Neonatal and pediatric oral drug delivery: Hopes and hurdles.

The neonatal and pediatric populations have long been neglected concerning the development of oral dosage forms. For close to two decades, caregivers have had to adjust the doses of the off-label medicines and drugs for adults to suit the neonatal and pediatric needs. This is due to the lack of rules and regulations regarding neonates and pediatrics clinical trials while pharmaceutical industries see this as a non-lucrative approach. Despite such limitations, the administration of solid and liquid dosage forms to neonates and pediatrics necessitates the development of new technologies and even new strategies to meet the needs. Current approaches have not only focused on the development of suitable dosage forms but also the advancement of devices to enhance drug administration to pediatrics and neonates. Though current approaches have significantly added to the number of pediatric and neonatal oral dosage formulations on the market, there is still more room for improvement(s). While novel dosage forms including multiparticulates, orodispersible tablets/films, and chewable tablets have extensively been researched, some administration devices (e.g., nipple shield, pill swallowing cup, and solid dosage pen) have also been explored. Although a few of these products are in the market, the concerted efforts of regulation administrative bodies, pharmaceutical industry settings, and scientists in academia have been oriented to address all issues and advance the neonatal and pediatric-centric pharmaceutical products.