Claims for Patent: 11,040,006

Summary for Patent: 11,040,006

Title:	Topical antiviral compositions, delivery systems, and methods of using the same
Abstract:	The present invention relates generally to topical antiviral compositions, delivery systems, and methods of using the same.
Inventor(s):	McHale Kimberly, Doxey Ryan, Stasko Nathan
Assignee:	Novan, Inc.
Application Number:	US16840657
Patent Claims:	1. A delivery system comprising a composition , the composition comprising a nitric oxide (NO)-releasing active pharmaceutical ingredient and water ,wherein the NO-releasing active pharmaceutical ingredient is a diazeniumdiolated co-condensed silica particle,{'sub': 'max', 'wherein the composition has a Cof greater than 160 pmol of NO/mg, as measured by in vitro release testing, and'}wherein the NO-releasing active pharmaceutical ingredient is present in the composition in an amount of 0.01% to 30% by weight of the composition.2. The delivery system of claim 1 , wherein the composition stores and/or releases nitric oxide in an amount of about 0.05% to about 10% by weight of the composition.3. The delivery system of claim 1 , wherein the delivery system is configured for delivery to a body cavity of a subject.4. The delivery system of claim 1 , wherein the delivery system is configured to contact the composition to a mucous membrane of the subject.5. The delivery system of claim 1 , wherein the delivery system is configured to contact the composition to a nostril claim 1 , mouth claim 1 , tongue claim 1 , and/or pharynx of the subject.6. The delivery system of claim 1 , wherein the composition has a pH of about 5 to about 8.7. The delivery system of claim 1 , wherein the delivery system administers nitric oxide in an amount sufficient to induce apoptosis in virally infected cells.8. The delivery system of claim 1 , wherein the delivery system administers nitric oxide in an amount sufficient to reduce or eliminate viral replication with less than about 50% host cell cytotoxicity.9. The delivery system of claim 1 , wherein the NO-releasing active pharmaceutical ingredient is present in the composition in an amount of about 0.5% to about 25% by weight of the composition.10. The delivery system of claim 1 , wherein the diazeniumdiolated co-condensed silica particle comprises a co-condensed silica network comprising diazeniumdiolated aminoethylaminopropyl trimethoxy silane (AEAP3) and tetra methyl orthosilicate (TMOS).11. The delivery system of claim 1 , wherein the diazeniumdiolated co-condensed silica particle comprises a co-condensed silica network comprising diazeniumdiolated methylaminopropyl trimethoxysilane (MAP3) and tetra methyl orthosilicate (TMOS).12. The delivery system of claim 1 , wherein the diazeniumdiolated co-condensed silica particle comprises a co-condensed silica network comprising diazeniumdiolated methylaminopropyl trimethoxysilane (MAP3) and tetraethyl orthosilicate (TEOS).13. A method of administering nitric oxide to a subject to treat and/or prevent a viral infection in a subject claim 1 , the method comprising:administering a composition comprising a nitric oxide (NO)-releasing active pharmaceutical ingredient and water,wherein the NO-releasing active pharmaceutical ingredient is a diazeniumdiolated co-condensed silica particle,wherein the composition has a Cmax of greater than 160 pmol of NO/mg, as measured by in vitro release testing, andwherein the NO-releasing active pharmaceutical ingredient is present in the composition in an amount of 0.01% to 30% by weight of the composition.14. The method of claim 13 , wherein the composition stores and/or releases nitric oxide in an amount of about 0.05% to about 10% by weight of the composition.15. The method of claim 13 , wherein the administering comprises administering the composition to a body cavity of a subject.16. The method of claim 13 , wherein the administering comprises administering the composition to a mucous membrane of the subject.17. The method of claim 13 , wherein the administering comprises administering the composition to a nostril claim 13 , mouth claim 13 , tongue claim 13 , and/or pharynx of the subject.18. The method of claim 13 , wherein the administering comprises administering nitric oxide in an amount sufficient to induce apoptosis in virally infected cells in the subject.19. The method of claim 13 , wherein the administering comprises administering nitric oxide in an amount sufficient to reduce or eliminate viral replication with less than about 50% host cell cytotoxicity.20. The method of claim 13 , wherein the NO-releasing active pharmaceutical ingredient is present in the composition in an amount of about 0.5% to about 25% by weight of the composition.21. The delivery system of claim 1 , wherein the NO-releasing active pharmaceutical ingredient is present in the composition in an amount of 0.1% to 15% by weight of the composition.22. The method of claim 13 , wherein the NO-releasing active pharmaceutical ingredient is present in the composition in an amount of 0.1% to 15% by weight of the composition.