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Neonatal and pediatric oral drug delivery: Hopes and hurdles
Kwadwo Amanor Mfoafo1, Masoud Omidian2, Charise Dallazem Bertol3
1College of Pharmacy, Nova Southeastern University, Fort Lauderdale, FL, USA.
Insights
Pediatric and neonatal patients require specialized oral medications due to a lack of adult-approved formulations. Ongoing research and development are creating new dosage forms and administration devices to meet these critical needs.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Medicine
- Drug Delivery Systems
Background:
- Neonatal and pediatric populations have historically been underserved regarding oral dosage form development.
- Caregivers frequently rely on off-label use and dose adjustments of adult medications for pediatric patients.
- Limited clinical trials and perceived low profitability have hindered pharmaceutical industry investment in pediatric drug development.
Purpose of the Study:
- To address the unmet needs for oral dosage forms in neonatal and pediatric populations.
- To explore novel drug delivery technologies and strategies for pediatric medication administration.
- To review advancements in both dosage forms and administration devices for young patients.
Main Methods:
- Review of current research and development in pediatric oral dosage forms.
- Analysis of novel dosage forms such as multiparticulates, orodispersible tablets/films, and chewable tablets.
- Examination of innovative drug administration devices including nipple shields, pill swallowing cups, and solid dosage pens.
Main Results:
- Significant progress has been made in developing new pediatric and neonatal oral formulations.
- Several novel dosage forms and administration devices have been explored and some are commercially available.
- Collaborative efforts among regulatory bodies, industry, and academia are driving innovation.
Conclusions:
- Despite advancements, further improvements are needed in pediatric and neonatal oral drug formulations.
- Continued research into novel dosage forms and administration technologies is essential.
- A multidisciplinary approach is crucial for advancing pharmaceutical products tailored for pediatric and neonatal use.
Abstract:
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.
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