Method of treating traumatic brain or spinal cord injury with biomembrane sealing agent and magnesium compounds

Patent metadata

Field	Value
Publication number	US-9717756-B2
Application number	US-201414493002-A
Country	US
Kind code	B2
Filing date	Sep 22, 2014
Priority date	May 3, 2006
Publication date	Aug 1, 2017
Grant date	Aug 1, 2017

Abstract

The invention provides methods and kits for treatment of pain or inflammation. In one embodiment, the kit comprises a biomembrane sealing agent, such as PEG, and a bioactive agent, such as a magnesium compound. The biomembrane sealing agent and/or the bioactive agent an intravenous administration, an intramuscular administration, an intrathecal administration, a subcutaneous administration, an epidural administration, a parenteral administration, an intra-articular administration, a direct application onto or adjacent to a site of the pathological condition, and any combinations thereof. Alternatively, the biomembrane sealing agent and/or the bioactive agent may be delivered from a pump or an implant.

First claim

The invention claimed is:

1. A method of treating pain or inflammation associated with a traumatic brain injury or spinal cord injury, the method comprising delivering to a subject in need thereof a first dose comprising a therapeutically effective amount of at least one biomembrane sealing agent comprising polyethylene glycol (PEG) and a therapeutically effective amount of at least one bioactive agent comprising magnesium, and delivering to the subject in need thereof a second dose of the PEG and the magnesium after the first dose, wherein the at least one biomembrane sealing agent is delivered in an injectable composition, and the at least one biomembrane sealing agent comprises from about 15% to about 30% weight/volume of the injectable composition, and the injectable composition further comprises an antioxidant, and the PEG is PEG3350, and the first dose is delivered 15 minutes post-injury and the second dose is delivered 6 hours after the first dose, and the first dose and the second dose combined is 1.4 g/kg of PEG and 0.230 mmol/kg of magnesium.

2. The method of claim 1 , wherein the inflammation is selected from the group consisting of an acute inflammation, a chronic inflammation, and any combination thereof.

3. The method of claim 1 wherein the therapeutically effective amount of at least one biomembrane sealing agent and the therapeutically effective amount of at least one bioactive agent are delivered by a method selected from the group consisting of an intravenous administration, an intramuscular administration, an intrathecal administration, a subcutaneous administration, an epidural administration, a parenteral administration, an intra-articular administration, a direct application or deposition onto or adjacent to a site of the traumatic brain injury or spinal cord injury, and any combinations thereof.

4. The method of claim 3 wherein the method is intravenous administration.

5. The method of claim 1 , wherein the at least one biomembrane sealing agent and the at least one bioactive agent are combined before the step of delivering the at least one biomembrane sealing agent and the at least one bioactive agent to the subject in need thereof.

6. The method of claim 1 , wherein the at least one biomembrane sealing agent or the at least one bioactive agent are delivered from an implant.

7. The method of claim 1 wherein the at least one biomembrane sealing agent or the at least one bioactive agent are delivered from a pump.

8. The method of claim 1 , further comprising the step of delivering at least one marker with the at least one biomembrane sealing agent or the at least one bioactive agent.

9. The method of claim 1 , wherein at least one compound is delivered prior to an occurrence of the traumatic brain injury or spinal cord injury, said one compound selected from the group consisting of the at least one biomembrane sealing agent and the at least one bioactive agent.

10. A method of treating a traumatic brain injury or spinal cord injury, the method comprising delivering to a subject in need thereof a first dose and a second dose, each dose comprising a therapeutically effective amount of at least one biomembrane sealing agent and a therapeutically effective amount of at least one magnesium compound, wherein the at least one biomembrane sealing agent is delivered in an injectable composition, and the at least one biomembrane sealing agent comprises from about 15% to about 30% weight/volume of the injectable composition, and the injectable composition further comprises an antioxidant, and the at least one biomembrane sealing agent is PEG3350, and the first dose is delivered 15 minutes post-injury and the second dose is delivered 6 hours after the first dose, and the first dose and the second dose combined is 1.4 g/kg of PEG and 0.230 mmol/kg of magnesium.

11. The method of claim 10 wherein the at least one magnesium compound is selected from the group consisting of magnesium sulfate, magnesium chloride, magnesium gluconate, magnesium ATP, and any combination thereof.

12. The method of claim 10 , wherein the at least one magnesium compound is selected from the group consisting of magnesium sulfate, magnesium chloride, and any combination thereof.

13. The method of claim 1 , wherein the antioxidant comprises free radical scavengers and chelators enzymes, co-enzymes, spin-trap agents, ion and metal chelators, lipid peroxidation inhibitors, N-tert-butyl-alpha-phenylnitrone, Edaravone, glutathione and derivates, and any combinations thereof.

Assignees

• Warsaw Orthopedic Inc

Inventors

• Roy Josee
• Mckay William F
• Marx Jeffrey C

Classifications

• A61K31/765

  Polymers containing oxygen · CPC title

• A61K33/06

  Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay} · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K33/14 Primary

  Alkali metal chlorides; Alkaline earth metal chlorides · CPC title

• A61K31/717

  Celluloses · CPC title