Claims for Patent: 10,568,855

Summary for Patent: 10,568,855

Title:	Compositions and methods for enhancing the efficacy of contraceptive microbicides
Abstract:	The present disclosure relates to compositions and methods for contraception that also enhance the efficacy of microbicides. Such compositions serve the dual purpose of preventing pregnancy and lessening the risk of spreading sexually transmitted diseases. More specifically, the compositions and methods relate to syngergistic contraceptive microbicide and antiviral compositions comprising a combination of a contraceptive microbicide and an antiviral agent in an acidic carrier that enhances the efficacy of both the contraceptive microbicide and antiviral agent.
Inventor(s):	Guthrie; Wendell (San Diego, CA)
Assignee:	Evofem, Inc. (San Diego, CA)
Application Number:	16/239,314
Patent Claims:	1. A method for preventing pregnancy comprising intravaginally administering a composition to a subject in need thereof, wherein the composition comprises: a) a matrix-forming compound selected from the group consisting of: alginic acid, chitosan, gellan gum, and poloxamer; b) a bioadhesive compound that is the same or different from the matrix-forming compound; c) L-lactic acid; and d) an aqueous-based pharmaceutically acceptable carrier, wherein the composition has a nonmatrix state when not in contact with ejaculate, and a matrix state when in contact with ejaculate, and wherein the composition is essentially free of D-lactic acid. 2. The method of claim 1, wherein the composition further comprises a humectant. 3. The method of claim 2, wherein the humectant is selected from the group consisting of glycerol, polyethylene glycol, polypropylene glycol, sorbitol, and triacetin. 4. The method of claim 3, wherein the composition further comprises a preservative. 5. The method of claim 4, wherein the preservative is selected from the group consisting of benzoic acid, sodium benzoate, methylparaben, ethylparaben, butylparaben, propylparaben, benzyalkonium chloride, phenylmercuric nitrate, and chlorhexidine. 6. The method of claim 1, wherein the matrix-forming compound is alginic acid. 7. The method of claim 6, wherein the alginic acid has an average molecular weight in the range of about 20,000 to about 300,000 g/mole. 8. The method of claim 1, wherein the bioadhesive compound is selected from the group consisting of xanthan gum, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, chitosan, polycarbophil, and carbopol. 9. The method of claim 8, wherein the bioadhesive compound is xanthan gum. 10. The method of claim 1, wherein the composition in the matrix state is capable of trapping and inactivating sperm. 11. The method of claim 1, wherein the composition in the matrix state is capable of inhibiting the growth of or reducing the infectivity of microbes causing sexually transmitted infections. 12. The method of claim 1, wherein the composition comprises about 1-10% of the matrix forming compound, about 1-10% of the bioadhesive compound, and 1-10% L-lactic acid. 13. The method of claim 1, wherein the composition comprises about 3-5% of the matrix forming compound, 2.5-3.5% of the bioadhesive compound, and 1-7% L-lactic acid. 14. The method of claim 1, wherein the pH of the composition is 5.0 or below. 15. The method of claim 1, wherein the composition maintains the pH of the vagina at pH 5.0 or below in the presence of normal amounts of ejaculate. 16. A method for preventing pregnancy comprising intravaginally administering a composition to a subject in need thereof, wherein the composition comprises: a) alginic acid; b) xanthan gum; c) L-lactic acid; and d) water, wherein the composition has a nonmatrix state when not in contact with ejaculate, and a matrix state when in contact with ejaculate, and wherein the composition is essentially free of D-lactic acid. 17. The method of claim 16, wherein the alginic acid has an average molecular weight in the range of about 20,000 to about 300,000 g/mole. 18. The method of claim 16, wherein the composition in the matrix state is capable of trapping and inactivating sperm. 19. The method of claim 16, wherein the composition in the matrix state is capable of inhibiting the growth of or reducing the infectivity of microbes causing sexually transmitted infections. 20. The method of claim 16, wherein the composition further comprises at least one of citric acid, potassium bitartrate, and benzoic acid. 21. The method of claim 20, wherein the composition further comprises glycerol. 22. The method of claim 16, wherein the pH of the composition is 5.0 or below. 23. The method of claim 16, wherein the composition maintains the pH of the vagina at pH 5.0 or below in the presence of normal amounts of ejaculate. 24. The method of claim 1, further comprising reducing the risk of transmission of a sexually transmitted infection. 25. The method of claim 24, wherein the sexually transmitted infection is chlamydia. 26. The method of claim 24, wherein the sexually transmitted infection is gonorrhea. 27. The method of claim 16, further comprising reducing the risk of transmission of a sexually transmitted infection. 28. The method of claim 27, wherein the sexually transmitted infection is chlamydia. 29. The method of claim 27, wherein the sexually transmitted infection is gonorrhea.