Brain and neural treatments comprising peptides and other compositions

• US 10,034,914 B2
• Filed: 03/16/2017
• Issued: 07/31/2018
• 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:
  US15/460,527
• Publication Number:
  US 20170252398A1
• Time in Patent Office: 502 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 38/09 Luteinising hormone-releasing hormone [LHRH] , i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
• 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 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• 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 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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 such as thyrotropin-releasing hormone (TRH) and/or GnRH (gonadotropin-releasing hormone). 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 structures 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 gonadotropin-releasing hormone (GnRH) and molecular nitric oxide to treat or prevent the neurological disorder, and a carrier having a phosphatidylcholine component entrapping the nitric oxide, wherein the composition is stable at room temperature.

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

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

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

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

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

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

8. The method of claim 1, wherein the neurological disorder is cisplatin neuropathy.

9. The method of claim 1, wherein the neurological disorder is Parkinson'"'"'s disease.

10. The method of claim 1, wherein the neurological disorder is Alzheimer'"'"'s disease.

11. The method of claim 1, wherein the molecular nitric oxide is present within the carrier as a gas or bound by hydrogen bonds or van der Waals forces.

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

13. A method, comprising contacting the skin of a subject having or at risk of a neurological disorder with a composition comprising:

an emulsion comprising a first phase comprising gonadotropin-releasing hormone (GnRH), molecular nitric oxide, and lecithin, and a second phase comprising an emulsifier, wherein the lecithin is present at least about 0.25% by weight of the composition, and wherein the first phase comprises no more than about 250 ppm of water by weight of the composition.

14. The method of claim 13, wherein the molecular nitric oxide is present within the emulsion as a gas or bound by hydrogen bonds or van der Waals forces to the lecithin.

15. The method of claim 13, wherein at least some of the molecular nitric oxide is present within the first phase bound to phosphatidylcholine.

16. The method of claim 13, wherein the lecithin comprises a phosphatidylcholine, and wherein at least some of the phosphatidylcholine comprises a polyenylphosphatidylcholine.

17. A method, comprising:

administering, to the skin of a subject having or at risk of a neurological disorder, a composition comprising a first phase comprising phosphatidylcholine and an effective amount of gonadotropin-releasing hormone (GnRH) to treat or prevent the neurological disorder, and a second phase comprising an emulsion, wherein the composition comprises no more than about 250 ppm of water by weight of the composition.

18. The method of claim 17, wherein the composition comprises a liquid crystal structure comprising the phosphatidylcholine.

19. The method of claim 18, wherein at least a portion of the liquid crystal structure is multilamellar.

20. The method of claim 17, wherein at least some of the phosphatidylcholine comprises a polyenylphosphatidylcholine.