Drug Delivery Formulations and Devices Tailored for Paediatric and Older Patients

Abstract

“Drugs don’t work in patients who don’t take them,” C. Everett Coop, US Surgeon General (1985). This is a quote widely used in discussions of poor compliance with drug dosing regimens. It is particularly apt in relation to the non-adherence to medications by children and older persons, where ascertaining correct doses in the context of physiological differences according to age profiles is a key consideration in making acceptable formulations and devices for delivery. The concept of the average patient is a myth—there is no average child or older person, hence one formulation will not necessarily be safe and effective for all patients. When a new medicine is submitted to regulatory agencies for approval, clinical trials are generally carried out on patients over the age of 18 and under the age of 65. Trials in “average” patients aim to determine if a medicine will be safe and efficacious, but drugs are also required for patients that lie outside of the average, including paediatrics and older persons. Few drugs have undergone clinical trials in paediatric patients, so in the absence of specific formulations, physicians can opt to use such drugs off-label and/or in an unlicensed fashion (Chen et al., 2021). Off-label use is one when a licenced product is used outside the specifics of the license or label granted by the national regulator. For use in paediatrics and older persons, this might include the age range, the dose level, or its use in other clinical indications.