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The development of paediatric medicines can be challenging since this is a different patient population with specific needs. A medicine designed for use in paediatric patients must consider the following aspects: patient population variability; the need for dose flexibility; route of administration; patient compliance; excipient tolerability. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Globally, about 75% of drugs do not carry regulatory approval for use in children; worldwide, many medications prescribed for the treatment of paediatric diseases are used off-label, and less than 20% of package inserts have sufficient information for treating children. This book provides an update on both state-of-the-art methodology and operational challenges in paediatric formulation design and development. It aims at re-evaluating what is needed for more progress in the design and development of age-appropriate treatments for paediatric diseases, focusing on: formulation development; drug delivery design; efficacy, safety, and tolerability of drugs and excipients.

Medicine --- dasatinib --- Duchenne muscular dystrophy --- cyclodextrin inclusion complex --- phase solubility studies --- paediatric age --- liquid formulation --- tumorspheres --- retinoblastoma --- topotecan --- penetration --- confocal microscopy --- poorly water soluble drug --- solubility enhancement --- grinding --- spray congealing --- neglected tropical diseases --- polymorph --- Norvir® --- ritonavir --- poorly soluble compound --- pediatric --- palatability assessment --- bioavailability --- flavor profile --- Interleukin-1 --- anakinra --- canakinumab --- innovative biotechnologies --- autoinflammatory disease --- Kawasaki disease --- systemic juvenile idiopathic arthritis --- personalized medicine --- child --- pediatrics --- neonates --- formulation --- product development --- formulation development --- oral --- parenteral --- topical --- inhaled --- intra nasal --- biopharmaceutics --- administration --- excipient --- NICU --- device --- medication error --- dosage form --- modified release --- drug delivery --- paediatric formulation development --- paediatric dosage forms --- chronic myeloid leukemia --- tyrosine kinase inhibitors --- pediatric age --- imatinib --- nilotinb --- ponatinib --- Orodispersible formulation --- pyrazinamide --- pediatric drug delivery --- tuberculosis --- design of experiments --- children --- edible films --- development --- design --- paediatric --- age-related --- palatable --- taste-masking --- acceptable --- dasatinib --- Duchenne muscular dystrophy --- cyclodextrin inclusion complex --- phase solubility studies --- paediatric age --- liquid formulation --- tumorspheres --- retinoblastoma --- topotecan --- penetration --- confocal microscopy --- poorly water soluble drug --- solubility enhancement --- grinding --- spray congealing --- neglected tropical diseases --- polymorph --- Norvir® --- ritonavir --- poorly soluble compound --- pediatric --- palatability assessment --- bioavailability --- flavor profile --- Interleukin-1 --- anakinra --- canakinumab --- innovative biotechnologies --- autoinflammatory disease --- Kawasaki disease --- systemic juvenile idiopathic arthritis --- personalized medicine --- child --- pediatrics --- neonates --- formulation --- product development --- formulation development --- oral --- parenteral --- topical --- inhaled --- intra nasal --- biopharmaceutics --- administration --- excipient --- NICU --- device --- medication error --- dosage form --- modified release --- drug delivery --- paediatric formulation development --- paediatric dosage forms --- chronic myeloid leukemia --- tyrosine kinase inhibitors --- pediatric age --- imatinib --- nilotinb --- ponatinib --- Orodispersible formulation --- pyrazinamide --- pediatric drug delivery --- tuberculosis --- design of experiments --- children --- edible films --- development --- design --- paediatric --- age-related --- palatable --- taste-masking --- acceptable