CHAPTER 10: Paediatric Pharmaceutics—The Science of Formulating Medicines for Children

Paediatrics (also spelled pediatrics) deals with the medical care of neonates, infants, children, and adolescents, from birth up to 18 years of age. Child health is key to overall human life expectancy, as paediatric diseases may have a lifelong effect on quality of life. On a global scale nearly 5.8 million children under the age of five died in 2015, representing a 52% decline in the number of under-five deaths since 1990. Neonatal deaths fell at a slower pace since 1990, decreasing 42% to 2.6 million; stillbirths declined 47% to 2.1 million. Although life expectancy has improved around the world between 1990 and 2015, it still remains the case that people in more developed countries can look forward to longer and healthier lives than people in less developed countries. One of the factors driving the increases in life expectancy at birth is better health outcomes for young children, implying urgent need for medicines that keep children healthy. Children have the right to access medicines that are appropriate to their unique needs and to have adequate assurance of their quality, safety and efficacy. This has been widely acknowledged on a worldwide platform and prompted global initiatives and legislative changes that have transformed this once niche area into an integral part of the drug development process. This chapter discusses the specific needs of children, how the implementation of paediatric regulations has influenced/promoted the research into this previously neglected population and key attributes to consider during the designing and development of paediatric dosage forms to provide adequate paediatric therapies.