The development of pediatric formulations showed to be an exceptionally complex process and
therefore the use of soft food as a vehicle may be the only option for delivering the drug to the
pediatric population. The aim of this study was to evaluate the effect of co-administration with peach
puree and vanilla pudding on the dissolution performance of oral powder of propranolol under
pediatric simulating conditions. Propranolol is a beta-blocker used to treat hypertension and infantile
hemangioma in pediatric patients. Significant effect on dissolution of propranolol from the oral
powder co-administrated with food was shown in comparison to the administration with water. Drug
dissolution was the highest when the oral powder was mixed with pudding (95.73%) and the lowest
when the powder was mixed with peach puree (67.15%), while administration with water resulted in
80,64% of drug released. These differences may be a result of different pH and composition of the
vehicles, which impact drug solubility and consequently drug dissolution performance. The
alterations in drug solubility and dissolution performance could also affect its bioavailability, which
could ultimately compromise the safety and therapeutic effect of the drug. Thus, peach puree and
pudding may not be acceptable vehicle for administration of propranolol in pediatric patients, which
emphasizes the importance of considering the effect of the co-administration with food on drug
performance during pediatric formulation development.
