Vaginal treatment composition containing xylitol

• US 7,786,176 B2
• Filed: 07/29/2005
• Issued: 08/31/2010
• Est. Priority Date: 07/29/2005
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Johnson, Robert B., Arehart, Kelly, Huang, Lei, Martin, Stephanie M., Sayre, Curtis, Villanueva, Julie, Yang, Shu-Ping, Greene, Sharon Linda, Huang, Yanbin
• Primary Examiner(s): Ford; Allison M
• Application Number:
  US11/194,064
• Publication Number:
  US 20070026074A1
• Time in Patent Office: 1,859 Days
• Field of Search: None
• US Class Current: 514/738
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/70 Carbohydrates; Sugars; Derivatives thereof sorbitol A61K31/047
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• 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
• CPC Class Codes: A61P 33/02 Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis

Abstract

A vaginal treatment composition that rapidly forms a gel when placed into contact with monovalent or polyvalent cations, such as sodium (Na⁺) and calcium (Ca²⁺) cations naturally found in vaginal mucosa, is provided. The gel may form in less than about 1 hour, in some embodiments less than about 1 minute, and in some embodiments, less than about 30 seconds. Among other things, such rapid gelation reduces the likelihood of leakage during use. In addition, because the gel may form intravaginally, it is more likely to retain its structure and shape over an extended period of time. In this manner, the gel may provide the prolonged release of a therapeutic agent that inhibits and/or treats vaginal infection. For instance, the gel may remain within the vagina for about 2 to about 48 hours to provide the desired effect.

Claims

1. A vaginal treatment composition comprising:

at least one low acyl gellan gum capable of forming a gel in the presence of monovalent or polyvalent cations;

xylitol in an amount of from about 0.01 wt/vol % to about 20 wt/vol %; and

At least one phenolic acid selected from the group consisting of p-hydrobenzoic acid, protocatechuic acid, vanillic acid, chlorogenic acid, caffeic acid, ferulic acid, gallic acid, sinapic acid, syringic acid, coumaric acid, cinnamic acid, gentisic acid, salicylic acid, veratric acid, anisic acid, crotonic acid, hydroxy benzoic acid, hydroxy phenyl acetic acids, and combinations thereof ;

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 composition lacks monovalent and divalent salts in an amount sufficient for gelation, such that a gel is formed only after the composition is delivered to the vaginal of a female.

2. The vaginal treatment composition of claim 1, wherein the gellan gum is present in the composition in an amount of from about 0.01 wt/vol % to about 10 wt/vol %.

3. The vaginal treatment composition of claim 1, wherein the gellan gum is present in the composition in an amount of from about 0.1 wt/vol % to about 1 wt/vol %.

4. The vaginal treatment composition of claim 1, wherein the gellan gum has a degree of deacylation of at least about 20%.

5. The vaginal treatment composition of claim 1, wherein the gellan gum has a degree of deacylation of at least about 50%.

6. The vaginal treatment composition of claim 1, wherein the gellan gum is nonaclyated.

7. The vaginal treatment composition of claim 1, wherein the gellan gum has a gelation temperature within the range 30°

C. to 50°

C.

8. The vaginal treatment composition of claim 1, wherein xylitol is present in the composition in an amount of from about 0.1 wt/vol % to about 10 wt/vol %.

9. The vaginal treatment composition of claim 1, wherein the phenolic acid is gallic acid.

10. The vaginal treatment composition of claim 1, wherein phenolic acids constitute from 0.001 wt/vol % to about 5 wt/vol % of the composition.

11. The vaginal treatment composition of claim 1, wherein phenolic acids constitute from 0.01 wt/vol % to about 0.25 wt/vol % of the composition.

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

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

14. The vaginal treatment composition of claim 1, further comprising at least one nonionic tonicity agent.

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