Claims for Patent: 8,211,460

Summary for Patent: 8,211,460

Title:	Formulations, devices and methods for treating and preventing mucositis
Abstract:	The present invention is directed to compositions, devices, and methods for non-irritatively treating and preventing mucositis, such as chronic rhinosinusitis (CRS). Some aspects of the invention concern compositions comprising or consisting essentially of sodium phosphate buffer (e.g., sodium phosphate dibasic and sodium phosphate monobasic) and calcium carbonate; mucoadministration devices and kits containing such compositions; and methods for treating or preventing mucositis conditions such as CRS, comprising mucoadministering a composition of the invention to a subject in need thereof.
Inventor(s):	O\'Donnell, Jr.; Francis E. (Longboat Key, FL), Stergiou; Angelos M. (Marousi-Athens, Athens, GR)
Assignee:	Accentia Biopharmaceuticals, Inc. (Tampa, FL)
Application Number:	12/534,575
Patent Claims:	1. A method of treating mucositis in a subject in need thereof, comprising mucoadministering to the subject an effective amount of a composition consisting essentially of sodium phosphate buffer and calcium carbonate. 2. The method of claim 1, wherein the mucositis is chronic rhinosinusitis. 3. The method of claim 1, wherein the composition is mucoadministered using a mucoadministration device. 4. The method of claim 3, wherein the device is selected from the group consisting of a nasal pump sprayer, nasal irrigator, and nebulizer. 5. The method of claim 1, wherein the subject is a human. 6. The method of claim 1, wherein the mucoadministration comprises irrigating the nasal-paranasal anatomy of the subject with a liquid form of the composition. 7. The method of claim 1, wherein about 5 mL to about 100 mL of the composition is mucoadministered per nostril of the subject. 8. The method of claim 1, wherein about 20 mL of the composition is mucoadministered per nostril of the subject. 9. The method of claim 1, wherein the frequency of mucoadministration is from about four times a day to about once every other week. 10. The method of claim 1, wherein the frequency of mucoadministration is from about three times a day to about once a week. 11. The method of claim 1, wherein the frequency of mucoadministration is from about one to four times a day. 12. The method of claim 1, wherein the frequency of mucoadministration is twice daily in each nostril. 13. The method of claim 1, wherein the duration of mucoadministration is greater than about 30 days. 14. The method of claim 1, wherein the subject is suffering from chronic rhinosinusitis (CRS), and wherein said mucoadministration results in a reduction of polyposis and/or sinus inflammation in the subject. 15. The method of claim 1, wherein the subject is suffering from chronic rhinosinusitis (CRS), and said mucoadministration results in alleviation or resolution of one or more signs or symptoms of CRS. 16. The method of claim 15, wherein the one or more signs or symptoms of CRS are selected from the group consisting of congestion, sinus headache, polyposis, and mucosal thickening. 17. The method of claim 1, wherein the composition is a powder that is reconstituted with a diluent prior to mucoadministration. 18. The method of claim 1, wherein the composition has 2% to 3% sodium phosphate buffer and about 0.005 to about 0.030% calcium carbonate, by weight based on the total weight of the composition". 19. The method of claim 1, wherein the composition has 2.55% sodium phosphate buffer and 0.015% calcium carbonate, by weight based on the total weight of the composition". 20. The method of claim 1, wherein the composition has 1.59% sodium phosphate dibasic, 0.96% sodium phosphate monobasic, and 0.015% calcium carbonate, by weight based on the total weight of the composition". 21. The method of claim 1, wherein the composition includes a dye. 22. The method of claim 21, wherein the dye is FD&C Yellow 5. 23. The method of claim 1, wherein the composition includes water. 24. The method of claim 1, wherein the composition consists essentially of sodium phosphate dibasic; sodium phosphate monobasic; calcium carbonate; a dye; and sterile water. 25. A method of treating mucositis in a human subject in need thereof, comprising mucoadministering to the subject an effective amount of a liquid composition, wherein the liquid composition includes sodium phosphate buffer and calcium carbonate, and no additional active agents. 26. A method of treating mucositis in a human subject in need thereof, comprising mucoadministering to the subject an effective amount of a composition, wherein the composition consists of sodium phosphate dibasic, sodium phosphate monobasic, calcium carbonate, FD&C Yellow 5, and sterile water.

Details for Patent 8,211,460

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		2028-04-02