Metolazone emulsion formulation

A parenteral metolazone oil-in-water emulsion formulation, comprising:

• a) 0.1-10 mg/mL of metolazone or a pharmaceutically acceptable salt thereof;
• b) 2-30% v/v of a lipid selected from the group consisting of soybean oil, safflower seed oil, olive oil, cottonseed oil, sunflower oil, sesame oil, peanut oil, corn oil, medium chain triglycerides, triacetin, propylene glycol diesters, monoglycerides, and a mixture of two or more thereof;
• c) 0.1-2% w/v of an emulsifier selected from the group consisting of egg yolk phospholipids, soybean phospholipids, synthetic phosphatidyl cholines, purified phosphatidyl cholines and hydrogenated phosphatidyl choline, and mixtures of two or more thereof;
• d) 1-4% w/v of a tonicity modifier selected from the group consisting of sodium chloride, sodium acetate, potassium chloride, mannitol, sucrose, lactose, fructose, maltose, dextrose, dextrose anhydrous, and glycerin;
• and,
• e) 0.05-5% v/v of a co-emulsifier selected from the group consisting of poloxamers, polyoxyethylene stearates, sorbitan fatty acid esters, polysorbates, tocopherol PEG succinate, cholic acid, deoxycholic acid, oleic acid, and pharmaceutically acceptable salts thereof;
• wherein:
• benzyl alcohol is excluded,
• the polydispersity index of the formulation is less than 0.2 measured on a dispersion of the formulation in 10 mM NaCl.