Method for preparing a liposomal rehydration salt formulation

A method for preparing a liposomal rehydration salt formulation, comprising:

• a. preparing an aqueous phase or buffer comprising sodium chloride, potassium citrate, and sodium citrate dissolved in distilled water, wherein the aqueous phase or buffer comprises sodium chloride at a concentration of about 0.35 grams/liter (g/l) to 1.17 g/l;
• potassium citrate at a concentration of about 0.31 g/l to 2.14 g/l;
• sodium citrate at a concentration of about 0.52 g/l to 1.29 g/l;
• and distilled water;
• b. separately preparing an alcohol phase by dissolving a phospholipid in ethanol at a concentration of about 25.0 g/l to 60 g/l and an antioxidant at a concentration of 2.0 g/l to 5.0 g/l;
• c. inducing formation of liposomes by injecting the alcohol phase into the aqueous phase at room temperature, while mixing to form a liposomal dispersion;
• d. removing up to 90% volume of the previous liposomal dispersion and aqueous phase solutes that are not trapped in the liposomes using tangential flow ultrafiltration;
• and
• e. filtering the solution obtained in step d using tangential flow ultrafiltration while feeding the solution at a speed equal to the permeation speed with an aqueous saline solution comprising a sodium concentration of 0.28 g/l to 1.15 g/l;
• a potassium concentration of 0.12 g/l to 0.55 g/l;
• a chloride concentration of 0.18 g/l to 1.42 g/l;
• a citrate concentration of 0.58 g/l to 1.92 g/l;
• and a carbohydrate, and maintaining the liposomes and the contents therein and forming the liposomal rehydration salt formulation comprising phospholipids, salts, and wherein the salts comprise sodium chloride at a concentration of about 0.7 g/l to 2.8 g/l, potassium citrate at a concentration of about 0.8 g/l to 2.5 g/l, sodium citrate at a concentration of about 0.5 g/l to 2.9 g/l, an antioxidant at a concentration of about 2.0 g/l to 5.0 g/l, a carbohydrate, water, and a percentage inclusion ratio of salts (salts retained within total salts/liposomes) of at least 50% and wherein the formulation has an osmotic concentration lower than 190 mosm/l, and the liposomes comprising a particle diameter from about 225 nm to 450 nm.