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.

Keywords: acceptability studies; drug delivery devices; mini-tablets; multiparticulates; orodispersible formulations; pediatric drug formulations.