Aqueous paediatric retinol formulations

A method of treating or preventing vitamin A deficiency or a vitamin A deficiency-associated disease, the method comprising administering an aqueous pharmaceutical composition to a subject in need thereof, wherein the composition comprises:

• retinol or a pharmaceutically acceptable ester thereof, wherein the pharmaceutically acceptable ester of retinol is selected from retinol acetate, retinol propionate, and retinol palmitate;
• one or more polyethylene glycol esters of hydroxystearic acid, wherein the one or more polyethylene glycol esters of hydroxystearic acid comprise macrogol-15-hydroxystearate;
• and
• one or more pharmaceutically acceptable excipients;
• wherein the composition has a pH in the range of about 5.5 to about 7.5;
• wherein the retinol or the pharmaceutically acceptable ester thereof and the one or more polyethylene glycol esters of hydroxystearic acid are present as micelles having a mean particle size of about 100 nm or less;
• wherein the composition has an osmolality of about 100 to about 600 mOsm/kg;
• wherein the composition is administered parenterally;
• and
• wherein the composition is a transparent aqueous solution and is free of polysorbate 80.