Topical gels and methods of using the same

• US 9,737,561 B2
• Filed: 11/16/2016
• Issued: 08/22/2017
• Est. Priority Date: 08/21/2009
• Status: Active Grant

• Current Assignee: LNHC Incorporated
• Original Assignee: Novan, Inc.
• Inventors: Stasko, Nathan, Bauman, Susanne, Joshi, Pranav R.
• Primary Examiner(s): YOUNG, MICAH PAUL
• Application Number:
  US15/353,301
• Publication Number:
  US 20170056437A1
• Time in Patent Office: 279 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/655 Azo (—N=N—), diazo (=N2), azoxy (>N—O—N< or N(=O)—N<), azido (—N3) or diazoamino (—N=N—N<) compounds
• CPC Class Codes: A61K 31/80 Polymers containing hetero atoms not provided for in groups A61K31/755 - A61K31/795
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 47/59 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
• CPC Class Codes: A61K 47/6903 the form being semi-solid, e.g. an ointment, a gel, a hydrogel or a solidifying gel
• CPC Class Codes: A61K 9/0014 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 Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/10 Anti-acne agents
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics

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.

Claims

1. A method of treating a skin ailment in a subject, the method comprising:

administering to a subject a topical composition comprising nitric oxide-releasing polysiloxane macromolecules and

a hydrophobic, non-aqueous gel base, the hydrophobic, non-aqueous gel base comprising mineral oil, wherein the nitric oxide (NO) storage per gram is in a range of 100 nmol NO/g to 1 mmol NO/g of the topical composition and at least 70% of NO of the nitric oxide-releasing polysiloxane macromolecule remains in the topical composition two days after initial formulation when the topical composition is stored at room temperature.

2. The method of claim 1, wherein the nitric oxide-releasing polysiloxane macromolecules are diazeniumdiolate-functionalized polysiloxane macromolecules.

3. The method of claim 1, wherein the method decreases inflammation in the subject.

4. The method of claim 1, wherein the method decreases inflammatory response factors in the subject.

5. The method of claim 1, wherein the method modulates inflammatory cytokines in the subject.

6. The method of claim 1, wherein the skin ailment is an inflammatory skin condition.

7. The method of claim 1, wherein the skin ailment is impetigo, psoriasis, tinea pedis, or onychomycosis.

8. The method of claim 1, wherein the topical composition is antimicrobial.

9. The method of claim 1, wherein the topical composition disperses a biofilm.

10. The method of claim 1, wherein the topical composition disrupts the structure of the biofilm and/or prevents biofilm formation.

11. The method of claim 1, wherein the topical composition kills bacteria present in a biofilm.

12. A method of treating a skin ailment in a subject, the method comprising:

administering to a subject a topical composition comprising nitric oxide-releasing polysiloxane macromolecules and a hydrophilic gel base, the hydrophilic gel base comprising an alcohol, wherein the nitric oxide (NO) storage per gram is in a range of 100 nmol NO/g to 1 mmol NO/g of the topical composition and at least 70% of NO of the nitric oxide-releasing polysiloxane macromolecule remains in the topical composition two days after initial formulation when the topical composition is stored at room temperature.

13. The method of claim 12, wherein the nitric oxide-releasing polysiloxane macromolecules are diazeniumdiolate-functionalized polysiloxane macromolecules.

14. The method of claim 12, wherein the method decreases inflammation in the subject.

15. The method of claim 12, wherein the method decreases inflammatory response factors in the subject.

16. The method of claim 12, wherein the method modulates inflammatory cytokines in the subject.

17. The method of claim 12, wherein the skin ailment is an inflammatory skin condition.

18. The method of claim 12, wherein the skin ailment is impetigo, psoriasis, tinea pedis, or onychomycosis.

19. The method of claim 12, wherein the topical composition is antimicrobial.

20. The method of claim 12, wherein the topical composition disperses a biofilm.

21. The method of claim 12, wherein the topical composition disrupts the structure of the biofilm and/or prevents biofilm formation.

22. The method of claim 12, wherein the topical composition kills bacteria present in a biofilm.