 wt. % to 0.25 wt. %;

sodium phosphate dibasic
0.10 wt. % to 0.40 wt. %;

sodium chloride
0.50 wt. % to 0.80 wt. %;

surfactant
0.05 wt. % to 0.30 wt. %;

HCl or NaOH
to adjust pH; and

purified water
Q.S. to volume.

55 . The method of claim 54 wherein the ophthalmic composition additionally comprises from about 0.001 wt. % to about 0.50 wt. % sodium hyaluronate.

56 . An antimicrobial preservative for use in a dermatology product, the preservative comprising from about 0.005 wt. % to about 0.20 wt. % chlorite compound and from about .005 wt. % to about 0.05 wt. % peroxy compound, wherein the preservative does not generate chlorine dioxide, and wherein the preservative is at a pH range between about 5.0 and about 8.8.

57 . The preservative of claim 56 wherein the chlorite compound is a metal chlorite.

58 . The preservative of claim 57 wherein the metal is sodium.

59 . The preservative of claim 57 wherein the metal is selected from the group consisting of potassium, calcium, and magnesium.

60 . The preservative of claim 56 wherein the peroxy compound is hydrogen peroxide.

61 . The preservative of claim 56 wherein the dermatology product is Decubitus gel or a cream.

62 . A method of treating a dermatological condition, the method comprising applying an antimicrobial dermatological composition onto the affected skin area, the composition comprising from about 0.005 wt. % to about 0.20 wt. % chlorite compound and from about 0.005 wt. % to about 0.05 wt. % peroxy compound, wherein the composition does not generate chlorine dioxide, and wherein the composition is at a pH range between about 5.0 and 8.8.

63 . The method of claim 62 wherein the chlorite compound of the dermatological composition is a metal chlorite.

64 . The method of claim 63 wherein the metal is sodium.

65 . The method of claim 63 wherein the metal is selected from a group consisting of potassium, calcium, and magnesium.

66 . The method of claim 62 wherein the peroxy compound of the dermatological composition is hydrogen peroxide.

67 . The method of claim 62 wherein the dermatological composition is Decubitus gel or a cream.

68 . The method of claim 67 wherein the dermatological composition additionally comprises:

lubricant
0.05 wt. % to 0.30 wt. %;

boric acid
0.15 wt. % to 0.30 wt. %;

sodium chloride
0.50 wt. % to 0.80 wt. %;

surfactant
0.05 wt. % to 0.30 wt. %;

HCl or NaOH
to adjust pH; and

purified water
Q.S. to volume.

69 . The method of claim 67 wherein the dermatological composition additionally comprises:

lubricant
0.05 wt. % to 0.30 wt. %;

sodium phosphate monobasic
0.10 wt. % to 0.25 wt. %;

sodium phosphate dibasic
0.10 wt. % to 0.40 wt. %;

sodium chloride
0.50 wt. % to 0.80 wt. %;

surfactant
0.05 wt. % to 0.30 wt. %;

HCl or NaOH
to adjust pH; and

purified water
Q.S. to volume.

70 . The method of claim 62 wherein the dermatological composition additionally comprises a sustained delivery component which limits the rate at which the chlorite and hydrogen peroxide become available for generation of oxygen.

71 . The method of claim 70 wherein the sustained delivery component comprises a polymeric matrix.

72 . The method of claim 70 wherein the sustained delivery component comprises a liposome.

73 . The method of claim 70 wherein the sustained delivery component comprises an ointment.

74 . The method of claim 70 wherein the sustained delivery component is selected from the group consisting of a cellulose ester, hydroxymethylpropyl cellulose, methylhydroxylethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, a salt of a cellulose ester, cellulose acetate, hydroxyproylmethyl cellulose phthalate, methacrylic acid-ethyl acetate copolymer, polyvinylpyrrolidone, polyvinyl alcohol, hyaluronic acid, a phospholipid, phospholipids having a neutral charge, phospholipids having a negative charge, dipalmytoyl phosphatidyl choline, dipalmytoyl phosphatidyl serine, and sodium salts thereof.

75 . The method of claim 70 wherein the sustained delivery component comprises 1 percent to 20 percent by weight of the preparation.

76 . The method of claim 73 wherein the ophthalmic composition comprises:

sodium chlorite
0.005 wt. % to 0.200 wt. %;

hydrogen peroxide
0.005 wt. % to 0.050 wt. %;

HPMC
0.05 wt. % to 0.20 wt. %;

sodium phosphate
0.01 wt. % to 0.30 wt. %;

monobasic monohydrate

HCl or NaOH
to adjust to pH 7.4

purified water
Q.S. to volume.

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