Systems and methods for delivery of peptides

• US 9,597,401 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:
  US14/705,126
• Publication Number:
  US 20150231253A1
• Time in Patent Office: 685 Days
• US Class Current: 1/1
• 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 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 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• 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 47/544 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

Abstract

The present invention generally relates to compositions and methods for topical or transdermal delivery. The compositions can be used in a variety of applications. 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. The composition can also be applied to a mucosal surface in some instances. 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 composition for transdermal delivery, 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 composition of claim 1, wherein the carrier comprises each of GnRH, and MSH.

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

4. The composition of claim 3, wherein at least a portion of the liquid crystal structure is multilamellar.

5. The composition of claim 1, wherein at least some of the phosphatidylcholine comprises a polyenylphosphatidylcholine.

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

7. The composition of claim 1, wherein the carrier further comprises a siloxylated polyether.

8. The composition of claim 1, wherein the siloxylated polyether comprises dimethyl, methyl(propylpolyethylene oxide propylene oxide, acetate) siloxane.

9. The composition of claim 1, wherein the carrier further comprises at least one polyglycol.

10. The composition of claim 1, wherein the carrier further comprises a silicone fluid.

11. The composition of claim 10, wherein the silicone fluid comprises polydimethylsiloxane.

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

13. The composition of claim 1, wherein at least some of the phosphatidylcholine comprises a polyenylphosphatidylcholine.

14. The composition of claim 13, wherein the polyenylphosphatidylcholine is present at between 0% and about 19% by weight of the carrier.

15. The composition of claim 13, wherein the polyenylphosphatidylcholine comprises linoleic acid.

16. The composition of claim 13, wherein the polyenylphosphatidylcholine comprises dilinoleoylphosphatidylcholine.

17. The composition of claim 11, wherein the carrier further comprises a transdermal penetration enhancer.

18. The composition of claim 11, 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.

19. The composition of claim 17, wherein the first phase comprises a fatty acid ester.

20. A method, comprising contacting the skin of a subject with the composition of claim 1.