Critical Reviews on Pediatric Dosage Form Developments and Medical Devices.

Abstract

The pediatric population is generally considered as "miniature adults," but they actually differ from adults due to their different body compositions and varied stages of organ development, which alter essential biopharmaceutical parameters. The physiological differences between the pediatric population and the adult population alter the essential kinetics and dynamics of the same drug administered at the same dose. For pediatric patients, the drug dose is generally calculated using different formulas based on age, body surface area, or weight, or is simply reduced to half of adult dose. This, however, is not the correct practice. New approaches have emerged for designing customized formulations and medical devices for the pediatric population. Examples of customized formulations are "mini-tablets" and "oro-dispersible films," which attempt to ease the administration of solid oral dosage forms. These specially designed medical devices have shown the ability to overcome many challenges in dose administration to children. One such medical device is the "oral solid dosage pen," which allows for dose adjustment by cutting a tablet-like drug carrier at a predefined height and offers flexibility and convenience for dose administration to the pediatric population. Other medical devices, such as the Nipple Shield Delivery System (NSDS) and Medibottle also aid in efficient drug delivery to pediatrics. This review summarizes the challenges in dosage form design and advances in suitable medical devices for better administration to the pediatric population to overcome accidents due to medical errors, incomplete absorption, and toxicity.