Liposomal rehydration salt formulation and associated methods of use

Abstract

A liposomal rehydration salt formulation used for preventing severe dehydration, maintaining body electrolytes and fluids in a human, and rehydrating a human includes phospholipids at a concentration of about 1.0 g/L to 10.0 g/L, salts, water, and a percentage inclusion ratio of salts (salts retained within total salts/liposomes) of at least 50% and a sodium electrolyte of about 12 mEq/L to 90 mEq/L, wherein said formulation has an actual osmolarity lower than 130 based on the at least 50% encapsulation of the salts and said liposomes comprise a particle diameter ranging from 200 nm to 500 nm.

That which is claimed is: 
     
         1 . A liposomal rehydration salt formulation, comprising phospholipids at a concentration of about 1.0 g/L to 10.0 g/L, salts, water, and a percentage inclusion ratio of salts (salts retained within total salts/liposomes) of at least 50% and a sodium electrolyte of about 12 mEq/L to 90 mEq/L, wherein said formulation has an actual osmolarity lower than 130 based on the at least 50% encapsulation of the salts and said liposomes comprise a particle diameter ranging from 200 nm to 500 nm. 
     
     
         2 . The liposomal rehydration salt formulation of  claim 1 , wherein said sodium electrolyte is from about 35 mEq/L to 55 mEq/L. 
     
     
         3 . The liposomal rehydration salt formulation of  claim 1 , further comprising about 15 mEq/L to 25 mEq/L of potassium electrolyte. 
     
     
         4 . The liposomal rehydration salt formulation of  claim 1 , wherein said phospholipids are selected from the group consisting of phosphatidylcholines (PCs), phosphatidylserines (PSs), phosphatidylethanolamines (PEs), phosphatidylglycerols (PGs), phosphatidylinositols (PIs), phosphatidic acids (PAs), and mixtures thereof. 
     
     
         5 . The liposomal rehydration salt formulation according to  claim 1 , wherein said formulation further comprises an antioxidant selected from the group consisting of phytosterol, tocopherol, and mixtures thereof. 
     
     
         6 . The liposomal rehydration salt formulation of  claim 1 , wherein said salts are selected from the group consisting of sodium chloride at a concentration of 0.7 g/L to 2.8 g/L, potassium citrate at a concentration of 0.8 g/L to 2.5 g/L, sodium citrate at a concentration of 0.5 g/L to 2.9 g/L, and mixtures thereof. 
     
     
         7 . The liposomal rehydration salt formulation of  claim 1 , wherein said formulation further comprises about 10 g/L to 17 g/L of glucose and about 8.0 g/L to 15 g/L of at least one additional sugar. 
     
     
         8 . The liposomal rehydration salt formulation of  claim 1 , wherein said formulation further comprises Stevia at a concentration of about 0.1 g/L to 0.25 g/L. 
     
     
         9 . The liposomal rehydration salt formulation of  claim 1 , wherein said formulation further comprises natural flavours at a concentration of about 1 g/L to 3.5 g/L. 
     
     
         10 . A method of preventing severe dehydration and maintaining body electrolytes and fluids in a human, comprising orally administering a liposomal rehydration salt formulation comprising phospholipids at a concentration of about 1.0 g/L to 10.0 g/L, salts, water, and a percentage inclusion ratio of salts (salts retained within total salts/liposomes) of at least 50% and a sodium electrolyte of about 12 mEq/L to 90 mEq/L, wherein the formulation has an actual osmolarity lower than 130 based on the at least 50% encapsulation of the salts and the liposomes comprise a particle diameter ranging from 200 nm to 500 nm. 
     
     
         11 . The method according to  claim 10 , wherein the liposomal rehydration salt formulation is formulated for oral administration for use by humans that are pregnant or breast-feeding or engaged in one or more of sport exercises, outdoor activities, extreme weather activities, climbing and flying. 
     
     
         12 . The method according to  claim 10 , wherein the liposomal rehydration salt formulation is formulated for oral administration for use by patients having one or more of stomach ailments, skin burns, parenteral or enteral nutrition ailments, celiac disorders, diabetes, SGLT2 inhibitor treatment disorders, intestinal failure, Short Bowel Syndrome, Cycling Vomiting Syndrome, Gastroparesis, Postural Orthostatic Tachycardia Syndrome, Ulcerative Colitis, Colon Cancer, Dysphagia, Sjogren Syndrome, Crohn's disease, Lupus, Alzheimer's disease, Renal complications, HIV, Inflammatory Bowel Disease, an Ostomy, Microvillus Inclusion Disease, and Cystic Fibrosis. 
     
     
         13 . The method of  claim 10 , wherein said sodium electrolyte is from about 35 mEq/L to 55 mEq/L. 
     
     
         14 . The method of  claim 10 , wherein the liposomal rehydration salt formulation comprises a potassium electrolyte and administering about 15 mEq/L to 25 mEq/L of the potassium electrolyte. 
     
     
         15 . The method of  claim 10 , wherein the liposomal rehydration salt formulation comprises about 10 g/L to 17 g/L of glucose and 8.0 g/L to 15 g/L of at least one additional sugar. 
     
     
         16 . A method of rehydrating a human suffering from dehydration comprising orally administering a liposomal rehydration salt formulation comprising phospholipids at a concentration of about 1.0 g/L to 10.0 g/L, salts, water, and a percentage inclusion ratio of salts (salts retained within total salts/liposomes) of at least 50% and a sodium electrolyte of about 12 mEq/L to 90 mEq/L, wherein the formulation has an actual osmolarity lower than 130 based on the at least 50% encapsulation of the salts and the liposomes comprise a particle diameter ranging from 200 nm to 500 nm. 
     
     
         17 . The method according to  claim 16 , wherein the liposomal rehydration salt formulation is formulated for oral administration for use by humans that are pregnant or breast-feeding or engaged in one or more of sport exercises, outdoor activities, extreme weather activities, climbing and flying. 
     
     
         18 . The method according to  claim 16 , wherein the liposomal rehydration salt formulation is formulated for oral administration for use by patients having one or more of stomach ailments, skin burns, parenteral or enteral nutrition ailments, celiac disorders, diabetes, SGLT2 inhibitor treatment disorders, intestinal failure, Short Bowel Syndrome, Cycling Vomiting Syndrome, Gastroparesis, Postural Orthostatic Tachycardia Syndrome, Ulcerative Colitis, Colon Cancer, Dysphagia, Sjogren Syndrome, Crohn's disease, Lupus, Alzheimer's disease, Renal complications, HIV, Inflammatory Bowel Disease, an Ostomy, Microvillus Inclusion Disease, and Cystic Fibrosis. 
     
     
         19 . The method of  claim 16 , wherein said sodium electrolyte is from about 35 mEq/L to 55 mEq/L. 
     
     
         20 . The method of  claim 16 , wherein the liposomal rehydration salt formulation comprises a potassium electrolyte and administering about 15 mEq/L to 25 mEq/L of the potassium electrolyte. 
     
     
         21 . The method of  claim 16 , wherein the liposomal rehydration salt formulation comprises about 10 g/L to 17 g/L of glucose and 8.0 g/L to 15 g/L of at least one additional sugar.