US 8,986,714 B2Granted

Formulations, methods and procedures for reducing or preventing the development, or the risk of development, of neuropathology as a result of trauma

AssigneeSapna Life Sciences Corporation

InventorJames Lorne Henry

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Abstract

Novel formulations and methods for their use in treating neuropathology incident to trauma are provided. Multiple-component formulations of the invention, and especially those having four components, comprise biologically active compounds configured for preventing or reducing the incidence and severity of damage caused by neurotrauma. Formulations and methods of the invention effect both neuroprotective actions to prevent or reduce secondary injuries, and neurotrophic actions to repair and restore cells and tissues affected by the trauma. Formulations and methods of the invention are especially useful in treating neurological trauma, such as those caused by sports injuries and improvised explosive devices in combat.

Claims12

Dependent claims

A formulation adapted for the prophylactic treatment of neuropathology caused by trauma to a subject, or for the amelioration of the effects caused by trauma to a subject, the formulation comprising four biologically active compounds in amounts that are pharmaceutically effective for each compound, respectively, when administered in combination with the other three biologically active compounds, the four compounds comprising a pharmaceutically effective amount of:

A. at least one biologically active compound from the group comprising anticonvulsants, wherein the anticonvulsant is at least one form of gabapentin, wherein the gabapentin is provided in a dosage range of from about 5.0 mg to about 9,600 mg;
B. at least one biologically active compound from the group comprising neurosteroids, wherein the neurosteroid is at least one form of progesterone, wherein the progesterone is provided in a dosage range of from about 0.05 mg to about 1,200 mg;
C. at least one biologically active compound from the group comprising NK-1 receptor antagonists, wherein the NK-1 receptor antagonist is at least one form of aprepitant, wherein the aprepitant is provided in a dosage range of from about .05 mg to about 750 mg;
and
D. at least one biologically active compound from the group comprising lithium-containing compounds, wherein the lithium-containing compound is at least one form of lithium carbonate, wherein the lithium carbonate is provided in a dosage range of from about 0.5 mg to about 3,600 mg;
wherein the formulation comprises a single dosage unit;
and
wherein the formulation is in a form and a dosage with respect to each of its components such that it is adapted and arranged for administration to a mammal in need thereof, such that the development, or the risk of development, of neuropathology caused by trauma or effects caused by trauma are reduced, lessened, attenuated or prophylactically treated.

5 more elements

A method for the prophylactic treatment of, for reducing the effects of, or for reducing the risk of development of neuropathology caused by trauma to a subject or the effects caused by trauma to a subject, the method comprising the steps or actions of:

A. providing a formulation comprising four biologically active compounds in amounts that are pharmaceutically effective for each compound, respectively, when administered in combination with the other three biologically active compounds, the four compounds comprising a pharmaceutically effective amount of:
i. at least one biologically active compound from the group comprising anticonvulsants, wherein the anticonvulsant is at least one form of gabapentin, wherein the gabapentin is provided in a dosage range of from about 5.0 mg to about 9,600 mg;
ii. at least one biologically active compound from the group comprising neurosteroids, wherein the neurosteroid is at least one form of progesterone, wherein the progesterone is provided in a dosage range of from about 0.05 mg to about 1,200 mg;
iii. at least one biologically active compound from the group comprising NK-1 receptor antagonists, wherein the NK-1 receptor antagonist is at least one form of aprepitant, wherein the aprepitant is provided in a dosage range of from about .05 mg to about 750 mg;
and
iv. at least one biologically active compound from the group comprising lithium-containing compounds, wherein the lithium-containing compound is at least one form of lithium carbonate, wherein the lithium carbonate is provided in a dosage range of from about 0.5 mg to about 3,600 mg;
wherein the formulation comprises a single dosage unit;
wherein the formulation is in a form adapted and arranged for administration to a mammal in need thereof, such that the development, or the risk of development, of neuropathology is reduced, lessened, attenuated or prophylactically treated, and
B. administering the formulation to a mammal in need thereof.

6 more elements

Dependencies are inferred from the claim text.

Facts

Application: 13/961,251Filed 7 Aug 2013 · continuation
Priority: 9 Jan 2013
Published: US 2014/0193526 A110 Jul 2014
Granted: 24 Mar 2015
Term ends: Not estimatedThe source records don’t support an estimate.

Classification20 codes

A61K 33/14
Medicinal preparations containing inorganic active ingredients: alkali metal chlorides; Alkaline earth metal chlorides
A61K 31/19
Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids: carboxylic acids, e.g. valproic acid
A61K 31/194
Carboxylic acids, e.g. valproic acid: having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
A61K 31/195
Carboxylic acids, e.g. valproic acid: having an amino group

Family

Application61/750,745Us provisional application · filed 9 Jan 2013
Application13/815,716Parent of this continuation · filed 15 Mar 2013
US 2014/0193527 A1Pre-grant publication · published 10 Jul 2014
US 2014/0193526 A1Published application
US 8,992,951 B2Related patent
US 8,986,714 B2This patent

From the US filing history. Foreign family members aren’t listed.