Considerations for Paediatric Drug Development
Developing safe, effective, and age-appropriate drug formulations for children requires careful consideration of factors such as taste, dosage form, dosing accuracy, and palatability. What are the key challenges that need to be considered in paediatric drug development?
Palatability and Taste Masking
Children often exhibit strong aversions to unpleasant tastes, making it difficult for them to swallow or consume medication. It becomes key to employ various techniques such as flavouring, sweeteners, or encapsulation to mask the bitterness and enhance palatability.
Patient Demographic
Paediatric patients span a wide age range, from newborn to adolescents. It is essential to consider age-appropriate dosage forms that are easy to administer, safe, and suitable for the child’s developmental stage. Infants and young children may require liquid formulations, while older children may have the ability to swallow tablets or capsules.
Dosing Accuracy
Dosing accuracy is challenging due to variations in body weight, age, and developmental stages in children. Formulations must be check weighed throughout the manufacture process to ensure accuracy in dosage forms. There should be a focus on simplifying dosing calculations, providing appropriate measuring devices, and offering a range of dosing strengths to ensure accurate administration.
Shelf Life
Developing stable formulations that retain efficacy and palatability throughout their shelf life is challenging, especially for liquid dosage forms. Minitablets, powders, and granules are equally palatable for children as liquid formulations and provide an increased ability to be able to retain these key factors.
Pharmacokinetics and Pharmacodynamics
Paediatric patients have different physiological characteristics from adult patients which influence drug safety and pharmacokinetics. These effect drug metabolism, absorption and delivery to the body, and require careful consideration during the development process.
Regulatory Requirements
Regulatory agencies have specific guidelines for paediatric drug development to ensure patient safety and efficacy. While they are extremely important, compliance with these guidelines can be time-consuming and costly, which in turn results in a limited number of approved paediatric formulations. Familiarisation with the current guidelines from the early phases of development leads to a clearer and definite adherence and is crucial to improving access to safe and effective medications for children.
Find out more about our paediatric capabilities: Paediatrics – Almac
