Claims for Patent: 10,736,839

Summary for Patent: 10,736,839

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:	US16431214
Patent Claims:	1. A method of treating and/or preventing a viral infection in a subject in need thereof comprising:administering a topical composition to the skin of a subject,wherein the topical composition comprises a nitric oxide (NO)-releasing active pharmaceutical ingredient in an amount of about 0.5% to about 25% by weight of the topical composition and the NO-releasing active pharmaceutical ingredient is a NO-releasing compound comprising an NO donor selected from the group consisting of a diazeniumdiolate, nitrosothiol, nitrosamine, hydroxyl nitrosamine, hydroxyl amine and hydroxyurea; and{'sub': 'max', 'wherein the topical composition has a Cof greater than 160 pmol of NO/mg, as measured by in vitro release testing, thereby treating and/or preventing the viral infection in the subject.'}2. The method of claim 1 , wherein the topical composition has a Cof greater than 175 pmol of NO/mg claim 1 , as measured by in vitro release testing.3. The method of claim 1 , wherein the topical composition has a Cof greater than 200 pmol of NO/mg claim 1 , as measured by in vitro release testing.4. The method of claim 1 , wherein the topical composition has a Cof greater than 160 pmol to about 3500 pmol of NO/mg claim 1 , as measured by in vitro release testing.5. The method of claim 1 , wherein the topical composition releases nitric oxide in an amount of about 0.05% to about 10% by weight of the topical composition claim 1 , as measured by real time in vitro release testing.6. The method of claim 1 , wherein the topical composition releases nitric oxide in a cumulative amount of about 10 nmol of NO/mg of the topical composition to 1000 nmol of NO/mg of the topical composition in a time period of 1 hour after administration of the topical composition to the skin of the subject claim 1 , as measured by real time in vitro release testing.7. The method of claim 1 , wherein the topical composition releases nitric oxide in a cumulative amount of about 90 nmol of NO/mg of the topical composition to 450 nmol of NO/mg of the topical composition in a time period of 4 hours after administration of the topical composition to the skin of the subject claim 1 , as measured by real time in vitro release testing.8. The method of any one of claim 1 , wherein the topical composition releases nitric oxide in a cumulative amount of about 180 nmol of NO/mg of the topical composition to 1000 nmol of NO/mg of the topical composition in a time period of 24 hours after administration of the topical composition to the skin of the subject claim 1 , as measured by real time in vitro release testing.9. The method of claim 1 , wherein the topical composition provides a continuous release of nitric oxide for at least about 5 hours after administration of the topical composition to the skin of the subject claim 1 , as measured by real time in vitro release testing.10. The method of claim 9 , wherein claim 9 , during the continuous release of nitric oxide claim 9 , the topical composition has a release of NO that claim 9 , on average claim 9 , is in a range of about 1 to about 500 pmol of NO/mg of the composition claim 9 , as measured by real time in vitro release testing.11. The method of claim 1 , wherein the nitric oxide-releasing active pharmaceutical ingredient releases nitric oxide in an amount of at least about 50% in about 9 minutes or more after administration of the topical composition to the skin of the subject claim 1 , based on a total NO release determined at 24 hours after administration and measured by real time in vitro release testing.12. The method of claim 1 , wherein the nitric oxide-releasing active pharmaceutical ingredient comprises a co-condensed silica network comprising diazeniumdiolated methylaminopropyl trimethoxysilane (MAP3) and tetra methyl orthosilicate (TMOS) and/or diazeniumdiolated methylaminopropyl trimethoxysilane (MAP3) and tetraethyl orthosilicate (TEOS).13. A method of treating and/or preventing molluscum contagiosum in a subject in need thereof comprising:administering a topical composition to the skin of a subject,wherein the topical composition comprises a nitric oxide (NO)-releasing active pharmaceutical ingredient in an amount of about 0.5% to about 25% by weight of the topical composition and the NO-releasing active pharmaceutical ingredient is a NO-releasing compound comprising an NO donor selected from the group consisting of a diazeniumdiolate, nitrosothiol, nitrosamine, hydroxyl nitrosamine, hydroxyl amine and hydroxyurea; and{'sub': 'max', 'wherein the topical composition has a Cof greater than 160 pmol of NO/mg, as measured by in vitro release testing, thereby treating and/or preventing molluscum contagiosum in the subject.'}14. A method of reducing the appearance and/or size of a lesion on a subject in need thereof comprising:administering a topical composition to the lesion on the subject,wherein the topical composition comprises a nitric oxide (NO)-releasing active pharmaceutical ingredient in an amount of about 0.5% to about 25% by weight of the topical composition and the NO-releasing active pharmaceutical ingredient is a NO-releasing compound comprising an NO donor selected from the group consisting of a diazeniumdiolate, nitrosothiol, nitrosamine, hydroxyl nitrosamine, hydroxyl amine and hydroxyurea; and{'sub': 'max', 'wherein the topical composition has a Cof greater than 160 pmol of NO/mg, as measured by in vitro release testing, thereby reducing the appearance and/or size of the lesion on the subject.'}15. The method of claim 14 , wherein the lesion is caused by cytomegalovirus (CMV) claim 14 , epstein-barr virus claim 14 , varicella zoster virus (VZV) claim 14 , vaccinia virus claim 14 , cowpox virus claim 14 , monkeypox virus claim 14 , herpes simplex virus (HSV) claim 14 , herpes zoster claim 14 , human herpes virus 6 (HHV-6) claim 14 , human herpes virus 8 (HHV-8) claim 14 , papillomavirus claim 14 , molluscum contagiosum claim 14 , orf claim 14 , variola claim 14 , and/or coxsackie virus.16. The method of claim 15 , wherein the lesion is caused by a papillomavirus.17. The method of claim 15 , wherein the lesion is caused by herpes simplex type 1 and/or herpes simplex type 2.18. The method of claim 15 , wherein the lesion is caused by molluscum contagiosum.19. The method of claim 14 , wherein the lesion is a benign lesion.20. The method of claim 14 , wherein the lesion is a malignant lesion.