Claims for Patent: 7,402,559

Summary for Patent: 7,402,559

Title:	Composition and method of treatment for urogenital conditions
Abstract:	The present invention is directed to a composition and method for treating uro-genital conditions. One embodiment disclosed is a pharmaceutical composition for use in the treatment of uro-genital conditions wherein said composition comprises a KPV dimer, a first preservative agent, a solvent, an alkalizer, an acrylic acid-based polymer, a second preservative agent and a gelatinizing agent. Another embodiment of the invention is disclosed wherein the composition comprises CKPV (SEQ ID NO: 5) dimer, API, Carbopol.RTM., NF, propylparaben, NF; methylparaben, NF; propylene glycol, USP; edetic acid (EDTA), USP; 2 M sodium hydroxide solution (NaOH); and sterile water for injection, USP. Also disclosed are methods and indications for use of the disclosed composition.
Inventor(s):	Catania; Anna P. (Milan, IT), Lipton; James M. (Woodland Hills, CA)
Assignee:	MSH Pharma, Incorporated (Los Angeles, CA)
Application Number:	10/659,053
Patent Claims:	1. A pharmaceutical composition comprising a KPV dimer, a first preservative agent, a solvent, an alkalizer, an acrylic acid-based polymer, a second preservative agent and a gelatinizing agent. 2. The composition of claim 1 further comprising a chelating agent. 3. The composition of claim 1 wherein the KPV dimer is CKPV (SEQ ID NO: 5) dimer. 4. The composition of claim 1 wherein the acrylic acid-based polymer is a high molecular weight, cross-linked, acrylic acid-based polymer. 5. The composition of claim 1 wherein the first preservative is selected from the group consisting of phenoxyethanol, methylparaben, butylparaben, ethylparaben propylparaben and potassium sorbate and combinations thereof. 6. The composition of claim 1 wherein the second preservative is selected from the group consisting of phenoxyethanol, methylparaben, butylparaben, ethylparaben propylparaben and potassium sorbate and combinations thereof. 7. The composition of claim 5 wherein the first preservative is methylparaben. 8. The composition of claim 6 wherein the second preservative is propylparaben. 9. The composition of claim 1 wherein the solvent is selected from the groups consisting of propylene glycol, ethanol, phenol, acetone, glycerol and isopropanol and combinations thereof. 10. The composition of claim 9 wherein the solvent is propylene glycol. 11. The composition of claim 2 wherein the chelating agent is selected from the group consisting of Coenzyme Q10, Zinc, L-Cysteine, L-Methionine, L-Lysine, Glutathione and EDTA and combinations thereof. 12. The composition of claim 11 wherein the chelating agent is EDTA. 13. The composition of claim 1 wherein the alkalizer is selected from the group consisting of HEPES, 2 M NaOH, MES hydrate, MOPS, TAPS and Bis-Tris and combinations thereof. 14. The composition of claim 13 wherein the alkalizer is NaOH. 15. The composition of claim 1 wherein the gelatinizing agent is selected from the group consisting of water, sterile water, distilled water, sterile saline and sterile water for injection and combinations thereof. 16. The composition of claim 15 wherein the gelatinizing agent is sterile water for injection. 17. The composition of claim 3 wherein the CKPV (SEQ ID NO: 5) dimer is at least about 0.05-0.15% of the composition. 18. The composition of claim 17 wherein the CKPV (SEQ ID NO: 5) dimer at least about 0.1% of the composition. 19. The composition of claim 4 wherein the high molecular weight, cross-linked, acrylic acid-based polymer is at least about 1.5-2.5% of the composition. 20. The composition of claim 19 wherein the high molecular weight, cross-linked, acrylic acid-based polymer is at least about 2% of the composition. 21. The composition of claim 7 wherein the methylparaben is at least about 0.1-0.2% of the composition. 22. The composition of claim 21 wherein the methylparaben is at least about 0.15% of the composition. 23. The composition of claim 8 wherein the propylparaben is at least about 0.025-0.075% of the composition. 24. The composition of claim 23 wherein the propylparaben is at least about 0.05% of the composition. 25. The composition of claim 10 wherein the propylene glycol is at least about 5-15% of the composition. 26. The composition of claim 25 wherein the propylene glycol is at least about 10% of the composition. 27. The composition of claim 12 wherein the EDTA is at least about 0.05-0.15% of the composition. 28. The composition of claim 27 wherein the EDTA is at least about 0.1% of the composition. 29. The composition of claim 14 wherein the 2 M NaOH is that quantity sufficient to bring the composition to a pH of 4.0.+-.0.1. 30. The composition of claim 15 wherein the sterile water for injection is that quantity sufficient to create a gel. 31. A pharmaceutical composition comprising a high molecular weight, cross-linked, acrylic acid-based polymer, propylparaben, methylparaben, propylene glycol, CKPV (SEQ ID NO: 5) dimer, 2 M NaOH and sterile water for injection. 32. The composition of claim 31 further comprising EDTA. 33. The composition of claim 31 wherein the CKPV (SEQ ID NO: 5) dimer is at least about 0.1% of the composition. 34. The composition of claim 31 wherein the high molecular weight, cross-linked, acrylic acid-based polymer is at least about 2% of the composition. 35. The composition of claim 31 wherein the methylparaben is at least about 0.15% of the composition. 36. The composition of claim 31 wherein the propylparaben is at least 0.05% of the composition. 37. The composition of claim 31 wherein the propylene glycol is at least about 10% of the composition. 38. The composition of claim 32 wherein the EDTA is at least about 0.1% of the composition. 39. The composition of claim 31 wherein the 2 M NaOH is that quantity sufficient to bring the composition to a pH of 4.0.+-0.1. 40. The composition of claim 31 wherein the sterile water for injection is that quantity sufficient to create a gel. 41. A pharmaceutical composition comprising 2% of a high molecular weight, cross-linked, acrylic acid-based polymer, 0.05% of propylparaben, 0.15% of methylparaben, 10% of propylene glycol, 0.1% g of EDTA, 2 M NaOH in a quantity sufficient to bring the composition to a pH of 4.0.+-0.1, 0.1% of CKPV (SEQ ID NO: 5) dimer and sterile water for injection quantity sufficient to create a gel. 42. A method of treating urogenital conditions comprising the use of a pharmaceutical composition comprising at least about 2% of a high molecular weight, cross-linked, acrylic acid-based polymer, at least about 0.05% of propylparaben, at least about 0.15% of methylparaben, at least about 10% of propylene glycol, at least about 0.1% of EDTA, 2 M NaOH in a quantity sufficient to bring the composition to a pH of 4.0.+-0.1, at least about 0.1% of CKPV (SEQ ID NO: 5) dimer and sterile water for injection quantity sufficient to create a gel.

Details for Patent 7,402,559

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2019-03-24