IP Library Granted Patent US 9,669,041
Granted Patent B2
US 9,669,041 · App. 14/353,599 · Granted Jun 6, 2017

Nitric oxide releasing bath compositions and methods of using the same

Inventors: Nathan Stasko (Durham, NC); Ryan Doxey (Raleigh, NC)
Assignee: Novan, Inc.
A61K31/695A01N59/00A61K8/19A61K8/40A61K33/00A61Q19/10
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Quick Facts
Patent No.
US 9,669,041
App. No.
14/353,599
Granted
Jun 6, 2017
Kind
B2
Abstract

The present invention relates to bath compositions that may release nitric oxide when combined with an aqueous solution, thereby producing a nitric oxide releasing soak and/or bath. The present invention also relates to methods of using nitric oxide releasing bath compositions.

Claims (22)

1. A bath composition comprising:

sodium bicarbonate at a concentration in a range from about 30% to about 60% by weight of the bath composition;

citric acid and/or tartaric acid at a concentration in a range from about 0.1% to about 5% by weight of the bath composition; and

at least one nitric oxide (NO)-releasing compound, wherein the at least one NO-releasing compound comprises a NO-releasing macromolecule comprising diazeniumdiolate-functionalized co-condensed silica at a concentration in a range from about 35% to about 65% by weight of the bath composition, wherein the diazeniumdiolate-functionalized cocondensed silica has a half-life of greater than about 60 minutes at 37° C. and pH 7.4, and wherein the bath composition provides a total NO release of about 1 mmol NO/L to about 100 mmol NO/L.

2. The bath composition of claim 1 , wherein the at least one NO-releasing compound releases NO upon reaction with water.

3. The bath composition of claim 1 , wherein the concentration of the diazeniumdiolate-functionalized co-condensed silica is in a range from about 35% to about 55% by weight of the bath composition.

4. The bath composition of claim 1 , wherein the sodium bicarbonate is present at a concentration in a range from about 35% to about 50% by weight of the bath composition.

5. The bath composition of claim 1 , wherein the citric acid and/or tartaric acid is present at a concentration in a range from about 0.2% to about 2% by weight of the bath composition.

6. The bath composition of claim 1 , further comprising an aromatherapy agent, wherein the concentration of the aromatherapy agent is in a range from about 0.1% to about 10% by weight of the bath composition.

7. The bath composition of claim 1 , further comprising a glidant, wherein the concentration of the glidant is in a range from about 0.1% to about 10% by weight of the bath composition.

8. The bath composition of claim 1 , further comprising an inert filler, wherein the concentration of the inert filler is in a range from about 0.1% to about 60% by weight of the bath composition.

9. The bath composition of claim 1 , wherein the diazeniumdiolate-functionalized co-condensed silica has an octanol/water partition coefficient in a range from 0.1 to 7.

10. The bath composition of claim 1 , wherein the diazeniumdiolate-functionalized co-condensed silica is present as particles and the particles have a hydrodynamic radius in a range from about 1 nm to about 10 microns.

11. The bath composition of claim 1 , wherein the diazeniumdiolate-functionalized co-condensed silica is present as particles and the nitric oxide storage of the diazeniumdiolate-functionalized co-condensed silica particles is in a range from about 0.1 pmol NO/g to about 1 mmol NO/g of the bath composition.

12. The bath composition of claim 1 , wherein the bath composition is in the form of a powder, a bead, a granule, a tablet, a film, a coating, a film-coated tablet, a polymer sheet, and any combination thereof.

13. The bath composition of claim 1 , wherein the composition further comprises at least one compound that provides a visual indicator of when NO, nitrous acid and/or salts thereof are present.

14. A method of treating a subject comprising: contacting the bath composition of claim 1 with an aqueous solution to form NO, thereby producing a nitric oxide releasing bath, and exposing at least a portion of the subject to the bath.

15. The method of claim 14 , further comprising adjusting the release rate of the NO by changing the temperature of the bath and/or modifying the pH of the bath.

16. The bath composition of claim 6 , wherein the aromatherapy agent is selected from menthol and/or camphor.

17. The bath composition of claim 7 , wherein the glidant is selected from colloidal silicon dioxide and/or talc.

18. The bath composition of claim 8 , wherein the inert filler is selected from microcrystalline cellulose and/or lactose.

19. The bath composition of claim 1 , wherein the bath composition is present as a coating on a surface of a container.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 30, 2025
From: LNHC, INC.
To: LIGAND PHARMACEUTICALS INCORPORATED
Reel/Frame 071481/0040 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2024
From: NOVAN, INC.
To: LNHC, INC.
Reel/Frame 066350/0942 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 23, 2015
From: STASKO, NATHAN; DOXEY, RYAN
To: NOVAN, INC.
Reel/Frame 036166/0381 →
Continuity (2)
Provisional Application 61552395 · Oct 27, 2011
Related Publication 20140255318A1 · Sep 11, 2014