Brain and neural treatments comprising peptides and other compositions

• US 10,213,457 B2
• Filed: 05/25/2017
• Issued: 02/26/2019
• 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:
  US15/604,928
• Publication Number:
  US 20170326173A1
• Time in Patent Office: 642 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 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 38/066 TRH, thyroliberin, thyrotropin releasing hormone
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; 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 38/34 Melanocyte stimulating hormone [MSH], e.g. alpha- or beta-melanotropin
• 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 9/107 Emulsions ; Emulsion preconcentrates; Micelles composition of emulsions A61K47/00
• CPC Class Codes: A61K 9/1274 Non-vesicle bilayer structures, e.g. liquid crystals, tubules, cubic phases, cochleates; Sponge phases

Abstract

The present invention generally relates to compositions and methods for treatment of subjects in need of muscle growth, muscle repair, improved muscular and neuromuscular control, and treatments for neuromuscular and neurological disorders, including brain disorders. In some cases, the composition may include nitric oxide and/or peptides. The nitric oxide and/or peptides 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 vesicles containing nitric oxide and/or peptide. 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, e.g., onto a location where muscle growth, muscle repair, or improved muscular and neuromuscular control is desired, or on another suitable portion of 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 or at risk of a neurological disorder, a composition comprising an effective amount of molecular nitric oxide and a peptide to treat or prevent the neurological disorder, and a carrier comprising lecithin containing the molecular nitric oxide, wherein the composition is stable at room temperature.

2. The method of claim 1, wherein the peptide comprises melanocyte-stimulating hormone (MSH).

3. The method of claim 1, wherein the peptide comprises vasopressin.

4. The method of claim 1, wherein the carrier further comprises polyenylphosphatidylcholine.

5. The method of claim 1, wherein the composition comprises a liquid crystal structure.

6. The method of claim 1, wherein the composition comprises no more than about 250 ppm of water by weight of the composition.

7. The method of claim 1, wherein the lecithin is present at at least about 0.25% by weight of the composition.

8. The method of claim 1, wherein the molecular nitric oxide is present at at least about 0.5% by weight of the composition without the molecular nitric oxide.

9. The method of claim 1, wherein the molecular nitric oxide is present within the composition as a gas.

10. The method of claim 1, wherein the molecular nitric oxide is bound by hydrogen bonds or van der Waals forces to the lecithin.

11. The method of claim 1, wherein the composition is a cream.

12. The method of claim 1, wherein the neurological disorder is spinocerebellar degeneration or spinal muscular atrophy.

13. The method of claim 1, wherein the neurological disorder is depression.

14. The method of claim 1, wherein the neurological disorder is neuropathic pain.

15. The method of claim 1, wherein the neurological disorder is brain ischemia.

16. A method, comprising:

administering, to the skin of a subject having or at risk of a neurological disorder, a composition comprising an effective amount of molecular nitric oxide and a peptide to treat or prevent the neurological disorder, and a carrier comprising lecithin containing the molecular nitric oxide, wherein the composition comprises no more than about 250 ppm of water by weight of the composition.

17. The method of claim 16, wherein the peptide comprises melanocyte-stimulating hormone (MSH).

18. The method of claim 16, wherein the peptide comprises vasopressin.

19. The method of claim 16, wherein the carrier further comprises polyenylphosphatidylcholine.

20. The method of claim 16, wherein the composition comprises a liquid crystal structure.

21. The method of claim 16, wherein the composition is stable at room temperature.

22. The method of claim 16, wherein the lecithin is present at at least about 0.25% by weight of the composition.

23. The method of claim 16, wherein the molecular nitric oxide is present at at least about 0.5% by weight of the composition without the molecular nitric oxide.

24. The method of claim 16, wherein the molecular nitric oxide is present within the composition as a gas.

25. The method of claim 16, wherein the molecular nitric oxide is bound by hydrogen bonds or van der Waals forces to the lecithin.