Paediatric formulations : pharmaceutical development and clinical evaluation

Drug development for children has long been a neglected area compared to adult drug development. There are many ‘older’ medicines that have an important place in the treatment of children, but often no suitable dosage form is available. There is a great need for well-studied, child-friendly, oral drugs, which preferably have a large dose flexibility. In collaboration with the Laboratory of Dutch Pharmacists (LNA), we developed two liquid formulations, taking into account the limited amount of excipients that can be safely used, and specific aspects such as taste (acceptance). Amlodipine and lorazepam were chosen as model compounds for water-soluble and non-water-soluble drugs. Subsequently the formulations were studied in adult volunteers and in paediatric patients, in which pharmacokinetics (PK), pharmacodynamics (PD), side effects and acceptance were investigated. In recent years, the importance of suitable dosage forms for children has been increasingly recognized. Pharmacy preparations play an important role here because of the lack of commercial products. Optimization and standardization of these preparations is necessary to guarantee good quality.