INTRODUCTION
- Dissolution of oral dosage forms depends on the GI tract physiological conditions, and definition of the dissolution profile in conditions that reflect the in vivo GI environment can lead to accurate prediction of the in vivo performance (1).
- Whenever IVIVCs are achieved clinical studies assessing product bioavailability can be reduced in number and size and this aspect is of primary importance for paediatric patients (2). Successful predictions of the in vivo performance of drugs can be achieved based on biorelevant in vitro experiments (2).
- Biorelevant media reflective of age specific paediatric populations (i.e. new born and infant) have been developed (3).
Aim: to develop biorelevant dissolution methods that are representative of the paediatric gastrointestinal tract by applying experimental parameters based on physiological relevant parameters in order to assess the possible effects on dissolution/release proprieties of oral formulations for paediatric patients.
AGE RELATED BIORELEVANT DISSOLUTION TESTING FOR PAEDIATRIC FORMULATIONS
A podium presentation given by Giovanna Mencarelli at the 8th EuPFI meeting in Portugal on 21st / 22nd September, 2016