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Details for Patent: 5,474,768

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Details for Patent: 5,474,768

Title: Vaginal tissue moisturizing composition and method
Abstract:A composition and method of moisturizing mammalian vaginal membranous tissue is disclosed. The composition utilized in this method includes water, a bioadhesive polymer as the moisturizing agent and a consistency-enhancing agent. The bioadhesive is a water-swellable, but water-insoluble, particulate, fibrous, cross-linked carboxy-functional polymer containing (a) a plurality of repeating units of which at least about 80 percent contain at least one carboxyl functionality, and (b) about 0.05 to about 1.5 percent cross-linking agent substantially free from polyalkenyl polyether. The consistency-enhancing agent is a watersoluble or -dispersible anionic or non-ionic polymer. The composition is contacted with the vaginal mucous membrane to be moisturized, and that contact is maintained for a time period sufficient to moisturize the contacted area.
Inventor(s): Robinson; Joseph R. (Madison, WI)
Assignee:
Filing Date:Feb 09, 1993
Application Number:08/015,683
Claims:1. A method of moisturizing mammalian vaginal mucous membrane comprising:

(A) contacting mammalian vaginal mucous membrane with an aqueous composition in an amount effective to moisturize vaginal mucosal cells, said aqueous composition, being essentially free of a treating agent, and comprising:

(1) water,

(2) a moisturizing amount of a bioadhesive, moisturizing, substantially non-esterified polymer in a free acid form, said bioadhesive polymer consisting essentially of particles of a water-swellable, but water-insoluble, cross-linked carboxyl-functional polymer that consists essentially of (a) a plurality of repeating units of which at least about 80 percent contain at least one carboxyl functionality, and b) about 0.05 to about 1.5 weight percent of a crosslinking agent free of polyalkenyl polyether; and

(3) a thickening-smoothing amount of a consistency-enhancing agent, said consistency-enhancing agent being a water-dispersible, non-ionic or anionic polymer; and

(B) maintaining said contact for a time period sufficient to moisturize said contacted vaginal mucous membrane.

2. The method according to claim 1 wherein said bioadhesive polymer particles are sized to pass through a 400 mesh size sieve, U.S. Standard Sieve Series, when dry.

3. The method according to claim 2 wherein said bioadhesive polymer particles have a number average longest dimension of about 2 to about 5 microns.

4. The method according to claim 1 wherein at least about 90 percent of said repeating units contain at least one carboxyl functionality.

5. The method according to claim 1 wherein said consistency-enhancing agent is an anionic polymer having a plurality of carboxyl groups.

6. The method according to claim 1 wherein said consistency-enhancing agent is present at about 0.25 to about 10 weight percent of said composition.

7. A method of moisturizing mammalian vaginal mucous membrane comprising:

(A) contacting mammalian vaginal mucous membrane with an aqueous composition in an amount effective to moisturize vaginal mucosal cells, said aqueous composition, being essentially free of treating agent and comprising:

(1) water;

(2) a moisturizing amount of a bioadhesive moisturizing substantially non-esterified polymer in a free acid form, said bioadhesive polymer consisting essentially of particles of a water-swellable, but water-insoluble, cross-linked carboxyl-functional polymer present at about 0.25 to about 5 weight percent of said composition, said polymer particles sized to pass through a 400 mesh size sieve, U.S. Standard Sieve Series and consisting essentially of (a) a plurality of repeating units of which at least about 80 percent contain at least one carboxyl functionality, and (b) about 0.05 to about 1.5 weight percent of a crosslinking agent free of polyalkenyl polyether; and

(3) a consistency-enhancing agent, said consistency-enhancing agent being a water-dispersible non-ionic or anionic polymer having a plurality of carboxyl groups that is present in an amount of about 0.5 to about 5 weight percent of said composition; and

(B) maintaining said contact for a time period sufficient to moisturize said mucous membrane.

8. The method according to claim 7 wherein said composition has a gel-like consistency.

9. The method according to claim 8 wherein the vaginal mucosa are contacted with about 1 to about 5 grams of said composition that contains about 0.25 to about 3 weight percent of said bioadhesive polymer.

10. The method according to claim 8 wherein said consistency-enhancing agent is a cross-linked anionic polymer.

11. The method according to claim 8 wherein said consistency-enhancing agent is polyacrylic acid cross-linked with the polyallyl sucrose containing an average of at least three allyl groups per molecule.

12. The method according to claim 8 wherein said composition further includes one or more pharmaceutically or cosmetically acceptable adjuvants selected from the group consisting of a preservative, emollient, lubricating oil, emulsifying agent, humectant, coloring agent and odorant.

13. A vaginal moisturizing composition consisting essentially of:

(A) water;

(B) an amount sufficient to moisturize vaginal tissue of a substantially non-esterified bioadhesive in a free acid form moisturizing polymer, said bioadhesive moisturizing polymer consisting essentially of particles of a water-swellable, but water-insoluble cross-linked carboxyl-functional polymer that consists essentially of (a) a plurality of repeating units of which at least about 80 percent contain at least one carboxyl functionality, and (b) about 0.05 to about 1.5 weight percent of a cross-linking agent that is substantially free from polyalkenyl polyether; and

(C) a thickening-smoothing amount of a consistency-enhancing agent, said consistency-enhancing agent being a water-dispersible non-ionic or anionic polymer.

14. The composition according to claim 13 wherein said bioadhesive polymer particles are sized to pass through a 400 mesh size sieve, U.S. Standard Sieve Series, when dry.

15. The composition according to claim 14 wherein said bioadhesive polymer particles have a number average longest dimension of about 2 to about 5 microns.

16. The composition according to claim 13 wherein at least about 90 percent of said repeating units contain at least one carboxyl functionality.

17. The composition according to claim 13 wherein said consistency-enhancing agent is an anionic polymer having a plurality of carboxyl groups.

18. The composition according to claim 13 wherein said consistency-enhancing agent is present at about 0.25 to about 10 weight percent of said composition.

19. A vaginal moisturizing composition consisting essentially of:

(A) water;

(B) an amount sufficient to moisturize a vagina of a substantially non-esterified bioadhesive in a free acid form moisturizing polymer, said bioadhesive moisturizing polymer consisting essentially of particles of a water-swellable, but water-insoluble, cross-linked carboxyl-functional polymer consisting essentially of (a) a plurality of repeating units of which at least about 80 percent contain at least one carboxyl functionality, and (b) about 0.05 to about 1.5 weight percent of a cross-linking agent that is substantially free from polyalkenyl ether;

(C) a thickening-smoothing amount of consistency-enhancing agent, said consistency-enhancing agent being a water-dispersible non-ionic or anionic polymer; and

(D) an adjuvant selected from the group consisting of a preservative, emollient, lubricant, emulsifying agent, humectant, coloring agent, odorant and perfume.

20. The composition according to claim 19 wherein said composition has a gel-like consistency.

21. The composition according to claim 20 wherein the vaginal mucosa are contacted with about 1 to about 5 grams of said composition that contains about 0.25 to about 3 weight percent of said bioadhesive polymer.

22. The composition according to claim 20 wherein said consistency-enhancing agent is polyacrylic acid cross-linked with polyallyl sucrose containing an average of at least three allyl groups per molecule.
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