Methods of delivering therapeutics to the brain

• US 20070031341A1
• Filed: 08/08/2005
• Published: 02/08/2007
• Est. Priority Date: 08/08/2005
• Status: Abandoned Application

• Current Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Lilienfeld, Sean, Attawia, Mohamed, Toselli, Richard, DiMauro, Thomas
• Application Number:
  US11/200,438
• Publication Number:
  US 20070031341A1
• Time in Patent Office: Days
• US Class Current: 424/45
• 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 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/375 Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 31/405 Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 38/34 Melanocyte stimulating hormone [MSH], e.g. alpha- or beta-melanotropin
• CPC Class Codes: A61K 38/44 Oxidoreductases (1)
• CPC Class Codes: A61K 38/446 Superoxide dismutase (1.15)
• CPC Class Codes: A61K 41/00 Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: C12Y 111/01006 Catalase (1.11.1.6)
• CPC Class Codes: C12Y 115/01001 Superoxide dismutase (1.15.1.1)

Abstract

Intranasal iontophoretic administration of therapeutics such as Reduced Water (RW) or lubeluzole as a means of treating diseases of the CNS involving oxidative stress.

Claims

1. A method of treating a patient having a disease of the central nervous system, comprising:

a) intranasally administering through a cribriform plate an effective amount of a therapeutic agent selected from the group consisting of reduced water, lubeluzole, catalase, SOD, melatonin, α

MSH and Vitamins C and E.

2. The method of claim 1 wherein the intranasal administration is augmented by iontophoresis.

3. The method of claim 2 wherein the iontophoresis is accomplished with an intranasal probe having a reservoir of the therapeutic agent.

4. The method of claim 3 wherein the intranasal probe comprises a monopolar probe.

5. The method of claim 4 wherein the iontophoresis is accomplished with an anode placed upon a back of a head of the patient.

6. The method of claim 3 wherein the intranasal probe comprises a bipolar probe.

7. The method of claim 2 wherein the intranasal administration is accomplished by providing a pressure gradient across the cribriform plate.

8. The method of claim 7 wherein intracranial pressure within a skull of the patient is reduced.

9. The method of claim 1 wherein the therapeutic agent is reduced water.

10. The method of claim 1 wherein the therapeutic agent is lubeluzole.

11. A device for treating a patient having a disease of the central nervous system, comprising:

a) an intranasal container having an open distal end and a closed proximal end, the container forming a reservoir, and

b) a therapeutic agent selected from the group consisting of reduced water and lubeluzole contained within the reservoir.

12. The device of claim 11 wherein the therapeutic agent is reduced water having a redox potential of between −

50 mV and −

1000 mV.

13. The device of claim 11 wherein the device further comprises:

c) an electrode.

14. The device of claim 13 wherein the closed proximal end of the container forms an inner proximal face, and the electrode is attached to the inner proximal face of the container.

15. The device of claim 13 wherein the intranasal probe comprises a monopolar cathodic probe.

16. The device of claim 13 wherein the intranasal probe comprises a bipolar probe further comprising d) a first anode.

17. The device of claim 16 wherein the first anode is located distal to the cathode.

18. The device of claim 13 wherein the intranasal probe comprises a bipolar probe further comprising e) a second anode.

19. The device of claim 18 wherein the second anode is located proximal to the cathode.

20. The method of claim 11 wherein the container is pressurized.

21. The device of claim 11 further comprising:

c) a porous fibrous plug attached to the open distal end of the container.

22. The device of claim 11 wherein the therapeutic agent is lubeluzole.

23. A method of delivering charged molecules to a patient having a skull, a dura, and a subarachnoid space, comprising:

a) removing a portion of the skull to expose the dura, and

b) iontophoretically delivering a therapeutic agent through the exposed dura and into the subarachnoid space.

24. The method of claim 23 wherein the patient has suffered a stroke.

25. The method of claim 23 wherein the therapeutic agent is reduced water.

26. The method of claim 23 wherein the therapeutic agent is lubeluzole.

27. The method of claim 23 wherein step a) produces a hole in the skull, and further comprising the step of:

c) inserting a device comprising an electrode into the hole in the skull.

28. The device of claim 27 wherein the device has a threaded outer surface.

29. The device of claim 27 wherein the device has an inner surface defining a throughbore.

30. A method of treating a patient having a disease of the central nervous system, comprising:

a) intranasally administering through a cribriform plate an effective amount of a therapeutic agent, wherein the intranasal administration is accomplished by providing a pressure gradient across the cribriform plate.

31. The method of claim 30 wherein intracranial pressure is reduced.