Navigating the Complexities of Pediatric Formulation Development and Challenges

Abstract

The formulation of pediatric dosage forms continues to be a great challenge due to significant differences in profiles of children and adults in terms of physiology, anatomy, and development. Buccal drug delivery systems have been developed as an alternative to oral drug delivery when oral dosage forms are not suitable and have several benefits to be noted, including better patient compliance, ease of administration, avoidance of first-pass metabolism, and better bioavailability. However, excipients frequently used in adults’ formulations are not suitable in children and can present potential safety and efficacy issues. Hence, the physiology of the pediatric group, as well as the suitability of excipients, must be carefully considered in the successful development of pediatric buccal dosage forms. Going forward, formulation strategies should be directed at the identification and evaluation of safe pediatric excipients, the incorporation of novel drug delivery technologies for the precise and individual delivery of drugs, and the enhanced cooperation between regulatory agencies, researchers, and the pharmaceutical industry. Such efforts are necessary to fill in existing therapeutic voids to enhance health care in children.