Therapeutic agents for inhibiting and/or treating vaginal infection

• US 20060105963A1
• Filed: 07/29/2005
• Published: 05/18/2006
• Est. Priority Date: 11/12/2004
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Huang, Lei, Martin, Stephanie M., Sayre, Curtis, Villanueva, Julie, Yang, Shu-Ping, Greene, Sharon, Johnson, Robert B., Arehart, Kelly
• Granted Patent: US 7,619,008 B2
• Time in Patent Office: Days
• US Class Current: 514/23
• 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 inhibiting and/or treating vaginal infection, the method comprising topically administering a vaginal treatment composition to the vagina of a female, the vaginal treatment composition comprising an effective amount of at least one therapeutic agent selected from the group consisting of sugars and sugar alcohols, and further wherein the vaginal treatment composition has an osmolarity of from about 270 to about 310 milliosmoles per liter.

2. The method of claim 1, wherein the therapeutic agent is a pentose alcohol.

3. The method of claim 2, wherein the pentose alcohol is selected from the group consisting of D-xylitol, D-arabitol, meso-ribitol (adonitol), and isomers thereof.

4. The method of claim 3, wherein the pentose alcohol is D-xylitol or an isomer thereof.

5. The method of claim 1, wherein the therapeutic agent is a hexose alcohol.

6. The method of claim 5, wherein the hexose alcohol is selected from the group consisting of glycerol, meso-galacitol (dulcitol), inositol, D-mannitol, D-sorbitol, and isomers thereof.

7. The method of claim 1, wherein the therapeutic agent is a pentose sugar selected from the group consisting of D-arabinose, D-ribose, D-ribulose, D-xylose, D-xylulose, D-lyxose, and isomers thereof.

8. The method of claim 7, wherein the pentose sugar is D-ribose.

9. The method of claim 1, wherein the therapeutic agent is a hexose sugar selected from the group consisting of D-galactose, D-inositose, D-mannose, and isomers thereof.

10. The method of claim 1, wherein the therapeutic agent comprises from about 0.2 wt/vol % to about 5 wt/vol % of the vaginal treatment composition.

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

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

13. The method of claim 1, wherein the vaginal treatment composition is substantially free of additional tonicity agents.

14. The method of claim 1, wherein the vaginal treatment composition has a pH of from about 2.0 to about 5.5.

15. The method of claim 1, wherein the vaginal treatment composition further comprises at least one gelling agent.

16. The method of claim 1, wherein the therapeutic agent inhibits the growth of Trichomonas vaginalis.

17. The method of claim 1, wherein the therapeutic agent inhibits the growth of Candida albicans .

18. The method of claim 1, wherein the therapeutic agent inhibits the growth of Gardnerella vaginalis.

19. The method of claim 1, wherein the therapeutic agent inhibits the growth of Gardnerella vaginalis, Candida albicans , or Trichomonas vaginalis without substantially inhibiting the growth of Lactobacillus acidophilus.

20. A method for inhibiting and/or treating trichomonas vaginitis, the method comprising topically administering a vaginal treatment composition to the vagina of a female, the vaginal treatment composition comprising an effective amount of at least one therapeutic agent that inhibits the growth of Trichomonas vaginalis, wherein the therapeutic agent is selected from the group consisting of pentose sugars and pentose alcohols.

21. The method of claim 20, wherein the therapeutic agent is a pentose alcohol selected from the group consisting of D-xylitol, D-arabitol, meso-ribitol (adonitol), and isomers thereof.

22. The method of claim 21, wherein the pentose alcohol is D-xylitol or an isomer thereof.

23. The method of claim 20, wherein the therapeutic agent is D-ribose.

24. The method of claim 20, wherein the therapeutic agent comprises from about 0.2 wt/vol % to about 5 wt/vol % of the vaginal treatment composition.

25. The method of claim 20, wherein the therapeutic agent comprises from about 0.5 wt/vol % to about 4.5 wt./vol % of the vaginal treatment composition.

26. The method of claim 20, wherein the vaginal treatment composition has an osmolarity of from about 270 to about 310 milliosmoles per liter.

27. The method of claim 20, wherein the vaginal treatment composition is substantially free of additional tonicity agents.

28. The method of claim 20, wherein the vaginal treatment composition has a pH of from about 3.0 to about 4.5.

29. The method of claim 20, wherein the therapeutic agent does not substantially inhibit the growth of Lactobacillus acidophilus.

30. A method for inhibiting and/or treating bacterial vaginosis, the method comprising topically administering a vaginal treatment composition to the vagina of a female, the vaginal treatment composition comprising an effective amount of at least one therapeutic agent that inhibits the growth of Gardnerella vaginalis, wherein the therapeutic agent is selected from the group consisting of pentose sugars and pentose alcohols.

31. The method of claim 30, wherein the therapeutic agent is a pentose alcohol selected from the group consisting of D-xylitol, D-arabitol, meso-ribitol (adonitol), and isomers thereof.

32. The method of claim 31, wherein the pentose alcohol is D-xylitol or an isomer thereof.

33. The method of claim 30, wherein the therapeutic agent is D-ribose.

34. The method of claim 30, wherein the therapeutic agent comprises from about 0.2 wt/vol % to about 5 wt/vol % of the vaginal treatment composition.

35. The method of claim 30, wherein the therapeutic agent comprises from about 0.5 wt/vol % to about 4.5 wt/vol % of the vaginal treatment composition.

36. The method of claim 30, wherein the vaginal treatment composition has an osmolarity of from about 270 to about 310 milliosmoles per liter.

37. The method of claim 30, wherein the vaginal treatment composition is substantially free of additional tonicity agents.

38. The method of claim 30, wherein the vaginal treatment composition has a pH of from about 3.0 to about 4.5.

39. The method of claim 30, wherein the therapeutic agent does not substantially inhibit the growth of Lactobacillus acidophilus.