Pediatric Drug Formulations: A Review of Challenges and Progress

Abstract

Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

Residual volume in vials of antibiotics used in pediatrics

“…As the most consistent bedside care providers, nurses have an ideal position to improve antibiotic management through multidisciplinary collaboration, optimizing treatment, monitoring and administration, while improving pediatric patient safety and quality of care (11) . The lack of parenteral drugs in adequate presentation for pediatrics represents a worldwide problem, constituting one of the factors that most contributes to the reuse of these medicines and also to increased care costs (13)(14) . The waste of antibiotics evidenced by the existence of residual volume reinforces another worrying finding, which is the inadequate disposal of the vials containing residual volumes of medicines.…”

Deficiencies in Traditional Oral Dosage Forms and the Emergence of Controlled-Release Powder Manufacturing

“…et al, 2008;Engelen L. et al, 2005;Imai E. et al, 1995;Ivanovska V. et al, 2014;Lopez F.L. et al, 2015;Matsui D., 2007;Milne C.P.…”

Medicines for children: Rationale and recent advances

“…Moving to solid oral paediatric formulations (flexible solid oral dosage forms) appears to be the most sensible solution to address the above problems. Such alternative flexible solid oral dosage forms include multiparticulate formulations (minitablets, sprinkles and granules), orodispersible formulations (orodispersible minitablets, disintegrating tablets, oral strips, buccal wafers, medicated lollipops) and dispersible tablets [40,41,42,43].…”