Claims for Patent: 10,376,538

Summary for Patent: 10,376,538

Title:	Topical gels and methods of using the same
Abstract:	Provided according to some embodiments of the invention are topical gels that may release nitric oxide. Also provided are methods of using such topical gels in the treatment of wounds and other skin ailments.
Inventor(s):	Stasko Nathan, Bauman Susanne, Joshi Pranav R.
Assignee:	Novan, Inc.
Application Number:	US15652824
Patent Claims:	1. A topical composition comprising:nitric oxide-releasing polysiloxane macromolecules, wherein the nitric oxide-releasing polysiloxane macromolecules comprise a co-condensation of at least one aminoalkoxysilane and an alkoxysilane, anda hydrophobic, non-aqueous gel base comprising mineral oil,wherein the nitric oxide-releasing polysiloxane macromolecules are present in the hydrophobic, non-aqueous gel base and at least 70% of nitric oxide (NO) of the nitric oxide-releasing polysiloxane macromolecules remains in the topical composition two days after initial formulation of the topical composition, when the topical composition is stored at room temperature.2. The topical composition of claim 1 , wherein the concentration of the nitric oxide-releasing polysiloxane macromolecules is in a range of 0.1% to 20% by weight of the topical composition.3. The topical composition of claim 1 , wherein the hydrophobic claim 1 , non-aqueous gel base further comprises a silicone gel.4. The topical composition of claim 1 , wherein the hydrophobic claim 1 , non-aqueous gel base further comprises petrolatum.5. The topical composition of claim 1 , wherein the mineral oil is present in the topical composition at a concentration in a range of 10% to 90% by weight of the topical composition.6. The topical composition of claim 1 , wherein the hydrophobic claim 1 , non-aqueous gel base further comprises gel excipients and the nitric oxide-releasing polysiloxane macromolecules and gel excipients have an octanol/water partition coefficient in a range of 0.1 to 7.7. The topical composition of claim 1 , wherein the nitric oxide-releasing polysiloxane macromolecules have a hydrodynamic radius in a range of 1000 nm to 10 microns.8. The topical composition of claim 1 , wherein the nitric oxide-releasing polysiloxane macromolecules have a hydrodynamic radius in a range of 1 nm to 100 nm.9. The topical composition of claim 1 , further comprising an anti-acne agent claim 1 , antimicrobial agent claim 1 , benzoyl peroxide claim 1 , or a corticosteroid.10. The topical composition of claim 1 , wherein at least 80% of NO of the nitric oxide-releasing polysiloxane macromolecules remains in the topical composition two days after initial formulation of the topical composition claim 1 , when the topical composition is stored at room temperature.11. The topical composition of claim 1 , wherein the topical composition comprises one or more hydrophobic components and the total concentration of the one or more hydrophobic components present in the topical composition is at least 49% by weight of the topical composition.12. The topical composition of claim 1 , wherein the topical composition comprises one or more hydrophobic components and the total concentration of the one or more hydrophobic components present in the topical composition is at least 80% by weight of the topical composition.13. A topical composition comprising:nitric oxide-releasing polysiloxane macromolecules, wherein the nitric oxide-releasing polysiloxane macromolecules comprise a co-condensation of at least one aminoalkoxysilane and an alkoxysilane, anda hydrophilic gel base comprising an alcohol,wherein the nitric oxide-releasing polysiloxane macromolecules are present in the hydrophilic gel base and at least 70% of nitric oxide (NO) of the nitric oxide-releasing polysiloxane macromolecules remains in the topical composition two days after initial formulation of the topical composition, when the topical composition is stored at room temperature.14. The topical composition of claim 13 , wherein the concentration of the nitric oxide-releasing polysiloxane macromolecules is in a range of 0.1% to 20% by weight of the topical composition.15. The topical composition of claim 13 , further comprising isopropyl alcohol and/or ethanol at a concentration in a range of 60% to 90% by weight of the topical composition; and hydroxypropyl cellulose at a concentration in a range of 0.75% to 2.5% by weight of the topical composition.16. The topical composition of claim 13 , wherein the hydrophilic gel base further comprises gel excipients and the nitric oxide-releasing polysiloxane macromolecules and the gel excipients have an octanol/water partition coefficient in a range of −2 to 0.17. The topical composition of claim 13 , wherein the nitric oxide-releasing polysiloxane macromolecules have a hydrodynamic radius in a range of 1000 nm to 10 microns.18. The topical composition of claim 13 , wherein the nitric oxide-releasing polysiloxane macromolecules have a hydrodynamic radius in a range of 1 nm to 100 nm.19. The topical composition of claim 13 , further comprising a retinoid claim 13 , antimicrobial agent claim 13 , benzoyl peroxide claim 13 , or a corticosteroid.20. The topical composition of claim 13 , wherein at least 80% of NO of the nitric oxide-releasing polysiloxane macromolecules remains in the topical composition two days after initial formulation of the topical composition claim 13 , when the topical composition is stored at room temperature.21. The topical composition of claim 13 , wherein the alcohol is present in the topical composition at a concentration of at least 60% by weight of the topical composition.22. The topical composition of claim 13 , wherein the alcohol is present in the topical composition at a concentration in a range of 60% to 90% by weight of the topical composition.23. The topical composition of claim 13 , wherein the alcohol is isopropyl alcohol.24. The topical composition of claim 13 , wherein the hydrophilic gel base further comprises hydroxypropyl cellulose.25. The topical composition of claim 24 , wherein the hydroxypropyl cellulose is present at a concentration in a range of 0.75% to 2.5% by weight of the composition.26. The topical composition of claim 13 , wherein the topical composition is non-aqueous.27. A method of treating a wound comprising applying the topical composition of .28. A method of treating a wound comprising applying the topical composition of .29. A method of treating a burn comprising applying the topical composition of .30. A method of treating acne comprising applying the topical composition of .31. A method of treating acne comprising applying the topical composition of .32. The topical composition of claim 1 , wherein the hydrophobic claim 1 , non-aqueous gel base further comprises polyethylene.33. The topical composition of claim 13 , wherein the alcohol is ethanol.