Milk as a medium for pediatric formulations: Experimental findings and regulatory aspects

Abstract

In the case of pediatric medicinal products the selection of an appropriate and palatable liquid dosage form can make the difference between treatment success and failure. Since the recent adoption of Pediatric Regulations in the U.S. and E.U., there is a greater demand for age-appropriate medicines for children. Extended research on the use of milk on drug administration in pediatric population has shown the multiple benefits of its use. Milk exhibits great solubilizing, gastroprotective and taste masking properties, which are very important characteristics in the case of insoluble, irritating and bitter-tasting active compounds. Milk-based formulations rely on a novel, simple and user-friendly approach for the delivery of ionized and unionized lipophilic drugs. In parallel they can provide critical nutritive elements and a wide range of biologically active peptides, very important elements especially for pediatric patients.