Drug Formulations: Standards and Novel Strategies for Drug Administration in Pediatrics

Abstract

Child‐appropriate drug formulations are a prerequisite of successful drug therapy in children. Efficacy and safety must be given for the active pharmaceutical ingredient, but safety also for the used excipients, components of primary packaging materials, and devices. We are presently experiencing exciting times for pediatric drug development, stimulated by previous governmental incentives in both the European Union and the United States. The most important advances in pediatric drug formulation development are reviewed and evaluated in this article. Scientific publications and recent industry strategies indicate a clear shift from liquid dosage forms to novel solid dosage forms. Solid formulations are usually composed from excipients generally regarded as safe, whereas many liquid formulations contain excipients such as preservatives, antioxidants, or taste‐masking agents that raise concerns. Further, some recent clinical studies on swallowability, acceptability, and preference indicate superiority for small‐sized tablets, so‐called mini‐tablets, over conventional liquids. In general, multiparticulate solid dosage forms could partly replace the liquids and provide more stable and cheaper alternatives to existing drug products or new developments. Dispersible solid drug dosage forms like orodispersible tablets, mini‐tablets and films are even better opportunities for efficient and safe use in pediatrics. Novel measuring and administration devices may facilitate the handling and drug administration of these modern drug dosage forms. Combination products (drug‐device combinations) can easily be linked with new e‐health technologies in near future to further improve pediatric drug therapy.

Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations

“…However, limitations with high doses remain and an effective counting device is crucial to prevent the risk of incorrect dosing if multiple mini-tablets are required per dose [ 4 ]. Nevertheless, shifting from liquids to solid forms should be relevant regarding stability, cost, and global availability of medicines [ 33 , 34 ].…”

Global sales of oral antibiotics formulated for children

“…Future efforts should focus on developing improved solid forms of antibiotics suitable for use in children and encouraging their widespread use. 35 …”

A Pediatrics Utilization Study in The Netherlands to Identify Active Pharmaceutical Ingredients Suitable for Inkjet Printing on Orodispersible Films

“…The acceptability of formulations for pediatrics have been under investigation since the development and establishment of the European Pediatric Regulation [6]. The taste is one of the key factors for the acceptance of a dosage form [29,30]. ODFs have been studied in children, and they positively respond to this dosage form [9].…”