Topical antiviral compositions, delivery systems, and methods of using the same

Patent metadata

Field	Value
Publication number	US-11723858-B2
Application number	US-202117329587-A
Country	US
Kind code	B2
Filing date	May 25, 2021
Priority date	Jul 11, 2014
Publication date	Aug 15, 2023
Grant date	Aug 15, 2023

Abstract

The present invention relates generally to topical antiviral compositions, delivery systems, and methods of using the same.

First claim

That which is claimed is:

1. A delivery system comprising a composition, the composition comprising a nitric oxide (NO)-releasing active pharmaceutical ingredient,
wherein the NO-releasing active pharmaceutical ingredient is a diazeniumdiolated co-condensed silica particle and is present in the composition in an amount of 0.01% to 30% by weight of the composition,
wherein the composition has a Cmax of greater than 160 pmol of NO/mg, as measured by in vitro release testing, and
wherein the composition has a pH of about 5 to about 8.

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, mouth, tongue, and/or pharynx of the subject.

6. The delivery system of claim 1 , wherein the composition further comprises water.

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 diazeniumdiolated co-condensed silica particle comprises a co-condensed silica network comprising diazeniumdiolated aminoethylaminopropyl trimethoxy silane (AEAP3) and tetra methyl orthosilicate (TMOS).

10. 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).

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 tetraethyl orthosilicate (TEOS).

12. A method of administering nitric oxide to a subject to treat and/or prevent a viral infection in a subject, the method comprising:
administering a composition comprising a nitric oxide (NO)-releasing active pharmaceutical ingredient,
wherein the NO-releasing active pharmaceutical ingredient is a diazeniumdiolated co-condensed silica particle and is present in the composition in an amount of 0.01% to 30% by weight of the composition,
wherein the composition has a C max of greater than 160 pmol of NO/mg, as measured by in vitro release testing, and
wherein the composition has a pH of about 5 to about 8.

13. The method of claim 12 , wherein the composition stores and/or releases nitric oxide in an amount of about 0.05% to about 10% by weight of the composition.

14. The method of claim 12 , wherein the administering comprises administering the composition to a body cavity of a subject.

15. The method of claim 12 , wherein the administering comprises administering the composition to a mucous membrane of the subject.

16. The method of claim 12 , wherein the administering comprises administering the composition to a nostril, mouth, tongue, and/or pharynx of the subject.

17. The method of claim 12 , wherein the administering comprises administering nitric oxide in an amount sufficient to induce apoptosis in virally infected cells in the subject.

18. The method of claim 12 , 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.

19. The method of claim 12 , wherein the composition further comprises water.

20. The method of claim 12 , wherein the diazeniumdiolated co-condensed silica particle comprises a co-condensed silica network comprising diazeniumdiolated methylaminopropyl trimethoxysilane (MAP3) and tetra methyl orthosilicate (TMOS).

Assignees

• Novan Inc

Inventors

• Mchale Kimberly
• Doxey Ryan
• Stasko Nathan

Classifications

• A61K9/0014 Primary

  Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00) · CPC title

• A61K9/06

  Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} · CPC title

• A61K31/675

  having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate · CPC title

• A61K33/00

  Medicinal preparations containing inorganic active ingredients · CPC title

• A61K47/02

  Inorganic compounds · CPC title