Peptide systems and methods for metabolic conditions

• US 9,597,400 B2
• Filed: 05/06/2015
• Issued: 03/21/2017
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Transdermal Biotechnology, Inc.
• Original Assignee: Transdermal Biotechnology, Inc.
• Inventors: Perricone, Nicholas V.
• Primary Examiner(s): Maewall, Snigdha
• Application Number:
  US14/705,112
• Publication Number:
  US 20150231252A1
• Time in Patent Office: 685 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 38/066 TRH, thyroliberin, thyrotropin releasing hormone
• CPC Class Codes: A61K 38/09 Luteinising hormone-releasing hormone [LHRH] , i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
• CPC Class Codes: A61K 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• 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 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: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/107 Emulsions ; Emulsion preconcentrates; Micelles composition of emulsions A61K47/00
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin

Abstract

The present invention generally relates to compositions and methods for topical or transdermal delivery, and treatment of metabolic conditions. In some cases, the composition may include nitric oxide and/or peptides such as thyrotropin-releasing hormone (TRH) and/or GnRH (gonadotropin-releasing hormone). The nitric oxide and/or peptide may be present within a first phase comprising a lecithin, such as phosphatidylcholine. In certain embodiments, the lecithin is present in liposomes, micelles, or other structures containing nitric oxide, peptides, or both. The composition can take the form of a gel, a cream, a lotion, an ointment, a solution, a solid “stick,” etc., that can be rubbed or sprayed onto the skin. Other aspects of the present invention are generally directed to methods of making or using such compositions, methods of promoting such compositions, kits including such compositions, or the like.

Claims

1. A method, comprising:

administering, to the skin of a subject having a metabolic condition, a composition comprising a phosphatidylcholine carrier comprising molecular nitric oxide and one or more of gonadotropin-releasing hormone (GnRH), and melanocyte-stimulating hormone (MSH), wherein the composition is stable at room temperature.

2. The method of claim 1, wherein the metabolic condition is metabolic syndrome.

3. The method of claim 1, wherein the metabolic condition is diabetes.

4. The method of claim 1, wherein the metabolic condition is impaired glucose tolerance (IGT).

5. The method of claim 1, wherein the metabolic condition is hyperglycemia.

6. The method of claim 1, wherein the metabolic condition is obesity.

7. The method of claim 1, wherein the carrier comprises each of GnRH and MSH.

8. The method of claim 1, wherein the carrier comprises a liquid crystal structure comprising the phosphatidylcholine.

9. The method of claim 8, wherein at least a portion of the liquid crystal structure is multilamellar.

10. The method of claim 1, wherein at least some of the phosphatidylcholine comprises a polyenylphosphatidylcholine.

11. The method of claim 1, wherein the composition is a cream, a gel, a lotion, or an ointment.

12. The method of claim 1, wherein the carrier further comprises a siloxylated polyether.

13. The method of claim 1, wherein the carrier further comprises at least one polyglycol.

14. The method of claim 1, wherein the carrier further comprises a silicone fluid.

15. The method of claim 1, wherein the phosphatidylcholine is present at between about 19% and about 65% by weight of the carrier.

16. The method of claim 1, wherein at least some of the phosphatidylcholine comprises a polyenylphosphatidylcholine.

17. The method of claim 16, wherein the polyenylphosphatidylcholine comprises linoleic acid.

18. The method of claim 16, wherein the polyenylphosphatidylcholine comprises dilinoleoylphosphatidylcholine.

19. The method of claim 16, wherein at least about 30 wt % of the phosphatidylcholine is a polyenylphosphatidylcholine.

20. The method of claim 1, wherein the carrier comprises a first phase comprising the phosphatidylcholine carrier and the one or more of GnRH and MSH, and a second phase comprising an emulsifier.