Xylitol for treatment of vaginal infections

• US 7,619,008 B2
• Filed: 07/29/2005
• Issued: 11/17/2009
• Est. Priority Date: 11/12/2004
• Status: Expired due to Fees

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Greene, Sharon, Huang, Lei, Martin, Stephanie M., Sayre, Curtis, Villanueva, Julie, Yang, Shu-Ping, Johnson, Robert B., Arehart, Kelly
• Primary Examiner(s): Ford; Allison M
• Application Number:
  US11/194,039
• Publication Number:
  US 20060105963A1
• Time in Patent Office: 1,572 Days
• Field of Search: None
• US Class Current: 514/738
• CPC Class Codes: A61K 31/047 having two or more hydroxy groups, e.g. sorbitol
• CPC Class Codes: A61K 31/7004 Monosaccharides having only carbon, hydrogen and oxygen atoms
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61P 15/02 for disorders of the vagina
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics

Abstract

A vaginal treatment composition that employs a therapeutic agent to inhibit and/or treat vaginal infection is provided. The therapeutic agent is capable of inhibiting and/or killing Gardnerella (e.g., Gardnerella vaginalis), Candida (e.g., Candida albicans), and/or Trichomonas (e.g., Trichomonas vaginalis) pathogens. Desirably, such antimicrobial efficacy is achieved without substantially inhibiting the growth of Lactobacillus acidophilus. For instance, sugars and/or sugar alcohols may be employed in the present invention as a therapeutic agent for inhibiting and/or treating vaginal infection. In one particular embodiment, D-xylitol is used as the therapeutic agent.

Claims

1. A method for treating bacterial vaginosis caused by Gardnerella vaginalis, the method comprising topically administering to the vagina of a female in need thereof a vaginal treatment composition comprising:

from about 0.1 wt/vol % to about 10 wt/vol % of at least one therapeutic agent that includes xylitol, and

from about 0.05 wt/vol % to about 5 wt/vol % of at least one gelling agent that includes gellan gum,

wherein the vaginal treatment composition has an osmolarity of from about 270 to about 310 milliosmoles per liter and a pH of from about 2.5 to about 5.0, and

wherein the treatment composition forms a gel after application to the vagina.

2. The method of claim 1, wherein the vaginal treatment composition comprises from about 0.2 wt/vol % to about 5.0 wt/vol % of xylitol.

3. The method of claim 1, wherein the vaginal treatment composition comprises from about 0.5 wt/vol % to about 4.5 wt/vol % of xylitol.

4. The method of claim 1, wherein the vaginal treatment composition has an osmolarity of from about 280 to about 300 milliosmoles per liter.

5. The method of claim 1, wherein the vaginal treatment composition is substantially free of tonicity agents other than xylitol.

6. The method of claim 1, wherein the therapeutic agent consists of xylitol.

7. The method of claim 1, wherein the vaginal treatment composition has a pH of from about 3.0 to about 4.5.

8. The method of claim 1, wherein the vaginal treatment composition further comprises a pH modifier.

9. The method of claim 8, wherein the pH modifier is a carboxylic acid.

10. The method of claim 8, wherein the pH modifier is lactic acid.

11. The method of claim 8, wherein the pH modifier is gallic acid.

12. The method of claim 1, wherein the gelling agent is present in the composition in an amount of from about 0.1 wt/vol % to about 1 wt/vol %.

13. The method of claim 1, wherein the composition is substantially free of monovalent and divalent salts.

14. The method of claim 1, wherein the gelling agent includes low acyl gellan gum.

15. The method of claim 1, wherein the vaginal treatment composition inhibits the growth of Gardnerella vaginalis.

16. The method of claim 1, wherein the vaginal treatment composition does not substantially inhibit the growth of Lactobacillus acidophilus.

17. A method for treating trichomonas vaginitis caused by Trichomonas vaginalis, the method comprising topically administering to the vagina of a female in need thereof a vaginal treatment composition comprising:

from about 0.1 wt/vol % to about 10 wt/vol % of at least one therapeutic agent that includes xylitol, and

from about 0.05 wt/vol % to about 5 wt/vol % of at least one gelling agent that includes gellan gum,

wherein the vaginal treatment composition has an osmolarity of from about 270 to about 310 milliosmoles per liter and a pH of from about 2.5 to about 5.0, and

wherein the treatment composition forms a gel after application to the vagina.

18. The method of claim 17, wherein the vaginal treatment composition comprises from about 0.2 wt/vol % to about 5.0 wt/vol % of xylitol.

19. The method of claim 17, wherein the vaginal treatment composition comprises from about 0.5 wt/vol % to about 4.5 wt/vol % of xylitol.

20. The method of claim 17, wherein the vaginal treatment composition has an osmolarity of from about 280 to about 300 milliosmoles per liter.

21. The method of claim 17, wherein the therapeutic agent consists of xylitol.

22. The method of claim 17, wherein the vaginal treatment composition has a pH of from about 3.0 to about 4.5.

23. The method of claim 17, wherein the vaginal treatment composition further comprises a pH modifier.

24. The method of claim 17, wherein the pH modifier is a carboxylic acid.

25. The method of claim 23, wherein the pH modifier is lactic acid.

26. The method of claim 23, wherein the pH modifier is gallic acid.

27. The method of claim 17, wherein the gelling agent is present in the composition in an amount of from about 0.1 wt/vol % to about 1 wt/vol %.

28. The method of claim 17, wherein the composition is substantially free of monovalent and divalent salts.

29. The method of claim 17, wherein the gelling agent includes a low acyl gellan gum.

30. The method of claim 17, wherein the vaginal treatment composition inhibits the growth of Trichomonas vaginalis.

31. The method of claim 17, wherein the vaginal treatment composition does not substantially inhibit the growth of Lactobacillus acidophilus.

32. The method of claim 17, wherein the vaginal treatment composition is substantially free of tonicity agents other than xylitol.