Paediatric Formulation: Design and Development

• Other Authors: Denora, Nunzio (Editor), Lopalco, Antonio (Editor)
• Format: Electronic Book Chapter
• Language: English
• Published: Basel, Switzerland MDPI - Multidisciplinary Digital Publishing Institute 2021
• Subjects: 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
• Online Access: DOAB: download the publication; DOAB: description of the publication

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.