Three-component formulations, methods and procedures, and combinations thereof, for reducing or preventing the development, or the risk of development, of neuropathology resulting from trauma

Abstract

Novel three-component formulations, procedures and methods for use in treating neuropathology incident to trauma are provided. Three-component formulations of the invention comprise biologically active forms of at least one neurosteroid, at least one anti-epileptic or anticonvulsant, and at least one lithium-containing or lithium-related compound. The provided formulations are configured or adapted to prevent or reduce the incidence and severity of neurological damage caused by neurotrauma. Formulations, procedures and methods of the invention advantageously effect both neuroprotective actions to prevent or reduce secondary injuries, and neurotrophic actions to repair and restore cells and tissues affected by the trauma, and are especially useful in treating neurological trauma, such as those caused by sports injuries, chemical weapons, vehicle collisions and improvised explosive devices in combat.

Description

RELATED APPLICATION AND PRIORITY[0001]This Utility patent application claims the priority and benefit of commonly owned U.S. Provisional Patent Application Ser. No. 61 / 750,745 of James L. Henry, as filed 9 Jan. 2013, and as entitled “Formulations, Methods And Procedures For Reducing Or Preventing The Development Or The Risk Of Development Of Neuropathology As A Result Of Traumatic Injury” which provisional patent application is hereby incorporated by reference in its entirety into the present patent application. Also hereby incorporated by reference in their entireties are each of the references cited herein, as well as those cited in Provisional Patent Application Ser. No. 61 / 750,745.FIELD OF THE INVENTION[0002]The presently disclosed invention, and the many particular embodiments of the invention, relate to multiple-component formulations, the use of such formulations, and to methods, procedures and combinations thereof to prevent, eliminate, or reduce, or to reduce the risk of, t...

AI Technical Summary

Benefits of technology

[0084]The present disclosed technology presents and illustrates at least four particular advantageous aspects of the invention embodiments, together comprising formulations, methods and procedures for reducing or preventing the development or the risk of development of neuropathology as a result of traumatic injury.

[0085]One particular advantageous aspect of embodiments of the invention includes the formulations of the presently disclosed technology, which formulations comprise two or more pharmaceutical compounds from four families of chemical compounds, administered together or sequentially at clinically effective doses. In general, each chemical compound, or entity, in the formulation is theorized to target a different biological process or different biological processes that is or are involved in governing the degree of secondary injury that follows a primary traumatic injury. Alternatively stated, some components of the formulations are directed at optimizing or facilitating the restorative processes that follow, or are triggered by, a primary traumatic injury. Some components of the formulation are directed at minimizing or inhibiting the degenerative processes that follow or are triggered by a primary traumatic injury. As described herein, restorative processes lead to recovery and, in contrast, degenerative processes lead to tissue damage and cell death. Applicant posits that optimal treatment to prevent or reduce secondary injury is best achieved by a multi-drug approach to include promotion of a number of different restorative processes and in addition inhibition of a number of different degenerative processes. The present disclosed technology and its embodiments are directed at maximizing control of the processes that govern eventual functional outcomes of trauma and neuropathology and neurodegeneration.

[0086]Before the present invention, the particular combinations of compounds described herein that make up or constitute the present formulations were unknown. Evidence of the efficaciousness of single-compound treatments for neurotrauma is spotty or contradictory. Hindsight with respect to the field of neurotrauma hints only generally toward single-component remedies, and not to any particular combination of drugs to possibly be selected from the various categories of pharmaceuticals and myriad permutations possibly selectable from them. Nonetheless, Applicant posits that the formulations, methods and procedures of the presently disclosed invention are effective in reducing or preventing the development of, or the degree of, or the

Problems solved by technology

This gap represents an unsolved medical need.

Cell loss caused by this primary injury is beyond treatment.

Indeed, the damage caused by these secondary processes can be as serious and extensive as, or even more