Methods and compositions for treating conditions related to lack of blood supply, shock and neuronal injuries

Inventors

Simpkins, Cuthbert O.

Assignees

Vivacelle Bio Inc

Publication Number

US-8906855-B2

Publication Date

2014-12-09

Expiration Date

2028-12-16

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Abstract

A pharmaceutical composition comprising an amphiphilic emulsifier, a polar liquid carrier and, optionally, a lipid component. The amphiphilic emulsifier form free-moving, optionally lipid-carrying, micelles (LMs) in the polar liquid carrier. The pharmaceutical composition is free of hemoglobin and fluorocarbon and can be used for treating conditions related to lack of blood supply and to raise the blood pressure and correct hypovolemia.

Core Innovation

The invention provides a pharmaceutical composition comprising an amphiphilic emulsifier and a polar liquid carrier, in which the emulsifier forms free-moving micelles with a lipophilic core. Optionally, the composition may also include a lipid component present in the lipophilic core. The pharmaceutical composition is free of hemoglobin and fluorocarbon.

This pharmaceutical composition is designed to address conditions related to lack of blood supply, such as hypovolemia due to bleeding, dehydration, shock, and neuronal injuries, by raising blood pressure and correcting hypovolemia. The micellar structure enables the absorption and delivery of oxygen and lipophilic gases to tissues, enhancing perfusion and tissue viability in the absence of natural or modified hemoglobin.

Current treatments using crystalloids or colloid-based fluids face limitations, including complications such as increased bleeding risk or renal failure, and can be inadequate for complex shock pathophysiology. The invention aims to provide a safer, more effective, and hemoglobin-free volume expander that delivers oxygen, nutrients, and modulates inflammatory mediators, thereby improving outcomes in shock and blood supply deficiency.

Claims Coverage

There are two independent claims, each defining main inventive features for compositions and methods of treating conditions related to lack of blood supply and raising blood pressure with a specific pharmaceutical composition.

Method for treating conditions related to lack of blood supply using a defined pharmaceutical composition

The method involves administering to a subject in need a pharmaceutical composition comprising: - An amphiphilic emulsifier - A polar liquid carrier Where the amphiphilic emulsifier forms free-moving micelles with a lipophilic core in the polar liquid carrier, and the pharmaceutical composition is free of hemoglobin and fluorocarbon.

Method for raising the blood pressure in a subject with hypovolemia using a defined pharmaceutical composition

The method comprises administering to a subject with hypovolemia an effective amount of a pharmaceutical composition including: - An amphiphilic emulsifier - A polar liquid carrier Where the amphiphilic emulsifier forms free-moving micelles with a lipophilic core in the polar liquid carrier, and the pharmaceutical composition is free of hemoglobin and fluorocarbon.

The independent claims establish coverage for methods of treating lack of blood supply and hypovolemia using a pharmaceutical composition of free-moving micelles formed by amphiphilic emulsifiers in polar carriers, explicitly free of hemoglobin and fluorocarbons.

Stated Advantages

The pharmaceutical composition raises blood pressure and corrects hypovolemia more effectively than standard resuscitation fluids.

It can deliver oxygen and other lipophilic gases to tissues in the absence of natural or modified hemoglobin.

The composition is free of hemoglobin and fluorocarbons, reducing risks associated with these substances.

It acts as a blood volume expander while simultaneously providing oxygen and nutrients to tissues.

The micelles can absorb mediators of tissue injury, such as prostaglandins, nitric oxide, leukotrienes, and others.

Albumin in the composition stabilizes the micelles and has antioxidant effects.

Lipid micelles can reversibly absorb nitric oxide, providing a variable reservoir and modulating vascular tone.

The composition can be rapidly infused at high volumes without a theoretical upper limit.

Documented Applications

Treating conditions related to lack of blood supply, including hypovolemia caused by bleeding, dehydration, vomiting, severe burns, SIRS, and drug-induced causes.

Raising blood pressure in subjects with hypovolemia or severe hemorrhagic shock.

Use as a blood volume expander in acute resuscitation.

Carrying and delivering oxygen and other therapeutic lipophilic gases (e.g., nitric oxide, xenon, argon) to tissues.

Absorbing mediators of tissue injury and modulating inflammatory response.

Treatment of seizure or neuronal injury using xenon- or argon-carrying formulations.

Treatment of vasoconstriction or hypertension using nitric oxide-carrying formulations.

Treatment of hypotension in septic shock by absorbing endogenous nitric oxide.

Preservation of organs for transplant using the pharmaceutical composition for perfusion.

Use in exchange transfusion or whole circulation perfusion to remove or absorb harmful materials from the bloodstream.

Diagnosis, by circulating the composition and analyzing absorbed lipophilic moieties associated with disease.

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