Compositions for the treatment of autodigestion
Inventors
HALLAM, Thomas • JACKMAN, Robin • Rodenrys, John
Assignees
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Publication Number
US-11123317-B2
Publication Date
2021-09-21
Expiration Date
Abstract
Compositions for the treatment of shock, autodigestion, multi-organ failure, intestinal ischemia, or intestinal hypoperfusion are provided.
Core Innovation
The invention relates to enteral aqueous treatment compositions for shock/auto-digestion/multi-organ failure and for intestinal ischemia/hypoperfusion. The compositions include tranexamic acid combined with polyethylene glycol 3350, glucose, and electrolytes including sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride.
The aqueous solutions are defined with specified gram ranges for tranexamic acid, PEG 3350, glucose, and each listed electrolyte component. The document also includes example aqueous solutions and describes kit formats having separated components for reconstitution with water prior to use.
The described uses include enteral administration via multiple routes and in vivo evaluation in animal models of intestinal ischemia and hemorrhagic shock, including a superior mesenteric artery occlusion intestinal ischemia model. Reported results emphasize improved villus structural integrity relative to comparators omitting PEG, including assessments of goblet cells and villi structure.
The document further includes clinical evaluation described as Phase 2 clinical study designs addressing septic shock and post-cardiovascular surgery shock/multiorgan dysfunction. Reported outcomes include improved days alive without organ support and reduced mortality, with additional reported measures including SOFA score and lactate, and mention of interventions such as vasopressors and renal replacement therapy.
Claims Coverage
The provided claim content centers on one independent claim defining a single core formulation based on specified gram ranges for inventive ingredients, with dependent claims narrowing ingredient amounts and adding aqueous solution volume constraints.
Specified aqueous solution with tranexamic acid, PEG 3350, glucose, and electrolytes
An aqueous solution comprising 6.75 grams to 8.25 grams of tranexamic acid; 29.25 grams to 35.75 grams of polyethylene glycol 3350; 25.2 grams to 30.8 grams of glucose; 3.6 grams to 4.4 grams of sodium sulfate; 1.08 grams to 1.32 grams of sodium bicarbonate; 0.9 grams to 1.1 grams of sodium chloride; and 0.45 grams to 0.55 grams of potassium chloride.
Across the provided claim set, the coverage centers on the specified aqueous formulation containing tranexamic acid, PEG 3350, glucose, and the listed electrolytes, with dependent claims further narrowing component amounts and restricting the aqueous solution volume.
Stated Advantages
Improved villus structural integrity versus PEG-omitted comparators.
Improved days alive without organ support.
Reduced mortality.
Documented Applications
Enteral treatment for shock/auto-digestion/multi-organ failure.
Enteral treatment for intestinal ischemia/hypoperfusion.
Use in animal models including SMAO intestinal ischemia and hemorrhagic shock.
Phase 2 clinical evaluation in septic shock.
Phase 2 clinical evaluation in post-cardiovascular surgery shock/multiorgan dysfunction.
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